Naratriptan Side Effects

Brand Names: Amerge

Please note - some side effects for Naratriptan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Naratriptan - for the Consumer

Naratriptan

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Naratriptan:

Dizziness; drowsiness; nausea; numbness or tingling of the skin; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the eyelids, mouth, face, lips, or tongue); blood in stool; bluish discoloration of fingers and toes; chest pain; confusion; fast or irregular heartbeat; feeling hot or cold; fever, chills, or sore throat; increased sensitivity to light; mental or mood changes; neck or throat pain; one-sided weakness; paleness of your skin; persistent numbness or tingling of the skin; sudden, severe, or persistent stomach pain; shortness of breath; slurred speech; tightness of the jaw, neck, or chest; vision changes; vomiting.

Side Effects by Body System

Nervous system

Nervous system side effects have been reported in 7% of patients receiving 2.5 mg, 4% of patients receiving 1 mg, and 3% of patients receiving placebo. These effects included dizziness in 2% of patients receiving 2.5 mg and 1% of patients receiving 1 mg or placebo. These neurological adverse effects also include drowsiness in 2% of patients receiving 2.5 mg, 1% of patients receiving 1 mg, and <1% of patients receiving placebo. Malaise/fatigue have been reported in 2% of patients receiving either 2.5 or 1 mg, and 1% of patients receiving placebo.

Cerebral vascular accidents, including transient ischemic attack, subarachnoid hemorrhage, and cerebral infarction have been reported. Vertigo has been reported frequently. Tremors, disorders of cognitive function, sleep, and/or equilibrium have been reported infrequently. Compressed nerve syndromes, confusion, sedation, hyperesthesia, coordination disorders, paralysis of cranial nerves, decreased consciousness, dreams, altered sense of taste, neuralgia, neuritis, aphasia, hypoesthesia, motor retardation, muscle twitching and fasciculation, psychomotor restlessness, and convulsions have been reported rarely.

Atypical sensation has been reported in 4% of patients receiving 2.5 mg, 2% of patients receiving 1 mg, and 1% of patients receiving placebo. These sensations included paresthesias in 2% of patients receiving 2.5 mg, 1% of patients receiving 1 mg, and <1% of patients receiving placebo. Warm/cold temperature sensations have been reported frequently. A strange feeling and a burning/stinging sensation have been reported infrequently.

Gastrointestinal

Gastrointestinal side effects have been reported in 7% of patients receiving 2.5 mg, 6% of patients receiving 1 mg, and 5% of patients receiving placebo. These effects included nausea in 5% of patients receiving 2.5 mg, and 4% in patients receiving 1 mg or placebo. Colonic ischemia with abdominal pain and bloody diarrhea has also been reported in patients using naratriptan. Hyposalivation has been reported frequently. Dyspeptic symptoms, diarrhea, gastrointestinal discomfort and pain, gastroenteritis, and constipation have been reported infrequently. Abnormal liver function tests, abnormal bilirubin levels, hemorrhoids, gastritis, esophagitis, salivary gland inflammation, oral itching and irritation, reflux, regurgitation, and gastric ulcers have been reported rarely.

While vomiting has been reported frequently, it occurred even more frequently in subjects receiving placebo than in patients receiving 2.5 mg.

Other

Other side effects have included pain and pressure sensation which have been reported in 4% of patients receiving 2.5 mg, and 2 % of patients receiving 1 mg or placebo. Throat/neck symptoms have been reported in 2% of patients receiving 2.5 mg and 1% of patients receiving 1 mg or placebo. Pressure/tightness/heaviness sensations have been reported frequently. Drug-induced headache has also been reported.

Ear, nose, and throat infections have been reported frequently. Phonophobia, sinusitis, upper respiratory inflammation, and tinnitus have been reported infrequently. Allergic rhinitis, labyrinthitis, hearing difficulty, and hemorrhage of the ear, nose, and throat, have been reported rarely.

Chills and/or fever, edema and swelling have been reported infrequently. Spasms and mobility disorders have been reported rarely.

Cardiovascular

Cardiovascular side effects including palpitations, increased blood pressure, tachyarrhythmias, and abnormal ECG (PR prolongation, QTc prolongation, ST/T wave abnormalities, premature ventricular contractions, atrial flutter, or atrial fibrillation), peripheral vascular ischemia, and syncope have been reported infrequently. Bradycardia, varicosities, hypotension, and heart murmurs have been reported rarely. Angina and myocardial infarction have also been reported.

Endocrine

Endocrine side effects including thirst and polydipsia, dehydration, and fluid retention have been reported infrequently. Hyperlipidemia, hypercholesterolemia, hypothyroidism, hyperglycemia, glycosuria, ketonuria, and parathyroid neoplasm have been reported rarely.

Ocular

Ocular side effects including photophobia have been reported frequently. Blurred vision has been reported infrequently. Eye pain and discomfort, sensation of eye pressure, eye hemorrhage, dry eyes, difficulty focusing, and scotoma have been reported rarely.

Hematologic

Hematologic side effects including increased white blood cells have been reported infrequently. Thrombocytopenia, quantitative red blood cell or hemoglobin defects, anemia, and purpura have been reported rarely.

Respiratory

Respiratory side effects including bronchitis, cough, and pneumonia have been reported infrequently. Tracheitis, asthma, pleuritis, and airway constriction and obstruction have been reported rarely. Dyspnea has also been reported.

Musculoskeletal

Musculoskeletal side effects including muscle pain, arthralgia and articular rheumatism, muscle cramps and spasms, joint and muscle stiffness, tightness, and rigidity have been reported infrequently. Bone and skeletal pain have been reported rarely.

Hypersensitivity

Hypersensitivity side effects have been reported including anaphylaxis/anaphylactoid reactions, in some cases severe (e.g., circulatory collapse). Allergies and allergic reactions have been reported infrequently.

Psychiatric

Psychiatric side effects including anxiety, depressive disorders, and detachment have been reported infrequently. Aggression and hostility, agitation, hallucinations, panic, and hyperactivity have been reported rarely.

Genitourinary

Genitourinary side effects including bladder inflammation, polyuria, and diuresis have been reported infrequently. Urinary tract hemorrhage, urinary urgency, pyelitis, urinary incontinence, lumps of the female reproductive tract, inflammation of the breast, vagina, and/or fallopian tube, breast discharge, endometrium disorders, decreased libido, and breast lumps have been reported rarely.

Dermatologic

Dermatologic side effects including sweating, skin rashes, pruritus, and urticaria have been reported infrequently. Skin erythema, dermatitis and dermatosis, hair loss and alopecia, pruritic skin rashes, acne and folliculitis, allergic skin reactions, macular skin/rashes, skin photosensitivity, photodermatitis, skin flakiness, and dry skin have been reported rarely.

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