Topiramate Side Effects

Brand Names: Topamax

Please note - some side effects for Topiramate 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 Topiramate - for the Consumer

Topiramate

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 Topiramate:

Constipation; decreased sweating; diarrhea; dizziness; drowsiness; dry mouth; flu-like symptoms; headache; loss of appetite; nausea; nervousness or anxiety; numbness or tingling of the skin; runny nose; sore throat; stomach pain or upset; taste changes; tiredness; trouble sleeping; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; blurred vision; bone pain; chest pain; confusion; decreased coordination; depression; double vision or other vision changes; eye pain; irregular heartbeat; loss of consciousness; memory problems; menstrual changes; mental or mood changes; muscle or joint pain, cramps, or weakness; rapid, shallow breathing; red, swollen, blistered, or peeling skin; ringing in the ears; severe or persistent loss of appetite; severe stomach, side, or back pain; significant weight loss; speech problems; stupor; suicidal thoughts or actions; tremor; trouble thinking, concentrating, or remembering things; trouble walking; unexplained fever; unusual bruising or bleeding; unusual eye movements; unusual tiredness.

Topiramate Sprinkle Capsules

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 Topiramate Sprinkle Capsules:

Constipation; decreased sweating; diarrhea; dizziness; drowsiness; dry mouth; flu-like symptoms; headache; loss of appetite; nausea; nervousness or anxiety; numbness or tingling of the skin; runny nose; sore throat; stomach pain or upset; taste changes; tiredness; trouble sleeping; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; blurred vision; bone pain; chest pain; confusion; decreased coordination; depression; double vision or other vision changes; eye pain; irregular heartbeat; loss of consciousness; memory problems; menstrual changes; mental or mood changes; muscle or joint pain, cramps, or weakness; rapid, shallow breathing; red, swollen, blistered, or peeling skin; ringing in the ears; severe or persistent loss of appetite; severe stomach, side, or back pain; significant weight loss; speech problems; stupor; suicidal thoughts or actions; tremor; trouble thinking, concentrating, or remembering things; trouble walking; unexplained fever; unusual bruising or bleeding; unusual eye movements; unusual tiredness.

Side Effects by Body System

General

General side effects including fatigue, fever, and malaise have been reported to occur frequently. Oligohidrosis, pain, chest pain, and hyperthermia have also been reported.

Nervous system

The majority of cognitive-related adverse events were mild to moderate in severity and frequently occurred in isolation. Rapid titration rate and higher initial doses were associated with higher incidences of cognitive-related adverse events.

Nervous system side effects have been common and have included somnolence, dizziness (greater than 25%), ataxia, speech disorders, psychomotor slowing, hypokinesia, vertigo, grand mal seizures, diplopia, nystagmus, tinnitus, and paresthesias. These nervous system adverse reactions do not appear to be dose-related. Dose-related adverse effects have included fatigue (frequently), nervousness, difficulty with concentration or attention, confusion, psychomotor slowing, difficulty with concentration/attention, difficulty with memory, speech, or language problems (particularly word finding difficulties), and tremor. Headache, vertigo, sensory disturbance, and aggravated migraine have also been reported. A case has been reported of cerebrospinal fluid acidosis associated with hyperventilation that was probably caused by topiramate.

Hepatic

Hepatic side effects including hepatic failure (sometimes fatal) and hepatitis have been reported.

Ocular

The primary treatment of cases of secondary angle closure glaucoma cause by topiramate is discontinuation of the drug.

Ocular side effects including cases of secondary angle closure glaucoma characterized by ocular pain, acute myopia, abnormal accommodation, and increased intraocular pressure have been reported. Maculopathy has also been reported.

Gastrointestinal

Gastrointestinal side effects include diarrhea, vomiting, pancreatitis, gastroenteritis, constipation, gastroesophageal reflux, tooth disorder, and flatulence have been reported. Tongue edema has been reported rarely.

Cardiovascular

Cardiovascular side effects including palpitations have been reported frequently. Hypertension and hypotension have been reported infrequently.

Hematologic

Hematologic side effects including anemia and epistaxis have been a reported frequently.

Metabolic

Metabolic side effects have included metabolic acidosis, dehydration, diabetes mellitus, and weight increase.

Musculoskeletal

Musculoskeletal side effects including arthralgia, myalgia, and muscle weakness have been reported. A case of hemiparesis has also been reported.

Psychiatric

Psychiatric side effects including insomnia, personality disorder, impotence, hallucination, euphoria, psychosis, decreased libido, anxiety, depression, mood problems, and suicide attempts have been reported. Two cases of panic attacks have also been reported.

Depression and mood problems were dose related.

Genitourinary

Genitourinary side effects in the female frequently have included intermenstrual bleeding, leukorrhea, menorrhagia, vaginitis, and amenorrhea. Urinary tract infections, micturition frequency, urinary incontinence, dysuria, and renal calculus have also been reported frequently. Cases of reversible anorgasmia have also been reported. Kidney stones (1.5%) have occurred more frequently in men.

Respiratory

Respiratory side effects including pulmonary embolism, coughing, pneumonia, asthma, and bronchitis have been reported.

Dermatologic

Dermatologic side effects including bullous skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), pemphigus, acne, rash, and alopecia have been reported. Pruritus has been reported rarely.

Other

Other side effects including taste perversion have been reported frequently. Headaches have also been reported to occur.

Renal

Renal side effects including kidney stones (1.3% to 1.5%) and renal tubular acidosis have been reported.

Hypersensitivity

Hypersensitivity side effects including allergic reaction have been reported.

Immunologic

Immunologic side effects have been reported including infection and genital moniliasis.

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