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Topamax (Topiramate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The data described in the following section were obtained using TOPAMAX® (topiramate) Tablets.

Monotherapy Epilepsy

The adverse events in the controlled trial that occurred most commonly in adults in the 400 mg/day group and at a rate higher than the 50 mg/day group were: paresthesia, weight decrease, somnolence, anorexia, dizziness, and difficulty with memory NOS [see Table 4 ].

The adverse events in the controlled trial that occurred most commonly in children (10 years up to 16 years of age) in the 400 mg/day group and at a rate higher than the 50 mg/day group were: weight decrease, upper respiratory tract infection, paresthesia, anorexia, diarrhea, and mood problems [see Table 5 ].

Approximately 21% of the 159 adult patients in the 400 mg/day group who received topiramate as monotherapy in the controlled clinical trial discontinued therapy due to adverse events. Adverse events associated with discontinuing therapy (≥2%) included depression, insomnia, difficulty with memory (NOS), somnolence, paresthesia, psychomotor slowing, dizziness, and nausea.

Approximately 12% of the 57 pediatric patients in the 400 mg/day group who received topiramate as monotherapy in the controlled clinical trial discontinued therapy due to adverse events. Adverse events associated with discontinuing therapy (≥5%) included difficulty with concentration/attention.

The prescriber should be aware that these data cannot be used to predict the frequency of adverse events in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during the clinical study. Similarly, the cited frequencies cannot be directly compared with data obtained from other clinical investigations involving different treatments, uses, or investigators. Inspection of these frequencies, however, does provide the prescribing physician with a basis to estimate the relative contribution of drug and non-drug factors to the adverse event incidences in the population studied.

Table 4: Incidenceof Treatment-Emergent Adverse Events in the Monotherapy Epilepsy Trial in Adultsa Where Rate Was at Least 2% in the 400 mg/day Topiramate Group and Greater Than the Rate in the 50 mg/day Topiramate Group
TOPAMAX® Dosage (mg/day)
Body System /
Adverse Event
50
(N= 160)
400
(N=159)

a Values represent the percentage of patients reporting a given adverse event. Patients may have reported more than one adverse event during the study and can be included in more than one adverse event category

Body as a Whole-General Disorders
   Asthenia46
   Leg Pain23
   Chest Pain12
Central & Peripheral Nervous System Disorders
   Paresthesia2140
   Dizziness1314
   Hypoaesthesia45
   Ataxia34
   Hypertonia03
Gastro-Intestinal System Disorders
   Diarrhea56
   Constipation14
   Gastritis03
   Dry Mouth13
   Gastroesophageal Reflux12
Liver and Biliary System Disorders
   Gamma-GT Increased13
Metabolic and Nutritional Disorders
   Weight Decrease616
Psychiatric Disorders
   Somnolence915
   Anorexia414
   Difficulty with Memory NOS510
   Insomnia89
   Depression79
   Difficulty with Concentration/Attention78
   Anxiety46
   Psychomotor Slowing35
   Mood Problems25
   Confusion34
   Cognitive Problem NOS14
   Libido Decreased03
Reproductive Disorders, Female
   Vaginal Hemorrhage03
Red Blood Cell Disorders
   Anemia12
Resistance Mechanism Disorders
   Infection Viral68
   Infection23
Respiratory System Disorders
   Bronchitis34
   Rhinitis24
   Dyspnea12
Skin and Appendages Disorders
   Rash14
   Pruritus14
   Acne23
Special Senses Other, Disorders
   Taste Perversion35
Urinary System Disorders
   Cystitis13
   Renal Calculus03
   Urinary Tract Infection12
   Dysuria02
   Micturition Frequency02
Table 5: Incidence of Treatment-Emergent Adverse Events in the Monotherapy Epilepsy Trial in Children Ages 10 up to 16 Yearsa Where Rate Was at Least 5% in the 400 mg/day Topiramate Group and Greater Than the Rate in the 50 mg/day Topiramate Group
TOPAMAX® Dosage (mg/day)
Body System /
Adverse Event
50
(N=57)
400
(N=57)

a Values represent the percentage of patients reporting a given adverse event. Patients may have reported more than one adverse event during the study and can be included in more than one adverse event category.

Body as a Whole-General Disorders
   Fever09
Central & Peripheral Nervous System Disorders
   Paresthesia216
Gastro-Intestinal System Disorders
   Diarrhea511
Metabolic and Nutritional Disorders
   Weight Decrease721
Psychiatric Disorders
   Anorexia1114
   Mood Problems211
   Difficulty with Concentration/Attention49
   Cognitive Problems NOS07
   Nervousness45
Resistance Mechanism Disorders
   Infection Viral49
   Infection27
Respiratory System Disorders
   Upper Respiratory Tract Infection1618
   Rhinitis27
   Bronchitis27
   Sinusitis25
Skin and Appendages Disorders
   Alopecia25

Adjunctive Therapy Epilepsy

The most commonly observed adverse events associated with the use of topiramate at dosages of 200 to 400 mg/day in controlled trials in adults with partial onset seizures, primary generalized tonic-clonic seizures, or Lennox-Gastaut syndrome, that were seen at greater frequency in topiramate-treated patients and did not appear to be dose-related were: somnolence, dizziness, ataxia, speech disorders and related speech problems, psychomotor slowing, abnormal vision, difficulty with memory, paresthesia and diplopia [see Table 6 ]. The most common dose-related adverse events at dosages of 200 to 1,000 mg/day were: fatigue, nervousness, difficulty with concentration or attention, confusion, depression, anorexia, language problems, anxiety, mood problems, and weight decrease [see Table 8 ].

Adverse events associated with the use of topiramate at dosages of 5 to 9 mg/kg/day in controlled trials in pediatric patients with partial onset seizures, primary generalized tonic-clonic seizures, or Lennox-Gastaut syndrome, that were seen at greater frequency in topiramate-treated patients were: fatigue, somnolence, anorexia, nervousness, difficulty with concentration/attention, difficulty with memory, aggressive reaction, and weight decrease [see Table 9 ].

In controlled clinical trials in adults, 11% of patients receiving topiramate 200 to 400 mg/day as adjunctive therapy discontinued due to adverse events. This rate appeared to increase at dosages above 400 mg/day. Adverse events associated with discontinuing therapy included somnolence, dizziness, anxiety, difficulty with concentration or attention, fatigue, and paresthesia and increased at dosages above 400 mg/day. None of the pediatric patients who received topiramate adjunctive therapy at 5 to 9 mg/kg/day in controlled clinical trials discontinued due to adverse events.

Approximately 28% of the 1,757 adults with epilepsy who received topiramate at dosages of 200 to 1,600 mg/day in clinical studies discontinued treatment because of adverse events; an individual patient could have reported more than one adverse event. These adverse events were: psychomotor slowing (4.0%), difficulty with memory (3.2%), fatigue (3.2%), confusion (3.1%), somnolence (3.2%), difficulty with concentration/attention (2.9%), anorexia (2.7%), depression (2.6%), dizziness (2.5%), weight decrease (2.5%), nervousness (2.3%), ataxia (2.1%), and paresthesia (2.0%). Approximately 11% of the 310 pediatric patients who received topiramate at dosages up to 30 mg/kg/day discontinued due to adverse events. Adverse events associated with discontinuing therapy included aggravated convulsions (2.3%), difficulty with concentration/attention (1.6%), language problems (1.3%), personality disorder (1.3%), and somnolence (1.3%).

Incidence in Epilepsy Controlled Clinical Trials – Adjunctive Therapy – Partial Onset Seizures, Primary Generalized Tonic-Clonic Seizures, and Lennox-Gastaut Syndrome

Table 6 lists treatment-emergent adverse events that occurred in at least 1% of adults treated with 200 to 400 mg/day topiramate in controlled trials that were numerically more common at this dose than in the patients treated with placebo. In general, most patients who experienced adverse events during the first eight weeks of these trials no longer experienced them by their last visit. Table 9 lists treatment-emergent adverse events that occurred in at least 1% of pediatric patients treated with 5 to 9 mg/kg topiramate in controlled trials that were numerically more common than in patients treated with placebo.

The prescriber should be aware that these data were obtained when TOPAMAX® was added to concurrent antiepileptic drug therapy and cannot be used to predict the frequency of adverse events in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with data obtained from other clinical investigations involving different treatments, uses, or investigators.Inspection of these frequencies, however, does provide the prescribing physician with a basis to estimate the relative contribution of drug and non-drug factors to the adverse event incidences in the population studied.

Other Adverse Events Observed During Double-Blind Epilepsy Adjunctive Therapy Trials

Other events that occurred in more than 1% of adults treated with 200 to 400 mg of topiramate in placebo-controlled epilepsy trials but with equal or greater frequency in the placebo group were: headache, injury, anxiety, rash, pain, convulsions aggravated, coughing, fever, diarrhea, vomiting, muscle weakness, insomnia, personality disorder, dysmenorrhea, upper respiratory tract infection, and eye pain.

Table 6: Incidence of Treatment-Emergent Adverse Events in Placebo-Controlled, Add-On Epilepsy Trials in Adultsa,b Where Rate Was > 1% in Any Topiramate Group and Greater Than the Rate in Placebo-Treated Patients
TOPAMAX® Dosage (mg/day)
Body System /
Adverse Eventc
Placebo
(N=291)
200-400
(N=183)
600-1,000
(N=414)

a Patients in these add-on trials were receiving 1 to 2 concomitant antiepileptic drugs in addition to TOPAMAX® or placebo.

b Values represent the percentage of patients reporting a given adverse event. Patients may have reported more than one adverse event during the study and can be included in more than one adverse event category.

c Adverse events reported by at least 1% of patients in the TOPAMAX® 200-400 mg/day group and more common than in the placebo group are listed in this table.

Body as a Whole-General Disorders
   Fatigue131530
   Asthenia163
   Back Pain453
   Chest Pain342
   Influenza-Like Symptoms234
   Leg Pain224
   Hot Flushes121
   Allergy123
   Edema121
   Body Odor010
   Rigors01<1
Central & Peripheral Nervous System Disorders
   Dizziness152532
   Ataxia71614
   Speech Disorders/Related Speech Problems21311
   Paresthesia41119
   Nystagmus71011
   Tremor699
   Language Problems1610
   Coordination Abnormal244
   Hypoaesthesia121
   Gait Abnormal132
   Muscle Contractions Involuntary122
   Stupor021
   Vertigo112
Gastro-Intestinal System Disorders
   Nausea81012
   Dyspepsia676
   Abdominal Pain467
   Constipation243
   Gastroenteritis121
   Dry Mouth124
   Gingivitis<111
   GI Disorder<110
Hearing and Vestibular Disorders
   Hearing Decreased121
Metabolic and Nutritional Disorders
   Weight Decrease3913
Muscle-Skeletal System Disorders
   Myalgia122
   Skeletal Pain010
Platelet, Bleeding,& Clotting Disorders
   Epistaxis121
Psychiatric Disorders
   Somnolence122928
   Nervousness61619
   Psychomotor Slowing21321
   Difficulty with Memory31214
   Anorexia41012
   Confusion51114
   Depression5513
   Difficulty with Concentration/Attention2614
   Mood Problems249
   Agitation233
   Aggressive Reaction233
   Emotional Lability133
   Cognitive Problems133
   Libido Decreased12<1
   Apathy113
   Depersonalization112
Reproductive Disorders, Female
   Breast Pain240
   Amenorrhea122
   Menorrhagia021
   Menstrual Disorder121
Reproductive Disorders, Male
   Prostatic Disorder<120
Resistance Mechanism Disorders
   Infection121
   Infection Viral12<1
   Moniliasis<110
Respiratory System Disorders
   Pharyngitis263
   Rhinitis676
   Sinusitis456
   Dyspnea112
Skin and Appendages Disorders
   Skin Disorder<121
   Sweating Increased<11<1
   Rash Erythematous<11<1
Special Sense Other, Disorders
   Taste Perversion024
Urinary System Disorders
   Hematuria12<1
   Urinary Tract Infection123
   Micturition Frequency112
   Urinary Incontinence<121
   Urine Abnormal01<1
Vision Disorders
   Vision Abnormal21310
   Diplopia51010
White Cell and RES Disorders
   Leukopenia121

Incidence in Study 119 – Add-On Therapy– Adults with Partial Onset Seizures

Study 119 was a randomized, double-blind, placebo-controlled, parallel group study with 3 treatment arms: 1) placebo; 2) topiramate 200 mg/day with a 25 mg/day starting dose, increased by 25 mg/day each week for 8 weeks until the 200 mg/day maintenance dose was reached; and 3) topiramate 200 mg/day with a 50 mg/day starting dose, increased by 50 mg/day each week for 4 weeks until the 200 mg/day maintenance dose was reached. All patients were maintained on concomitant carbamazepine with or without another concomitant antiepileptic drug.

The incidence of adverse events ( Table 7 ) did not differ significantly between the 2 topiramate regimens. Because the frequencies of adverse events reported in this study were markedly lower than those reported in the previous epilepsy studies, they cannot be directly compared with data obtained in other studies.

Table 7: Incidence of Treatment-Emergent Adverse Events in Study 119a,b Where Rate Was ≥ 2% in the Topiramate Group and Greater Than the Rate in Placebo-Treated Patients
TOPAMAX® Dosage (mg/day)
Body System/
AdverseEventc
Placebo
(N=92)
200
(N=171)

a Patients in these add-on trials were receiving 1 to 2 concomitant antiepileptic drugs in addition to TOPAMAX® or placebo.

b Values represent the percentage of patients reporting a given adverse event. Patients may have reported more than one adverse event during the study and can be included in more than one adverse event category.

c Adverse events reported by at least 2% of patients in the TOPAMAX® 200 mg/day group and more common than in the placebo group are listed in this table.

Body as a Whole-General Disorders
   Fatigue49
   Chest Pain12
Cardiovascular Disorders, General
   Hypertension02
Central & Peripheral Nervous System Disorders
   Paresthesia29
   Dizziness47
   Tremor23
   Hypoasthesia02
   Leg Cramps02
   Language Problems02
Gastro-Intestinal System Disorders
   Abdominal Pain35
   Constipation04
   Diarrhea12
   Dyspepsia02
   Dry Mouth02
Hearing and Vestibular Disorders
   Tinnitus02
Metabolic and Nutritional Disorders
   Weight Decrease48
Psychiatric Disorders
   Somnolence915
   Anorexia79
   Nervousness29
   Difficulty with Concentration/Attention05
   Insomnia34
   Difficulty with Memory12
   Aggressive Reaction02
Respiratory System Disorders
   Rhinitis04
Urinary System Disorders
   Cystitis02
Vision Disorders
   Diplopia02
   Vision Abnormal02
Table 8: Incidence (%) of Dose-Related Adverse Events From Placebo-Controlled, Add-On Trials in Adults with Partial Onset Seizuresa
TOPAMAX® Dosage (mg/day)

Adverse Event
Placebo
(N = 216)
200
(N = 45)
400
(N = 68)
600 - 1,000
(N = 414)

a Dose-response studies were not conducted for other adult indications or for pediatric indications.

Fatigue13111230
Nervousness7131819
Difficulty with Concentration/Attention17914
Confusion491014
Depression69713
Anorexia44612
Language problems<12910
Anxiety62310
Mood problems2069
Weight decrease34913
Table 9: Incidence (%) of Treatment-Emergent Adverse Events in Placebo-Controlled, Add-On Epilepsy Trials in Pediatric Patients Ages 2 -16 Yearsa,b (Events that Occurred in at Least 1% of Topiramate-Treated Patients and Occurred More Frequently in Topiramate-Treated Than Placebo-Treated Patients)
Body System/
Adverse Event
Placebo
(N=101)
Topiramate
(N=98)

a Patients in these add-on trials were receiving 1 to 2 concomitant antiepileptic drugs in addition to TOPAMAX® or placebo.

b Values represent the percentage of patients reporting a given adverse event. Patients may have reported more than one adverse event during the study and can be included in more than one adverse event category.

Body as a Whole - General Disorders
    Fatigue516
    Injury1314
    Allergic Reaction12
    Back Pain01
    Pallor01
Cardiovascular Disorders, General
    Hypertension01
Central & Peripheral Nervous System Disorders
    Gait Abnormal58
    Ataxia26
    Hyperkinesia45
    Dizziness24
    Speech Disorders/Related Speech Problems24
    Hyporeflexia02
    Convulsions Grand Mal01
    Fecal Incontinence01
    Paresthesia01
Gastro-Intestinal System Disorders
    Nausea56
    Saliva Increased46
    Constipation45
    Gastroenteritis23
    Dysphagia01
    Flatulence01
    Gastroesophageal Reflux01
    Glossitis01
    Gum Hyperplasia01
Heart Rate and Rhythm Disorders
    Bradycardia01
Metabolic and Nutritional Disorders
    Weight Decrease19
    Thirst12
    Hypoglycemia01
    Weight Increase01
Platelet, Bleeding,& Clotting Disorders
    Purpura48
    Epistaxis14
    Hematoma01
    Prothrombin Increased01
    Thrombocytopenia01
Psychiatric Disorders
    Somnolence1626
    Anorexia1524
    Nervousness714
    Personality Disorder (Behavior Problems)911
    Difficulty with Concentration/Attention210
    Aggressive Reaction49
    Insomnia78
    Difficulty with Memory NOS05
    Confusion34
    Psychomotor Slowing23
    Appetite Increased01
    Neurosis01
Reproductive Disorders, Female
    Leukorrhoea02
Resistance Mechanism Disorders
    Infection Viral37
Respiratory System Disorders
    Pneumonia15
    Respiratory Disorder01
Skin and Appendages Disorders
    Skin Disorder23
    Alopecia12
    Dermatitis02
    Hypertrichosis12
    Rash Erythematous02
    Eczema01
    Seborrhoea01
    Skin Discoloration01
Urinary System Disorders
    Urinary Incontinence24
    Nocturia01
Vision Disorders
    Eye Abnormality12
    Vision Abnormal12
    Diplopia01
    Lacrimation Abnormal01
    Myopia01
White Cell and RES Disorders
    Leukopenia02

Other Adverse Events Observed During All Epilepsy Clinical Trials

Topiramate has been administered to 2,246 adults and 427 pediatric patients with epilepsy during all clinical studies, only some of which were placebo controlled. During these studies, all adverse events were recorded by the clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals having adverse events, similar types of events were grouped into a smaller number of standardized categories using modified WHOART dictionary terminology. The frequencies presented represent the proportion of patients who experienced an event of the type cited on at least one occasion while receiving topiramate. Reported events are included except those already listed in the previous tables or text, those too general to be informative, and those not reasonably associated with the use of the drug.

Events are classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent occurring in at least 1/100 patients; infrequent occurring in 1/100 to 1/1000 patients; rare occurring in fewer than 1/1000 patients.

Autonomic Nervous System Disorders: Infrequent: vasodilation.

Body as a Whole: Frequent: syncope. Infrequent: abdomen enlarged. Rare: alcohol intolerance.

Cardiovascular Disorders, General: Infrequent: hypotension, postural hypotension, angina pectoris.

Central& Peripheral Nervous System Disorders: Infrequent : neuropathy, apraxia, hyperaesthesia, dyskinesia, dysphonia, scotoma, ptosis, dystonia, visual field defect, encephalopathy, EEG abnormal. Rare: upper motor neuron lesion, cerebellar syndrome, tongue paralysis.

Gastrointestinal System Disorders:. Infrequent: hemorrhoids, stomatitis, melena, gastritis, esophagitis. Rare: tongue edema.

Heart Rate and Rhythm Disorders: Infrequent: AV block.

Liver and Biliary System Disorders: Infrequent: SGPT increased, SGOT increased.

Metabolic and Nutritional Disorders: Infrequent: dehydration, hypokalemia, alkaline phosphatase increased, hypocalcemia, hyperlipemia, hyperglycemia, xerophthalmia, diabetes mellitus,. Rare: hyperchloremia, hypernatremia, hyponatremia, hypocholesterolemia, hypophosphatemia, creatinine increased.

Musculoskeletal System Disorders: Frequent: arthralgia. Infrequent: arthrosis.

Neoplasms: Infrequent: thrombocythemia. Rare: polycythemia.

Platelet, Bleeding, and Clotting Disorders: Infrequent: gingival bleeding, pulmonary embolism.

Psychiatric Disorders: Frequent: impotence, hallucination, psychosis, suicide attempt. Infrequent: euphoria, paranoid reaction, delusion, paranoia, delirium, abnormal dreaming. Rare: libido increased, manic reaction.

Red Blood Cell Disorders: Frequent: anemia. Rare: marrow depression, pancytopenia.

Reproductive Disorders, Male: Infrequent: ejaculation disorder, breast discharge.

Skin and Appendages Disorders: Infrequent: urticaria, photosensitivity reaction, abnormal hair texture. Rare: chloasma.

Special Senses Other, Disorders: Infrequent: taste loss, parosmia.

Urinary System Disorders: Infrequent: urinary retention, face edema, renal pain, albuminuria, polyuria, oliguria.

Vascular (Extracardiac) Disorders: Infrequent: flushing, deep vein thrombosis, phlebitis. Rare: vasospasm.

Vision Disorders: Frequent: conjunctivitis. Infrequent: abnormal accommodation, photophobia, strabismus. Rare: mydriasis, iritis.

White Cell and Reticuloendothelial System Disorders: Infrequent: lymphadenopathy, eosinophilia, lymphopenia, granulocytopenia. Rare: lymphocytosis.

Migraine

In the four multicenter, randomized, double-blind, placebo-controlled, parallel group migraine prophylaxis clinical trials, most of the adverse events with topiramate were mild or moderate in severity. Most adverse events occurred more frequently during the titration period than during the maintenance period.

Table 10 includes those adverse events reported for patients in the placebo-controlled trials where the incidence rate in any topiramate treatment group was at least 2 % and was greater than that for placebo patients.

Table 10: Incidence of Treatment-Emergent Adverse Events in Placebo-Controlled, Migraine Trials Where Rate Was ≥2 % in Any Topiramate Group and Greater than the Rate in Placebo-Treated Patients a
TOPAMAX®  Dosage (mg/day)
Body System /
Adverse Event
Placebo
(N=445)
50
(N=235)
100
(N=386)
200
(N=514)

a Values represent the percentage of patients reporting a given adverse event. Patients may have reported more than one adverse event during the study and can be included in more than one adverse event category.

b Blurred vision was the most common term considered as vision abnormal. Blurred vision was an included term that accounted for > 50 % of events coded as vision abnormal, a preferred term.

Body as a Whole-General Disorders
    Fatigue11141519
    Injury7966
    Asthenia1<122
    Fever1112
    Influenza-Like Symptoms<1<1<12
    Allergy<12<1<1
Central & Peripheral Nervous System Disorders
    Paresthesia6355149
    Dizziness108912
    Hypoaesthesia2678
    Language Problems2767
    Involuntary Muscle Contractions1224
    Ataxia<1121
    Speech Disorders/Related Speech Problems<11<12
Gastro-Intestinal System Disorders
    Nausea891314
    Diarrhea491111
    Abdominal Pain5667
    Dyspepsia3453
    Dry Mouth2235
    Vomiting2123
    Gastroenteritis1332
Hearing and Vestibular Disorders
    Tinnitus1<112
Metabolic and Nutritional Disorders
    Weight Decrease16911
    Thirst<1221
Musculoskeletal System Disorders
    Arthralgia2731
Neoplasms
    Neoplasm NOS<12<1<1
Psychiatric Disorders
    Anorexia691514
    Somnolence58710
    Difficulty with Memory NOS27711
    Difficulty with Concentration/Attention23610
    Insomnia5676
    Anxiety3456
    Mood Problems2365
    Depression4346
    Nervousness2444
    Confusion2234
    Psychomotor Slowing1324
    Libido Decreased1112
    Aggravated Depression1122
    Agitation1221
    Cognitive Problems NOS1<122
Reproductive Disorders, Female
    Menstrual Disorder2322
Reproductive Disorders, Male
    Ejaculation Premature0300
Resistance Mechanism Disorders
    Viral Infection3443
    Otitis Media<1211
Respiratory System Disorders
    Upper Respiratory Tract Infection12131412
    Sinusitis61068
    Pharyngitis4562
    Coughing2243
    Bronchitis2333
    Dyspnea2132
    Rhinitis1122
Skin and Appendages Disorders
    Pruritis2422
Special Sense Other, Disorders
    Taste Perversion115812
    Taste Loss<1112
Urinary System Disorders
    Urinary Tract Infection2424
    Renal Calculus0012
Vision Disorders
    Vision Abnormal<1123
    Blurred Vision b2424
    Conjunctivitis1121

Of the 1,135 patients exposed to topiramate in the placebo-controlled studies, 25% discontinued due to adverse events, compared to 10% of the 445 placebo patients. The adverse events associated with discontinuing therapy in the topiramate-treated patients included paresthesia (7%), fatigue (4%), nausea (4%), difficulty with concentration/attention (3%), insomnia (3%), anorexia (2%), and dizziness (2%).

Patients treated with topiramate experienced mean percent reductions in body weight that were dose-dependent. This change was not seen in the placebo group. Mean changes of 0%, –2%, – 3%, and – 4% were seen for the placebo group, topiramate 50, 100, and 200 mg groups, respectively.

Table 11 shows adverse events that were dose-dependent. Several central nervous system adverse events, including some that represented cognitive dysfunction, were dose-related. The most common dose-related adverse events were paresthesia, fatigue, nausea, anorexia, dizziness, difficulty with memory, diarrhea, weight decrease, difficulty with concentration/attention, and somnolence.

Table 11: Incidence (%) of Dose-Related Adverse Events From Placebo-Controlled, Migraine Trialsa
TOPAMAX® Dosage (mg/day)

Adverse Event
Placebo
(N =445)
50
(N = 235)
100
(N = 386)
200
(N = 514)

a The incidence rate of the adverse event in the 200 mg/day group was ≥2% than the rate in both the placebo group and the 50 mg/day group.

Paresthesia6355149
Fatigue11141519
Nausea891314
Anorexia691514
Dizziness108912
Weight decrease16911
Difficulty with Memory NOS27711
Diarrhea491111
Difficulty with Concentration/Attention23610
Somnolence58710
Hypoaesthesia2678
Anxiety3456
Depression4346
Mood Problems2365
Dry Mouth2235
Confusion2234
Involuntary Muscle Contractions1224
Abnormal Vision<1123
Renal Calculus0012

Other Adverse Events Observed During Migraine Clinical Trials

Topiramate, for the treatment of prophylaxis of migraine headache, has been administered to 1,367 patients in all clinical studies (includes double-blind and open-label extension). During these studies, all adverse events were recorded by the clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals having adverse events, similar types of events were grouped into a smaller number of standardized categories using modified WHOART dictionary terminology.

The following additional adverse events that were not described earlier were reported by greater than 1% of the 1,367 topiramate-treated patients in the controlled clinical trials:

Body as a Whole: Pain, chest pain, allergic reaction.

Central & Peripheral Nervous System Disorders: Headache, vertigo, tremor, sensory disturbance, migraine aggravated.

Gastrointestinal System Disorders: Constipation, gastroesophageal reflux, tooth disorder.

Musculoskeletal System Disorders: Myalgia.

Platelet, Bleeding, and Clotting Disorders: Epistaxis.

Reproductive Disorders, Female: Intermenstrual bleeding.

Resistance Mechanism Disorders: Infection, genital moniliasis.

Respiratory System Disorders: Pneumonia, asthma.

Skin and Appendages Disorders: Rash, alopecia.

Vision Disorders: Abnormal accommodation, eye pain.

Postmarketing and Other Experience

In addition to the adverse experiences reported during clinical testing of TOPAMAX®, the following adverse experiences have been reported worldwide in patients receiving TOPAMAX® post-approval.

These adverse experiences have not been listed above and data are insufficient to support an estimate of their incidence or to establish causation. The listing is alphabetized: bullous skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), hepatic failure (including fatalities), hepatitis, maculopathy, pancreatitis, pemphigus and renal tubular acidosis.



REPORTS OF SUSPECTED TOPAMAX SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Topamax. The information is not vetted and should not be considered as verified clinical evidence.

Possible Topamax side effects / adverse reactions in female

Reported by a physician from Spain on 2011-10-03

Patient: female

Reactions: Obsessive-Compulsive Disorder, Tardive Dyskinesia

Suspect drug(s):
Risperdal Consta

Olanzapine
    Indication: Schizophrenia, Paranoid Type

Olanzapine

Topamax
    Indication: Schizophrenia, Paranoid Type

Risperdal Consta
    Indication: Schizophrenia, Paranoid Type

Other drugs received by patient: Clonazepam



Possible Topamax side effects / adverse reactions in 18 year old female

Reported by a health professional (non-physician/pharmacist) from Italy on 2011-10-04

Patient: 18 year old female

Reactions: Self Injurious Behaviour

Suspect drug(s):
Topamax



Possible Topamax side effects / adverse reactions in 31 year old female

Reported by a physician from Italy on 2011-10-04

Patient: 31 year old female

Reactions: Multiple Drug Overdose Intentional, Self Injurious Behaviour

Suspect drug(s):
Topamax
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Zoloft
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



See index of all Topamax side effect reports >>

Drug label data at the top of this Page last updated: 2008-04-18

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