Fumitory

What is Fumitory?

The Austrian patient leaflet for Oddibil, a 250 mg fumitory extract tablet, lists bile duct stones as a use when an operation is not possible. The French Oddibil label lists gallstones as a contraindication. Same herb, same brand name, opposite instructions for the condition a buyer with pain under the right ribs most needs to get right. The Austrian leaflet (holder Sanofi-aventis GmbH, Vienna; text last approved June 2012) allows up to 6 tablets at once for acute biliary pain; the French label (holder Coopération Pharmaceutique Française) excludes "calculs biliaires et toute autre pathologie biliaire," and the European Medicines Agency's 2023 monograph advises against use in gallstones and any other biliary disease.

Fumaria officinalis L. is a scrambling annual weed of fields and waste ground, native to Europe, North Africa and western Asia and introduced elsewhere, including Australia. Older floras put it in its own family, Fumariaceae; current botany folds it into the poppy family, Papaveraceae, alongside Corydalis and greater celandine. The medicinal material is the dried flowering aerial part, Fumariae herba, which the European Pharmacopoeia (monograph 1869) requires to contain at least 0.40% total alkaloids expressed as protopine. Medieval Latin called it fumus terrae, "smoke of the earth," and the Greek name kapnos also means smoke; the usual explanation is the gray-green foliage and pale pink flowers.

Licensed products are sold in Austria, Germany, France and Spain, mostly as tablets or tea. In the United States it is a minor dietary supplement, mainly powdered-herb capsules and liquid extracts.

Common Names

Fumitory, common fumitory, earth smoke, drug fumitory, Fumariae herba, Herba Fumariae, Erdrauch (German), fumeterre (French), fumaria. "Fumewort" now usually means Corydalis. Several related species are also sold or studied as "fumitory": Fumaria parviflora (fine-leaved fumitory; shahtareh in Persian, pitpapra in India), F. indica and F. vaillantii. Research on those species is regularly cited as if it applied to F. officinalis.

Primary Active Compounds

Isoquinoline alkaloids, with protopine usually reported as the largest single one. A gas chromatography survey of five Fumaria species from Bulgaria, including F. officinalis, found 14 isoquinoline alkaloids, led by protopine, cryptopine, sinactine, parfumine, fumariline, fumarophycine and fumaritine (Vrancheva and colleagues, Zeitschrift für Naturforschung C, 2016). Alongside the alkaloids: flavonol glycosides (mainly quercetin glycosides), phenolic acids including chlorogenic and caffeic acid, and fumaric acid.

Key Note

Gallbladder and bile duct pain is the indication this herb was approved for, and it is also the situation in which the newest European assessment says not to use it, because a stone, an infection or a blocked duct can sit behind the same symptom (Sections 7 and 19).

What follows: the 1986 approval, the trials, the alkaloids, one hepatitis case and the toxicology gaps.

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Primary Functions & Benefits

The approval and its evidence base

Commission E assessed herbs from literature, clinical experience and manufacturers' submissions, without requiring placebo-controlled trials. For fumitory, the literature was a cluster of French, Austrian and German reports from 1966 to 1979, many built around a spray-dried water extract called "Fumaria nebulisate." The European Medicines Agency's herbal committee (HMPC) reread them for its 2023 assessment (EMA/HMPC/367013/2021) and summarized them this way:

• Heully and colleagues (Annales Médicales de Nancy, 1969) gave 20 people 500 mg of water extract delivered into the duodenum. The HMPC described the results as "very variable and not comparable."

• Zawodsky (Wiener Medizinische Wochenschrift, 1974) treated 64 patients with 250 mg tablets of a 4 to 6:1 water extract, three a day for 21 days, and reported no adverse effects.

• Hunold (Zeitschrift für Allgemeinmedizin, 1975) reported on 85 patients with organic and functional gallbladder and bile duct disorders. The HMPC found no usable dosing detail.

• Kopp (Therapiewoche, 1979) is described by the HMPC as a double-blind, placebo-controlled study in 30 patients given three 250 mg nebulisate tablets a day for 28 days, with results summarized only as positive.

• Müscher (Ärztliche Praxis, 1971) described a group treated for one year; the assessment gives 178 patients in one place and 176 in another.

Across these reports the HMPC counted 710 patients treated with water extracts for 10 days to 21 weeks, mostly at 1,500 mg a day. Its verdict: the studies are "short and old ones," and efficacy is "only plausible but not proven by clinical data."

The 1979 Oddibil study, reported two ways

The English abstract indexed in PubMed for Zacharewicz and colleagues (Wiener Medizinische Wochenschrift, 1979) describes 85 patients with gallbladder disease given the Fumaria preparation Oddibil: success in 70% overall and in more than 80% of those with biliary dyskinesia, the best result after 10 days on average, no side effects, and a statistically significant difference from placebo. The HMPC assessment describes the same paper as an open study of 45 patients, 27 of them with biliary dyskinesia, given three 250 mg tablets a day for 16 days, with 80% improved. Both accounts cannot be right, and I could not obtain the German full text to settle it. Either way, it is a single 1979 report that the EU's herbal committee did not accept as proof.

The irritable bowel trial

Brinkhaus and colleagues (Scandinavian Journal of Gastroenterology, 2005) ran the one modern, fully reported, placebo-controlled trial of Fumaria officinalis alone that I found. Patients took fumitory, 1,500 mg of powdered herb per day according to the HMPC's description, in three doses for 18 weeks. The comparator herb was Curcuma xanthorrhiza (Javanese turmeric, a different species from kitchen turmeric) at 60 mg a day. The intention-to-treat population was 106 people, mean age 48, 63% women.

• Pain on a 0 to 50 mm visual scale: down 0.9 mm on fumitory, down 0.3 mm on placebo, up 2.0 mm on Curcuma (p = 0.81 across groups).

• Distension: up 0.3 mm on fumitory, down 2.1 mm on placebo, down 1.4 mm on Curcuma (p = 0.48).

• Global symptom change and IBS-related psychological stress: no significant difference among the three groups.

The authors concluded that neither herb "showed any therapeutic benefit over placebo" and that their use for IBS "cannot be recommended." A 2008 systematic review in the World Journal of Gastroenterology (Shi and colleagues) rated this trial as one of only 4 good-quality studies among 22 herbal IBS trials, and calculated a relative risk of global improvement of 1.13 for fumitory versus placebo, with a 95% confidence interval of 0.74 to 1.72, which spans no effect.

Secondary references do not always carry the null result forward. The professional fumitory monograph on Drugs.com summarizes this trial as finding less IBS-associated pain with Fumaria; the primary abstract reports a 0.6 mm difference from placebo on a 50 mm scale, with p = 0.81.

Trials of other Fumaria species

• Hot flashes: Khosropanah and colleagues (Journal of Integrative and Complementary Medicine, 2022) randomized 96 breast cancer survivors on hormone deprivation therapy to 5 mL three times a day of a Persian syrup of chicory and fumitory extracts (the study keywords name Fumaria parviflora) or placebo syrup for 4 weeks. Hot flash frequency and severity fell 57% on the syrup and 10% on placebo, but those analyses covered 66 people, not the 96 randomized. It tested a two-herb syrup, a different Fumaria species, and one month of treatment.

• Hand eczema: a 4% F. parviflora cream was tested against vehicle in 44 patients (Jowkar and colleagues, 2011). Skin conditions are covered in another issue.

Laboratory claims

Most of the "liver-protective" literature uses other species, chiefly F. indica and F. parviflora, in rats given a chemical liver poison. One F. officinalis paper in that genre, on permethrin liver injury in rats (Aoiadni and colleagues, Journal of Biochemical and Molecular Toxicology, 2022), was retracted in 2025 for unattributed reuse of data and images. Antioxidant, antidiabetic and antimicrobial results in cells and rodents have no F. officinalis human trials behind them.

Forms & Standardization

Cut herb and tea

The pharmacopoeial material is the dried flowering herb with at least 0.40% total alkaloids, expressed as protopine, on the dried drug (European Pharmacopoeia monograph 1869; that figure is a minimum, not a typical value). The HMPC assessment cites literature values of 0.3 to 1% alkaloids calculated as protopine, plus a 0.13% figure that it does not identify as total alkaloids or protopine alone. The 2023 EU monograph gives a tea of 2 g in 250 mL of boiling water (or 1.6 g in 150 mL), 4.8 to 6.4 g a day in 3 or 4 doses, before meals. Germany has authorized a fumitory tea since 1986. At the pharmacopoeial floor, 6 g of herb carries at least 24 mg of total alkaloids; I found no measurement of how much of that an infusion extracts.

What "expressed as protopine" does and does not mean

The pharmacopoeial assay measures all the alkaloids together and reports them in protopine units. It is not a protopine content. When protopine itself was measured by HPLC in five Bulgarian Fumaria species, it ran from 210.6 micrograms per gram (F. schrammii) to 334.5 micrograms per gram (F. rostellata), that is 0.021 to 0.033% of dry weight, less than a tenth of the 0.40% total-alkaloid floor (Vrancheva and colleagues, 2016). The mix also varies. One extract study cited by the HMPC found protopine to be 34.48% of a total alkaloid extract; an LC-MS/MS profile of an F. officinalis alkaloid extract (Yahiaoui and colleagues, Journal of Computer-Aided Molecular Design, 2025) detected 17 isoquinoline alkaloids and reported jatrorrhizine at 29.29% and protopine at 8%. "Protopine is the main alkaloid" is a frequent statement, not a constant.

Dry aqueous extracts (the European tablet form)

• Oddibil, Austria: 250 mg of dry water extract per film-coated tablet, drug-to-extract ratio 5:1 (so about 1.25 g of herb per tablet), with at least 2.5 mg of Fumaria alkaloids calculated as protopine, which is 1% of the extract. Nonprescription, ATC code A05AX (other bile therapy).

• Oddibil, France: 220 mg of dry water extract of the flowering aerial parts per coated tablet, ratio 3.5 to 4.5:1, with lactose, sucrose and peanut oil among the excipients. Registered as a traditional herbal medicine "to increase bile flow" and relieve indigestion.

• Other authorized extracts listed by the HMPC: a French 250 mg coated tablet (ratio 3.5 to 4.5:1) on the market since 1963, a French 200 mg capsule since 1987, and an Austrian 250 mg tablet since 1992 standardized to at least 1.5% alkaloids as protopine.

• A combination tablet authorized in Austria since 1988 pairs 275.1 mg of fumitory dry extract with 83.1 mg of milk thistle fruit extract.

The EU monograph allows dry water extracts of ratio 3.5 to 5:1 at 250 mg per dose, up to 1,000 mg a day.

Liquid preparations

The monograph covers a liquid extract (1:1 in 25% ethanol), a tincture (1:5 in 45% ethanol) and juice pressed from the fresh plant. Both alcoholic forms carry ethanol labeling, and both are restricted to adults.

Powdered herb in capsules

France has authorized a 220 mg powdered-herb dose (at most 1,100 mg a day) since 1982 and Spain 160 mg capsules since 1993. The EU ceiling for powdered herb is 1,100 mg a day. In the US, Botanic Choice Fumitory Herb (distributed by Indiana Botanic Gardens) packs 340 mg of aerial-part powder per capsule, labeled "Skin Support," with directions of 2 capsules three times daily. That is 2,040 mg a day, about 1.9 times the EU ceiling for the same form, with no alkaloid content on the label (per the label image in the NIH Dietary Supplement Label Database).

Which form the trials used

The 2005 IBS trial used 1,500 mg of powdered herb a day. The 1970s biliary studies used a spray-dried 4 to 6:1 water extract, typically three 250 mg tablets a day. No trial I found used a US product.

Not fumitory: fumaric acid ester drugs

Dimethyl fumarate (Tecfidera, for multiple sclerosis) and the German psoriasis drug Fumaderm are manufactured fumaric acid esters. Some consumer references discuss them on the fumitory page. Their trial results tell you nothing about the herb.

Food Sources

Fumitory is not a food. Exposure comes through four routes.

• European herbal medicines: the tea, tablets and capsules described in Section 4, sold in Austria, Germany, France and Spain, plus a Polish combination of Cape aloe (Aloe ferox) and fumitory with boldine that the HMPC lists as marketed since 2000 for digestive disturbances.

• US dietary supplements: powdered-herb capsules and liquid extracts, usually single-ingredient, sometimes in "liver" or "skin" blends.

• Unani, Ayurvedic and Persian products made from related species, mainly Fumaria parviflora and F. indica (shahtareh, shahtra, pitpapra), sold as syrups, creams and powders.

• Protopine from other plants. The same alkaloid occurs in greater celandine, Corydalis and Macleaya cordata, the source of feed additives used in livestock. A residue study in laying hens fed a Chinese veterinary alkaloid powder (Bopp Total Alkali Powder) found protopine in eggs at a peak of 2.8 micrograms per kilogram on day 7 at the 400 mg/kg dose level, undetectable 5 days after withdrawal, and 16.72 micrograms per kilogram one day after stopping a 2,000 mg/kg level (Liu and colleagues, Poultry Science, 2025). A 60 g egg at the 2.8 microgram figure holds about 0.17 micrograms of protopine. Six grams of fumitory at the Bulgarian HPLC values (0.021 to 0.033%) holds about 1.3 to 2.0 mg, roughly 7,500 to 12,000 times more.

Dietary intake of fumitory itself is effectively zero.

Who Should Take Fumitory

No group has been shown in a placebo-controlled trial to benefit from Fumaria officinalis. The one modern trial, in irritable bowel syndrome, was null on every outcome it reported. The biliary indication rests on reports from 1966 to 1979 that the HMPC would not accept as proof, and recurring pain from the gallbladder or bile ducts needs an ultrasound and liver tests, not a bitter.

What remains is the narrow use the EU kept in 2023: an adult, or an adolescent drinking the tea, with occasional fullness, slow digestion or flatulence, no gallbladder or liver disease, and no warning signs (Section 7), who wants a traditional preparation and accepts that the support is long use rather than trial evidence. The monograph's own limit applies: if symptoms persist beyond 2 weeks or get worse, stop and see a doctor.

US fumitory sold for "skin support" has no F. officinalis human trial behind it.

Who Should AVOID or Use Caution

Contraindications

• Gallstones, bile duct stones, bile duct obstruction, cholangitis or any other biliary disease, known or suspected. The 2023 EU monograph says that "due to possible stimulation on bile secretion" fumitory is not recommended in these conditions, and the French Oddibil label contraindicates them outright. The Austrian Oddibil leaflet contraindicates obstruction but lists bile duct stones as an indication when surgery is not possible; that is a decision for the physician managing the stone, not a reason for self-treatment.

• Liver disease of any kind. The EU monograph lists liver disease, the French label lists hepatitis, and the Austrian label lists severe hepatocellular insufficiency and acute inflammation of the liver or gallbladder. A case of acute hepatitis attributed to fumitory-containing products is described in Section 12.

• Pregnancy and breastfeeding. No human data and no reproductive or developmental toxicity studies exist (HMPC, 2023). The Austrian label forbids use in both.

• Children under 12 for the tea, and anyone under 18 for every other form, because safety has not been established.

• Allergy to peanut or soy, for the French Oddibil tablet, which contains peanut oil. Anyone avoiding alcohol should avoid the tincture (45% ethanol) and liquid extract (25% ethanol).

Use Caution

• Glaucoma. The HMPC assessment records that raised intraocular pressure and edema "have been reported as possible effects," citing Anderson and Phillipson (1986). I found no case report behind that line and no measurement of eye pressure in anyone taking fumitory. The signal is thin, but an unnoticed pressure rise does lasting damage, so people with glaucoma or ocular hypertension should skip this herb.

• Seizure disorders. Purified protopine at lethal oral doses in mice caused poisoning signs the authors described as matching those of the crude extract, which included tremor and spastic muscle contractions (Hu and colleagues, Frontiers in Veterinary Science, 2021), and a GC-MS survey of ten Fumaria taxa found bicuculline, a laboratory convulsant that blocks GABA-A receptors, among the genus's alkaloids (Suau and colleagues, Phytochemical Analysis, 2002; the abstract does not say which species carried it). No human seizure has been reported. The signal is animal and theoretical.

• Kidney disease. Rabbits given 400 mg per kilogram of a hydroalcoholic F. officinalis extract for 28 days had a significant rise in serum creatinine (Khoshvaghti and colleagues, as summarized by the HMPC), and a single 250 mg per kilogram dose increased urine volume and sodium and potassium excretion in rats (Păltinean and colleagues, 2017, as summarized by the HMPC).

• Low blood pressure or several blood pressure drugs. Fumitory was among the Bulgarian plants Petkov studied for blood-pressure-lowering action in animals (American Journal of Chinese Medicine, 1979), and protopine relaxed rat aortic strips at 30 to 100 micromolar (Li and colleagues, 2005).

• Anyone taking sedatives, antidepressants, antiplatelet drugs or anticoagulants (Section 17).

Critical Safety Point

Pain under the right ribs that lasts more than a few hours, or comes with fever, chills, yellowing of the skin or eyes, dark urine, pale stools or vomiting, can mean a stone stuck in a duct, an infected gallbladder, cholangitis or pancreatitis. Those are emergencies. A product sold to relax the bile ducts can delay the diagnosis, and the current EU monograph tells users with gallstones or biliary disease not to take this one. Get the scan before you get the bottle.

Recommended Dosages

No dose of fumitory has been shown in a placebo-controlled trial to relieve any symptom. The figures below are the posology the European Union's 2023 monograph attaches to its traditional-use registration, for occasional fullness, slow digestion and flatulence in adults (tea also for adolescents), taken by mouth before meals. They describe what a regulator accepts on long use, not a demonstrated effective dose. Historical, acute-pain and animal figures are in Section 19.

Tea (cut herb)

2 g in 250 mL of boiling water, or 1.6 g in 150 mL, as a single dose; 4.8 to 6.4 g a day split into 3 or 4 doses.

Powdered herb

220 mg per dose, no more than 1,100 mg a day.

Dry aqueous extract (3.5 to 5:1)

250 mg per dose, no more than 1,000 mg a day. The French Oddibil tablet (220 mg) is labeled at 4 tablets a day: one before each main meal and one at bedtime.

Liquid extract (1:1, 25% ethanol)

0.5 to 2 mL per dose, 2 to 4 mL a day. Adults only.

Tincture (1:5, 45% ethanol)

0.5 to 1 mL per dose, 1 to 4 mL a day. Adults only.

Fresh plant juice

3.5 to 4 g a day.

US powdered-herb capsules

The Botanic Choice label's 2,040 mg a day is almost double the EU's 1,100 mg ceiling for the same form. If you use a US capsule product, the EU figure is the more conservative reference, and neither number has trial support.

Duration

Two weeks, then stop and see a doctor if symptoms continue (EU monograph). The longest controlled exposure on record is the 18-week IBS trial. The one published liver injury case followed about 7 months of use. There are no long-term safety studies.

Timing & Administration

The EU monograph and the French Oddibil label direct fumitory before meals, consistent with its traditional role as a bitter taken ahead of food; the French tablet adds a bedtime dose. The Austrian leaflet says three times a day without tying doses to meals. No human study compared timings for any outcome.

The tea is very bitter. A 4 mL daily dose of the 45% tincture delivers about 1.4 g of ethanol, which matters for anyone in recovery or taking disulfiram or metronidazole.

Take fumitory alone rather than stacked with other "liver flush" or bile-stimulating herbs; combination products are where the published liver injury case came from (Section 12).

Timeline of Effects

Onset

The 1979 Oddibil abstract reports the best result "after 10 days on average." That is the only onset figure in the biliary literature, from a single uncontrolled or poorly controlled report. Treatment courses in the HMPC's tally of 710 patients ran from 10 days to 21 weeks.

What the controlled trial showed over time

In the IBS trial, 18 weeks of 1,500 mg a day produced no measurable difference from placebo at the end of treatment. Eighteen weeks is a long and fair test, and for IBS symptoms the question has been asked and answered.

A fair trial, and when to stop

For the traditional indication the EU monograph sets the clock: if fullness or flatulence has not improved within 2 weeks, or gets worse at any point, stop and get assessed. No trial supplies an expected onset, and nothing supports continuing past that limit.

Absorption

No pharmacokinetic study of any fumitory preparation exists (HMPC, 2023). The only human data are qualitative: Racing Analytical Services in Melbourne identified protopine metabolites in the urine of horses and one human volunteer given F. officinalis or purified protopine, and found metabolism "qualitatively similar in the horse and human" (Wynne and colleagues, Journal of Chromatography B, 2004). No blood level, half-life or time to peak has been published.

Benefits of Taking Fumitory

No benefit of Fumaria officinalis has been demonstrated in a placebo-controlled trial. The one such trial with a full report found nothing in irritable bowel syndrome after 18 weeks. The biliary benefit rests on reports from the 1960s and 1970s claiming improvement in roughly 70 to 80% of patients, without the controls, blinding detail or dosing records a modern reviewer can verify. The EU keeps fumitory on the market as a traditional herbal medicine for fullness, slow digestion and flatulence, which is an acknowledgment of long use, not a finding of efficacy. The one positive randomized result in the wider genus, for hot flashes, came from a two-herb syrup made with Fumaria parviflora.

Potential Negatives & Side Effects

In the clinical reports

The 1970s biliary studies reported no adverse effects, and the ESCOP monograph (2018) summarizes human studies as showing very good tolerability with only minor adverse events. In the IBS trial, bloating moved slightly in the wrong direction on fumitory (up 0.3 mm, against a 2.1 mm improvement on placebo), a difference that was not statistically significant. The trial abstract does not report adverse event counts.

On the labels

The EU monograph and the French Oddibil label list no known undesirable effects. The Austrian Oddibil leaflet lists, as very rare (fewer than 1 in 10,000 users): dizziness, drowsiness, headache, nausea, stomach pain, diarrhea, constipation and hives.

Liver injury case

Bonnet, Mejdoubi, Sommet and Alric (Gastroentérologie Clinique et Biologique, 2007) reported acute hepatitis "probably induced" by herbal products containing fumitory and red vine leaf (Vitis vinifera tinctoria), in a 56-year-old woman who had taken them for about 7 months for high cholesterol. The HMPC's summary of the same letter describes a combination product that also contained dandelion, boldo, artichoke and horsetail, and the agency's own text is inconsistent about the co-ingredients. The letter has no abstract and I could not reach the full text, so I cannot report the liver test values or whether she recovered. It is one case, causality is "probable," and fumitory was never taken alone. It is also the only published human liver injury report I found for this herb, which is sold for liver complaints, where a drug-induced injury is easiest to miss.

Pharmacovigilance

The HMPC found no new safety issues in the EudraVigilance or VigiLyze databases through March 2022. For a herb this rarely used, silence in a reporting database says little.

Deficiency Symptoms

What fumitory addresses

There is no fumitory deficiency. Protopine, the other isoquinoline alkaloids and the herb's flavonoids have no required role in human metabolism, and someone who has never encountered the plant lacks nothing. The symptoms it is sold for, fullness, bloating and biliary pain, arise from gallstones, functional gut disorders, infection or diet, not from a shortage of any compound in this herb.

Bottom line

No blood or urine test measures "fumitory status," and none could. Compare iodine, where low intake causes a recognizable disease (goiter) and urinary iodine can document the shortfall in a population; nothing comparable exists here.

Toxicity Symptoms

At high intake

No human overdose of a fumitory product has been reported, and the HMPC found no single-dose (lethal dose) toxicity data for any fumitory preparation (2023 assessment). The toxicology that exists is fragmentary:

• Genotoxicity: in Edziri and colleagues' 2020 work, as summarized by the HMPC, no extract was genotoxic in a bacterial test, but a methanolic extract increased DNA damage in the comet assay at concentrations that were not toxic to the cells. Adequate genotoxicity testing has not been done, and carcinogenicity and reproductive toxicity have never been tested. Those gaps are why the HMPC declined to add fumitory to the EU list of herbal substances eligible for simplified registration.

• Repeated dosing in animals: rabbits given 200 or 400 mg per kilogram of a hydroalcoholic extract for 28 days had higher serum creatinine at the high dose, and lower hemoglobin and red and white cell counts at both doses (Khoshvaghti and colleagues, as summarized by the HMPC). A related species, F. indica, produced no deaths in mice at single oral doses up to 5 g per kilogram of a 50% ethanol extract and no blood, organ or tissue changes in rats at 100 and 400 mg per kilogram for 30 days (Singh and Kumar, Journal of Ethnopharmacology, 2011).

• Protopine itself: purified protopine (isolated from Macleaya cordata) had an oral lethal dose for half of mice (LD50) of 313.10 mg per kilogram, 95% confidence interval 245.26 to 397.17 (Hu and colleagues, 2021). Mice that died did so mostly within 10 to 30 minutes, with bleeding in the lungs, congestion and swelling of the heart, liver, kidney and brain, and damaged liver, kidney and hippocampal cells on microscopy. In a 2026 follow-up (Hu, Jia and Sheng, Neurotoxicology), female mice given 31.3 or 62.6 mg per kilogram a day by mouth for 7 days, one-tenth and one-fifth of that LD50, lost weight, developed gait abnormalities and showed injury in the cerebral cortex and hippocampus with a leaky blood-brain barrier. The authors state that this does not establish risk at human exposure levels.

To put the mouse figure on a human scale (as illustration, not as a safety margin): FDA's 2005 starting-dose guidance converts a mouse dose to a human equivalent by dividing by about 12.3, so 31.3 mg per kilogram in a mouse corresponds to about 2.5 mg per kilogram, roughly 180 mg for a 70 kg adult. Six grams of herb at 0.40 to 1% total alkaloids carries about 24 to 60 mg of alkaloids expressed as protopine. Actual protopine is a fraction of that, and nobody has measured how much reaches the blood from tea or tablets. The gap is real but not large, and it is the main reason not to exceed labeled amounts or run long courses.

Signs to reduce or stop

Yellowing of the eyes or skin, dark urine, pale stools, itching, loss of appetite or new pain under the right ribs: stop, and get a liver panel that includes bilirubin and alkaline phosphatase. Stop and seek same-day eye care for eye pain, blurred vision or halos around lights. Stop for tremor, muscle twitching, unusual drowsiness or confusion, dizziness or fainting, and for hives or swelling of the lips or face.

General note

Fumitory has no defined human toxic dose and no human poisoning case on record. The documented harm is one probable hepatitis case in a multi-herb regimen; the structural risk is a buyer treating a gallstone or a liver problem with a product the current EU monograph says not to use for either.

How Fumitory Works

The "amphocholeretic" claim

French and German authors of the 1960s and 1970s described fumitory as amphocholeretic: raising bile flow when it is low and damping it when it is high. The evidence was animal work. Boucard and Laubenheimer (1966) gave a water extract by mouth to animals and reported that it raised reduced bile flow and slowed artificially increased flow. Reynier and colleagues (1977) found that a water extract had no effect on normal bile secretion in rats but modified artificially increased or decreased flow. In the only human measurement, Heully's 20 subjects given 500 mg of water extract, the results were too variable to interpret. A property defined as pushing flow toward normal from either direction is hard to falsify.

Protopine and smooth muscle: mixed signals

The approval called fumitory mildly antispasmodic, but the laboratory record on its main alkaloid points both ways:

• A 1986 reference work cited by the HMPC (Van Hellemont) states that protopine has a contractile action on the sphincter of Oddi in animals, the muscle valve at the bottom of the bile duct. A contracting sphincter is the opposite of the effect the 1986 indication implies.

• In rat aortic strips, protopine at 30 and 100 micromolar blunted contraction caused by noradrenaline or high potassium, and at 50 and 100 micromolar it lowered the rise in intracellular calcium (Li and colleagues, Acta Physiologica Sinica, 2005), after earlier rabbit work had linked its vessel-relaxing effect to higher cyclic AMP and cyclic GMP.

• Protopine inhibits acetylcholinesterase, the enzyme that clears acetylcholine, with a half-maximal concentration of 16.1 micromolar in one assay (Kim and colleagues, Archives of Pharmacal Research, 2004, using protopine from Corydalis speciosa). By ordinary pharmacology, more acetylcholine at the gut wall favors contraction rather than relaxation. That is an inference, not a measured effect of fumitory in people.

Other protopine actions found in the laboratory

Protopine blocked the serotonin and noradrenaline transporters in cell assays and produced antidepressant-like behavior in mice at 3.75 to 30 mg per kilogram (Xu and colleagues, Neuropharmacology, 2006). It inhibited rabbit platelet aggregation triggered by several agonists in a screen of 41 isoquinoline alkaloids (Chia and colleagues, Planta Medica, 2006). In rats, 11 mg per kilogram twice daily for 2 days prolonged pentobarbital sleep and increased strychnine toxicity, signs that it slows the liver's drug-metabolizing enzymes (Janbaz, Saeed and Gilani, Pharmacological Research, 1998). The same rats were protected from acetaminophen and carbon tetrachloride liver injury, which the authors attributed to that enzyme inhibition.

Would any of this happen at a tea dose?

Unknown, because no one has measured protopine in human blood after fumitory. An upper bound shows the scale. Protopine weighs 353.4 g per mole, so 16.1 micromolar is about 5.7 mg per liter. If a full day's 24 to 60 mg of alkaloids were all protopine, all absorbed at once and spread through about 42 liters of body water, the concentration would be about 0.6 to 1.4 mg per liter, or 1.6 to 4 micromolar: below the acetylcholinesterase figure and well below the 30 micromolar aortic effect. Concentrations inside the gut wall, where the herb arrives first, could be higher, and mouse distribution work found protopine most concentrated in the small intestine. The systemic effects above are therefore most plausible at high doses and least plausible from a cup of tea.

Synergistic Supplements

I found no fumitory combination tested against its single ingredients. Combinations exist on the market: the Austrian fumitory and milk thistle tablet for biliary dyskinesia with liver involvement, the Polish product pairing it with Cape aloe and boldine, and the Persian chicory syrup from the hot flash trial.

What not to stack

• Other protopine sources, chiefly greater celandine (Chelidonium majus) and Corydalis products, which add alkaloid load with no data on the combination. Greater celandine carries its own liver injury record and should not be paired with another herb sold for the liver.

• Multi-herb "liver detox" or "gallbladder flush" blends. The only published liver injury case involving fumitory came from a multi-herb regimen.

• Stimulant laxative herbs (the Cape aloe in the Polish product is one), which add cramping and fluid loss to an herb already showing diuretic effects in rats.

Interactions & What NOT to Take

No human interaction study of fumitory exists: the EU monograph reports none, the French label states that none has been conducted. Everything below is extrapolated from protopine work in animals and cells, a reason for caution rather than a documented reaction.

Sedatives and other central nervous system depressants

Barbiturates, benzodiazepines (diazepam, alprazolam), zolpidem, opioids, sedating antihistamines and alcohol. Protopine prolonged pentobarbital sleep in rats (Janbaz and colleagues, 1998), and the tinctures add ethanol of their own.

Serotonergic and noradrenergic drugs

SSRIs (fluoxetine, sertraline, escitalopram), SNRIs (venlafaxine, duloxetine), tricyclics, tramadol, triptans used frequently, linezolid and MAO inhibitors. Protopine blocked serotonin and noradrenaline reuptake in cell assays (Xu and colleagues, 2006). No case of serotonin toxicity involving fumitory has been reported.

Antiplatelet drugs and anticoagulants

Aspirin, clopidogrel, prasugrel, ticagrelor, warfarin, apixaban, rivaroxaban, dabigatran. Protopine inhibited platelet aggregation in vitro (Chia and colleagues, 2006). There is no human bleeding report.

Cholinesterase inhibitors and anticholinergic drugs

Donepezil, rivastigmine and galantamine act on the same enzyme protopine inhibited in vitro; oxybutynin, tolterodine and other anticholinergics push the other way. The clinical relevance at herbal doses is unknown.

Blood pressure drugs

Additive lowering is possible given protopine's vessel-relaxing effect in rat tissue and the animal blood pressure work, especially with several agents together.

Drugs cleared by the liver with a narrow margin

The rat finding that protopine slows drug metabolism (Janbaz and colleagues, 1998) did not identify which enzymes. With no human data, people on phenytoin, carbamazepine, warfarin, cyclosporine, tacrolimus or similar drugs should not add fumitory.

Liver-loading drugs and supplements

Methotrexate, isoniazid, valproate, amiodarone, ketoconazole, high-dose acetaminophen, and herbal products with liver injury reports such as greater celandine, kava and green tea extract concentrates. The fumitory liver signal is a single probable case, but it arose in a regimen of several herbs.

Bile acid therapy

Ursodeoxycholic acid (ursodiol) and obeticholic acid treat gallstones and cholestatic liver disease. If you take either, your condition is already a reason the EU monograph advises against fumitory.

Quality, Testing & Adulteration

Wrong species

Fumaria parviflora, F. indica and F. vaillantii are the species of Persian, Unani and Indian practice and of most recent pharmacology papers. In Turkish folk medicine F. parviflora is used for liver and bile complaints and imported from Iran (Jameel and colleagues, Journal of Advanced Pharmaceutical Technology & Research, 2014). A label reading "Fumaria officinalis" is the only assurance most buyers get, and the published alkaloid profiles differ between species (Suau and colleagues, 2002; Vrancheva and colleagues, 2016).

Weak material

The pharmacopoeia sets a floor of 0.40% total alkaloids as protopine. The HMPC assessment cites literature values from 0.3% upward, below that floor at the low end. The US capsule label I examined states milligrams of herb, not alkaloid content.

A documented adulteration case

Karioti and colleagues at the University of Florence (Journal of Pharmaceutical and Biomedical Analysis, 2013) analyzed a commercial dietary supplement whose label declared hawthorn (Crataegus oxyacantha), olive (Olea europaea), shepherd's purse (Capsella bursa-pastoris) and fumitory, after patients taking it collapsed. The marker constituents of the declared plants, fumitory among them, were absent. The product instead contained Rauwolfia alkaloids, ajmaline, reserpine and yohimbine, with reserpine at a therapeutic dose, which the authors concluded was responsible for the collapses. A "natural" blood pressure blend carrying fumitory on its label was in fact delivering an old prescription antihypertensive.

Third-party programs

I found no USP monograph, USP or NSF verification program, or published ConsumerLab review specific to fumitory. In Europe the authorized medicines (Oddibil and the German tea) are made to pharmacopoeial and marketing-authorization specifications; US supplements are not held to the European monograph.

The paperwork worth asking for, and what you can check without a lab

A useful certificate of analysis for a fumitory product names Fumaria officinalis and the plant part (flowering aerial parts), gives an identity method (microscopy plus thin-layer or liquid chromatography against a reference sample), reports total alkaloids as protopine against the 0.40% floor, states any extract ratio and solvent, and covers lead, cadmium, mercury, arsenic, pesticide residues and microbial counts. For an "extract," it should say which one: a 5:1 water extract and a crude powder are very different doses. On your own, you can reject products that do not name the species, prefer a single-herb product to a "liver" or "blood pressure" blend, check that any directions stay within the EU daily maximum for that form, and treat a product that produces a sudden fall in blood pressure, sedation or a racing heart as suspect and report it to FDA MedWatch.

Special Considerations

Historical, prescription and animal doses, kept out of the dosing section on purpose

Commission E's 1986 figure was an average of 6 g of herb a day for spasmodic biliary complaints, an indication the EU no longer recognizes. The 1970s studies typically used three 250 mg tablets of a 4 to 6:1 water extract a day, with some patients reaching 2,000 mg a day. The Austrian Oddibil leaflet directs 1 to 2 tablets three times a day, an extra tablet at night for nocturnal pain, and up to 6 tablets (1,500 mg of 5:1 extract, roughly 7.5 g of herb) at once for acute biliary pain, all under a license that treats bile duct stones as an indication. Animal studies used 200 to 400 mg per kilogram of extract in rabbits and rats and up to 5 g per kilogram in single mouse doses. None of these is a supplement dose, and the acute-pain directions belong to a medical setting.

After gallbladder removal

The Austrian leaflet lists complaints after cholecystectomy as an indication. Persistent pain after the operation can come from a stone left in the common bile duct or from sphincter of Oddi dysfunction, both of which need investigation. The one animal finding on protopine and that sphincter describes contraction, not relaxation.

Before surgery or endoscopy

Given the in vitro antiplatelet effect and the sedative potentiation in rats, stop fumitory 2 weeks before a planned operation or ERCP and tell the anesthetist.

What US labels leave out

The Botanic Choice label warns only about medications, pregnancy and nursing. It carries none of the European warnings: nothing on gallstones, bile duct obstruction, cholangitis, liver disease, the under-18 restriction or the 2-week limit.

Research Status & Evidence Quality

Tier 1: controlled human evidence for F. officinalis

One double-blind, placebo-controlled randomized trial with a full English report: Brinkhaus and colleagues, 2005, 106 patients with irritable bowel syndrome, 1,500 mg of powdered herb daily for 18 weeks, no benefit over placebo on pain, distension, global symptoms or IBS-related stress. Rated good quality in a 2008 systematic review. Negative.

Tier 2: biliary reports, 1966 to 1979

About 710 patients across mostly open or poorly reported French, Austrian and German studies of water extracts, including at least two described as placebo-controlled (Kopp, 1979, 30 patients; Zacharewicz, 1979, reported as 85 patients in its English abstract and as an open study of 45 by the HMPC). The HMPC judged them insufficient for well-established use. This is the evidence base of the 1986 German approval.

Tier 3: trials of related species and combinations

A two-herb chicory and F. parviflora syrup for hot flashes (96 randomized, 66 analyzed, 4 weeks), and a topical F. parviflora cream for hand eczema (44 patients). Neither tests F. officinalis taken by mouth alone.

Tier 4: animal and laboratory pharmacology

Bile flow studies in rats from the 1960s and 1970s; protopine effects on smooth muscle, acetylcholinesterase, monoamine transporters, platelets and liver enzymes in cells and rodents; acute protopine toxicity in mice. Much of it uses protopine from other plants (Macleaya, Corydalis, Dactylicapnos).

Research Limitations

No pharmacokinetic study of any fumitory preparation, so no laboratory concentration can be tied to a human dose. No adequate genotoxicity, carcinogenicity or reproductive toxicity testing. Species confusion runs through the literature, with F. parviflora and F. indica results routinely cited for F. officinalis. The biliary studies are old, short, mostly in German or French, and in one case reported two incompatible ways. The regulatory review itself is inconsistent: the HMPC assessment lists the IBS trial as 16 days in one table and 18 weeks in its text, gives 178 and 176 patients for the same Müscher study, and names different co-ingredients for the hepatitis case in different sections. No trial has tested fumitory against placebo for the biliary indication with a modern design and an English report that I could find.

Summary & Key Takeaways

Bottom Line

Fumitory won German approval in 1986 for spasmodic gallbladder and bile duct complaints on the strength of reports a European regulator later called "short and old." The one modern placebo-controlled trial of the herb alone, in irritable bowel syndrome, found nothing over 18 weeks. In 2023 the EU narrowed its status to a traditional remedy for fullness and flatulence and advised against use in gallstones, biliary disease and liver disease. Its main alkaloid, protopine, does several things in a dish and in mice, some of them in opposite directions, and has no published human blood measurement after a dose of the herb.

Key Safety Points

• Do not use fumitory for suspected gallstones, bile duct problems, cholangitis or any liver disease, and get urgent care for right-sided pain with fever, jaundice, dark urine or pale stools.

• Avoid in pregnancy, breastfeeding and anyone under 18 (under 12 for the tea), and in glaucoma or ocular hypertension.

• Stop and get liver tests for jaundice, itching, dark urine or new right-sided pain; the one published case of hepatitis followed about 7 months of multi-herb use.

• Use caution with sedatives, serotonergic antidepressants, antiplatelet drugs and anticoagulants, and blood pressure drugs; avoid stacking with greater celandine, Corydalis or "liver detox" blends.

• Stay within EU daily maximums for the form you buy, and stop after 2 weeks if symptoms persist.

Special Note

"Traditional herbal medicinal product" on a European fumitory pack is a legal category, not a finding. The French label states it plainly: use is reserved for the stated indication "sur la base exclusive de l'ancienneté de l'usage," on the basis of long-standing use alone.

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Researched and drafted with AI assistance. Every claim verified against primary sources and human-reviewed before publication. Last reviewed: October 26, 2026. Corrections: reply to any issue.

This issue is for education only and is not medical advice. If you take prescription medication, have gallbladder, liver or kidney disease or glaucoma, are pregnant or breastfeeding, or have any diagnosed condition, talk to a clinician before starting or stopping anything.