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Qudexy XR

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Qudexy XR




Qudexy XR Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 4/23/2015

Qudexy XR (topiramate) extended-release is an antiseizure medicine used to?treat certain types of seizures (partial-onset seizures and primary generalized tonic-clonic seizures) in adults and children 10 years of age and older, and with other medicines to treat certain types of seizures (partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome) in adults and children 2 years and older. Common side effects of Qudexy XR include tingling of the arms and legs, irregular movements of the eyes, loss of appetite, nausea, indigestion, changes in taste, diarrhea, weight loss, nervousness, fatigue, dizziness, difficulty concentrating, confusion, mood problems, flushing, and upper respiratory tract infection.

The recommended initial adult dose of Qudexy XR is 25 to 50 mg daily, increased to 200 to 400 mg daily. Pediatric dose is determined by the child's weight. Qudexy XR may interact with metformin; valproic acid; phenytoin; carbamazepine; other carbonic anhydrase inhibitors; lithium; any medicines that impair or decrease your thinking, concentration, or muscle coordination; birth control pills; medicines used to prevent seizures; or any other carbonic anhydrase inhibitors. Tell your doctor all medications and supplements you use. Qudexy XR is not recommend for use during pregnancy. It may harm a fetus. Women should use birth control while taking Qudexy XR. If you become pregnant, tell your doctor immediately. Patients are encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. The effects of this drug on nursing infants are unknown. Consult your doctor before breastfeeding. If you have epilepsy and you stop taking Qudexy XR suddenly, you may have seizures that do not stop.

Our Qudexy XR (topiramate) extended-release Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Qudexy XR FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

Clinical Trials Experience With Immediate-Release Topiramate

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Increased Risk for Bleeding

Topiramate treatment is associated with an increased risk for bleeding. In a pooled analysis of placebo-controlled studies of approved and unapproved indications, bleeding was more frequently reported as an adverse event for topiramate than for placebo (4.5% versus 3.0% in adult patients, and 4.4% versus 2.3% in pediatric patients). In this analysis, the incidence of serious bleeding events for topiramate and placebo was 0.3% versus 0.2% for adult patients, and 0.4% versus 0% for pediatric patients.

Adverse bleeding reactions reported with topiramate ranged from mild epistaxis, ecchymosis, and increased menstrual bleeding to life-threatening hemorrhages. In patients with serious bleeding events, conditions that increased the risk for bleeding were often present, or patients were often taking drugs that cause thrombocytopenia (other antiepileptic drugs) or affect platelet function or coagulation (e.g., aspirin, nonsteroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors, or warfarin or other anticoagulants).

Adverse Reactions Observed in Monotherapy Trial

Patients 16 Years and Older

The adverse reactions in the monotherapy controlled trial (Study 1) that occurred most commonly in adults in the 400 mg per day topiramate group and at an incidence ≥ 5% higher than the 50 mg per day group were paresthesia, weight decrease, somnolence, anorexia, and difficulty with memory (see Table 4).

Approximately 21% of the 159 adult patients in the 400 mg per day group who received topiramate as monotherapy in Study 1 discontinued therapy due to adverse reactions. The most common ( ≥ 2% more frequent than for topiramate 50 mg per day) adverse reactions causing discontinuation in this trial were difficulty with memory, fatigue, asthenia, insomnia, somnolence and paresthesia.

Pediatric Patients 6 to less than 16 Years of Age

The adverse reactions in Study 1 that occurred most commonly in pediatric patients in the 400 mg per day topiramate group and at an incidence ≥ 5% higher than in the 50 mg per day group were fever, weight decrease, mood problems, cognitive problems, infection, flushing, and paresthesia (see Table 4).

Approximately 14% of the 77 pediatric patients in the 400 mg per day group who received topiramate as monotherapy in Study 1 discontinued therapy due to adverse reactions. The most common ( ≥ 2% more frequent than for topiramate 50 mg per day) adverse reactions resulting in discontinuation in this trial were difficulty with concentration/attention, fever, flushing, and confusion.

Table 4: Adverse Reactions in the Immediate-Release Topiramate Monotherapy Trial with incidence ≥ 2% in any topiramate group and incidence in the 400 mg per day group greater than in the 50 mg per day group

Body System/ Adverse Reaction Age Group
Pediatric(6 to ≥ 16 Years) Adult(Age ≥ 16 Years)
Immediate-release Topiramate Daily Dosage
Group (mg per day)
50
(N=74) %a
400
(N=77) %a
50
(N=160) %a
400
(N=159) %a
Body as a Whole-General Disorders
Asthenia 0 3 4 6
Chest pain 1 2
Fever 1 12
Leg pain 2 3
Central & Peripheral Nervous System Disorders
Ataxia 3 4
Dizziness 13 14
Hypertonia 0 3
Hypoasthesia 4 5
Muscle contractions involuntary 0 3
Paresthesia 3 12 21 40
Vertigo 0 3
Gastro-intestinal System Disorders
Constipation 1 4
Diarrhea 8 9
Gastritis 0 3
Gastroesophageal reflux 1 2
Dry mouth 1 3
Liver and Biliary System Disorders
Gamma-GT increased 1 3
Metabolic and Nutritional Disorders
Weight Decrease 7 17 6 17
Platelet, Bleeding & Clotting Disorders
Epistaxis 0 4
Psychiatric Disorders
Anorexia 4 14
Anxiety 4 6
Cognitive problems 1 6 1 4
Confusion 0 3
Depression 0 3 7 9
Difficulty with concentration/attention 7 10 7 8
Difficulty with memory 1 3 6 11
Insomnia 8 9
Libido decreased 0 3
Mood problems 1 8 2 5
Personality disorder (behavior problems) 0 3
Psychomotor slowing 3 5
Somnolence 10 15
Red Blood Cell Disorders
Anemia 1 3
Reproductive Disorders, Femaleb
Intermenstrual bleeding 0 3
Vaginal hemorrhage 0 3
Resistance Mechanism Disorders
Infection 3 8 2 3
Infection viral 3 6 6 8
Respiratory System Disorders
Bronchitis 1 5 3 4
Dyspnea 1 2
Rhinitis 5 6 2 4
Sinusitis 1 4
Upper respiratory tract infection 16 18
Skin and Appendages Disorders
Acne 2 3
Alopecia 1 4 3 4
Pruritus 1 4
Rash 3 4 1 4
Special Senses Other, Disorders
Taste perversion 3 5
Urinary System Disorders
Cystitis 1 3
Dysuria 0 2
Micturition frequency 0 3 0 2
Renal calculus 0 3
Urinary incontinence 1 3
Urinary tract infection 1 2
Vascular (Extracardiac) Disorders
Flushing 0 5
aPercentages calculated with the number of subjects in each group as denominator
bN with Female Reproductive Disorders - Incidence calculated relative to the number of females; Pediatric TPM 50 mg n=40; Pediatric TPM 400 mg n=33; Adult TPM 50 mg n=84; TPM 400 mg n=80

Adverse Reactions Observed in Adjunctive Therapy Epilepsy Trials

The most commonly observed adverse reactions associated with the use of topiramate at dosages of 200 to 400 mg per day (recommended dose range) in controlled trials in adults with partial onset seizures, primary generalized tonic-clonic seizures, or Lennox-Gastaut syndrome, that were seen at an incidence of higher ( ≥ 5%) than in the placebo group were: somnolence, weight decrease, anorexia, dizziness, ataxia, speech disorders and related speech problems, language problems, psychomotor slowing, confusion, abnormal vision, difficulty with memory, paresthesia, diplopia, nervousness, and asthenia (see Table 5). Dose-related adverse reactions at dosages of 200 mg to 1,000 mg per day are shown in Table 7).

The most commonly observed adverse reactions associated with the use of topiramate at dosages of 5 mg/kg/day 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 an incidence higher ( ≥ 5%) than in the placebo group were: fatigue, somnolence, anorexia, nervousness, difficulty with concentration/attention, difficulty with memory, aggressive reaction, and weight decrease (see Table 8). Table 8 also presents the incidence of adverse reactions occurring in at least 1% of pediatric patients treated with topiramate and occurring with greater incidence than placebo.

In controlled clinical trials in adults, 11% of patients receiving topiramate 200 to 400 mg per day as adjunctive therapy discontinued due to adverse reactions. This rate appeared to increase at dosages above 400mg per 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 per day. None of the pediatric patients who received topiramate adjunctive therapy at 5 mg/kg/day to 9 mg/kg/day in controlled clinical trials discontinued due to adverse reactions.

Approximately 28% of the 1757 adults with epilepsy who received topiramate at dosages of 200 mg to 1,600 mg per day in clinical studies discontinued treatment because of adverse reactions; an individual patient could have reported more than one adverse reaction. These adverse reactions 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 reactions. Adverse reactions 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 5 lists the incidence of adverse reactions that occurred in at least 1% of adults treated with 200 to 400 mg per day topiramate (and also higher daily dosing of 600 mg to 1,000 mg) in controlled trials that was numerically greater with topiramate than with placebo. In general, most patients who experienced adverse reactions during the first eight weeks of these trials no longer experienced them by their last visit. Table 8 lists the incidence of treatment-emergent adverse reactions that occurred in at least 1% of pediatric patients treated with 5 to 9 mg/kg topiramate in controlled trials and that was numerically greater than the incidence in patients treated with placebo.

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

Other adverse reactions that occurred in more than 1% of adults treated with 200 mg 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 5: Incidence of Adverse Reactions in Placebo-Controlled, Adjunctive Epilepsy Trials in Adultsa,b,c

Body System/ Adverse Reactionc Placebo
(N=291)
Topiramate Dosage
(mg per day)
200 to 400
(N=183)
600 to 1,000
(N=414)
Body as a Whole-General Disorders
  Fatigue 13 15 30
  Asthenia 1 6 3
  Back pain 4 5 3
  Chest pain 3 4 2
  Influenza-like symptoms 2 3 4
  Leg pain 2 2 4
  Hot flushes 1 2 1
  Allergy 1 2 3
  Edema 1 2 1
  Body odor 0 1 0
  Rigors 0 1 < 1
Central & Peripheral Nervous System Disorders
  Dizziness 15 25 32
  Ataxia 7 16 14
  Speech disorders/Related speech problems 2 13 11
  Paresthesia 4 11 19
  Nystagmus 7 10 11
  Tremor 6 9 9
  Language problems 1 6 10
  Coordination abnormal 2 4 4
  Hypoaesthesia 1 2 1
  Gait abnormal 1 3 2
  Muscle contractions involuntary 1 2 2
  Stupor 0 2 1
  Vertigo 1 1 2
Gastro-intestinal System Disorders
  Nausea 8 10 12
  Dyspepsia 6 7 6
  Abdominal pain 4 6 7
  Constipation 2 4 3
  Gastroenteritis 1 2 1
  Dry mouth 1 2 4
  Gingivitis < 1 1 1
  GI disorder < 1 1 0
Hearing and Vestibular Disorders
  Hearing decreased 1 2 1
Metabolic and Nutritional Disorders
  Weight decrease 3 9 13
Musculo-Skeletal System Disorders
  Myalgia 1 2 2
  Skeletal pain 0 1 0
Platelet, Bleeding & Clotting Disorders
  Epistaxis 1 2 1
Psychiatric Disorders
  Somnolence 12 29 28
  Nervousness 6 16 19
  Psychomotor slowing 2 13 21
  Difficulty with memory 3 12 14
  Anorexia 4 10 12
  Confusion 5 11 14
  Depression 5 5 13
  Difficulty with concentration/attention 2 6 14
  Mood problems 2 4 9
  Agitation 2 3 3
  Aggressive reaction 2 3 3
  Emotional liability 1 3 3
  Cognitive problems 1 3 3
  Libido decreased 1 2 < 1
  Apathy 1 1 3
  Depersonalization 1 1 2
Reproductive Disorders, Female
  Breast pain 2 4 0
  Amenorrhea 1 2 2
  Menorrhagia 0 2 1
  Menstrual disorder 1 2 1
Reproductive Disorders, Male
  Prostatic disorder < 1 2 0
Resistance Mechanism Disorders
  Infection 1 2 1
  Infection viral 1 2 < 1
  Moniliasis < 1 1 0
Respiratory System Disorders
  Pharyngitis 2 6 3
  Rhinitis 6 7 6
  Sinusitis 4 5 6
  Dyspnea 1 1 2
Skin and Appendages Disorders
  Skin disorder < 1 2 1
  Sweating increased < 1 1 < 1
  Rash, erythematous < 1 1 < 1
Special Senses Other, Disorders
  Taste perversion 0 2 4
Urinary System Disorders
  Hematuria 1 2 < 1
  Urinary tract infection 1 2 3
  Micturition frequency 1 1 2
  Urinary incontinence < 1 2 1
  Urine abnormal 0 1 < 1
Vision Disorders
  Vision abnormal 2 13 10
  Diplopia 5 10 10
White Cell and RES Disorders
  Leukopenia 1 2 1
aPatients in these adjunctive trials were receiving 1 to 2 concomitant antiepileptic drugs in addition to topiramate or placebo
bValues represent the percentage of patients reporting a given reaction. Patient may have reported more than one adverse reaction during the study and can be included in more than one adverse reaction category.
cAdverse reactions reported by at least 1% of patients in the topiramate 200 mg to 400 mg per day group and more common than in the placebo group

Adverse Reactions Observed in Adjunctive Therapy Trial in Adults with Partial Onset Seizures (Study 7)

Study 7 was a randomized, double-blind, adjunctive, placebo-controlled, parallel group study with 3 treatment arms: 1) placebo; 2) topiramate 200 mg per day with a 25 mg per day starting dose, increased by 25 mg per day each week for 8 weeks until the 200 mg per day maintenance dose was reached; and 3) topiramate 200 mg per day with a 50 mg per day starting dose, increased by 50 mg per day each week for 4 weeks until the 200 mg per day maintenance dose was reached. All patients were maintained on concomitant carbamazepine with or without another concomitant antiepileptic drug.

The most commonly observed adverse reactions associated with the use of topiramate that were seen at an incidence higher ( ≥ 5%) than in the placebo group were: paresthesia, nervousness, somnolence, difficulty with concentration/attention, and fatigue (Table 6). Because these topiramate treatment difference incidence (topiramate % -Placebo %) of many adverse reactions 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 6: Incidence of Adverse Reactions in Study 7a,b,c

Body System/ Adverse Reactionc Placebo
(N=92)
Topiramate Dosage (mg per day) 200
(N=171)
Body as a Whole-General Disorders
  Fatigue 4 9
  Chest pain 1 2
Cardiovascular Disorders, General
  Hypertension 0 2
Central & Peripheral Nervous System Disorders
  Paresthesia 2 9
  Dizziness 4 7
  Tremor 2 3
  Hypoesthesia 0 2
  Leg cramps 0 2
  Language problems 0 2
Gastro-intestinal System Disorders
  Abdominal pain 3 5
  Constipation 0 4
  Diarrhea 1 2
  Dyspepsia 0 2
  Dry mouth 0 2
Hearing and Vestibular Disorders
  Tinnitus 0 2
Metabolic and Nutritional Disorders
  Weight decrease 4 8
Psychiatric Disorders
  Somnolence 9 15
  Anorexia 7 9
  Nervousness 2 9
  Difficulty with concentration/attention 0 5
  Insomnia 3 4
  Difficulty with memory 1 2
  Aggressive reaction 0 2
Respiratory System Disorders
  Rhinitis 0 4
Urinary System Disorders
  Cystitis 0 2
Vision Disorders
  Diplopia 0 2
  Vision abnormal 0 2
aPatients in these adjunctive trials were receiving 1 to 2 concomitant antiepileptic drugs in addition to topiramate or placebo
bValues represent the percentage of patients reporting a given adverse reaction. Patients may have reported more than one adverse reaction during the study and can be included in more than one adverse reaction category
cAdverse reactions reported by at least 2% of patients in the topiramate 200 mg per day group and more common than in the placebo group

Table 7: Incidence (%) of Dose-Related Adverse Reactions From Placebo-Controlled, Adjunctive Trials in Adults With Partial Onset Seizures (Studies 2 through 7)a

Adverse Reaction Placebo
(N=216)
Topiramate Dosage (mg per day)
200
(N=45)
400
(N=68)
600 to 1,000
(N=414)
Fatigue 13 11 12 30
Nervousness 7 13 18 19
Difficulty with concentration/attention 1 7 9 14
Confusion 4 9 10 14
Depression 6 9 7 13
Anorexia 4 4 6 12
Language Problems < 1 2 9 10
Anxiety 6 2 3 10
Mood Problems 2 0 6 9
Weight Decrease 3 4 9 13
aDose-response studies were not conducted for other adult indications or for pediatric indications

Table 8: Incidence (%) of Adverse Reaction in Placebo-Controlled, Adjunctive Epilepsy Trial in Pediatric Patients (Ages 2 Years to 16 Years)a,b,c (Study 8)

Body System/ Adverse Reaction Placebo
(N=101)
Topiramate
(N=98)
Body as a Whole-General Disorders
  Fatigue 5 16
  Injury 13 14
  Allergic reaction 1 2
  Back pain 0 1
  Pallor 0 1
Cardiovascular Disorders, General
  Hypertension 0 1
Central & Peripheral Nervous System Disorders
  Gait abnormal 5 8
  Ataxia 2 6
  Hyperkinesia 4 5
  Dizziness 2 4
  Speech disorders/Related speech problems 2 4
  Hyporeflexia 0 2
  Convulsions grand mal 0 1
  Fecal incontinence 0 1
  Paresthesia 0 1
Gastro-Intestinal System Disorders
  Nausea 5 6
  Saliva increased 4 6
  Constipation  4 5
  Gastroenteritis 2 3
  Dysphasia 0 1
  Flatulence 0 1
  Gastroesophageal reflux 0 1
  Glossitis 0 1
  Gum hyperplasia 0 1
Heart Rate and Rhythm Disorders
  Bradycardia 0 1
Metabolic and Nutritional Disorders
  Weight decrease 1 9
  Thirst 1 2
  Hypoglycemia 0 1
  Weight increase 0 1
Platelet, Bleeding & Clotting Disorders
  Purpura 4 8
  Epistaxis 1 4
  Hematoma 0 1
  Prothrombin increased 0 1
  Thrombocytopenia 0 1
Psychiatric Disorders
  Somnolence 16 26
  Anorexia 15 24
  Nervousness 7 14
  Personality disorder (Behavior Problems) 9 11
  Difficulty with concentration/attention 2 10
  Aggressive reaction 4 9
  Insomnia 7 8
  Difficulty with memory 0 5
  Confusion 3 4
  Psychomotor slowing 2 3
  Appetite increased 0 1
  Neurosis 0 1
Reproductive Disorders, Female
  Leukorrhea 0 2
Resistance Mechanism Disorders
  Infection viral 3 7
Respiratory System Disorders
  Pneumonia 1 5
  Respiratory disorder 0 1
Skin and Appendages Disorders
  Skin Disorder 2 3
  Alopecia 1 2
  Dermatitis 0 2
  Hypertrichosis 1 2
  Rash erythematous 0 2
  Eczema 0 1
  Seborrhea 0 1
  Skin discoloration 0 1
Urinary System Disorders
  Urinary incontinence 2 4
  Nocturia 0 1
Vision Disorders
  Eye abnormality 1 2
  Vision abnormal 1 2
  Diplopia 0 1
  Lacrimation abnormal 0 1
  Myopia 0 1
White Cell and RES Disorders
  Leukopenia 0 2
aPatients in these adjunctive trials were receiving 1 to 2 concomitant antiepileptic drugs in addition to topiramate or placebo
bValues represent the percentage of patients reporting a given adverse reaction. Patients may have reported more than one adverse reaction during the study and can be included in more than one adverse reaction category
cReactions that Occurred in at Least 1% of Topiramate-Treated Patients and Occurred More Frequently in Topiramate-Treated Than Placebo-Treated Patients

Laboratory Abnormalities

Topiramate decreases serum bicarbonate [see WARNINGS AND PRECAUTIONS].

Immediate-release topiramate treatment was associated with changes in several clinical laboratory analytes in randomized, double-blind, placebo-controlled studies. Similar effects should be anticipated with use of QUDEXY XR.

Controlled trials of adjunctive topiramate treatment of adults for partial onset seizures showed an increased incidence of markedly decreased serum phosphorus (6% topiramate, 2% placebo), markedly increased serum alkaline phosphatase (3% topiramate, 1% placebo), and decreased serum potassium (0.4 % topiramate, 0.1 % placebo).

Changes in several clinical laboratory analytes (i.e., increased creatinine, BUN, alkaline phosphatase, total protein, total eosinophil count and decreased potassium) have been observed in a clinical investigational program in very young (2 years and younger) pediatric patients who were treated with adjunctive topiramate for partial onset seizures [see Use In Specific Populations].

Topiramate treatment produced a dose-related increased shift in serum creatinine from normal at baseline to an increased value at the end of 4 months treatment in adolescent patients (ages 12 years to 16 years) in a double-blind, placebo-controlled study. The incidence of these abnormal shifts was 4% for placebo, 4% for 50 mg, and 18% for 100 mg.

Topiramate treatment with or without concomitant valproic acid (VPA) can cause hyperammonemia with or without encephalopathy [see WARNINGS AND PRECAUTIONS].

Clinical Trials Experience With QUDEXY XR

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In the QUDEXY XR study, a dose of 200 mg per day was administered to a limited number of patients; therefore, these results cannot be directly compared to immediate-release topiramate experience.

The safety data presented below are from 249 patients with partial epilepsy on concomitant AEDs who participated in the QUDEXY XR study [see Clinical Studies].

Table 9 displays the incidence of treatment-emergent adverse reactions that occurred in ≥ 2% of patients and numerically greater than placebo.

Table 9: Incidence ( ≥ 2%) of Treatment-Emergent Adverse Reactions in Placebo-Controlled Adjunctive Therapy Clinical Trial in Patients With Partial Onset Seizures

Body System/ Adverse Reaction Placebo
(N=125)
QUDEXY XR (200 mg)
(N=124)
General Disorders
  Fatigue 5 6
  Asthenia 1 2
  Irritability 1 2
Nervous System Disorders
  Somnolence 2 12
  Dizziness 6 7
  Paresthesia 2 7
  Aphasia 0 2
  Dysarthria 1 2
  Memory impairment 1 2
Psychiatric Disorder
  Psychomotor retardation 0 2
Cardiovascular Disorders, General
  Hypertension 1 3
Metabolic and Nutritional Disorders
  Weight decrease 0 7
  Decreased appetite 2 4
  Anorexia 1 2

In the controlled clinical study using QUDEXY XR, 8.9% of patients who received QUDEXY XR and 4.0% who received placebo discontinued as a result of treatment-emergent adverse reactions.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of topiramate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The listing is alphabetized: bullous skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), hepatic failure (including fatalities), hepatitis, maculopathy, pancreatitis, and pemphigus.

Read the entire FDA prescribing information for Qudexy XR (Topiramate Extended-Release Capsules)

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