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ATC Code: N05BA09

Side effects

Options: Hide MedDRA Preferred Terms

MedDRA Preferred Term Side effect Data for drug Placebo Labels
1 2 3
Somnolence Drowsiness 32% x x
Somnolence 16% - 32% 12% - 15% x
Body temperature increased Body temperature increased 10% - 17% 3% x
Upper respiratory tract infection Upper respiratory tract infection 10% - 14% 10% x
Drooling Drooling 0% - 14% 3% x
Lethargy Lethargy 5% - 15% 5% x
Aggression Aggression 3% - 14% 5% x x x
Vomiting Vomiting 5% - 9% 5% x x
Ataxia Ataxia 2% - 10% 3% x x x
Cough Cough 3% - 7% 0% x
Asthenia Fatigue 3% - 5% 2% x x x
Asthenia x
Fatigue Fatigue 3% - 5% 2% x x x
Irritability Irritability 1.5% - 11% 5% x x x
Insomnia Insomnia 1.8% - 7% 2% x x
Urinary tract infection Urinary tract infection 2% - 5% 0% x
Headache Headache 3.6% x x
Depression Depression 3.5% x
Pneumonia Pneumonia 3% - 7% 2% x
Dry mouth Dry mouth 3.2% x
Agitation Agitation postmarketing, 3% - 5% 3% x x x
Increased appetite Increased appetite 2% - 5% 0% x
Decreased appetite Decreased appetite 0% - 7% 3% x x
Anorexia x
Appetite absent x
Dysarthria Dysarthria 2% - 5% 0% x
Slurred speech 1.6% x
Osteoarthritis Dysarthria 2% - 5% 0% x
Constipation Constipation 2% - 10% 0% x x x
Bronchitis Bronchitis 0% - 5% 0% x
Diarrhoea Diarrhoea 1.4% x
Nausea Nausea 1.3% x x
Tremor Tremor 1.3% x
Tremor fine x x
Hypotension Hypotension 1.2% x
Dysphagia Dysphagia 0% - 5% 0% x
Confusional state Confusional state postmarketing, 1.6% x x x
Feeling abnormal Confusional state postmarketing, 1.6% x x x
Dermatitis Rash postmarketing, 1.4% x x x
Rash Rash postmarketing, 1.4% x x x
Abdominal distension Abdominal distension postmarketing x
Anaemia Anaemia postmarketing x
Anxiety Anxiety postmarketing x
Mental disorder Mental disorder postmarketing x
Delirium Delirium postmarketing x
Delusion Delusion postmarketing x x x
Diplopia Diplopia postmarketing x x x
Eosinophilia Eosinophilia postmarketing x
Eye disorder Eye disorder postmarketing x x
Gastrointestinal disorder Gastrointestinal disorder postmarketing x
Hallucination Hallucination postmarketing x x x
Blood disorder Blood disorder postmarketing x
Leukopenia Leukopenia postmarketing x
Muscle spasms Muscle spasms postmarketing x x x
Thrombocytopenia Thrombocytopenia postmarketing x
Urticaria Urticaria postmarketing x x x
Apathy Apathy postmarketing x
Flat affect Apathy postmarketing x
Skin disorder Unspecified disorder of skin and subcutaneous tissue postmarketing x x
Respiratory depression Respiratory depression postmarketing x x
Pulmonary function test decreased Respiratory depression postmarketing x x
Hepatic enzyme increased Hepatic enzyme increased postmarketing x
Vision blurred Vision blurred postmarketing x x x
Amnesia Amnesia x
Asthma Asthma x
Abnormal behaviour Behavior disorder x
Infection Infection x
Libido decreased Libido decreased x
Disturbance in sexual arousal Libido decreased x
Dizziness Dizziness x x
Toxic epidermal necrolysis Toxic epidermal necrolysis x
Hostility Hostility x
Nervous system disorder Nervous system disorder x
Nervousness Nervousness x
Tension Nervousness x
Nightmare Nightmare x x
Nystagmus Nystagmus x x
Pruritus Pruritus x
Psychotic disorder Psychotic disorder x x
Respiratory failure Respiratory insufficiency x
Erythema multiforme Stevens-Johnson syndrome x
Stevens-Johnson syndrome Stevens-Johnson syndrome x
Hyperhidrosis Sweating x
Visual impairment Disorder sight x x
Weight increased Weight increased x x
Drug withdrawal syndrome Withdrawal symptom x
Liver function test abnormal Liver function test abnormal x
Muscular weakness Muscular weakness x
Malnutrition Malnutrition x
Hangover Hangover x
Myalgia Myalgia x
Musculoskeletal discomfort Myalgia x
Disorientation Disorientation x
Anterograde amnesia Anterograde amnesia x
Euphoric mood Euphoric mood x
Drug dependence Dependence psychological x
Musculoskeletal stiffness Stiffness x
Balance disorder Unsteadiness x x
Dependence Dependence x
Infestation Infestation NOS x
Suicidal behaviour Suicidal behaviour x
Loss of libido Loss of libido x x


Information about indications was extracted from the indications and usage sections of the labels.


Side effects:51
Source:FDA Structured Product Label


Side effects:32
Source:Health Canada


Side effects:55

Color scheme:


    frequent (1% to 100%)
    infrequent (0.1% to 1%)
    rare (<0.1%)
    no frequency information
    not found on label