Cafatine Side Effects
Generic Name: caffeine / ergotamine
Note: This document contains side effect information about caffeine / ergotamine. Some of the dosage forms listed on this page may not apply to the brand name Cafatine.
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
Uncommon (0.1% to 1%): Diarrhea
Frequency not reported: Retroperitoneal fibrosis[Ref]
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
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
1. Clementz GL, Dailey JW "Psychotropic effects of caffeine." Am Fam Physician 37 (1988): 167-72
2. Sawynok J "Pharmacological rationale for the clinical use of caffeine." Drugs 49 (1995): 37-50
3. Orton DA, Richardson RJ "Ergotamine absorption and toxicity." Postgrad Med J 58 (1982): 6-11
4. Dahlof C "Placebo-controlled clinical trials with ergotamine in the acute treatment of migraine." Cephalalgia 13 (1993): 166-71
5. Sanders SW, Haering N, Mosberg H, Jaeger H "Pharmacokinetics of ergotamine in healthy volunteers following oral and rectal dosing." Eur J Clin Pharmacol 30 (1986): 331-4
6. Merello MJ, Nogues MA, Leiguarda RC, Lopez Saubidet C "Dystonia and reflex sympathetic dystrophy induced by ergotamine." Mov Disord 6 (1991): 263-4
7. Hokkanen E, Waltimo O, Kallanranta T "Toxic effects of ergotamine used for migraine." Headache 18 (1978): 95-8
8. Redfield MM, Nicholson WJ, Edwards WD, Tajik AJ "Valve disease associated with ergot alkaloid use: echocardiographic and pathologic correlations." Ann Intern Med 117 (1992): 50-2
9. Ibraheem JJ, Paalzow L, Tfelt-Hansen P "Linear pharmacokinetics of intravenous ergotamine tartrate." Eur J Clin Pharmacol 29 (1985): 61-6
10. Lindboe CF, Dahl T, Rostad B "Fatal stroke in migraine: a case report with autopsy findings." Cephalalgia 9 (1989): 277-80
11. Stillman AE, Weinberg M, Mast WC, Palpant S "Ischemic bowel disease attributable to ergot." Gastroenterology 72 (1977): 1336-7
12. Bernstein AL "More on ergotamine withdrawal ." Headache 27 (1987): 458
13. Bondeson J, Ericsson UB, Falke P, Mattiasson I, Nyman U, Lindell E, Bernow J "Tongue necrosis in temporal arteritis provoked by ergotamine." J Intern Med 232 (1992): 541-4
14. Benedict CR, Robertson D "Angina pectoris and sudden death in the absence of atherosclerosis following ergotamine therapy for migraine." Am J Med 67 (1979): 177-8
15. Zicot M, Grandfils F, Honore D "Prolonged arterial hemodynamic disturbances in the lower limbs after oral use of ergotamine." Angiology 29 (1978): 495-6
16. Mathew NT "Chronic refractory headache." Neurology 43 (1993): s26-33
17. Lepage-Savary D, Vallieres A "Ergotamine as a possible cause of retroperitoneal fibrosis." Clin Pharm 1 (1982): 179-80
18. Klein LS, Simpson RJ, Jr Stern R, Hayward JC, Foster JR "Myocardial infarction following administration of sublingual ergotamine." Chest 82 (1982): 375-6
19. Fincham RW, Perdue Z, Dunn VD "Bilateral focal cortical atrophy and chronic ergotamine abuse." Neurology 35 (1985): 720-2
20. Allen MB, Tosh G, Walters G, Muers MF "Pleural and pericardial fibrosis after ergotamine therapy." Respir Med 88 (1994): 67-9
21. Deviere J, Reuse C, Askenasi R "Ischemic pancreatitis and hepatitis secondary to ergotamine poisoning." J Clin Gastroenterol 9 (1987): 350-2
22. Pusey CD, Rainford DJ "St Anthony's fire and pseudochronic renal failure." Br Med J 2 (1977): 935
23. Taal BG, Spierings EL, Hilvering C "Pleuropulmonary fibrosis associated with chronic and excessive intake of ergotamine." Thorax 38 (1983): 396-8
24. Gupta DR, Strobos RJ "Bilateral papillitis associated with Cafergot therapy." Neurology 22 (1972): 793-7
25. Mintz U, Bar-Meir S, De Vries A "Ergotamine-induced venous thrombosis." Postgrad Med J 50 (1974): 244-6
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.