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Zonegran (Zonisamide) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The most commonly observed adverse events associated with the use of ZONEGRAN in controlled clinical trials that were not seen at an equivalent frequency among placebo-treated patients were somnolence, anorexia, dizziness, headache, nausea, and agitation/irritability.

In controlled clinical trials, 12% of patients receiving ZONEGRAN as adjunctive therapy discontinued due to an adverse event compared to 6% receiving placebo. Approximately 21% of the 1,336 patients with epilepsy who received ZONEGRAN in clinical studies discontinued treatment because of an adverse event. The adverse events most commonly associated with discontinuation were somnolence, fatigue and/or ataxia (6%), anorexia (3%), difficulty concentrating (2%), difficulty with memory, mental slowing, nausea/vomiting (2%), and weight loss (1%). Many of these adverse events were dose-related (see WARNINGS and PRECAUTIONS).

Adverse Event Incidence in Controlled Clinical Trials

Table 3 lists treatment-emergent adverse events that occurred in at least 2% of patients treated with ZONEGRAN in controlled clinical trials that were numerically more common in the ZONEGRAN group. In these studies, either ZONEGRAN or placebo was added to the patient's current AED therapy. Adverse events were usually mild or moderate in intensity.

The prescriber should be aware that these figures, obtained when ZONEGRAN was added to concurrent AED therapy, cannot be used to predict the frequency of adverse events in the course of usual medical practice when patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescriber with one basis by which to estimate the relative contribution of drug and non-drug factors to the adverse event incidences in the population studied.

Table 3. Incidence (%) of Treatment-Emergent Adverse Events in Placebo-Controlled, Add-On Trials (Events that occurred in at least 2% of ZONEGRAN-treated patients and occurred more frequently in ZONEGRAN-treated than placebo-treated patients)
BODY SYSTEM/PREFERRED TERMZONEGRAN(n=269)
%
PLACEBO(n=230)
%
BODY AS A WHOLE
Headache 10 8
Abdominal Pain 6 3
Flu Syndrome 4 3
DIGESTIVE
Anorexia 13 6
Nausea 9 6
Diarrhea 5 2
Dyspepsia 3 1
Constipation 2 1
Dry Mouth 2 1
HEMATOLOGIS AND LYMPHATIC
Ecchymosis 2 1
METABOLIC AND NUTRITIONAL
Weight Loss 3 2
NERVOUS SYSTEM
Dizziness 13 7
Ataxia 6 1
Nystagmus 4 2
Paresthesia 4 1
NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-ALTERED COGNITIVE FUNCTION
Confusion 6 3
Difficulty Concentrating 6 2
Difficulty with Memory 6 2
Mental Slowing 4 2
NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-BEHAVIORAL ABNORMALITIES (NON-PYSCHOSIS-RELATED)
Agitation/Irritability 9 4
Depression 6 3
Insomnia 6 3
Anxiety 3 2
Nervousness 2 1
NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-BEHAVIORAL ABNORMALITIES (PYSCHOSIS-RELATED)
Schizophrenic/Schizophreniform Behavior 2 0
NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-CNS DEPRESSION
Somnolence 17 7
Fatigue 8 6
Tiredness 7 5
NEUROPSYCHIATRIC AND COGNITIVE DYSFUNCTION-SPEECH AND LANGUAGE ABNORMALITIES
Speech Abnormalities 5 2
Difficulties in Verbal Expression 2 <1
RESPIRATORY
Rhinitis 2 1
SKIN AND APPENDAGES
Rash 3 2
SPECIAL SENSES
Diplopia 6 3
Taste Perversion20

Other Adverse Events Observed During Clinical Trials

ZONEGRAN has been administered to 1,598 individuals during all clinical trials, only some of which were placebo-controlled. During these trials, all events were recorded by the investigators using their own terms. To provide a useful estimate of the proportion of individuals having adverse events, similar events have been grouped into a smaller number of standardized categories using a modified COSTART dictionary. The frequencies represent the proportion of the 1,598 individuals exposed to ZONEGRAN who experienced an event on at least one occasion. All events are included except those already listed in the previous table or discussed in WARNINGS or PRECAUTIONS, trivial events, those too general to be informative, and those not reasonably associated with ZONEGRAN.

Events are further classified within each category and listed in order of decreasing frequency as follows: frequent occurring in at least 1:100 patient; infrequent occurring in 1:100 to 1:1000 patients; rare occurring in fewer than 1:1000 patients.

Body as a Whole: Frequent: Accidental injury, asthenia. Infrequent: Chest pain, flank pain, malaise, allergic reaction, face edema, neck rigidity. Rare: Lupus erythematosus.

Cardiovascular: Infrequent: Palpitation, tachycardia, vascular insufficiency, hypotension, hypertension, thrombophlebitis, syncope, bradycardia. Rare: Atrial fibrillation, heart failure, pulmonary embolus, ventricular extrasystoles.

Digestive: Frequent: Vomiting. Infrequent: Flatulence, gingivitis, gum hyperplasia, gastritis, gastroenteritis, stomatitis, cholelithiasis, glossitis, melena, rectal hemorrhage, ulcerative stomatitis, gastro-duodenal ulcer, dysphagia, gum hemorrhage. Rare: Cholangitis, hematemesis, cholecystitis, cholestatic jaundice, colitis, duodenitis, esophagitis, fecal incontinence, mouth ulceration.

Hematologic and Lymphatic: Infrequent: Leukopenia, anemia, immunodeficiency, lymphadenopathy. Rare: Thrombocytopenia, microcytic anemia, petechia.

Metabolic and Nutritional: Infrequent: Peripheral edema, weight gain, edema, thirst, dehydration. Rare: Hypoglycemia, hyponatremia, lactic dehydrogenase increased, SGOT increased, SGPT increased.

Musculoskeletal: Infrequent: Leg cramps, myalgia, myasthenia, arthralgia, arthritis.

Nervous System: Frequent: Tremor, convulsion, abnormal gait, hyperesthesia, incoordination. Infrequent: Hypertonia, twitching, abnormal dreams, vertigo, libido decreased, neuropathy, hyperkinesia, movement disorder, dysarthria, cerebrovascular accident, hypotonia, peripheral neuritis, parathesia, reflexes increased. Rare: Circumoral paresthesia, dyskinesia, dystonia, encephalopathy, facial paralysis, hypokinesia, hyperesthesia, myoclonus, oculogyric crisis.

Behavioral Abnormalities —Non-Psychosis-Related: Infrequent: Euphoria.

Respiratory: Frequent: Pharyngitis, cough increased. Infrequent: Dyspnea. Rare: Apnea, hemoptysis.

Skin and Appendages: Frequent: Pruritus. Infrequent: Maculopapular rash, acne, alopecia, dry skin, sweating, eczema, urticaria, hirsutism, pustular rash, vesiculobullous rash.

Special Senses: Frequent: Amblyopia, tinnitus. Infrequent: Conjunctivitis, parosmia, deafness, visual field defect, glaucoma. Rare: Photophobia, iritis.

Urogenital: Infrequent: Urinary frequency, dysuria, urinary incontinence, hematuria, impotence, urinary retention, urinary urgency, amenorrhea, polyuria, nocturia. Rare: Albuminuria, enuresis, bladder pain, bladder calculus, gynecomastia, mastitis, menorrhagia.



REPORTS OF SUSPECTED ZONEGRAN SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Zonegran side effects / adverse reactions in 75 year old male

Reported by a physician from Germany on 2011-10-13

Patient: 75 year old male

Reactions: Skin Reaction

Suspect drug(s):
Zonegran



Possible Zonegran side effects / adverse reactions in 25 year old male

Reported by a physician from Switzerland on 2011-10-20

Patient: 25 year old male weighing 55.0 kg (121.0 pounds)

Reactions: Depressed Level of Consciousness, Acidosis

Adverse event resulted in: hospitalization

Suspect drug(s):
Zonegran



Possible Zonegran side effects / adverse reactions in 10 year old male

Reported by a consumer/non-health professional from United Kingdom on 2011-10-24

Patient: 10 year old male weighing 42.6 kg (93.7 pounds)

Reactions: Agitation, Cataract, Drug Ineffective, Abnormal Behaviour, Rash, OFF Label USE, Fatigue, Sleep Disorder, Screaming, Crying

Suspect drug(s):
Zonegran
    Administration route: Oral
    Start date: 2007-01-01
    End date: 2007-01-01

Zonegran
    Dosage: 200mg am, 175 mg pm
    Administration route: Oral
    End date: 2011-10-01

Zonegran
    Dosage: unknown
    Administration route: Oral
    Indication: Epilepsy

Zonegran
    Administration route: Oral
    Start date: 2011-10-01
    End date: 2011-10-01

Zonegran
    Dosage: reduced dose unknown
    Administration route: Oral
    Start date: 2011-10-01

Other drugs received by patient: Valproate Sodium



See index of all Zonegran side effect reports >>

Drug label data at the top of this Page last updated: 2007-07-13

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