Caffeine / ergotamine Side Effects
Not all side effects for caffeine / ergotamine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to caffeine / ergotamine: tablets
Other dosage forms:
Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur while taking caffeine / ergotamine:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blue color of the fingers or toes; chest pain or tightness; cold or pale fingers or toes; diarrhea; dizziness; hallucinations; headache; irregular heartbeat; leg cramps or weakness; mental or mood changes; muscle pain; numbness or tingling of the hands, feet, or skin; ringing in the ears; seizure; severe or persistent nausea or vomiting; shortness of breath; swelling; temporary fast or slow heartbeat; vomiting; weak pulse.
For Healthcare Professionals
Applies to caffeine / ergotamine: oral tablet, rectal suppository
Gastrointestinal side effects including nausea, vomiting, and diarrhea have occurred commonly with ergotamine use.
The extremities are most frequently affected by arterial spasm and amputation has occasionally been required.
The headaches during ergotamine withdrawal are often subjectively different in character from the headaches that prompted ergotamine therapy.
Other side effects including arterial spasm, sometimes with resulting distal necrosis, have been reported rarely with ergotamine use. Other vascular effects which have been reported rarely include myocardial ischemia or infarction, pulselessness, tongue necrosis, bilateral papillitis, blindness, ischemic pancreatitis, ischemic hepatitis, bowel infarction, renal arteriospasm with acute renal failure, fatal stroke, venous thrombosis, and cerebral arteriopathy.
Withdrawal symptoms, particularly headaches, have been frequently reported after discontinuation of ergotamine, especially after long-term use.
In one study of the effects of caffeine, 634 women with fibrocystic breast disease (compared to 1066 women without the disease), the occurrence of fibrocystic breast disease was positively associated with average daily consumption of caffeine. Women who consumed 31 to 250 mg/day of caffeine were reported to have a 1.5 times increase in odds to have the disease. Women who consumed over 500 mg/day of caffeine were reported to have a 2.3 times increase in odds.
Retroperitoneal fibrosis, pleuropulmonary fibrosis, and pericardial fibrosis have been reported rarely with chronic use of ergotamine and other ergot alkaloids.
Cardiovascular side effects including hypertension, tachycardia, bradycardia, precordial distress, chest pain, and valvular disease have been reported with ergotamine use.
The valvular lesions induced by ergotamine are echocardiographically similar to those seen in rheumatic heart disease, but are more often found on the mitral and aortic valves. A new murmur heard during ergot therapy should prompt evaluation for ergot-induced valvular disease. Rapid discontinuation of ergot therapy may allow the murmur and valvular lesions to regress.
General side effects including caffeinism have been reported. Consumption of higher doses of caffeine (>600 mg/day) has been reported to have lead to caffeinism. Caffeinism is a syndrome characterized by anxiety, restlessness, and sleep disorders (similar to anxiety states). It has also been reported that chronic, heavy caffeine ingestion may be associated with depression. Caffeine may cause anxiety and panic in panic disorder patients and may aggravate PMS.
Musculoskeletal side effects including joint pain, muscle cramps, and weakness have been reported with ergotamine use.
Nervous system side effects including drowsiness, paresthesias, headache, peripheral neuropathy, vertigo, tremor, dystonia, and reflex sympathetic dystrophy have been reported with ergotamine use.
Local side effects including solitary rectal ulcers, anovaginal fistulae, and rectovaginal fistulae have been reported in association with the use of ergotamine suppositories.
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