Topiragen Side Effects

Generic name: topiramate

Note: This document contains side effect information about topiramate. Some of the dosage forms listed on this page may not apply to the brand name Topiragen.

Some side effects of Topiragen 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 topiramate: oral capsule, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking topiramate (the active ingredient contained in Topiragen) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have a serious side effect such as:

• sudden vision loss, pain around or behind your eyes;

• dry mouth, increased thirst, drowsiness, decreased sweating, increased body temperature, and hot, dry skin,

• confusion, slowed thinking, memory problems, trouble concentrating, problems with speech or balance;

• vomiting, loss of appetite, tired feeling, irregular heartbeats, feeling like you might pass out; or

• severe pain in your side or lower back, painful or difficult urination.

Less serious side effects of topiramate may include:

• mild dizziness, feeling nervous;

• numbness or tingly feeling;

• diarrhea, weight loss; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to topiramate: oral capsule, oral tablet

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 (the active ingredient contained in Topiragen) 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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