Cafetrate Side Effects
Generic name: caffeine / ergotamine
Medically reviewed by Drugs.com. Last updated on Aug 23, 2024.
Note: This document provides detailed information about Cafetrate.
For healthcare professionals
Applies to caffeine / ergotamine: oral tablet, rectal suppository Side Effects associated with caffeine / ergotamine. Some dosage forms listed on this page may not apply specifically to the brand name Cafetrate.
For healthcare professionals
Applies to caffeine / ergotamine: oral tablet, rectal suppository.
General
The most commonly reported adverse effects have included nausea and vomiting.[Ref]
Gastrointestinal
- Common (1% to 10%): Nausea, vomiting, abdominal pain
- Uncommon (0.1% to 1%): Diarrhea
- Frequency not reported: Retroperitoneal fibrosis[Ref]
Nervous system
- 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]
Cardiovascular
- 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]
Respiratory
- Rare (Less than 0.1%): Dyspnea
- Frequency not reported: Pleuropulmonary fibrosis, fibrotic thickening of pulmonary valves
Musculoskeletal
Hypersensitivity
Ocular
- 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.
Local
- 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]
Other
Dermatologic
- Rare (Less than 0.1%): Rash, face edema, urticaria
References
1. Clementz GL, Dailey JW (1988) "Psychotropic effects of caffeine." Am Fam Physician, 37, p. 167-72
2. Sawynok J (1995) "Pharmacological rationale for the clinical use of caffeine." Drugs, 49, p. 37-50
3. Orton DA, Richardson RJ (1982) "Ergotamine absorption and toxicity." Postgrad Med J, 58, p. 6-11
4. Sanders SW, Haering N, Mosberg H, Jaeger H (1986) "Pharmacokinetics of ergotamine in healthy volunteers following oral and rectal dosing." Eur J Clin Pharmacol, 30, p. 331-4
5. Dahlof C (1993) "Placebo-controlled clinical trials with ergotamine in the acute treatment of migraine." Cephalalgia, 13, p. 166-71
6. Hokkanen E, Waltimo O, Kallanranta T (1978) "Toxic effects of ergotamine used for migraine." Headache, 18, p. 95-8
7. Merello MJ, Nogues MA, Leiguarda RC, Lopez Saubidet C (1991) "Dystonia and reflex sympathetic dystrophy induced by ergotamine." Mov Disord, 6, p. 263-4
8. Redfield MM, Nicholson WJ, Edwards WD, Tajik AJ (1992) "Valve disease associated with ergot alkaloid use: echocardiographic and pathologic correlations." Ann Intern Med, 117, p. 50-2
9. Ibraheem JJ, Paalzow L, Tfelt-Hansen P (1985) "Linear pharmacokinetics of intravenous ergotamine tartrate." Eur J Clin Pharmacol, 29, p. 61-6
10. Benedict CR, Robertson D (1979) "Angina pectoris and sudden death in the absence of atherosclerosis following ergotamine therapy for migraine." Am J Med, 67, p. 177-8
11. Zicot M, Grandfils F, Honore D (1978) "Prolonged arterial hemodynamic disturbances in the lower limbs after oral use of ergotamine." Angiology, 29, p. 495-6
12. Pusey CD, Rainford DJ (1977) "St Anthony's fire and pseudochronic renal failure." Br Med J, 2, p. 935
13. Klein LS, Simpson RJ, Jr Stern R, Hayward JC, Foster JR (1982) "Myocardial infarction following administration of sublingual ergotamine." Chest, 82, p. 375-6
14. Stillman AE, Weinberg M, Mast WC, Palpant S (1977) "Ischemic bowel disease attributable to ergot." Gastroenterology, 72, p. 1336-7
15. Bondeson J, Ericsson UB, Falke P, Mattiasson I, Nyman U, Lindell E, Bernow J (1992) "Tongue necrosis in temporal arteritis provoked by ergotamine." J Intern Med, 232, p. 541-4
16. Gupta DR, Strobos RJ (1972) "Bilateral papillitis associated with Cafergot therapy." Neurology, 22, p. 793-7
17. Fincham RW, Perdue Z, Dunn VD (1985) "Bilateral focal cortical atrophy and chronic ergotamine abuse." Neurology, 35, p. 720-2
18. Mintz U, Bar-Meir S, De Vries A (1974) "Ergotamine-induced venous thrombosis." Postgrad Med J, 50, p. 244-6
19. Lindboe CF, Dahl T, Rostad B (1989) "Fatal stroke in migraine: a case report with autopsy findings." Cephalalgia, 9, p. 277-80
20. Lepage-Savary D, Vallieres A (1982) "Ergotamine as a possible cause of retroperitoneal fibrosis." Clin Pharm, 1, p. 179-80
21. Bernstein AL (1987) "More on ergotamine withdrawal ." Headache, 27, p. 458
22. Deviere J, Reuse C, Askenasi R (1987) "Ischemic pancreatitis and hepatitis secondary to ergotamine poisoning." J Clin Gastroenterol, 9, p. 350-2
23. Taal BG, Spierings EL, Hilvering C (1983) "Pleuropulmonary fibrosis associated with chronic and excessive intake of ergotamine." Thorax, 38, p. 396-8
24. Mathew NT (1993) "Chronic refractory headache." Neurology, 43, s26-33
25. Allen MB, Tosh G, Walters G, Muers MF (1994) "Pleural and pericardial fibrosis after ergotamine therapy." Respir Med, 88, p. 67-9
More about Cafetrate (caffeine / ergotamine)
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Further information
Cafetrate side effects can vary depending on the individual. 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.