Applies to caffeine / ergotamine: oral tablet. Other dosage forms:

• rectal suppository

Serious side effects

Along with its needed effects, caffeine/ergotamine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking caffeine / ergotamine:

Incidence not known

• Chest pain, discomfort, or tightness
• cold, pale, or a bluish color skin of the fingers or toes
• continuing loss of appetite
• continuing or severe nausea and vomiting
• continuing or severe stomach pain
• increased frequency of urination
• irregular heartbeat
• itching skin
• lower back pain
• numbness or tingling of the fingers or toes
• pain in the fingers or toes
• pain in arms legs, or lower back, especially pain in calves or heels upon exertion
• sweating
• swelling of hands, ankles, feet, or lower legs
• weakness
• weak or absent pulses in the legs

Get emergency help immediately if any of the following symptoms of overdose occur while taking caffeine / ergotamine:

Symptoms of overdose

• Blurred vision
• change or loss of consciousness
• cold clammy skin
• decreased awareness or responsiveness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• headache
• nervousness
• numbness, tingling, pain, and bluish color of the fingernails, lips, skin, palms, or nail beds
• pounding in the ears
• seizures
• severe sleepiness
• slow or fast heartbeat
• sweating
• unusual tiredness or weakness
• vomiting

Other side effects

Some side effects of caffeine / ergotamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• dizziness or lightheadedness
• feeling of constant movement of self or surroundings
• sensation of spinning

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

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]

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]

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

Uncommon (0.1% to 1%): Extremity pain

Rare (Less than 0.1%): Myalgia^[Ref]

Hypersensitivity

Rare (less than 0.1%): Rash, face edema, urticaria

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

Frequency not reported: Vertigo^[Ref]

Dermatologic

Rare (Less than 0.1%): Rash, face edema, urticaria