| MedDRA Preferred Term | Side effect | Data for drug | Placebo | Labels | 
|  | 1 | 2 | 
| Abdominal pain | Abdominal pain | frequent, 5.8% | 2.1% | x | x | 
| Gastrointestinal pain | Abdominal pain | frequent, 5.8% | 2.1% | x | x | 
| Amnesia | Amnesia | frequent |  | x | x | 
| Anaemia | Anaemia | frequent, 1.1% | 1% | x | x | 
| Anxiety | Anxiety | frequent, 6.4% | 4.3% | x | x | 
| Arthralgia | Arthralgia | frequent, 1.6% | 2.1% | x | x | 
| Musculoskeletal discomfort | Arthralgia | frequent, 1.6% | 2.1% | x | x | 
| Myalgia | frequent, 1.1% | 1% | x | x | 
| Asthenia | Asthenia | frequent, 4.2% | 4.8% | x | x | 
| Back pain | Back pain | frequent, 1.6% | 2.1% | x | x | 
| Neck pain | Neck pain | frequent, 2.7% | 1.6% | x | x | 
| Chest pain | Chest pain | frequent, 3.7% | 2.1% | x | x | 
| Constipation | Constipation | frequent, 10.6% | 5.9% | x | x | 
| Dysphagia | Dysphagia | frequent |  | x | x | 
| Diarrhoea | Diarrhoea | frequent, 6.4% | 2.7% | x | x | 
| Diplopia | Diplopia | frequent, 2.1% | 0% | x | x | 
| Dizziness | Dizziness | frequent, 19.1% | 13.9% | x | x | 
| Syncope | frequent, 2.1% | 1.1% | x | x | 
| Dyskinesia | Dyskinesia | frequent, 62.4% | 24.6% | x | x | 
| Dysmenorrhoea | Dysmenorrhoea | frequent |  | x | x | 
| Dyspepsia | Dyspepsia | frequent, 6.4% | 2.1% | x | x | 
| Dyspnoea | Dyspnoea | frequent, 4.8% | 1.1% | x | x | 
| Dermatitis | Rash | frequent, 3.2% | 2.1% | x | x | 
| Rash | Rash | frequent, 3.2% | 2.1% | x | x | 
| Extrapyramidal disorder | Extrapyramidal disorder | frequent, 1.6% | 1.1% | x | x | 
| Body temperature increased | Body temperature increased | frequent |  | x | x | 
| Hallucination | Hallucination | rare — 7.8% - 13.8% | 3.2% | x | x | 
| Headache | Headache | frequent, 5.3% | 6.4% | x | x | 
| Cardiac failure congestive | Cardiac failure congestive | frequent |  | x | x | 
| Haematuria | Haematuria | frequent, 1.1% | 1% | x | x | 
| Hypertension | Hypertension | frequent, 1.6% | 1.1% | x | x | 
| Orthostatic hypotension | Orthostatic hypotension | frequent, 9% | 7% | x | x | 
| Influenza | Influenza | frequent, 3.2% | 2.1% | x | x | 
| Nausea | Nausea | infrequent — 24.3% | 12.8% | x | x | 
| Nervousness | Nervousness | frequent |  | x | x | 
| Tension | Nervousness | frequent |  | x | x | 
| Pain | Pain | frequent, 7% | 2.1% | x | x | 
| Palpitations | Palpitations | frequent, 2.1% | 1% | x | x | 
| Paraesthesia | Paraesthesia | frequent, 1.6% | 3.2% | x | x | 
| Personality disorder | Personality disorder | frequent, 2.1% | 1% | x | x | 
| Pharyngitis | Pharyngitis | frequent |  | x | x | 
| Pneumonia | Pneumonia | frequent |  | x | x | 
| Psychotic disorder | Psychotic disorder | frequent, 2.1% | 0% | x | x | 
| Rhinitis | Rhinitis | frequent, 12.2% | 5.4% | x | x | 
| Hyperhidrosis | Sweating | frequent, 2.1% | 2.7% | x | x | 
| Shock | Syncope | frequent, 2.1% | 1.1% | x | x | 
| Shock | infrequent |  | x | x | 
| Syncope | Syncope | frequent, 2.1% | 1.1% | x | x | 
| Loss of consciousness | Syncope | frequent, 2.1% | 1.1% | x | x | 
| Tremor | Tremor | frequent, 4.2% | 7.5% | x | x | 
| Pollakiuria | Pollakiuria | frequent, 2.7% | 6.4% | x | x | 
| Urinary incontinence | Urinary incontinence | frequent |  | x | x | 
| Urinary tract infection | Urinary tract infection | frequent, 2.7% | 3.7% | x | x | 
| Weight increased | Weight increased | frequent, 1.6% | 0% | x | x | 
| Weight decreased | Weight decreased | frequent |  | x | x | 
| Dry mouth | Dry mouth | frequent, 3.7% | 1% | x | x | 
| Choreoathetosis | Choreoathetosis | frequent |  | x | x | 
| Akinesia | Akinesia | frequent, 1.1% | 1.1% | x | x | 
| Oedema peripheral | Oedema peripheral | frequent, 7.4% | 4.3% | x | x | 
| Injury | Accidental injury | frequent |  | x | x | 
| Paranoia | Paranoid reaction | frequent |  | x | x | 
| Myalgia | Myalgia | frequent, 1.1% | 1% | x | x | 
| Muscle twitching | Muscle twitching | frequent, 1.1% | 0% | x | x | 
| Thinking abnormal | Thinking abnormal | frequent |  | x | x | 
| Mental disability | Thinking abnormal | frequent |  | x | x | 
| Abnormal dreams | Abnormal dreams | frequent, 2.7% | 4.3% | x | x | 
| Coordination abnormal | Coordination abnormal | frequent, 1.6% | 1% | x | x | 
| Cough | Cough increased | frequent |  | x | x | 
| Gait disturbance | Gait disturbance | frequent, 1.6% | 1.6% | x | x | 
| Insomnia | Insomnia | frequent, 7.9% | 3.2% | x | x | 
| Somnolence | Somnolence | frequent, 10.1% | 3.7% | x | x | 
| Visual impairment | Abnormal vision | frequent, 5.8% | 5.4% | x | x | 
| Decreased appetite | Anorexia | 4.8% | 2.7% | x | x | 
| Depression | Depression | 3.2% | 5.4% | x | x | 
| Vomiting | Vomiting | infrequent, frequent |  | x | x | 
| Hypotension | Hypotension | 2.1% | 1% | x | x | 
| Confusional state | Confusional state | rare — 1.8% - 11.1% | 9.6% | x | x | 
| Feeling abnormal | Confusional state | rare — 1.8% - 11.1% | 9.6% | x | x | 
| Malaise | infrequent |  | x | x | 
| Bursitis | Bursitis | 1.6% | 1% | x | x | 
| Oedema | Oedema | 1.6% | 0% | x | x | 
| Arrhythmia | Arrhythmia | 1.1% | 1% | x | x | 
| Infection | Infection | 1.1% | 0% | x | x | 
| Eye disorder | Eye disorder | 1.1% | 0% | x | x | 
| Speech disorder | Speech disorder | 1.1% | 1.6% | x | x | 
| Abscess | Abscess | infrequent |  | x | x | 
| Adenoma benign | Adenoma benign | infrequent |  | x | x | 
| Alopecia | Alopecia | infrequent |  | x | x | 
| Anaemia megaloblastic | Anaemia megaloblastic | infrequent |  | x | x | 
| Angina pectoris | Angina pectoris | infrequent |  | x | x | 
| Apnoea | Apnoea | infrequent |  | x | x | 
| Arthritis | Arthritis | infrequent |  | x | x | 
| Asthma | Asthma | infrequent |  | x | x | 
| Ataxia | Ataxia | infrequent |  | x | x | 
| Atrial fibrillation | Atrial fibrillation | infrequent |  | x | x | 
| Atrioventricular block | Atrioventricular block | infrequent |  | x | x | 
| Block heart | rare |  | x | x | 
| Bronchitis | Bronchitis | infrequent |  | x | x | 
| Candida infection | Candida infection | infrequent |  | x | x | 
| Cellulitis | Cellulitis | infrequent |  | x | x | 
| Cholelithiasis | Cholelithiasis | infrequent |  | x | x | 
| Coma | Coma | infrequent |  | x | x | 
| Conjunctivitis | Conjunctivitis | infrequent |  | x | x | 
| Cyanosis | Cyanosis | infrequent |  | x | x | 
| Cystitis | Cystitis | infrequent |  | x | x | 
| Bladder pain | Cystitis | infrequent |  | x | x | 
| Cystitis noninfective | Cystitis | infrequent |  | x | x | 
| Deafness | Deafness | infrequent |  | x | x | 
| Libido decreased | Libido decreased | infrequent |  | x | x | 
| Disturbance in sexual arousal | Libido decreased | infrequent |  | x | x | 
| Libido increased | infrequent |  | x | x | 
| Dehydration | Dehydration | infrequent |  | x | x | 
| Delirium | Delirium | infrequent |  | x | x | 
| Delusion | Delusion | infrequent |  | x | x | 
| Dental caries | Dental caries | infrequent |  | x | x | 
| Fungal skin infection | Fungal skin infection | infrequent |  | x | x | 
| Diabetes mellitus | Diabetes mellitus | infrequent |  | x | x | 
| Dysgeusia | Dysgeusia | infrequent, 1.6% | 0% | x | x | 
| Dysuria | Dysuria | infrequent |  | x | x | 
| Ear pain | Ear pain | infrequent |  | x | x | 
| Eczema | Eczema | infrequent |  | x | x | 
| Epistaxis | Epistaxis | infrequent, 1.6% | 1% | x | x | 
| Eructation | Eructation | infrequent |  | x | x | 
| Oesophagitis | Oesophagitis | infrequent |  | x | x | 
| Eye haemorrhage | Eye haemorrhage | infrequent |  | x | x | 
| Fibrocystic breast disease | Fibrocystic breast disease | infrequent |  | x | x | 
| Flatulence | Flatulence | infrequent |  | x | x | 
| Gastritis | Gastritis | infrequent |  | x | x | 
| Gastroenteritis | Gastroenteritis | infrequent |  | x | x | 
| Gingivitis | Gingivitis | infrequent |  | x | x | 
| Glaucoma | Glaucoma | infrequent |  | x | x | 
| Gout | Gout | infrequent |  | x | x | 
| Cardiac arrest | Cardiac arrest | infrequent |  | x | x | 
| Haematemesis | Haematemesis | infrequent |  | x | x | 
| Haemoptysis | Haemoptysis | infrequent |  | x | x | 
| Hepatitis | Hepatitis | infrequent |  | x | x | 
| Hepatomegaly | Hepatomegaly | infrequent |  | x | x | 
| Hernia | Hernia | infrequent |  | x | x | 
| Herpes simplex | Herpes simplex | infrequent |  | x | x | 
| Herpes zoster | Herpes zoster | infrequent |  | x | x | 
| Hiccups | Hiccups | infrequent, 1.1% | 0% | x | x | 
| Hirsutism | Hirsutism | infrequent |  | x | x | 
| Hostility | Hostility | infrequent |  | x | x | 
| Hypercholesterolaemia | Hypercholesterolaemia | infrequent |  | x | x | 
| Hyperglycaemia | Hyperglycaemia | infrequent |  | x | x | 
| Salivary gland enlargement | Salivary gland enlargement | infrequent |  | x | x | 
| Hyperventilation | Hyperventilation | infrequent |  | x | x | 
| Hypoglycaemia | Hypoglycaemia | infrequent |  | x | x | 
| Hypokalaemia | Hypokalaemia | infrequent |  | x | x | 
| Body temperature decreased | Body temperature decreased | infrequent |  | x | x | 
| Hypothermia | Body temperature decreased | infrequent |  | x | x | 
| Hypothyroidism | Hypothyroidism | infrequent |  | x | x | 
| Inappropriate antidiuretic hormone secretion | Inappropriate antidiuretic hormone secretion | infrequent |  | x | x | 
| Libido increased | Libido increased | infrequent |  | x | x | 
| Intestinal obstruction | Intestinal obstruction | infrequent |  | x | x | 
| Nephrolithiasis | Calculus of kidney | infrequent |  | x | x | 
| Laryngitis | Laryngitis | infrequent |  | x | x | 
| Leukocytosis | Leukocytosis | infrequent |  | x | x | 
| Leukopenia | Leukopenia | infrequent |  | x | x | 
| Breast pain | Breast pain | infrequent |  | x | x | 
| Melaena | Melaena | infrequent |  | x | x | 
| Meningitis | Meningitis | infrequent |  | x | x | 
| Menopause | Menopause | infrequent |  | x | x | 
| Menorrhagia | Menorrhagia | infrequent |  | x | x | 
| Metrorrhagia | Metrorrhagia | infrequent |  | x | x | 
| Hypertonia | Hypertonia | infrequent, 1.1% | 0% | x | x | 
| Hypotonia | Hypotonia | infrequent |  | x | x | 
| Muscle relaxant therapy | Hypotonia | infrequent |  | x | x | 
| Myocardial infarction | Myocardial infarction | infrequent, 1.1% | 1% | x | x | 
| Acute coronary syndrome | Myocardial infarction | infrequent, 1.1% | 1% | x | x | 
| Myoclonus | Myoclonus | infrequent |  | x | x | 
| Myositis | Myositis | infrequent |  | x | x | 
| Neoplasm | Neoplasm | infrequent |  | x | x | 
| Neuralgia | Neuralgia | infrequent, 1.1% | 1% | x | x | 
| Neurosis | Neurosis | infrequent |  | x | x | 
| Otitis media | Otitis media | infrequent |  | x | x | 
| Pelvic pain | Pelvic pain | infrequent |  | x | x | 
| Tooth abscess | Abscess periodontal | infrequent |  | x | x | 
| Petechiae | Petechiae | infrequent |  | x | x | 
| Pleural effusion | Pleural effusion | infrequent |  | x | x | 
| Priapism | Priapism | infrequent |  | x | x | 
| Pruritus | Pruritus | infrequent |  | x | x | 
| Pulmonary oedema | Pulmonary oedema | infrequent |  | x | x | 
| Pulmonary embolism | Pulmonary embolism | infrequent |  | x | x | 
| Emphysema | Emphysema | infrequent |  | x | x | 
| Pyuria | Pyuria | infrequent |  | x | x | 
| Renal failure | Renal failure | infrequent |  | x | x | 
| Salpingitis | Salpingitis | infrequent |  | x | x | 
| Scotoma | Scotoma | infrequent |  | x | x | 
| Seborrhoeic dermatitis | Seborrhoeic dermatitis | infrequent |  | x | x | 
| Convulsion | Convulsion | infrequent |  | x | x | 
| Sinusitis | Sinusitis | infrequent |  | x | x | 
| Skin ulcer | Skin ulcer | infrequent |  | x | x | 
| Gastric ulcer | Gastric ulcer | infrequent |  | x | x | 
| Cerebrovascular accident | Cerebrovascular accident | infrequent |  | x | x | 
| Tachycardia | Tachycardia | infrequent |  | x | x | 
| Tenosynovitis | Tenosynovitis | infrequent |  | x | x | 
| Thirst | Thirst | infrequent |  | x | x | 
| Thrombocytopenia | Thrombocytopenia | infrequent |  | x | x | 
| Thrombophlebitis | Thrombophlebitis | infrequent |  | x | x | 
| Tinnitus | Tinnitus | infrequent |  | x | x | 
| Torticollis | Torticollis | infrequent |  | x | x | 
| Uterine haemorrhage | Uterine haemorrhage | infrequent |  | x | x | 
| Vaginal inflammation | Vaginal inflammation | infrequent |  | x | x | 
| Vaginal infection | Vaginal inflammation | infrequent |  | x | x | 
| Varicose vein | Varicose vein | infrequent |  | x | x | 
| Ventricular tachycardia | Ventricular tachycardia | infrequent |  | x | x | 
| Vertigo | Vertigo | infrequent |  | x | x | 
| Urinary retention | Urinary retention | infrequent |  | x | x | 
| Chills | Chills | infrequent, 1.1% | 0% | x | x | 
| Agitation | Agitation | infrequent |  | x | x | 
| Hyperkinesia | infrequent |  | x | x | 
| Apathy | Apathy | infrequent |  | x | x | 
| Flat affect | Apathy | infrequent |  | x | x | 
| Mood swings | Mood swings | infrequent |  | x | x | 
| Affect lability | Mood swings | infrequent |  | x | x | 
| Photophobia | Photophobia | infrequent |  | x | x | 
| Hypokinesia | Hypokinesia | infrequent |  | x | x | 
| Ventricular extrasystoles | Ventricular extrasystoles | infrequent |  | x | x | 
| Liver function test abnormal | Liver function test abnormal | infrequent |  | x | x | 
| Mania | Manic psychosis | infrequent |  | x | x | 
| Bone pain | Bone pain | infrequent |  | x | x | 
| Eye pain | Eye pain | infrequent |  | x | x | 
| Skin discolouration | Skin discolouration | infrequent |  | x | x | 
| Dry skin | Dry skin | infrequent |  | x | x | 
| Iron deficiency anaemia | Iron deficiency anaemia | infrequent |  | x | x | 
| Malaise | Malaise | infrequent |  | x | x | 
| Discomfort | Malaise | infrequent |  | x | x | 
| Ill-defined disorder | Malaise | infrequent |  | x | x | 
| Increased appetite | Increased appetite | infrequent |  | x | x | 
| Euphoric mood | Euphoric mood | infrequent |  | x | x | 
| Pain in jaw | Pain in jaw | infrequent |  | x | x | 
| Erectile dysfunction | Erectile dysfunction | infrequent |  | x | x | 
| Sepsis | Sepsis | infrequent |  | x | x | 
| Cervix carcinoma | Cervix carcinoma | infrequent |  | x | x | 
| Abdominal distension | Enlargement abdomen | infrequent |  | x | x | 
| Akathisia | Akathisia | infrequent, 1.6% | 0% | x | x | 
| Hyperkinesia | Hyperkinesia | infrequent |  | x | x | 
| Bradycardia | Bradycardia | infrequent |  | x | x | 
| Neuropathy peripheral | Neuropathy | infrequent |  | x | x | 
| Neuritis | rare |  | x | x | 
| Calculus urinary | Urolithiasis | infrequent |  | x | x | 
| Lymphadenopathy | Lymphadenopathy | infrequent |  | x | x | 
| Electrocardiogram abnormal | Electrocardiogram abnormal | infrequent |  | x | x | 
| Paralysis | Paralysis | infrequent |  | x | x | 
| Face oedema | Face oedema | infrequent, 1.1% | 0% | x | x | 
| Breast cancer | Carcinoma breast | infrequent |  | x | x | 
| Skin cancer | Skin carcinoma | infrequent |  | x | x | 
| Cerebral ischaemia | Cerebral ischaemia | infrequent |  | x | x | 
| Bone sarcoma | Bone sarcoma | infrequent |  | x | x | 
| Vaginal haemorrhage | Vaginal haemorrhage | infrequent |  | x | x | 
| Acute abdomen | Acute abdomen | rare |  | x | x | 
| Acidosis | Acidosis | rare |  | x | x | 
| Amenorrhoea | Amenorrhoea | rare |  | x | x | 
| Benign neoplasm of skin | Benign neoplasm of skin | rare |  | x | x | 
| Cachexia | Cachexia | rare |  | x | x | 
| Cholecystitis | Cholecystitis | rare |  | x | x | 
| Colitis | Colitis | rare |  | x | x | 
| Duodenitis | Duodenitis | rare |  | x | x | 
| Endocrine disorder | Endocrine disorder | rare |  | x | x | 
| Eosinophilia | Eosinophilia | rare |  | x | x | 
| Epididymitis | Epididymitis | rare |  | x | x | 
| VIIth nerve paralysis | Facial paralysis | rare |  | x | x | 
| Faecal incontinence | Faecal incontinence | rare |  | x | x | 
| Glossitis | Glossitis | rare |  | x | x | 
| Hemiplegia | Hemiplegia | rare |  | x | x | 
| Haemothorax | Haemothorax | rare |  | x | x | 
| Pulmonary hypertension | Pulmonary hypertension | rare |  | x | x | 
| Hypogonadism | Hypogonadism | rare |  | x | x | 
| Jaundice | Jaundice | rare |  | x | x | 
| Laryngeal oedema | Laryngeal oedema | rare |  | x | x | 
| Acute lymphocytic leukaemia | Acute lymphocytic leukaemia | rare |  | x | x | 
| Vaginal discharge | Leukorrhea | rare |  | x | x | 
| Systemic lupus erythematosus | Systemic lupus erythematosus | rare |  | x | x | 
| Lymphocytosis | Lymphocytosis | rare |  | x | x | 
| Muscle atrophy | Muscle atrophy | rare |  | x | x | 
| Myelitis | Myelitis | rare |  | x | x | 
| Nephrotic syndrome | Nephrosis | rare |  | x | x | 
| Neuritis | Neuritis | rare |  | x | x | 
| Osteomyelitis | Osteomyelitis | rare |  | x | x | 
| Osteoporosis | Osteoporosis | rare |  | x | x | 
| Pancreatitis | Pancreatitis | rare |  | x | x | 
| Peptic ulcer | Peptic ulcer | rare |  | x | x | 
| Pericarditis | Pericarditis | rare |  | x | x | 
| Pneumothorax | Pneumothorax | rare |  | x | x | 
| Polycythaemia | Polycythaemia | rare |  | x | x | 
| Pulmonary fibrosis | Pulmonary fibrosis | rare |  | x | x | 
| Purpura | Purpura | rare |  | x | x | 
| Vascular purpura | Purpura | rare |  | x | x | 
| Pyelonephritis | Pyelonephritis | rare |  | x | x | 
| Retinal detachment | Retinal detachment | rare |  | x | x | 
| Sialoadenitis | Sialoadenitis | rare |  | x | x | 
| Skin mass | Skin nodule | rare |  | x | x | 
| Subcutaneous nodule | rare |  | x | x | 
| Splenomegaly | Splenomegaly | rare |  | x | x | 
| Aphthous stomatitis | Aphthous stomatitis | rare |  | x | x | 
| Vasculitis | Vasculitis | rare |  | x | x | 
| Stupor | Stupor | rare |  | x | x | 
| Depressed level of consciousness | Stupor | rare |  | x | x | 
| Breast engorgement | Breast engorgement | rare |  | x | x | 
| Cataract | Cataract | rare |  | x | x | 
| Migraine | Migraine | rare |  | x | x | 
| Thyroid adenoma | Thyroid adenoma | rare |  | x | x | 
| Intracranial pressure increased | Intracranial pressure increased | rare |  | x | x | 
| Urethral pain | Urethral pain | rare |  | x | x | 
| Rash pustular | Vesiculobullous rash | rare |  | x | x | 
| Dermatitis bullous | Vesiculobullous rash | rare |  | x | x | 
| Oesophageal ulcer | Oesophageal ulcer | rare |  | x | x | 
| Withdrawal bleed | Withdrawal bleed | rare |  | x | x | 
| Retinal vascular disorder | Retinal vascular disorder | rare |  | x | x | 
| Lichenoid keratosis | Eruption lichenoid | rare |  | x | x | 
| Hyperuricosuria | Uricaciduria | rare |  | x | x | 
| Electrolyte imbalance | Electrolyte imbalance | rare |  | x | x | 
| Blindness | Blindness | rare |  | x | x | 
| Lung neoplasm malignant | Carcinoma of lung | rare |  | x | x | 
| Bladder cancer | Bladder carcinoma | rare |  | x | x | 
| Blood uric acid increased | Hyperuricaemia | rare |  | x | x | 
| Hyperuricaemia | Hyperuricaemia | rare |  | x | x | 
| Thrombocytosis | Thrombocytosis | rare |  | x | x | 
| Brain oedema | Brain oedema | rare |  | x | x | 
| Cerebral haemorrhage | Cerebral haemorrhage | rare |  | x | x | 
| Hypoxia | Hypoventilation | rare |  | x | x | 
| Respiratory failure | Hypoventilation | rare |  | x | x | 
| Hypoventilation | Hypoventilation | rare |  | x | x | 
| Neuroleptic malignant syndrome | Neuroleptic malignant syndrome |  |  | x | x |