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Darunavir

More information: STITCH, PubChem and possibly Wikipedia

ATC Code: J05AE10

Side effects

Options: Hide MedDRA Preferred Terms

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

Indications

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

DARUNAVIR

Side effects:47
Source:FDA Structured Product Label

darunavir

Side effects:46
Source:FDA Structured Product Label

darunavir

Side effects:47
Source:FDA Structured Product Label

darunavir

Side effects:50
Source:FDA Structured Product Label

darunavir / Prezista

Side effects:81
Source:FDA

DARUNAVIR (DARUNAVIR ETHANOLATE) / PREZISTA

Side effects:158
Source:Health Canada

darunavir / darunavir

Side effects:186
Source:EMA

Color scheme:

standard – alternative

    100%
    75%
    50%
    10%
    frequent (1% to 100%)
    infrequent (0.1% to 1%)
    rare (<0.1%)
    postmarketing
    0%
    no frequency information
    not found on label