Skip to main content
PlainMeds

What the label lists and what reports show

Caffeine and ergotamine side effects

Caffeine and ergotamine's FDA label lists its adverse reactions in its own words. FAERS holds 270 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (24 reports).

  • 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 FDA FAERS public dashboard.

What does the label list?

From the label: 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.

Source: FDA drug label, 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?

270 reports list caffeine and ergotamine among the medicines taken, 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. Of the 20 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)27
  • Headache (a use or a product term, not a reaction)27
  • Nausea (named in the label)24
  • Migraine (a use or a product term, not a reaction)22
  • Dyspnoea15
  • Fatigue14
  • Drug Hypersensitivity12
  • Vomiting (named in the label)11
  • Back Pain10
  • Malaise10
  • Ergot Poisoning9
  • Condition Aggravated (a use or a product term, not a reaction)8
  • Dizziness8
  • Drug Interaction (a use or a product term, not a reaction)8
  • Pain8
  • Pain In Extremity8
  • Paraesthesia (named in the label)8
  • Abdominal Pain Upper7
  • Anxiety7
  • Cough7
  • Drug Abuse7
  • Hypoaesthesia7
  • Peripheral Coldness7
  • Rash7
  • Tremor7

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Caffeine and ergotamine: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions