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ATC Codes: M01AE09, M02AA19, R02AX01, S01BC04

Side effects

Options: Hide MedDRA Preferred Terms

MedDRA Preferred Term Side effect Data for drug Placebo Labels
1 2 3 4 5 6 7 8
Abdominal pain Abdominal pain x x
Gastrointestinal pain Abdominal pain x x
Agranulocytosis Agranulocytosis x
Albuminuria Albuminuria x
Alopecia Alopecia x x
Amblyopia Amblyopia x
Amnesia Amnesia x x
Anaphylactic shock Anaphylactic shock x x
Anaemia Anaemia x x
Aplastic anaemia Aplastic anaemia x
Haemolytic anaemia Haemolytic anaemia x
Angina pectoris Angina pectoris x x
Angioedema Angioedema x x
Decreased appetite Anorexia x
Anxiety Anxiety x x
Arrhythmia Arrhythmia x x
Arthritis Arthritis x
Asthenia Asthenia x x
Asthma Asthma x x
Ataxia Ataxia x x
Blepharitis Blepharitis x
Bronchitis Bronchitis x x
Cholecystitis Cholecystitis x x
Colitis Colitis x x
Coma Coma x
Infection Infection x x
Confusional state Confusional state x x
Feeling abnormal Confusional state x x
Malaise x x
Conjunctivitis Conjunctivitis x x
Constipation Constipation x x
Corneal opacity Corneal opacity x x
Cystitis Cystitis x
Bladder pain Cystitis x
Cystitis noninfective Cystitis x
Libido decreased Libido decreased x
Disturbance in sexual arousal Libido decreased x
Dermatitis exfoliative Dermatitis exfoliative x
Diarrhoea Diarrhoea x x
Diplopia Diplopia x
Dizziness Dizziness x x
Syncope x x
Somnolence Drowsiness x
Somnolence x x
Dyspepsia Dyspepsia x x
Heartburn x
Dyspnoea Dyspnoea x x
Dysuria Dysuria x x
Ear disorder Ear disorder x
Ecchymosis Ecchymosis x x
Eczema Eczema x x
Oedema Oedema x x
Enteritis Enteritis x x
Eosinophilia Eosinophilia x x
Toxic epidermal necrolysis Toxic epidermal necrolysis x x
Epistaxis Epistaxis x x
Eructation Eructation x x
Erythema multiforme Erythema multiforme x
Stevens-Johnson syndrome x x
Oesophageal disorder Oesophageal disorder x
Oesophagitis Oesophagitis x
Dermatitis Rash x x
Rash Rash x x
Body temperature increased Body temperature increased x
Fever chills x
Fibrosis Fibrosis x x x x
Flatulence Flatulence x x
Gastritis Gastritis x x
Gastroenteritis Gastroenteritis x
Gastrointestinal haemorrhage Gastrointestinal haemorrhage x x
Gingival bleeding Gingival bleeding x
Gingivitis Gingivitis x
Glaucoma Glaucoma x x
Glossitis Glossitis x x
Hallucination Hallucination x
Headache Headache x x
Cardiac failure congestive Cardiac failure congestive x
Haematemesis Haematemesis x x
Haematuria Haematuria x x
Haemorrhage Haemorrhage x x
Haemoglobin Haemorrhage x x
Hepatitis Hepatitis x x
Herpes simplex Herpes simplex x
Herpes zoster Herpes zoster x
Hyperglycaemia Hyperglycaemia x
Hyperkalaemia Hyperkalaemia x
Hypersensitivity Hypersensitivity x x x
Hypertension Hypertension x x
Hyperventilation Hyperventilation x x
Hyphaema Hyphaema x x x x x
Hypotension Hypotension x
Incontinence Incontinence x
Inflammatory bowel disease Inflammatory bowel disease x x
Influenza Influenza x
Jaundice Jaundice x
Jaundice cholestatic Jaundice cholestatic x
Arthropathy Arthropathy x
Osteoarthritis Arthropathy x
Keratitis Keratoconjunctivitis x
Nephrolithiasis Calculus of kidney x
Laryngitis Laryngitis x x
Leukocytosis Leukocytosis x
Leukopenia Leukopenia x x
Vaginal discharge Leukorrhea x
Lung disorder Lung disorder x
Breast pain Breast pain x
Melaena Melaena x x
Meningitis Meningitis x x
Meningitis aseptic Meningitis aseptic x
Hypertonia Hypertonia x x
Mydriasis Mydriasis x x x x x x
Myocardial infarction Myocardial infarction x x
Acute coronary syndrome Myocardial infarction x x
Nail disorder Nail disorder x
Nausea Nausea x x
Tubulointerstitial nephritis Nephritis interstitial x x
Nervousness Nervousness x x
Tension Nervousness x x
Neuralgia Neuralgia x
Neutropenia Neutropenia x
Oliguria Oliguria x
Palpitations Palpitations x x
Pancreatitis Pancreatitis x
Pancytopenia Pancytopenia x
Paraesthesia Paraesthesia x x
Peptic ulcer Peptic ulcer x x
Tooth abscess Abscess periodontal x x
Petechiae Petechiae x
Pharyngitis Pharyngitis x
Phlebitis Phlebitis x
Pneumonia Pneumonia x x
Polyuria Polyuria x
Urine output increased Polyuria x
Prostatic disorder Prostatic disorder x
Proteinuria Proteinuria x
Protein urine present Proteinuria x
Pruritus Pruritus x x
Pulmonary embolism Pulmonary embolism x x
Pulmonary infarction Pulmonary infarction x x
Purpura Purpura x
Vascular purpura Purpura x
Pyuria Pyuria x
Renal failure Renal failure x x
Retinal haemorrhage Retinal haemorrhage x
Rhinitis Rhinitis x x
Scleritis Scleritis x
Seborrhoeic dermatitis Seborrhoeic dermatitis x
Convulsion Convulsion x x
Sinusitis Sinusitis x
Skin ulcer Skin ulcer x
Speech disorder Speech disorder x
Stevens-Johnson syndrome Stevens-Johnson syndrome x x
Stomatitis Stomatitis x x
Cerebrovascular accident Cerebrovascular accident x x
Subarachnoid haemorrhage Subarachnoid haemorrhage x
Hyperhidrosis Sweating x x
Shock Syncope x x
Syncope Syncope x x
Loss of consciousness Syncope x x
Tachycardia Tachycardia x x
Tenosynovitis Tenosynovitis x
Thirst Thirst x
Thrombocytopenia Thrombocytopenia x x
Tinnitus Tinnitus x x
Tremor Tremor x x
Ulcer Ulcer x x
Urethritis Urethritis x
Urethritis noninfective Urethritis x
Urinary tract infection Urinary tract infection x x
Urticaria Urticaria x x
Uterine haemorrhage Uterine haemorrhage x
Vaginal inflammation Vaginal inflammation x
Vaginal infection Vaginal inflammation x
Angiopathy Angiopathy x
Vasculitis Vasculitis x x
Vasodilation procedure Vasodilation x
Vertigo Vertigo x x
Vomiting Vomiting x x
Vulvovaginitis Vulvovaginitis x
Dry mouth Dry mouth x x
Optic neuritis Neuritis retrobulbar x
Chills Chills x
Hepatic failure Hepatic failure x
Mood swings Mood swings x x
Affect lability Mood swings x x
Photophobia Photophobia x
Migraine Migraine x
Bleeding time prolonged Bleeding time prolonged x
Diarrhoea haemorrhagic Diarrhoea haemorrhagic x x
Electroencephalogram abnormal Electroencephalogram abnormal x
Gastrointestinal perforation Gastrointestinal perforation x
Renal impairment Kidney function abnormal x
Hyperreflexia Hyperreflexia x
Dry skin Dry skin x x
White blood cell disorder WBC abnormal NOS x
Endophthalmitis Ocular hyperaemia x x x x
Ocular hyperaemia Ocular hyperaemia x x x x
Iron deficiency anaemia Iron deficiency anaemia x x
Nail discolouration Nail discolouration x
Malaise Malaise x x
Discomfort Malaise x x
Discomfort x x
Ill-defined disorder Malaise x x
Emotional distress Distress x
Myalgia Myalgia x
Musculoskeletal discomfort Myalgia x
Muscle twitching Muscle twitching x x
Increased appetite Increased appetite x
Respiratory depression Respiratory depression x
Pulmonary function test decreased Respiratory depression x
Euphoric mood Euphoric mood x
Eye irritation Eye irritation x x x x x x
Right ventricular failure Cardiac failure right x
Urine abnormality Urine abnormality x
Urine analysis abnormal Urine abnormality x
Hepatic enzyme increased Hepatic enzyme increased x x
Skin exfoliation Skin exfoliation x
Erectile dysfunction Erectile dysfunction x
Sepsis Sepsis x
Rectal haemorrhage Rectal haemorrhage x x
Extrasystoles Extrasystoles x
Photosensitivity reaction Photosensitivity x x
Abdominal distension Enlargement abdomen x
Lymphadenopathy Lymphadenopathy x x
Anorectal discomfort Discomfort rectal x
Abdominal discomfort Distress gastrointestinal x
Cough Cough increased x
Pain Stinging x x x x x x
Drug interaction Drug interaction x
Blood uric acid increased Hyperuricaemia x x
Hyperuricaemia Hyperuricaemia x x
Cerebral ischaemia Cerebral ischaemia x x
Insomnia Insomnia x x
Muscular weakness Myasthenia x x
Gastrointestinal ulcer haemorrhage Gastrointestinal ulcer haemorrhage x
Deafness Hearing impaired x
Hearing impaired Hearing impaired x
Haemorrhagic disorder Bleeding tendency x x x x x x
Parosmia Parosmia x x
Visual impairment Visual impairment x


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

/ Ocufen Ophthalmic Solution

Side effects:5


Side effects:6
Source:FDA Structured Product Label


Side effects:7
Source:FDA Structured Product Label


Side effects:7
Source:FDA Structured Product Label


Side effects:140
Source:FDA Structured Product Label


Side effects:161
Source:Health Canada

Color scheme:


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