Wigraine 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 Wigraine.

Some side effects of Wigraine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to caffeine / ergotamine: oral tablet, rectal suppository

Get emergency medical help if you have any of these signs of an allergic reaction while taking caffeine / ergotamine: 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 of caffeine / ergotamine 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.

For Healthcare Professionals

Applies to caffeine / ergotamine: oral tablet, rectal suppository

Gastrointestinal

Gastrointestinal side effects including nausea, vomiting, and diarrhea have occurred commonly with ergotamine use.

Other

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

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

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

Musculoskeletal side effects including joint pain, muscle cramps, and weakness have been reported with ergotamine use.

Nervous system

Nervous system side effects including drowsiness, paresthesias, headache, peripheral neuropathy, vertigo, tremor, dystonia, and reflex sympathetic dystrophy have been reported with ergotamine use.

Local

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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