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ATC Code: J05AE10

Side effects

Options: Show MedDRA Preferred Terms

Side effect Data for drug Placebo Labels
1 2 3 4 5 6 7
Vomiting 0.4% - 33% x x x x x x x
Diarrhoea 2.3% - 24% x x x x x x x
Rash 5% - 19% x x x x x x
Pruritus 8.3% x x x x x
Decreased appetite 8.3% x x x x x
Hyperuricaemia 2.2% - 6.9% x x
Hyperglycaemia 2.3% - 8.1% x x x x x x x
Headache 0.9% - 9% x x x x x x x
Abdominal pain 0.8% - 10% x x x x x x x
Nausea 4% - 25% x x x x x x x
Blood amylase increased 3.3% x x
Hypoalbuminaemia 1.6% - 4.3% x x
Hypertriglyceridaemia 1.53% - 3.23% x x x x x x
Fatigue 2.42% - 3.05% x x x x x x x
Flatulence 2.42% - 3.05% x x x x x x x
Blood triglycerides increased 0.612% - 3.05% x
Hyperbilirubinaemia 0.9% - 15.4% x x x x x x
Gamma-glutamyltransferase increased 2.2% x
Abdominal distension 0.806% - 3.05% x x x x x x x
Hypoglycaemia 1.5% - 3.7% x x
Anorexia 0% - 5% x x x x x x x
Insomnia 0.806% - 3.05% x x
Constipation 0.6% - 4.58% x x x
Dizziness 0% - 2.29% x x
Asthenia 0% - 2.14% x x x x x x x
Hypocalcaemia 0% - 4% x x
Hyponatraemia 0% - 2.5% x x
Angina pectoris uncommon x
Dysuria uncommon x
Flushing uncommon x
Gynaecomastia uncommon x x x
Herpes simplex uncommon x
Hypersensitivity uncommon x x x x x
Hypothyroidism uncommon x
Nocturia uncommon x
Proteinuria uncommon x
Renal failure uncommon x
Tachycardia uncommon x x x
Pollakiuria uncommon x
Vertigo uncommon x x x
Blood creatinine increased uncommon x
Erectile dysfunction uncommon x
Nephrolithiasis uncommon x x
Blood thyroid stimulating hormone increased uncommon x
Renal failure acute uncommon, 0.4% x x x
Hypertension uncommon, 0.2% x x x
Myocardial infarction uncommon, 0.2% x x x
Confusional state 0.2% x x x
Diabetes mellitus 0.2% x x x x x x x
Disorientation 0.2% x x x
Drug eruption postmarketing x x x
Eosinophilia postmarketing x x
Toxic epidermal necrolysis postmarketing x x x x x x
Palpitations rare x
Rhabdomyolysis postmarketing x x x x x x
Sinus bradycardia rare x
Acute myocardial infarction rare x
Creatinine low rare x
Acute generalised exanthematous pustulosis postmarketing x x x x
Pancreatitis acute x x x x
Alopecia x x x
Anaemia x x
Angioedema x x x x x x
Anxiety x x x
Arthralgia x x x
Arthritis x
Autoimmune disorder x
Mental disorder x x x x x x
Breast disorder x x
Burning mouth syndrome x
Transient ischaemic attack x x
Cheilitis x
Chest pain x
Cholestasis x
Clostridial infection x
Tongue coated x
Connective tissue disorder x x x x x x
Cough x x x
Cryptosporidiosis infection x
Libido decreased x
Dermatitis x x x
Dermatitis atopic x x x
Drug hypersensitivity x
Dysgeusia x
Dyspepsia 0% - 1.83% x x x x x x x
Dyspnoea x x x
Eczema x x x
Endocrine disorder x
Grand mal convulsion x
Petit mal epilepsy x
Epistaxis x
Eructation x
Erythema multiforme x x x
Eye disorder x x
Facial paralysis x
Body temperature increased x x x
Folliculitis x x
Gastritis x
Gastrooesophageal reflux disease x
Gastrointestinal disorder x x x x x x x
Gout x
Basedow's disease x
Cardiac disorder x x
Haematemesis x
Haematuria x
Haemorrhage x
Hepatitis x x
Hepatitis B x x x x x x x
Hepatitis C x x x x x x
Hepatomegaly x
Hiccups x x
Hypercholesterolaemia x x x x x x x
Hyperhidrosis x x x
Hyperkalaemia x
Hyperlipidaemia x x x
Hypernatraemia 0% - 2.3% x x
Hypertrophy of breast x
Hypoaesthesia x x x
Immune system disorder x x x x x x
Inflammation x
Insulin resistance x
Irritability x x x
Jaundice x
Lethargy x
Progressive multifocal leukoencephalopathy x
Leukopenia x
Lipodystrophy x
Hepatic cirrhosis x
Lymphoma x
Mediastinal disorder x x
Myocarditis x
Myositis x x
Nasopharyngitis x
Neoplasm x
Nervous system disorder x x x x x x x
Neuromyopathy x
Neutropenia x
Night sweats x x x
Nightmare x x x
Obesity x x
Opportunistic infection x
Osteonecrosis x x x x x
Osteopenia x x
Osteoporosis x x x
Pain x
Pain in extremity x x x
Pancreatitis x x
Pancytopenia x
Paraesthesia x x x
Neuropathy peripheral x x x
Pneumothorax x
Polyuria x x
Prurigo x
Acute respiratory distress syndrome x
Seborrhoeic dermatitis x
Convulsion x
Skin lesion x
Muscle spasms x
Stevens-Johnson syndrome x x x x x x x
Stomatitis x
Aphthous stomatitis x
Cerebrovascular accident x
Syncope x
Thrombocytopenia x
Erythema x
Urinary tract disorder x x
Urticaria x x x x x
Angiopathy x x
Hepatitis viral x x
Weight increased x x
Weight decreased x
Xeroderma x
Dry mouth x x x
B-cell lymphoma x
Chills x
Polydipsia x x x
Hepatic failure x
Agitation x
Mood swings x x x
Oedema peripheral x x x
Pancreatitis chronic x
Altered state of consciousness x
Amylase increased x x x x
Congenital musculoskeletal anomaly x
Swelling face x
Liver function test abnormal x
Muscular weakness x
Aspartate aminotransferase increased x x x x x x
Alanine aminotransferase increased x x x x x x
Dry skin x
Joint stiffness x
Malnutrition x x x x x x x
Unspecified disorder of skin and subcutaneous tissue x x x x x x
Metabolic acidosis x
Malaise x
Myalgia x x x x x x x
Increased appetite x
Abdominal discomfort x
Retching x
Disturbance in attention x
Memory impairment x x x
Abnormal dreams x x x x x
Hepatotoxicity x x x x x x
Hepatic enzyme increased x x x x
Encephalitis cytomegalovirus x
Oesophageal candidiasis x
Sepsis x
Xerosis x
Rectal haemorrhage x
Hepatobiliary disease x x x x x x
Hepatitis acute x x x x x x
Eye swelling x
Blood bilirubin increased x x
Dry eye x
Hepatic cancer x
Rash maculo-papular x x
Rigors x x
Bradycardia x
Rash generalised x
Buffalo hump x
Toxic skin eruption x x
Electrocardiogram abnormal x
Chronic hepatitis B x
Visual disturbance x
Low density lipoprotein increased x x x x
Lipase increased x
Lip dry x
Sensation of heaviness x
Drug interaction x
Throat irritation x
Pharyngeal lesion x
Hyperlactacidaemia x
Infestation NOS x x
Blood and lymphatic system disorders x x
Ear and labyrinth disorders x x
Sleep disorder x
Sleep phase rhythm disturbance x
Completed suicide x
Blood alkaline phosphatase increased x
Blood creatine phosphokinase increased x
Fat redistribution x x
Cytolytic hepatitis x x x x x x x
Musculoskeletal stiffness x
Nail pigmentation x
Respiratory failure x
Rhinorrhoea x
Ischaemic cerebral infarction x
Lipohypertrophy x
Lipoatrophy x x x
Feeling abnormal x
Renal impairment x x
Renal tubular necrosis x
Conjunctival hyperaemia x
Eosinophil count increased x
Ageusia x
Hepatic steatosis x
Somnolence x x x
Feeling hot x


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


Side effects:47
Source:FDA Structured Product Label


Side effects:46
Source:FDA Structured Product Label


Side effects:47
Source:FDA Structured Product Label


Side effects:50
Source:FDA Structured Product Label

darunavir / Prezista

Side effects:81


Side effects:158
Source:Health Canada

darunavir / darunavir

Side effects:186

Color scheme:


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