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Side effects

Options: Hide MedDRA Preferred Terms

MedDRA Preferred Term Side effect Data for drug Placebo Labels
1 2
Dizziness Dizziness 10% - 20% 7% x x
Somnolence Somnolence 9% - 15% 5% x x
Dry mouth Dry mouth 8% - 10% 1% x x
Nausea Nausea 7% - 10% 8% x x
Tachycardia Tachycardia 3% - 12% 1% x x
Nasal congestion Nasal congestion 5% - 8% 2% x x
Diarrhoea Diarrhoea 5% - 7% 4% x x
Asthenia Fatigue 4% - 6% 3% x x
Fatigue Fatigue 4% - 6% 3% x x
Weight decreased Weight decreased frequent x x
Weight increased Weight increased 1% - 9% 1% x x
Extrapyramidal disorder Extrapyramidal disorder 4% - 5% 4% x x
Extrapyramidal symptoms x x
Orthostatic hypotension Orthostatic hypotension 3% - 5% 1% x x
Nasopharyngitis Nasopharyngitis 3% - 4% 3% x x
Rhinorrhoea x x
Arthralgia Arthralgia 3% 2% x x
Musculoskeletal discomfort Arthralgia 3% 2% x x
Myalgia x x
Tremor Tremor 2.5% - 3.1% 1.9% - 2% x x
Dermatitis Rash 2% - 3% 2% x x
Rash Rash 2% - 3% 2% x x
Upper respiratory tract infection Upper respiratory tract infection 2% - 3% 1% x x
Dyspnoea Dyspnoea 2% 1% x x
Lethargy Lethargy 1% - 3% 1% x x
Abdominal discomfort Abdominal discomfort 1% - 3% 1% x x
Ejaculation failure Ejaculation failure 2% 1% x x
Vision blurred Vision blurred 1% - 3% 2% x x
Akathisia Akathisia 1.7% - 2.3% 2.7% x x
Musculoskeletal stiffness Musculoskeletal stiffness 1% - 3% 1% x x
Hypotension Hypotension 1% - 3% 1% x x
Dyskinesia Dyskinesia 1% - 1.7% 1.5% x x
Bradykinesia Bradykinesia 0.5% - 0.6% 0% x x
Parkinsonism Parkinsonism 0.2% - 0.3% 0% x x
Retrograde ejaculation Retrograde ejaculation postmarketing x
Aggression Aggression x x
Amenorrhoea Amenorrhoea x x
Amnesia Amnesia x x
Anaemia Anaemia x x
Arrhythmia Arrhythmia x x
Asthma Asthma x x
Mental disorder Mental disorder x x
Blepharitis Blepharitis x x
Breast disorder Breast disorder x x
Catatonia Catatonia x x
Cholelithiasis Cholelithiasis x x
Infection Infection x x
Confusional state Confusional state x x
Feeling abnormal Confusional state x x
Conjunctivitis Conjunctivitis x x
Connective tissue disorder Connective tissue disorder x x
Libido decreased Libido decreased x x
Disturbance in sexual arousal Libido decreased x x
Dehydration Dehydration x x
Delirium Delirium x x
Delusion Delusion x x
Duodenal ulcer Duodenal ulcer x x
Dysuria Dysuria x x
Oedema Oedema x x
Endocrine disorder Endocrine disorder x x
Enuresis Enuresis x x
Epistaxis Epistaxis x x
Gastrooesophageal reflux disease Reflux esophagitis x x
Eye disorder Eye disorder x x
Faecal incontinence Faecal incontinence x x
Body temperature increased Body temperature increased x x
Gastritis Gastritis x x
Gastrointestinal disorder Gastrointestinal disorder x x
Gynaecomastia Gynaecomastia x x
Cardiac disorder Cardiac disorder x x
Cardiac failure Cardiac failure x x
Blood disorder Blood disorder x x
Hostility Hostility x x
Hyperaemia Hyperaemia x x
Hypokalaemia Hypokalaemia x x
Hypothyroidism Hypothyroidism x x
Impulse-control disorder Impulse-control disorder x x
Renal failure acute Renal failure acute x x
Leukopenia Leukopenia x x
Breast pain Breast pain x x
Mediastinal disorder Mediastinal disorder x x
Menorrhagia Menorrhagia x x
Metrorrhagia Metrorrhagia x x
Nervous system disorder Nervous system disorder x x
Nystagmus Nystagmus x x
Obsessive-compulsive disorder Obsessive-compulsive disorder x x
Palpitations Palpitations x x
Paraesthesia Paraesthesia x x
Prostatitis Prostatitis x x
Restless legs syndrome Restless legs syndrome x x
Salivary hypersecretion Salivary hypersecretion x x
Sleep apnoea syndrome Sleep apnoea syndrome x x
Muscle spasms Muscle spasms x x
Stomatitis Stomatitis x x
Mouth ulceration x x
Aphthous stomatitis Aphthous stomatitis x x
Testicular pain Testicular pain x x
Thirst Thirst x x
Tinnitus Tinnitus x x
Torticollis Torticollis x x
Pollakiuria Pollakiuria x x
Urinary incontinence Urinary incontinence x x
Urethral disorder Urinary tract disorder x x
Urinary tract disorder Urinary tract disorder x x
Angiopathy Angiopathy x x
Vertigo Vertigo x x
Urinary retention Urinary retention x x
Atrioventricular block first degree Atrioventricular block first degree x x
Agitation Agitation x x
Mood swings Mood swings x x
Affect lability Mood swings x x
Cataract Cataract x x
Panic attack Panic attack x x
Mouth ulceration Mouth ulceration x x
Neutrophil count increased Neutrophil count increased x x
Hyperchlorhydria Hyperchlorhydria x x
Gastric pH decreased Hyperchlorhydria x x
Sinus congestion Sinus congestion x x
Menstruation irregular Menstruation irregular x x
Haemoglobin decreased Haemoglobin decreased x x
Eyelid oedema Eyelid oedema x x
Iron deficiency anaemia Iron deficiency anaemia x x
Malnutrition Malnutrition x x
Myalgia Myalgia x x
Dyspnoea exertional Dyspnoea exertional x x
Nasal dryness Nasal dryness x x
Increased appetite Increased appetite x x
Anorgasmia Anorgasmia x x
Dry throat Dry throat x x
Erectile dysfunction Erectile dysfunction x x
Cheilitis Lip ulceration x x
Lip pain Lip ulceration x x
Lip ulceration Lip ulceration x x
Hepatobiliary disease Hepatobiliary disease x x
Fluid retention Fluid retention x x
Eye swelling Eye swelling x x
Walking disability Walking disability x x
Gait disturbance Walking disability x x
Dry eye Dry eye x x
Mania Mania x x
Nephrolithiasis Nephrolithiasis x x
Polydipsia psychogenic Polydipsia psychogenic x x
Haematocrit decreased Haematocrit decreased x x
Rhinorrhoea Rhinorrhoea x x
Major depression Major depression x x
Psychotic disorder Paranoia x x
Paranoia Paranoia x x
Lenticular opacities Lenticular opacities x x
Bulimia nervosa Bulimia nervosa x x
Hiatus hernia Hiatus hernia x x


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


Side effects:135
Source:FDA Structured Product Label


Side effects:136
Source:FDA Structured Product Label

Color scheme:


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