Caffeine / ergotamine Side Effects
For the Consumer
Applies to caffeine / ergotamine: oral tablet
Other dosage forms:
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- Chest pain or pressure.
- Fast or slow heartbeat.
- A heartbeat that does not feel normal.
- Dizziness or passing out.
- Muscle pain or weakness.
- Change in color of hands or feet from pale to blue or red.
- Numbness, pain, tingling, or cold feeling of the hands or feet.
- Any sores or wounds on the fingers or toes.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Upset stomach or throwing up.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
For Healthcare Professionals
Applies to caffeine / ergotamine: oral tablet, rectal suppository
Common (1% to 10%): Dizziness
Uncommon (0.1% to 1%): Paraesthesia, hypoaesthesia
Rare (less than 0.1%): Cerebral ischemia, drowsiness
Frequency not reported: Weakness, somnolence, drug-induced headaches, withdrawal headaches[Ref]
Reports of cerebral ischemia, including 1 death, have been reported for patients receiving ergotamine and protease inhibitors concomitantly. A black box warning is now required labeling for these drugs.
Drug-induced headaches have been reported during prolonged and uninterrupted use. Withdrawal headaches have been reported with discontinuation after prolonged use.[Ref]
Uncommon (0.1% to 1%): Peripheral vasoconstriction
Rare (0.01% to 0.1%): Tachycardia, bradycardia, increased blood pressure
Very rare (less than 0.01%): Myocardial ischemia, myocardial infarction, gangrene
Frequency not reported: Ischemia, cyanosis, absence of pulse, cold extremities, precordial distress, EKG changes[Ref]
Serious vasoconstrictive have occurred, more commonly with long-term therapy at relatively high doses, however, they have been reported with short-term or normal doses.[Ref]
Rare (Less than 0.1%): Dyspnea
Frequency not reported: Pleuropulmonary fibrosis, fibrotic thickening of pulmonary valves
Uncommon (0.1% to 1%): Extremity pain
Rare (Less than 0.1%): Myalgia[Ref]
Frequency not reported: Visual impairment
Postmarketing reports: Loss of vision
Sudden and transient loss of vision have been reported, possibly due to vasospasm and ischemic episode.
Rare (less than 0.1%): Rectal or anal ulcer[Ref]
Solitary rectal or anal ulcer have occurred, usually at higher than recommended doses or with continuous use for many years[Ref]
Rare (Less than 0.1%): Rash, face edema, urticaria
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.
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