Applies to almotriptan: oral tablet.

Serious side effects of Almotriptan

Along with its needed effects, almotriptan 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 almotriptan:

Less common

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain
• discharge from the eye
• eye irritation
• fast, irregular, pounding, or racing heartbeat or pulse
• itching, redness, or swelling of the skin
• neck pain or rigid neck
• redness of the inner lining of the eyelid
• skin rash
• shortness of breath
• tightness in the throat

Rare

• Abdominal or stomach cramping or pain
• black, tarry stools
• blood in the stools
• bringing back up of food
• chest pain, severe
• cool, pale skin
• diarrhea
• difficulty with swallowing
• earache
• fainting
• fever
• heartburn, repeated
• increased sweating
• loss of appetite
• loss of vision
• rapid breathing
• tightness in the chest
• weight loss

Other side effects of Almotriptan

Some side effects of almotriptan 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:

More common

• Burning, numbness, prickly, or tingling feeling
• dizziness
• dry mouth
• headache
• nausea
• sleepiness

Less common

• Aching, fullness, or tension in the sinuses
• anxious feeling
• back pain
• belching
• change in sense of taste
• chills
• cough producing mucus
• decreased sensitivity to touch
• feeling of constant movement of self or surroundings
• feeling of spinning
• feeling of warmth or heat
• flushing or redness of the skin
• increased sense of hearing
• indigestion
• lack or loss of strength
• muscle aches or weakness
• nosebleed
• painful menstrual period
• quivering or trembling
• restlessness
• runny or stuffy nose
• sore throat
• trouble sleeping
• vomiting

Rare

• Abnormal increase in reflexes
• abnormally increased feeling of mental and physical well-being
• buzzing or ringing in the ears
• change in dreams or nightmares
• change in sense of smell
• change in sense of touch
• clumsiness or unsteadiness
• continuous, uncontrolled, back-and-forth or rolling eye movements
• cough
• difficulty in concentrating
• double vision
• drooling
• dry eyes
• dry throat
• feeling of pins and needles
• hoarseness
• increased sensitivity to sunlight
• increased thirst
• loss of voice
• mental depression
• muscle stiffness
• nervousness
• pain, redness, swelling, or warmth in the joints
• sneezing
• stabbing pain

For Healthcare Professionals

Applies to almotriptan: oral tablet.

General

The most common adverse reactions in adults included nausea, dry mouth, and paresthesia. The most common adverse reactions in adolescents included dizziness, somnolence, headache, paresthesia, nausea, and vomiting.^[Ref]

Cardiovascular

At least 1 case of coronary vasospasm has been reported in a patient with no cardiac history and with documented absence of coronary artery disease (CAD) following administration of this drug. During clinical trials (n=3865), a 48-year old female patient who had previously taken 3-doses for earlier migraine attacks was hospitalized after an ECG found negative T-waves on the left leads 48 hours after receiving almotriptan 6.25 mg. Myocardial enzymes were normal. The patient had a family history of CAD. A coronary angiography and an ECG done 2 days later were normal.

Mean increases in systolic and diastolic blood pressure were observed in normotensive healthy subjects (0.21 and 1.35 mmHg) and patients with hypertension controlled by medication (4.87 and 0.26 mmHg), respectively, over the first 4 hours after receiving almotriptan 12.5 mg.^[Ref]

Uncommon (0.1% to 1%): Chest pain, vasodilation, palpitations, tachycardia

Rare (less than 0.1%): Hypertension, syncope

Frequency not reported: Coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, ventricular fibrillation, sensation of pain, tightness, pressure in the chest and/or throat, neck and jaw, peripheral vascular ischemia

Postmarketing reports: Acute myocardial infarction, coronary artery vasospasm, angina pectoris, tachycardia^[Ref]

Nervous system

Common (1% to 10%): Somnolence, headache, paresthesia, dizziness

Uncommon (0.1% to 1%): Tremor, hypoesthesia, CNS stimulation, shakiness

Rare (less than 0.1%): Impaired concentration, abnormal coordination, hyperreflexia, hypertonia, neuropathy, nystagmus, insomnia, parosmia, taste alteration

Postmarketing reports: Hemiplegia, hypoesthesia, seizures^[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, dry mouth, vomiting

Uncommon (0.1% to 1%): Abdominal cramp or pain, diarrhea, dyspepsia, gastroenteritis, increased thirst

Rare (less than 0.1%): Colitis, gastritis, esophageal reflux, increased salivation

Frequency not reported: Colonic ischemia

Postmarketing reports: Abdominal discomfort, abdominal pain, upper abdominal pain, colitis, hypoesthesia oral, swollen tongue^[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions including angioedema, anaphylactic reactions and anaphylactic shock^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Neck pain, rigid neck, back pain, myalgia, bone pain

Rare (less than 0.1%): Arthralgia, arthritis, myopathy, muscle weakness

Postmarketing reports: Arthralgia, myalgia, extremity pain^[Ref]

Respiratory

Uncommon (0.1% to 1%): Pharyngitis, rhinitis, dyspnea, laryngismus, sinusitis, bronchitis, throat tightness

Rare (less than 0.1%): Hyperventilation, laryngitis, sneezing, epistaxis^[Ref]

Other

Uncommon (0.1% to 1%): Asthenia, chills, fatigue, ear pain, tinnitus

Rare (less than 0.1%): Fever, otitis media, hyperacusis

Postmarketing reports: Malaise, peripheral coldness, vertigo^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Dysmenorrhea^[Ref]

Psychiatric

Uncommon (0.1% to 1%): Anxiety, restlessness

Rare (less than 0.1%): Changes in dreams, depressive symptoms, euphoria, nervousness, nightmares, insomnia

Postmarketing reports: Confusional state, restlessness^[Ref]

Metabolic

Uncommon (0.1% to 1%): Hyperglycemia, increased serum creatine phosphokinase

Rare (less than 0.1%): Hypercholesterolemia^[Ref]

Hepatic

Rare (less than 0.1%): Increased gamma glutamyl transpeptidase^[Ref]

Ocular

Rare (less than 0.1%): Diplopia, dry eyes, eye pain, scotoma, conjunctivitis, eye irritation

Postmarketing reports: Blepharospasm, visual impairment, blurred vision^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Diaphoresis, pruritus, rash

Rare (less than 0.1%): Photosensitivity reaction, dermatitis, erythema

Postmarketing reports: Cold sweat, erythema, hyperhidrosis^[Ref]

Endocrine

Postmarketing reports: Breast pain^[Ref]