{"id":"ergotamine","rwe":[{"pmid":"41860491","year":"2026","title":"Is Aortic Regurgitation Associated With Long-Term Ergotamine Use?","finding":"","journal":"JACC. Case reports","studyType":"Clinical Study"},{"pmid":"41848189","year":"2026","title":"DHE - past, present, and future: a narrative review.","finding":"","journal":"Pain management","studyType":"Clinical Study"},{"pmid":"41833043","year":"2026","title":"Pharmacology and Pharmacogenomics of Anti-Migraine Drugs.","finding":"","journal":"CNS & neurological disorders drug targets","studyType":"Clinical Study"},{"pmid":"41731751","year":"2026","title":"Identification of shared gene signature between lung cancer and postoperative delirium by transcriptome data analysis.","finding":"","journal":"Medicine","studyType":"Clinical Study"},{"pmid":"41696275","year":"2026","title":"Computational and Experimental Verification of Cabozantinib Targeting DDX11 to Inhibit DNA Damage Repair in Liver Cancer.","finding":"","journal":"ACS omega","studyType":"Clinical Study"}],"_fda":{"id":"ee9c58f6-c353-2cf3-e053-2a95a90a3f5e","set_id":"3a31ad0c-7bdd-544b-f5df-a99d04cf541c","openfda":{"nui":["N0000175739","N0000175729","N0000175790","M0023046"],"unii":["3G6A5W338E","MRU5XH3B48"],"route":["RECTAL"],"rxcui":["1293508","1293639"],"spl_id":["ee9c58f6-c353-2cf3-e053-2a95a90a3f5e"],"brand_name":["MIGERGOT"],"spl_set_id":["3a31ad0c-7bdd-544b-f5df-a99d04cf541c"],"package_ndc":["0713-0166-12"],"product_ndc":["0713-0166"],"generic_name":["ERGOTAMINE TARTRATE AND CAFFEINE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"pharm_class_cs":["Xanthines [CS]"],"pharm_class_pe":["Central Nervous System Stimulation [PE]"],"substance_name":["CAFFEINE","ERGOTAMINE TARTRATE"],"pharm_class_epc":["Central Nervous System Stimulant [EPC]","Methylxanthine [EPC]"],"manufacturer_name":["Cosette Pharmaceuticals, Inc."],"application_number":["ANDA086557"],"is_original_packager":[true]},"version":"7","warnings":["WARNINGS CYP 3A4 Inhibitors (e.g. Macrolide Antibiotics and Protease Inhibitors) Coadministration of ergotamine with potent CYP 3A4 inhibitors such as protease inhibitors or macrolide antibiotics has been associated with serious adverse events; for this reason, these drugs should not be given concomitantly with ergotamine (See CONTRAINDICATIONS ). While these reactions have not been reported with less potent CYP 3A4 inhibitors, there is a potential risk for serious toxicity including vasospasm when these drugs are used with ergotamine. Examples of less potent CYP 3A4 inhibitors include: saquinavir, nefazodone, fluconazole, fluoxetine, grapefruit juice, fluvoxamine, zileuton, metronidazole, and clotrimazole. These lists are not exhaustive, and the prescriber should consider the effects on CYP 3A4 of other agents being considered for concomitant use with ergotamine. Fibrotic Complications There have been a few reports of patients on ergotamine tartrate and caffeine therapy developing retroperitoneal and/or pleuropulmonary fibrosis. There have also been rare reports of fibrotic thickening of the aortic, mitral, tricuspid, and/or pulmonary valves with long-term continuous use of ergotamine tartrate and caffeine. Ergotamine tartrate suppositories should not be used for chronic daily administration (see DOSAGE AND ADMINISTRATION )."],"overdosage":["OVERDOSAGE The toxic effects of an acute overdosage of ergotamine tartrate and caffeine are due primarily to the ergotamine component. The amount of caffeine is such that its toxic effects will be overshadowed by those of ergotamine. Symptoms include vomiting, numbness, tingling, pain and cyanosis of the extremities associated with diminished or absent peripheral pulses; hypertension or hypotension; drowsiness, stupor, coma, convulsions and shock. A case has been reported of reversible bilateral papillitis with ring scotomata in a patient who received five times the recommended daily adult dose over a period of 14 days. Treatment consists of removal of the offending drug by enema. Maintenance of adequate pulmonary ventilation, correction of hypotension, and control of convulsions and blood pressure are important considerations. Treatment of peripheral vasospasm should consist of warmth, but not heat, and protection of the ischemic limbs. Vasodilators may be beneficial but caution must be exercised to avoid aggravating an already existent hypotension."],"description":["DESCRIPTION: Ergotamine Tartrate and Caffeine Suppository ergotamine tartrate USP 2 mg caffeine USP 100 mg Inactive Ingredients: tartaric acid NF, and hard fat NF Ergotamine Tartrate and Caffeine Suppositories are for rectal administration only. Ergotamine Tartrate and Caffeine Suppositories are sealed in foil to afford protection from leakage. If an unavoidable period of exposure to heat softens the suppository, it should be chilled in ice-cold water to solidify it before removing the foil."],"precautions":["PRECAUTIONS General Although signs and symptoms of ergotism rarely develop even after long term intermittent use of the rectally administered drug, care should be exercised to remain within the limits of recommended dosage. Ergotism is manifested by intense arterial vasoconstriction, producing signs and symptoms of peripheral vascular ischemia. Ergotamine induces vasoconstriction by a direct action on vascular smooth muscle. In chronic intoxication with ergot derivatives, headache, intermittent claudication, muscle pains, numbness, coldness and pallor of the digits may occur. If the condition is allowed to progress untreated, gangrene can result. While most cases of ergotism associated with ergotamine treatment result from frank overdosage, some cases have involved apparent hypersensitivity. There are few reports of ergotism among patients taking doses within the recommended limits or for brief periods of time. In rare instances, patients, particularly those who have used the medication indiscriminately over long periods of time, may display withdrawal symptoms consisting of rebound headache upon discontinuation of the drug. Rare cases of a solitary rectal or anal ulcer have occurred from abuse of ergotamine suppositories usually in higher than recommended doses or with continual use at the recommended dose for many years. Spontaneous healing occurs within usually 4-8 weeks after drug withdrawal. Information for Patients Patients should be advised that one suppository of ergotamine tartrate and caffeine should be taken at the first sign of a migraine headache. No more than 2 suppositories should be taken for any single migraine attack. No more than 5 suppositories should be taken during any 7-day period. Administration of Ergotamine Tartrate and Caffeine Suppositories should not exceed the dosing guidelines and should not be used for chronic daily administration (see DOSAGE AND ADMINISTRATION ). Ergotamine tartrate and caffeine should be used only for migraine headaches. It is not effective for other types of headaches and it lacks analgesic properties. Patients should be advised to report to the physician immediately any of the following: numbness or tingling in the fingers or toes, muscle pain in the arms and legs, weakness in the legs, pain in the chest or temporary speeding or slowing of the heart rate, swelling or itching. Drug Interactions CYP 3A4 Inhibitors (e.g. Macrolide Antibiotics and Protease Inhibitors) See CONTRAINDICATIONS and WARNINGS . Ergotamine tartrate and caffeine should not be administered with other vasoconstrictors. Use with sympathomimetics (pressor agents) may cause extreme elevation of blood pressure. The beta-blocker Inderal (propranolol) has been reported to potentiate the vasoconstrictive action of ergotamine tartrate and caffeine by blocking the vasodilating property of epinephrine. Nicotine may provoke vasoconstriction in some patients, predisposing to a greater ischemic response to ergot therapy. The blood levels of ergotamine-containing drugs are reported to be elevated by the concomitant administration of macrolide antibiotics and vasospastic reactions have been reported with therapeutic doses of the ergotamine-containing drugs when coadministered with these antibiotics. Pregnancy Teratogenic Effects There are no studies on the placental transfer or teratogenicity of the combined products of ergotamine tartrate and caffeine. Caffeine is known to cross the placenta and has been shown to be teratogenic in animals. Ergotamine crosses the placenta in small amounts, although it does not appear to be embryotoxic in this quantity. However, prolonged vasoconstriction of the uterine vessels and/or increased myometrial tone leading to reduced myometrial and placental blood flow may have contributed to fetal growth retardation observed in animals. (See CONTRAINDICATIONS ) Nonteratogenic Effects Ergotamine tartrate and caffeine is contraindicated in pregnancy due to the oxytocic effects of ergotamine. (See CONTRAINDICATIONS ) Labor and Delivery Ergotamine tartrate and caffeine is contraindicated in labor and delivery due to its oxytocic effect which is maximal in the third trimester. (See CONTRAINDICATIONS ) Nursing Mothers Ergot drugs are known to inhibit prolactin but there are no reports of decreased lactation with ergotamine tartrate and caffeine. Ergotamine is excreted in breast milk and may cause symptoms of vomiting, diarrhea, weak pulse and unstable blood pressure in nursing infants. Because of the potential for serious adverse reactions in nursing infants from ergotamine tartrate and caffeine, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"how_supplied":["HOW SUPPLIED: Ergotamine Tartrate and Caffeine Suppositories USP are supplied in boxes of 12 foil wrapped suppositories. NDC 0713-0166-12"],"boxed_warning":["WARNING Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate and caffeine with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of ergotamine tartrate and caffeine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated. (See also CONTRAINDICATIONS and WARNINGS section)"],"effective_time":"20221129","adverse_reactions":["ADVERSE REACTIONS Cardiovascular: Vasoconstrictive complications of a serious nature may occur at times. These include ischemia, cyanosis, absence of pulse, cold extremities, gangrene, precordial distress and pain, EKG changes and muscle pains. Although these effects occur most commonly with long-term therapy at relatively high doses, they have also been reported with short-term or normal doses. Other cardiovascular adverse effects include transient tachycardia or bradycardia and hypertension. Gastrointestinal: Nausea and vomiting; rectal or anal ulcer (from overuse of suppositories). Neurological: Paresthesias, numbness, weakness, and vertigo. Allergic: Localized edema and itching. Fibrotic Complications: (See WARNINGS ). To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch."],"contraindications":["CONTRAINDICATIONS Coadministration of ergotamine with potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, and troleandomycin) has been associated with acute ergot toxicity (ergotism) characterized by vasospasm and ischemia of the extremities (see PRECAUTIONS : Drug Interactions), with some cases resulting in amputation. There have been rare reports of cerebral ischemia in patients on protease inhibitor therapy when ergotamine tartrate and caffeine was coadministered, at least one resulting in death. Because of the increased risk for ergotism and other serious vasospastic adverse events, ergotamine use is contraindicated with these drugs and other potent inhibitors of CYP 3A4 (e.g., ketoconazole, itraconazole) (see WARNINGS : CYP 3A4 Inhibitors). Ergotamine tartrate and caffeine may cause fetal harm when administered to pregnant women. Ergotamine tartrate and caffeine is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this product, the patient should be apprised of the potential hazard to the fetus. Peripheral vascular disease, coronary heart disease, hypertension, impaired hepatic or renal function and sepsis. Hypersensitivity to any of the components."],"storage_and_handling":["Store and Dispense The suppositories should be refrigerated at 2° to 8°C (36° to 46°F). Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0166CPLNC1 Iss. 06/2020 VC7420"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Ergotamine is an alpha adrenergic blocking agent with a direct stimulating effect on the smooth muscle of peripheral and cranial blood vessels and produces depression of central vasomotor centers. The compound also has the properties of serotonin antagonism. In comparison to hydrogenated ergotamine, the adrenergic blocking actions are less pronounced and vasoconstrictive actions are greater. Caffeine, also a cranial vasoconstrictor, is added to further enhance the vasoconstrictive effect without the necessity of increasing ergotamine dosage. Many migraine patients experience excessive nausea and vomiting during attacks, making it impossible for them to retain any oral medication. In such cases, therefore, the only practical means of medication is through the rectal route where medication may reach the cranial vessels directly, evading the splanchnic vasculature and the liver. Pharmacokinetics: Interactions Pharmacokinetic interactions (increased blood levels of ergotamine) have been reported in patients treated orally with ergotamine and macrolide antibiotics (e.g., troleandomycin, clarithromycin, erythromycin), and in patients treated orally with ergotamine and protease inhibitors (e.g. ritonavir) presumably due to inhibition of cytochrome P450 3A metabolism of ergotamine (See CONTRAINDICATIONS ). Ergotamine has also been shown to be an inhibitor of cytochrome P450 3A catalyzed reactions. No pharmacokinetic interactions involving other cytochrome P450 isoenzymes are known."],"indications_and_usage":["INDICATIONS AND USAGE Ergotamine Tartrate and Caffeine Indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called “histaminic cephalalgia”."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Procedure For best results, dosage should start at the first sign of an attack. Rectally Two suppositories is the maximum dose for an individual attack. Total weekly dosage should not exceed 5 suppositories. Ergotamine Tartrate and Caffeine Suppositories should not be used for chronic daily administration. In carefully selected patients, with due consideration of maximum dosage recommendations, administration of the drug at bedtime may be an appropriate short-term preventive measure. Maximum Adult Dosage: One suppository at start of attack; second suppository after 1 hour, if needed for full relief. Early administration gives maximum effectiveness."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE There have been reports of drug abuse and psychological dependence in patients on ergotamine tartrate and caffeine therapy. Due to the chronicity of vascular headaches, it is imperative that patients be advised not to exceed recommended dosages with long-term use to avoid ergotism. (See PRECAUTIONS )"],"spl_product_data_elements":["MIGERGOT Ergotamine Tartrate and Caffeine TARTARIC ACID HARD FAT ERGOTAMINE TARTRATE ERGOTAMINE CAFFEINE CAFFEINE"],"package_label_principal_display_panel":["PACKAGE LABEL NDC 0713-0166-12 MIGERGOT ® Ergotamine Tartrate and Caffeine Suppositories USP Each Rectal Suppository Contains: Ergotamine Tartrate, USP 2 mg, Caffeine, USP 100 mg, Tartaric Acid 21.5 mg Usual Adult Dose: See Package insert. Refrigerate at 2º - 8ºC (36º - 46ºF) 12 Rectal Suppositories Rx Only Cosette Pharmaceuticals, Inc. Carton Label for MIGERGOT®, Ergotamine Tartrate and Caffeine Suppositories USP 12 count"]},"tags":[{"label":"Ergotamine Derivative","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"5-hydroxytryptamine receptor 1A","category":"target"},{"label":"HTR1A","category":"gene"},{"label":"HTR1D","category":"gene"},{"label":"ADRA2A","category":"gene"},{"label":"N02CA02","category":"atc"},{"label":"Rectal","category":"route"},{"label":"Sublingual","category":"route"},{"label":"Oral","category":"route"},{"label":"Suppository","category":"form"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Cluster Headache Prevention","category":"indication"},{"label":"Cluster headache syndrome","category":"indication"},{"label":"Migraine","category":"indication"},{"label":"Vascular headache","category":"indication"},{"label":"Approved 1940s","category":"decade"},{"label":"Adrenergic Agents","category":"pharmacology"},{"label":"Adrenergic Agonists","category":"pharmacology"},{"label":"Adrenergic alpha-1 Receptor Agonists","category":"pharmacology"},{"label":"Adrenergic alpha-Agonists","category":"pharmacology"},{"label":"Analgesics","category":"pharmacology"},{"label":"Analgesics, Non-Narcotic","category":"pharmacology"},{"label":"Cardiovascular Agents","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Oxytocics","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"},{"label":"Reproductive Control Agents","category":"pharmacology"},{"label":"Sensory System Agents","category":"pharmacology"},{"label":"Serotonin Agents","category":"pharmacology"},{"label":"Serotonin Receptor Agonists","category":"pharmacology"},{"label":"Vasoconstrictor Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":["WARNING Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate and caffeine with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of ergotamine tartrate and caffeine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated. (See also CONTRAINDICATIONS and WARNINGS section)"],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"34 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"31 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"26 reports"},{"date":"","signal":"MIGRAINE","source":"FDA FAERS","actionTaken":"25 reports"},{"date":"","signal":"DRUG INTERACTION","source":"FDA FAERS","actionTaken":"21 reports"},{"date":"","signal":"ERGOT POISONING","source":"FDA FAERS","actionTaken":"20 reports"},{"date":"","signal":"DRUG HYPERSENSITIVITY","source":"FDA FAERS","actionTaken":"18 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"17 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"15 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"13 reports"}],"drugInteractions":[{"url":"/drug/delavirdine","drug":"delavirdine","action":"Avoid combination","effect":"May interact with Delavirdine Mesylate, Ergotamine Tartrate","source":"DrugCentral","drugSlug":"delavirdine"},{"url":"/drug/efavirenz","drug":"efavirenz","action":"Avoid combination","effect":"May interact with Efavirenz, Ergotamine Tartrate","source":"DrugCentral","drugSlug":"efavirenz"},{"url":"/drug/erythromycin","drug":"erythromycin","action":"Avoid combination","effect":"May interact with Ergotamine Tartrate, Erythromycin","source":"DrugCentral","drugSlug":"erythromycin"},{"url":"/drug/fenfluramine","drug":"fenfluramine","action":"Avoid combination","effect":"May interact with Ergotamine Tartrate, Fenfluramine","source":"DrugCentral","drugSlug":"fenfluramine"},{"url":"/drug/fosamprenavir","drug":"fosamprenavir","action":"Avoid combination","effect":"May interact with Ergotamine Tartrate, Fosamprenavir","source":"DrugCentral","drugSlug":"fosamprenavir"},{"url":"/drug/glyceryl-trinitrate","drug":"glyceryl trinitrate","action":"Avoid combination","effect":"May interact with Ergotamine Tartrate, Nitroglycerin","source":"DrugCentral","drugSlug":"glyceryl-trinitrate"},{"url":"/drug/indinavir","drug":"indinavir","action":"Avoid combination","effect":"May interact with Ergotamine Tartrate, Indinavir Sulfate","source":"DrugCentral","drugSlug":"indinavir"},{"url":"/drug/itraconazole","drug":"itraconazole","action":"Avoid combination","effect":"May interact with Ergotamine Tartrate, Itraconazole","source":"DrugCentral","drugSlug":"itraconazole"},{"url":"/drug/ketoconazole","drug":"ketoconazole","action":"Avoid combination","effect":"May interact with Ergotamine Tartrate, Ketoconazole","source":"DrugCentral","drugSlug":"ketoconazole"},{"url":"/drug/lopinavir","drug":"lopinavir","action":"Avoid combination","effect":"May interact with Ergotamine Tartrate, Lopinavir","source":"DrugCentral","drugSlug":"lopinavir"},{"url":"/drug/naratriptan","drug":"naratriptan","action":"Avoid combination","effect":"May interact with Ergotamine Tartrate, Naratriptan Hydrochloride","source":"DrugCentral","drugSlug":"naratriptan"},{"url":"/drug/nelfinavir","drug":"nelfinavir","action":"Avoid combination","effect":"May interact with Ergotamine Tartrate, Nelfinavir Mesylate","source":"DrugCentral","drugSlug":"nelfinavir"},{"url":"/drug/oleandomycin","drug":"oleandomycin","action":"Avoid combination","effect":"May interact with Ergotamine Tartrate, Oleandomycin (As Troleandomycin)","source":"DrugCentral","drugSlug":"oleandomycin"},{"url":"/drug/propranolol","drug":"propranolol","action":"Avoid combination","effect":"May interact with Ergotamine Tartrate, Propranolol","source":"DrugCentral","drugSlug":"propranolol"},{"url":"/drug/rizatriptan","drug":"rizatriptan","action":"Avoid combination","effect":"May interact with Ergotamine Tartrate, Rizatriptan","source":"DrugCentral","drugSlug":"rizatriptan"},{"url":"/drug/saquinavir","drug":"saquinavir","action":"Avoid combination","effect":"May interact with Ergotamine Tartrate, Saquinavir","source":"DrugCentral","drugSlug":"saquinavir"},{"url":"/drug/sumatriptan","drug":"sumatriptan","action":"Avoid combination","effect":"May interact with Ergotamine Tartrate, Sumatriptan","source":"DrugCentral","drugSlug":"sumatriptan"},{"url":"/drug/tacrolimus","drug":"tacrolimus","action":"Avoid combination","effect":"May interact with Ergotamine Tartrate, Tacrolimus","source":"DrugCentral","drugSlug":"tacrolimus"},{"url":"/drug/voriconazole","drug":"voriconazole","action":"Avoid combination","effect":"May interact with Ergotamine Tartrate, Voriconazole","source":"DrugCentral","drugSlug":"voriconazole"},{"url":"/drug/zolmitriptan","drug":"zolmitriptan","action":"Avoid combination","effect":"May interact with Ergotamine Tartrate, Zolmitriptan","source":"DrugCentral","drugSlug":"zolmitriptan"}],"commonSideEffects":[{"effect":"Hypertension","drugRate":"reported","severity":"unknown"},{"effect":"Nausea","drugRate":"reported","severity":"unknown"},{"effect":"Vomiting","drugRate":"reported","severity":"unknown"},{"effect":"Tachycardia","drugRate":"reported","severity":"unknown"},{"effect":"Bradycardia","drugRate":"reported","severity":"unknown"},{"effect":"Paresthesias","drugRate":"reported","severity":"unknown"},{"effect":"Numbness","drugRate":"reported","severity":"unknown"},{"effect":"Weakness","drugRate":"reported","severity":"unknown"},{"effect":"Vertigo","drugRate":"reported","severity":"unknown"},{"effect":"Localized edema","drugRate":"reported","severity":"unknown"},{"effect":"Itching","drugRate":"reported","severity":"unknown"}],"contraindications":["Achalasia of esophagus","Acute exacerbation of asthma","Acute nephropathy","Agoraphobia","Alcoholism","Anemia","Angle-closure glaucoma","Atony of colon","Autonomic dysreflexia","Bacterial septicemia","Benign prostatic hyperplasia","Bladder outflow obstruction","Bleeding","Brain damage","Breastfeeding (mother)","Cardiovascular event risk","Cerebral ischemia","Chronic heart failure","Chronic lung disease","Chronic obstructive lung disease","Complete trisomy 21 syndrome","Conduction disorder of the heart","Depressive disorder","Diarrhea","Disease of liver"],"specialPopulations":{"Pregnancy":"Pregnancy Category X: There are no studies on the placental transfer or teratogenicity of Ergomar(R). Ergotamine crosses the placenta in small amounts, although it does not appear to be embryotoxic in this quantity. However, prolonged vasoconstriction of the uterine vessels and/or increased myometrial tone leading to reduced myometrial and placental blood flow may have contributed to fetal growth retardation observed in animals. (See CONTRAINDICATIONS). Nonteratogenic effects have been observed in animal studies.","Paediatric use":"Safety and effectiveness in pediatric patients have not been established."}},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ERGOTAMINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:58:12.162756+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Ergotamine","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:58:18.467946+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:58:17.066305+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:58:11.282287+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ERGOTAMINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:58:17.401344+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:58:09.013860+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:58:09.013890+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (boxed_warning)","rawText":"WARNING Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate and caffeine with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of ergotamine tartrate and caffeine, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated. (See also CONTR","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:58:09.013900+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:58:18.861891+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Adrenergic receptor alpha agonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:58:18.467900+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2448612/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:58:18.120603+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA086557","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:58:09.013905+00:00"}},"allNames":"migergot","offLabel":[],"synonyms":["ergotamine","ergotamin","ergotamine tartrate","ergotaminine"],"timeline":[{"date":"1948-11-26","type":"positive","source":"DrugCentral","milestone":"FDA approval"},{"date":"1983-02-24","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 2 manufacturers approved"}],"aiSummary":"Migergot (Ergotamine) is a small molecule ergot derivative that targets the 5-hydroxytryptamine receptor 1A. It was originally developed and is currently owned by various companies. FDA approved in 1948, it is used to treat cluster headache prevention, cluster headache syndrome, migraine, and vascular headache. As an off-patent medication, it is available from multiple generic manufacturers. Key safety considerations include its low bioavailability and short half-life.","approvals":[{"date":"1948-11-26","orphan":false,"company":"","regulator":"FDA"}],"brandName":"Migergot","ecosystem":[{"indication":"Cluster Headache Prevention","otherDrugs":[{"name":"caffeine","slug":"caffeine","company":"Novartis"}],"globalPrevalence":null},{"indication":"Cluster headache syndrome","otherDrugs":[{"name":"caffeine","slug":"caffeine","company":"Novartis"},{"name":"dihydroergotamine","slug":"dihydroergotamine","company":"Valeant"},{"name":"sumatriptan","slug":"sumatriptan","company":"Glaxosmithkline"}],"globalPrevalence":null},{"indication":"Migraine","otherDrugs":[{"name":"acetylsalicylic acid","slug":"acetylsalicylic-acid","company":"Endo Pharms"},{"name":"almotriptan","slug":"almotriptan","company":"Janssen Pharms"},{"name":"caffeine","slug":"caffeine","company":"Novartis"},{"name":"dihydroergotamine","slug":"dihydroergotamine","company":"Valeant"}],"globalPrevalence":1000000000},{"indication":"Vascular headache","otherDrugs":[{"name":"caffeine","slug":"caffeine","company":"Novartis"},{"name":"dihydroergotamine","slug":"dihydroergotamine","company":"Valeant"}],"globalPrevalence":null}],"mechanism":{"target":"5-hydroxytryptamine receptor 1A","novelty":"Follow-on","targets":[{"gene":"HTR1A","source":"DrugCentral","target":"5-hydroxytryptamine receptor 1A","protein":"5-hydroxytryptamine receptor 1A"},{"gene":"HTR1D","source":"DrugCentral","target":"5-hydroxytryptamine receptor 1D","protein":"5-hydroxytryptamine receptor 1D"},{"gene":"ADRA2A","source":"DrugCentral","target":"Alpha-2A adrenergic receptor","protein":"Alpha-2A adrenergic receptor"},{"gene":"HTR2A","source":"DrugCentral","target":"5-hydroxytryptamine receptor 2A","protein":"5-hydroxytryptamine receptor 2A"},{"gene":"HTR2B","source":"DrugCentral","target":"5-hydroxytryptamine receptor 2B","protein":"5-hydroxytryptamine receptor 2B"},{"gene":"DRD2","source":"DrugCentral","target":"D(2) dopamine receptor","protein":"D(2) dopamine receptor"},{"gene":"DRD3","source":"DrugCentral","target":"D(3) dopamine receptor","protein":"D(3) dopamine receptor"},{"gene":"ADRA2B","source":"DrugCentral","target":"Alpha-2B adrenergic receptor","protein":"Alpha-2B adrenergic receptor"},{"gene":"ADRA2C","source":"DrugCentral","target":"Alpha-2C adrenergic receptor","protein":"Alpha-2C adrenergic receptor"},{"gene":"HTR2C","source":"DrugCentral","target":"5-hydroxytryptamine receptor 2C","protein":"5-hydroxytryptamine receptor 2C"}],"modality":"Small Molecule","drugClass":"Central Nervous System Stimulant [EPC]","explanation":"","oneSentence":"","technicalDetail":"Migergot exerts its effects by selectively binding to the 5-HT1A receptor subtype, a subtype of serotonin receptor, which is involved in the regulation of vascular tone and pain transmission."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Caffeine","title":"Caffeine","extract":"Caffeine is a central nervous system (CNS) stimulant of the methylxanthine class and is the most commonly consumed psychoactive substance globally. It is mainly used for its eugeroic, ergogenic, or nootropic (cognitive-enhancing) properties; it is also used recreationally or in social settings. Caffeine acts by blocking the binding of adenosine at a number of adenosine receptor types, inhibiting the centrally depressant effects of adenosine and enhancing the release of acetylcholine. Caffeine has a three-dimensional structure similar to that of adenosine, which allows it to bind and block its receptors. Caffeine also increases cyclic AMP levels through nonselective inhibition of phosphodiesterase, increases calcium release from intracellular stores, and antagonizes GABA receptors, although these mechanisms typically occur at concentrations beyond usual human consumption.","wiki_history":"==History==\n\n===Discovery and spread of use===\nthumb|[[Coffeehouse in Palestine, |alt=An old photo of a dozen old and middle-aged men sitting on the ground around a mat. A man in front sits next to a mortar and holds a bat, ready for grinding. A man opposite to him holds a long spoon.]]\n\n\nAccording to Chinese legend, the Chinese emperor Shennong, reputed to have reigned in about 3000 BCE, inadvertently discovered tea when he noted that when certain leaves fell into boiling water, a fragrant and restorative drink resulted. Shennong is also mentioned in Lu Yu's Cha Jing, a famous early work on the subject of tea.\n\nThe earliest credible evidence of either coffee drinking or knowledge of the coffee plant appears in the middle of the fifteenth century, in the Sufi monasteries of the Yemen in southern Arabia. From Mokha, coffee spread to Egypt and North Africa, and by the 16th century, it had reached the rest of the Middle East, Persia and Turkey.  From the Middle East, coffee drinking spread to Italy, then to the rest of Europe, and coffee plants were transported by the Dutch to the East Indies and to the Americas.\n\nKola nut use appears to have ancient origins. It is chewed in many West African cultures, in both private and social settings, to restore vitality and ease hunger pangs.\n\nThe earliest evidence of cocoa bean use comes from residue found in an ancient Mayan pot dated to 600 BCE. Also, chocolate was consumed in a bitter and spicy drink called xocolatl, often seasoned with vanilla, chile pepper, and achiote. Xocolatl was believed to fight fatigue, a belief probably attributable to the theobromine and caffeine content. Chocolate was an important luxury good throughout pre-Columbian Mesoamerica, and cocoa beans were often used as currency.\n\nXocolatl was introduced to Europe by the Spaniards, and became a popular beverage by 1700. The Spaniards also introduced the cacao tree into the West Indies and the Philippines.\n\nThe leaves and stems of the yaupon holly (Ilex vo","wiki_society_and_culture":"==Society and culture==\n\n===Regulations===\n\n\n\n====United States====\nThe US Food and Drug Administration (FDA) considers safe beverages containing less than 0.02% caffeine; but caffeine powder, which is sold as a dietary supplement, is unregulated. It is a regulatory requirement that the label of most prepackaged foods must declare a list of ingredients, including food additives such as caffeine, in descending order of proportion. However, there is no regulatory provision for mandatory quantitative labeling of caffeine, (e.g., milligrams caffeine per stated serving size). There are a number of food ingredients that naturally contain caffeine. These ingredients must appear in food ingredient lists. However, as is the case for \"food additive caffeine\", there is no requirement to identify the quantitative amount of caffeine in composite foods containing ingredients that are natural sources of caffeine. While coffee or chocolate are broadly recognized as caffeine sources, some ingredients (e.g., guarana, yerba maté) are likely less recognized as caffeine sources. For these natural sources of caffeine, there is no regulatory provision requiring that a food label identify the presence of caffeine nor state the amount of caffeine present in the food. The FDA guidance was updated in 2018.\n\n===Consumption===\nGlobal consumption of caffeine has been estimated at 120,000 tonnes per year, making it the world's most popular psychoactive substance. The consumption of caffeine has remained stable between 1997 and 2015. Coffee, tea and soft drinks are the most common caffeine sources, with energy drinks contributing little to the total caffeine intake across all age groups. Some from these religions believe that one is not supposed to consume a non-medical, psychoactive substance, or believe that one is not supposed to consume a substance that is addictive. The Church of Jesus Christ of Latter-day Saints has said the following with regard to caffeinated beverages: \"... the Churc"},"commercial":{"launchDate":"1948","_launchSource":"DrugCentral (FDA 1948-11-26, )"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1043","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=ERGOTAMINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ERGOTAMINE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Caffeine","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T11:01:21.354937","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:58:21.157331+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"dihydroergotamine","drugSlug":"dihydroergotamine","fdaApproval":"1946-04-12","patentExpiry":"Sep 5, 2032","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"methysergide","drugSlug":"methysergide","fdaApproval":"1962-02-12","patentStatus":"Unknown","relationship":"same-class"}],"genericName":"ergotamine","indications":{"approved":[{"name":"Cluster Headache Prevention","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"adults"},{"name":"Cluster headache syndrome","source":"DrugCentral","snomedId":193031009,"regulator":"FDA","eligibility":"adults"},{"name":"Migraine","source":"DrugCentral","snomedId":37796009,"regulator":"FDA","eligibility":"adults","usPrevalence":39000000,"globalPrevalence":1000000000,"prevalenceMethod":"curated","prevalenceSource":"Lancet Neurology, 2023"},{"name":"Vascular headache","source":"DrugCentral","snomedId":128187005,"regulator":"FDA","eligibility":"adults"}],"offLabel":[],"pipeline":[]},"drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"dihydroergotamine","brandName":"dihydroergotamine","genericName":"dihydroergotamine","approvalYear":"1946","relationship":"same-class"},{"drugId":"methysergide","brandName":"methysergide","genericName":"methysergide","approvalYear":"1962","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07226362","phase":"PHASE1","title":"A Study Evaluating the Safety, Tolerability and Pharmacokinetics of ASY202 in Healthy Adults","status":"COMPLETED","sponsor":"Aspeya Switzerland SA","startDate":"2025-06-09","conditions":["Safety, and Tolerability"],"enrollment":44,"completionDate":"2025-10-02"},{"nctId":"NCT03525002","phase":"PHASE2","title":"Dopamine Action on Metabolism in Relation to Genotype","status":"COMPLETED","sponsor":"University Hospital Tuebingen","startDate":"2018-05-03","conditions":["Obesity"],"enrollment":120,"completionDate":"2024-08-14"},{"nctId":"NCT07124221","phase":"PHASE3","title":"A Phase III Clinical Study of Cabergoline Tablets Compared With Bromocriptine Mesylate Tablets","status":"RECRUITING","sponsor":"Changchun GeneScience Pharmaceutical Co., Ltd.","startDate":"2025-09-12","conditions":["Hyperprolactinemia"],"enrollment":382,"completionDate":"2026-12-30"},{"nctId":"NCT05180773","phase":"PHASE4","title":"Impact of Bromocriptine on Clinical Outcomes for Peripartum Cardiomyopathy","status":"RECRUITING","sponsor":"Dennis M. 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