Naratriptan Side Effects

Some side effects of naratriptan 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 naratriptan: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking naratriptan: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using naratriptan and call your doctor at once if you have a serious side effect such as:

• feeling of pain or tightness in your jaw, neck, or throat;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• sudden numbness or weakness, especially on one side of the body;

• sudden headache, confusion, problems with vision, speech, or balance;

• sudden and severe stomach pain and bloody diarrhea;

• numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or

• (if you are also taking an antidepressant) -- agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Less serious side effects of naratriptan may include:

• pressure or heavy feeling in any part of your body;

• dizziness, drowsiness, tired feeling; or

• warmth, redness, or mild tingling under your skin.

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 naratriptan: oral tablet

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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