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Topiragen Side Effects

Generic Name: topiramate

Note: This page contains side effects data for the generic drug topiramate. It is possible that some of the dosage forms included below may not apply to the brand name Topiragen.

It is possible that some side effects of Topiragen may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to topiramate: oral capsule, oral capsule extended release, oral tablet

As well as its needed effects, topiramate (the active ingredient contained in Topiragen) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking topiramate, check with your doctor immediately:

More common
  • Any vision problems, especially blurred vision, double vision, eye pain, or rapidly decreasing vision
  • burning, prickling, or tingling sensations
  • clumsiness or unsteadiness
  • confusion
  • continuous, uncontrolled back-and-forth or rolling eye movements
  • dizziness
  • drowsiness
  • eye redness
  • generalized slowing of mental and physical activity
  • increased eye pressure
  • memory problems
  • menstrual changes
  • menstrual pain
  • nervousness
  • speech or language problems
  • trouble in concentrating or paying attention
  • unusual tiredness or weakness
Less common
  • Abdominal or stomach pain
  • fever, chills, or sore throat
  • lessening of sensations or perception
  • loss of appetite
  • mood or mental changes, including aggression, agitation, apathy, irritability, and mental depression
  • red, irritated, or bleeding gums
  • weight loss
Rare
  • Blood in the urine
  • decrease in sexual performance or desire
  • difficult or painful urination
  • frequent urination
  • hearing loss
  • loss of bladder control
  • lower back or side pain
  • nosebleeds
  • pale skin
  • red or irritated eyes
  • ringing or buzzing in the ears
  • skin rash or itching
  • swelling
  • trouble breathing
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • blisters in the mouth
  • blisters on the trunk, scalp, or other areas
  • bloating
  • clay-colored stools
  • constipation
  • cough
  • diarrhea
  • increased rate of breathing
  • joint or muscle pain
  • pain or tenderness in upper abdomen or stomach
  • red skin lesions, often with a purple center
  • sores, ulcers, or white spots in the mouth or on the lips
  • yellow eyes or skin

If any of the following symptoms of overdose occur while taking topiramate, get emergency help immediately:

Symptoms of overdose
  • Decreased awareness or responsiveness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • severe sleepiness
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Some topiramate side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Breast pain in women
  • tremors
Less common
  • Back pain
  • chest pain
  • constipation
  • heartburn
  • hot flushes
  • increased sweating
  • leg pain

For Healthcare Professionals

Applies to topiramate: oral capsule, oral capsule extended release, oral tablet

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.[Ref]

Very common (10% or more): Paresthesia, somnolence, dizziness
Common (1% to 10%): Disturbance in attention, memory impairment, amnesia, cognitive disorder, mental impairment, psychomotor skills impaired, convulsion, coordination abnormal, tremor, lethargy, hypothesia, nystagmus, dysgeusia, balance disorder, dysarthria, intention tremor, sedation
Uncommon (0.1% to 1%): Depressed level of consciousness, grand mal convulsion, visual field defect, complex partial seizures, speech disorder, psychomotor hyperactivity, syncope, sensory disturbance, drooling, hypersomnia, aphasia, repetitive speech, hypokinesia, dyskinesia, dizziness postural, poor quality sleep, burning sensation, sensory loss, parosmia, cerebellar syndrome, dysesthesia, hypogeusia, stupor, clumsiness, aura, ageusia, dysgraphia, dysphasia, neuropathy peripheral, presyncope, dystonia, formication
Rare (less than 0.1%): Apraxia, circadian rhythm sleep disorder, hyperesthesia, hyposmia, anosmia, essential tremor, akinesia, unresponsive to stimuli[Ref]

Hepatic

Rare (less than 0.1%): Hepatitis, hepatic failure, increase in liver enzymes[Ref]

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.[Ref]

Common (1% to 10%): Vision blurred, diplopia, visual disturbance
Uncommon (0.1% to 1%): Visual acuity reduced, scotoma, myopia, abnormal sensation in eye, dry eye, photophobia, blepharospasm, lacrimation increased, photopsia, mydriasis, presbyopia
Rare (less than 0.1%): Blindness unilateral, blindness transient, glaucoma, accommodation disorder, altered visual depth perception, scintillating scotoma, eyelid edema, night blindness, amblyopia
Very rare (less than 0.01%):
Frequency not reported: Angle closure glaucoma, maculopathy, eye movement disorder[Ref]

Gastrointestinal

Very common (10% or more): Nausea, diarrhea
Common (1% to 10%): Vomiting, constipation, abdominal pain upper, dyspepsia, abdominal pain, dry mouth, stomach discomfort, paresthesia oral, gastritis, abdominal discomfort
Uncommon (0.1% to 1%): Pancreatitis, flatulence, gastroesophageal reflux disease, abdominal pain lower, hypoesthesia oral, gingival bleeding, abdominal distension, epigastric discomfort, abdominal tenderness, salivary hypersecretion, oral pain, breath odor, glossodynia[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Bradycardia, sinus bradycardia, palpitations, hypotension, orthostatic hypotension, flushing, hot flush
Rare (less than 0.1%): Raynaud's phenomenon[Ref]

Hematologic

Common (1% to 10%): Anemia, epistaxis
Uncommon (0.1% to 1%): Leucopenia, thrombocytopenia lymphadenopathy, white blood cell count decreased, eosinophilia
Rare (less than 0.1%): Neutropenia[Ref]

Metabolic

Very common (10% or more): Weight decreased
Common (1% to 10%): Anorexia, decreased appetite, weight increased
Uncommon (0.1% to 1%): Metabolic acidosis, hypokalemia, increased appetite, polydipsia
Rare (less than 0.1%): Acidosis hyperchloremic, blood bicarbonate decreased[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, muscle spasms, myalgia, muscle twitching, muscular weakness, musculoskeletal chest pain
Uncommon (0.1% to 1%): Joint swelling, musculoskeletal stiffness, flank pain, muscle fatigue
Rare (less than 0.1%): Limb discomfort[Ref]

Psychiatric

Depression and mood problems were dose related.[Ref]

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.[Ref]

Genitourinary

Uncommon (0.1% to 1%): Erectile dysfunction, sexual dysfunction, crystal urine present, intermenstrual bleeding, leukorrhea, menorrhagia, vaginitis, and amenorrhea., urinary tract infections, micturition frequency, urinary incontinence, dysuria[Ref]

Respiratory

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

Dermatologic

Common (1% to 10%): Alopecia, rash, pruritus
Uncommon (0.1% to 1%): Anhidrosis, hypoesthesia facial, urticaria, erythema, pruritus generalized, rash macular, skin discoloration, dermatitis allergic, swelling face
Rare (less than 0.1%): Stevens-Johnson syndrome, erythema multiforme, skin odor abnormal, periorbital edema, urticaria localized
Frequency not reported: Toxic epidermal necrolysis[Ref]

Other

Very common (10% or more): Fatigue
Common (1% to 10%): Vertigo, tinnitus, ear pain pyrexia, asthenia, irritability, gait disturbance, feeling abnormal, malaise
Uncommon (0.1% to 1%): Deafness, deafness unilateral, deafness neurosensory, ear discomfort, hearing impaired, hyperthermia, thirst, influenza like illness, sluggishness, peripheral coldness, feeling drunk, feeling jittery, tandem gait test abnormal
Rare (less than 0.1%): Face edema, calcinosis, learning disability[Ref]

Renal

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

Hypersensitivity

Common (1% to 10%): Hypersensitivity
Frequency not reported: Allergic edema, conjunctival edema[Ref]

Immunologic

Very common (10% or more): Nasopharyngitis
Frequency not reported: Genital moniliasis[Ref]

References

1. Shorvon SD "Safety of topiramate: adverse events and relationships to dosing." Epilepsia 37(suppl 2 (1996): s18-22

2. "Product Information. Topamax (topiramate)." Ortho Pharmaceutical Corporation, Raritan, NJ.

3. Sharief M, Viteri C, Ben-Menachem E, et al. "Double-blind, placebo-controlled study of topiramate in patients with refractory partial epilepsy." Epilepsy Res 25 (1996): 217-24

4. Stephen LJ, Maxwell JE, Brodie MJ "Transient hemiparesis with topiramate." Br Med J 318 (1999): 845

5. Montcriol A, Meaudre E, Kenane N, Asencio Y, Bordes J, Palmier B "Hyperventilation and cerebrospinal fluid acidosis caused by topiramate." Ann Pharmacother 42 (2008): 584-7

6. Bjoro K, Gjerstad L, Bentdal O, Osnes S, Schrumpf E "Topiramate and fulminant liver failure." Lancet 352 (1998): 1119

7. Adverse Drug Reactions Advisory Committee (ADRAC) and the Adverse Drug Reactions Unit of the TGA "Australian Adverse Drug Reactions Bulletin. Available from: URL: http://www.tga.gov.au/adr/aadrb/aadr0804.htm." ([2008 Apr]):

8. Damsa C, Warczyk S, Cailhol L, et al. "Panic attacks associated with topiramate." J Clin Psychiatry 67 (2006): 326-7

9. Newman LC, Broner SW, Lay CL "Reversible anorgasmia with topiramate therapy for migraine." Neurology 65 (2005): 1333-4

10. Ochoa JG "Pruritus, a rare but troublesome adverse reaction of topiramate." Seizure 12 (2003): 516-8

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