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Topamax (topiramate)

Side Effect Search

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Topamax may cause the following symptoms that are related to stuttering:

Language/speech problems. This symptom may occur with high doses
Speech/language problems Speech/language problems

Medical Source Information
Yellow highlights indicate symptoms related to stuttering.

The FDA has informed healthcare professionals that the agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions. Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.

Side effects most often associated were related to the central nervous system. The most frequent of these can be classified into three categories: 1) cognitive related dysfunction (e.g. confusion, psychomotor slowing, difficulty with concentration/attention, difficulty with memory, speech, or language problems, particularly word finding difficulties), 2) psychiatric/behavior disturbances (e.g. depression or mood problems), and 3) somnolence or fatigue. 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. Psychiatric/behavioral disturbances (depression or mood problems) were dose related. Somnolence and fatigue were the adverse events most frequently reported during clinical trials.

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.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself. Stop taking topiramate and call your doctor at once if you have any of these serious side effects: sudden vision loss, pain around or behind your eyes; dry mouth, increased thirst, confusion, drowsiness, decreased sweating, increased body temperature, and hot, dry skin, nausea, vomiting, increased urination, muscle pain or weakness, fast heart rate, feeling light-headed, fainting, or seizure (convulsions); or severe pain in your side or lower back, painful or difficult urination. Less serious side effects may include: slowed thinking, memory problems, trouble concentrating; problems with speech or balance; numbness or tingling; sleep problems (insomnia); tired feeling; headache, dizziness; or loss of appetite, weight loss. This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Side Effects to Watch
Watch closely for the following side effects and notify your physician immediately should any of these develop:

Abnormal bruising or signs of bleeding such as bleeding from the gums, nose, digestive tract, vagina (females), faintness, dizziness, loss of consciousness, or rash (signs of problems with blood clot formation)

Lab and Diagnostic Tests
If certain symptoms develop, ask your physician whether you need the following lab tests or other diagnostic tests (if you've not already had them):

Blood tests to assess normal clotting - in people who develop signs of bleeding such as abnormal bruising or signs of bleeding including bleeding from the gums, nose, digestive tract, vagina (females), faintness, dizziness, loss of consciousness, or rash

References

Double-blind, placebo-controlled study of topiramate in patients with refractory partial epilepsy. Sharief M, Viteri C, Ben-Menachem E, et al. Epilepsy Res 1996;25:217-24.
Product Information. Topamax (topiramate). Anonymous Ortho Pharmaceutical Corporation, Raritan, NJ. PROD;
Safety of topiramate: adverse events and relationships to dosing. Shorvon SD Epilepsia 1996;37(suppl 2:s18-22.
Transient hemiparesis with topiramate. Stephen LJ, Maxwell JE, Brodie MJ Br Med J 1999;318:845.
Hyperventilation and cerebrospinal fluid acidosis caused by topiramate. Montcriol A, Meaudre E, Kenane N, Asencio Y, Bordes J, Palmier B Ann Pharmacother 2008;42:584-7.

Multum version: 154.0 (Jun 16, 2010)

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