Prescription medicine
Caffeine and ergotamine Brand names: Cafergot, Migergot
Caffeine and ergotamine (Cafergot) is a prescription medicine with an FDA approval on record since 1948. FDA's NDC Directory lists it from 3 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the caffeine and ergotamine FDA label on DailyMed (effective November 29, 2022, Cosette Pharmaceuticals, Inc.); the NDA 6620 record on Drugs@FDA; every caffeine and ergotamine label on DailyMed.
Highlights of the record
FDA label of November 29, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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)
Used for
From the label: indications and usageErgotamine Tartrate and Caffeine Indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called “histaminic cephalalgia”.
Forms and strengths
- 1 mg / 100 mg
- 2 mg / 100 mg
Film-coated tablet; suppository.
On the market
- Earliest approval on file
- November 26, 1948 Cafergot, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first September 29, 1976; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 3 of which 3 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 270 through July 30, 2026
What is caffeine and ergotamine used for?
From the label: indications and usageErgotamine Tartrate and Caffeine Indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called “histaminic cephalalgia”.
FDA pharmacologic class: Central Nervous System Stimulant, Ergotamine Derivative and Methylxanthine.
Source: FDA drug label (MIGERGOT), Cosette Pharmaceuticals, Inc., effective November 29, 2022 (SPL set 3a31ad0c-7bdd-544b-f5df-a99d04cf541c), via openFDA; the full label on DailyMed
Is there a generic for caffeine and ergotamine (Cafergot)?
The FDA approved the first generic caffeine and ergotamine on September 29, 1976. 5 generic applications are approved; 2 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists caffeine and ergotamine from 3 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1948 earliest approval on file
- 1976 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the caffeine and ergotamine label say about other medicines?
The caffeine and ergotamine label names 13 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Clarithromycin | 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 : |
| Clotrimazole | warnings | … saquinavir, nefazodone, fluconazole, fluoxetine, grapefruit juice, fluvoxamine, zileuton, metronidazole, and clotrimazole. |
| Erythromycin | 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 : |
| Fluconazole | warnings | 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 … |
| Fluoxetine | warnings | … with ergotamine. Examples of less potent CYP 3A4 inhibitors include: saquinavir, nefazodone, fluconazole, fluoxetine, grapefruit juice, fluvoxamine, zileuton, metronidazole, and clotrimazole. |
| Fluvoxamine | warnings | … less potent CYP 3A4 inhibitors include: saquinavir, nefazodone, fluconazole, fluoxetine, grapefruit juice, fluvoxamine, zileuton, metronidazole, and clotrimazole. |
| Itraconazole | contraindications | 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 : |
| Ketoconazole | contraindications | 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 : |
| Metronidazole | warnings | … inhibitors include: saquinavir, nefazodone, fluconazole, fluoxetine, grapefruit juice, fluvoxamine, zileuton, metronidazole, and clotrimazole. |
| Nefazodone | warnings | 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 … |
| Nelfinavir | 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 : |
| Ritonavir | 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 : |
| Zileuton | warnings | … CYP 3A4 inhibitors include: saquinavir, nefazodone, fluconazole, fluoxetine, grapefruit juice, fluvoxamine, zileuton, metronidazole, and clotrimazole. |
Source: FDA drug label (MIGERGOT), Cosette Pharmaceuticals, Inc., effective November 29, 2022 (SPL set 3a31ad0c-7bdd-544b-f5df-a99d04cf541c), via openFDA; the full label on DailyMed
What do FAERS reports show for caffeine and ergotamine?
The FDA Adverse Event Reporting System holds 270 reports that list caffeine and ergotamine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 9 are coded as a death and 72 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other stimulants
- the pharmacologic class, with prices and generics
- Caffeine and ergotamine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other