Medical Source InformationYellow highlights indicate symptoms related to nausea.
The use of ergotamine in patients with the following conditions is considered contraindicated: peripheral vascular disease, coronary artery disease, uncontrolled hypertension, impaired hepatic or renal function, sepsis, and pregnancy.
"Ergotism" may rarely develop even after intermittent use of orally or rectally administered ergotamine. Due to the chronicity of migraines, it is imperative that patients be advised not to exceed the limits of recommended dosages. Ergotism is manifested by intense arterial vasoconstriction producing signs of peripheral vascular ischemia. Symptoms may include headache, intermittent claudication, muscle pains and also numbness, coldness and pallor of the digits. If the condition is allowed to progress untreated, gangrene can result.
People who regularly consume even low or moderate doses of caffeine may experience a withdrawal syndrome if their consumption of caffeine is stopped. This withdrawal syndrome may include headaches, drowsiness, fatigue, decreased performance, and possibly even nausea and vomiting. Even preoperative and postoperative headaches have been associated with a caffeine withdrawal syndrome. One study (n=287) has reported that for each 100 mg of caffeine a patient regularly consumed, there was a 12% increase in the odds of a headache developing in the immediate preoperative period, and a 16% increase in the odds of developing a postoperative headache.
Gastrointestinal side effects including nausea, vomiting, and diarrhea have occurred commonly with ergotamine use.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using caffeine and ergotamine and call your doctor at once if you have a serious side effect such as:
sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, problems with vision, speech, or balance;
fast or slow heart rate;
muscle pain in your arms or legs;
leg weakness;
numbness or tingling and a pale or blue-colored appearance in your fingers or toes;
severe pain in your stomach or lower back;
urinating less than usual or not at all;
painful sores on your rectum after using the rectal suppositories;
swelling or itching in any part of your body;
cough with stabbing chest pain and trouble breathing; or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Less serious side effects may include:
dizziness, spinning sensation;
weakness;
nausea, vomiting; or
mild itching.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Nervous system side effects including drowsiness, paresthesias, headache, peripheral neuropathy, vertigo, tremor, dystonia, and reflex sympathetic dystrophy have been reported with ergotamine use.
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.
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.