Quick answers
- What is Ergotamine tartrate and caffeine used for?
- The FDA-approved label (Cafergot, Trifluent Pharma, LLC, March 23, 2026) says: “Ergotamine tartrate and caffeine tablets are indicated as therapy to abort or prevent vascular headache; e.g., migraine, migraine variants or so-called “histaminic cephalalgia.”” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Ergotamine tartrate and caffeine?
- The “Adverse Reactions” section of the FDA label (Cafergot, Trifluent Pharma, LLC, March 23, 2026) begins: “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.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Ergotamine tartrate and caffeine?
- The “Drug Interactions” section of the FDA label (Cafergot, Trifluent Pharma, LLC, March 23, 2026) begins: “- CYP 3A4 Inhibitors (e.g. Macrolide Antibiotics and Protease Inhibitors) See CONTRAINDICATIONS and WARNINGS. Ergotamine tartrate and caffeine tablets should not be administered with other vasoconstrictors. Use with sympathomimetics (pressor agents) may cause extreme elevation of blood pressure.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ergotamine tartrate and caffeine have a boxed warning?
- Yes. The FDA label for Cafergot has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Ergotamine tartrate and caffeine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ergotamine tartrate and caffeine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ergotamine tartrate and caffeine?
- 3 companies list prescription products of Ergotamine tartrate and caffeine in the FDA NDC Directory, including Trifluent Pharma, LLC, Cintex Services, LLC and Cosette Pharmaceuticals, Inc.
What Ergotamine tartrate and caffeine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Ergotamine tartrate and caffeine tablets are indicated as therapy to abort or prevent vascular headache; e.g., migraine, migraine variants or so-called “histaminic cephalalgia.”
— FDA label: Cafergot, Trifluent Pharma, LLC, effective March 23, 2026. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, film coated, oral), Cafergot, Trifluent Pharma, LLC; it covers 1 product in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
3 of 3 FDA labels for this medicine have a boxed warning.
Ergotamine tartrate and caffeine boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
WARNING Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate and caffeine tablets with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of ergotamine tartrate and caffeine tablets, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased.
Read more of this section
Hence, concomitant use of these medications is contraindicated (see also CONTRAINDICATIONS and WARNINGS sections).
— FDA label: Cafergot, Trifluent Pharma, LLC, effective March 23, 2026. Read the full label on DailyMed →
Ergotamine tartrate and caffeine side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
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.
Read more of this section
Gastrointestinal: Nausea and vomiting Neurological: Paresthesias, numbness, weakness, and vertigo Allergic: Localized edema and itching. Fibrotic Complications: (see WARNINGS). To report SUSPECTED ADVERSE REACTIONS, contact Trifluent Pharma at 1-888-927-5191, or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
— FDA label: Cafergot, Trifluent Pharma, LLC, effective March 23, 2026. Read the full label on DailyMed →
Ergotamine tartrate and caffeine drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
- CYP 3A4 Inhibitors (e.g. Macrolide Antibiotics and Protease Inhibitors) See CONTRAINDICATIONS and WARNINGS. Ergotamine tartrate and caffeine tablets should not be administered with other vasoconstrictors. Use with sympathomimetics (pressor agents) may cause extreme elevation of blood pressure.
Read more of this section
The beta-blocker Inderal (propranolol) has been reported to potentiate the vasoconstrictive action of ergotamine tartrate and caffeine tablets 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.
— FDA label: Cafergot, Trifluent Pharma, LLC, effective March 23, 2026. Read the full label on DailyMed →
Ergotamine tartrate and caffeine dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Procedure: For the best results, dosage should start at the first sign of an attack. Adults: Take 2 tablets at the start of attack; 1 additional tablet every ½ hour, if needed for full relief (maximum 6 tablets per attack, 10 per week). Maximum Adult Dosage: Total daily dose for any one attack should not exceed 6 tablets. Total weekly dosage should not exceed 10 tablets. Ergotamine tartrate and caffeine tablets should not be used for chronic daily administration.
Read more of this section
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.
— FDA label: Cafergot, Trifluent Pharma, LLC, effective March 23, 2026. Read the full label on DailyMed →
Ergotamine tartrate and caffeine in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
- Teratogenic Effects - Pregnancy Category X There are no studies on the placental transfer or teratogenicity of the combined products of ergotamine tartrate and caffeine tablets. 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.
Read more of this section
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 tablets is contraindicated in pregnancy due to the oxytocic effects of ergotamine (see CONTRAINDICATIONS).
— FDA label: Cafergot, Trifluent Pharma, LLC, effective March 23, 2026. Read the full label on DailyMed →
Ergotamine tartrate and caffeine and breastfeeding
Quoted from the nursing mothers / lactation part of the FDA-approved label.
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.
Read more of this section
Because of the potential for serious adverse reactions in nursing infants from ergotamine tartrate and caffeine tablets, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
— FDA label: Cafergot, Trifluent Pharma, LLC, effective March 23, 2026. Read the full label on DailyMed →
When Ergotamine tartrate and caffeine should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
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.
Read more of this section
There have been rare reports of cerebral ischemia in patients on protease inhibitor therapy when ergotamine tartrate and caffeine tablets was coadministered, at least one resulting in death. Because of the increased risk of 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 tablets may cause fetal harm when administered to pregnant women. Ergotamine tartrate and caffeine tablets 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.
— FDA label: Cafergot, Trifluent Pharma, LLC, effective March 23, 2026. Read the full label on DailyMed →
Ergotamine tartrate and caffeine overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
The toxic effects of an acute overdosage of ergotamine tartrate and caffeine tablets 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.
Read more of this section
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 induction of emesis, gastric lavage, and catharsis. 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.
— FDA label: Cafergot, Trifluent Pharma, LLC, effective March 23, 2026. Read the full label on DailyMed →
Forms and how it is given
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Trifluent Pharma, LLC1 product
- Cintex Services, LLC1 product
- Cosette Pharmaceuticals, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (2)
- ANDA086557Cosette · October 4, 1983
- ANDA040590Pharmobedient · September 16, 2005
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1293504, 1293506, 1293508, 1293639 |
|---|---|
| SPL set ID of the quoted label | 4db7eece-2eef-bc1b-e063-6394a90a98cb |
| FDA labels (SPL) | 3 |
| FDA applications | 2 ANDA |
| Active ingredients (FDA) | CAFFEINE / ERGOTAMINE |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- CafergotBrand page: products, maker and price
- MigergotBrand page: products, maker and price
- Trifluent Pharma, LLCMaker or distributor
- Cintex Services, LLCMaker or distributor
- Cosette Pharmaceuticals, Inc.Maker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Cafergot, Trifluent Pharma, LLC, effective March 23, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →