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Side effects

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MedDRA Preferred Term Side effect Data for drug Placebo Labels
1 2 3
Asthenia Fatigue 65.7% x x
Fatigue Fatigue 65.7% x x
Cough Cough 62.7% x x x
Body temperature increased Body temperature increased 51% x x
Decreased appetite Decreased appetite 50% x x
Anorexia x
Dyspnoea Dyspnoea 48.3% x x x
Dizziness Lightheadedness 45.1% x x
Dizziness x x x
Syncope x x x
Wheezing Wheezing 32.4% x x
Infection Infection 15.2% x
Abdominal pain Abdominal cramps x
Abdominal pain x x
Gastrointestinal pain Abdominal pain x x
Abortion spontaneous Abortion spontaneous x x
Abscess Abscess x x x
Pancreatitis acute Pancreatitis acute x x
Anaphylactic shock Anaphylactic shock x x x
Anaemia Anaemia x x x
Angioedema Angioedema x
Anosmia Anosmia x
Anxiety Anxiety x x
Arrhythmia Arrhythmia x x
Arthralgia Arthralgia x x
Musculoskeletal discomfort Arthralgia x x
Myalgia x
Asthma Asthma x x
Pneumonia bacterial Pneumonia bacterial x
Blepharitis Blepharitis x x
Bronchospasm Bronchospasm x x x
Bronchitis Bronchitis x x
Candida infection Oral candidiasis x
Oral candidiasis Oral candidiasis x
Chest pain Chest pain x
Colitis Colitis x
Confusional state Confusional state x x
Feeling abnormal Confusional state x x
Conjunctivitis Conjunctivitis x x
Constipation Constipation x
Cyanosis Cyanosis x x
Pancytopenia Cytopenia x
Pancytopenia x x
Dermatitis Dermatitis x x
Rash x x x
Diabetes mellitus Diabetes mellitus x x
Diarrhoea Diarrhoea x x
Somnolence Drowsiness x x
Dyspepsia Dyspepsia x x
Eosinophilia Eosinophilia x x
Rash Rash x x x
Extravasation Extravasation x
Flank pain Flank pain x x
Flushing Flushing x
Retching Gagging x x
Gastritis Gastritis x
Gingivitis Gingivitis x
Gout Gout x
Hallucination Hallucination x x
Headache Headache x x
Haematochezia Haematochezia x x
Haematuria Haematuria x
Hemianopia Hemianopia x
Haemoptysis Haemoptysis x x
Hepatitis Hepatitis x x
Hepatomegaly Hepatomegaly x x
Herpes virus infection Herpes NOS x
Herpes zoster Herpes zoster x
Histoplasmosis Histoplasmosis x
Hyperglycaemia Hyperglycaemia x x x
Hyperkalaemia Hyperkalaemia x x
Hypersensitivity Hypersensitivity x x
Hypertension Hypertension x x
Hyperventilation Hyperventilation x x
Hypoaesthesia Hypoaesthesia x x x
Hypocalcaemia Hypocalcaemia x x x
Hypoglycaemia Hypoglycaemia x x x
Hypotension Hypotension x x x
Body temperature decreased Body temperature decreased x
Hypothermia Body temperature decreased x
Inappropriate antidiuretic hormone secretion Inappropriate antidiuretic hormone secretion x
Incontinence Incontinence x x
Influenza Influenza x
Renal failure acute Renal failure acute x
Laryngospasm Laryngospasm x x
Laryngitis Laryngitis x x
Lethargy Lethargy x
Leukopenia Leukopenia x x
Lung disorder Lung disorder x x
Melaena Melaena x x
Nasal congestion Nasal congestion x x
Nausea Nausea x x x
Necrosis Necrosis x
Nephritis Nephritis x x
Nervousness Nervousness x x
Tension Nervousness x x
Neuralgia Neuralgia x x
Neutropenia Neutropenia x x
Night sweats Night sweats x x
Ear infection Otitis x
Pain Pain x x
Palpitations Palpitations x x
Pancreatitis Pancreatitis x x
Paraesthesia Paraesthesia x x
Paresthesia of limbs x
Neuropathy peripheral Neuropathy peripheral x x
Neuropathy x x
Pharyngitis Pharyngitis x
Phlebitis Phlebitis x
Pleurisy Pleurisy x x
Pneumothorax Pneumothorax x x x
Pruritus Pruritus x x
Rales Rales x x
Renal failure Renal failure x x
Renal impairment x
Rhabdomyolysis Rhabdomyolysis x
Rhinitis Rhinitis x x
Coryza x x
Convulsion Convulsion x x
Salivary hypersecretion Salivary hypersecretion x x
Sinusitis Sinusitis x
Splenomegaly Splenomegaly x x
Erythema multiforme Stevens-Johnson syndrome x x
Stevens-Johnson syndrome Stevens-Johnson syndrome x x
Gastric ulcer Gastric ulcer x
Cerebrovascular accident Cerebrovascular accident x x
Shock Syncope x x x
Syncope Syncope x x x
Loss of consciousness Syncope x x x
Tachycardia Tachycardia x x
Thrombocytopenia Thrombocytopenia x x x
Tonsillitis Tonsillitis x
Torsade de pointes Torsade de pointes x x x
Tremor Tremor x x
Tuberculosis Tuberculosis x
Erythema Erythema x x
Urticaria Urticaria x x
Vasculitis Vasculitis x x
Ventricular tachycardia Ventricular tachycardia x x
Vertigo Vertigo x x
Vomiting Vomiting x x x
Dry mouth Dry mouth x x
Meningitis cryptococcal Meningitis cryptococcal x
Chills Chills x
Skin odour abnormal Body odor x
Mood swings Mood swings x x
Affect lability Mood swings x x
Hepatic function abnormal Hepatic function abnormal x x
Stomatitis Mouth ulceration x
Mouth ulceration Mouth ulceration x
Blood urea increased Blood urea increased x
Coagulation time prolonged Coagulation time prolonged x
Blood creatinine increased Creatinine increased x
Serum creatinine increased x
Hypomagnesaemia Hypomagnesaemia x
Liver function test abnormal Liver function test abnormal x
Raised liver function tests x
Eye pain Eye pain x x
Electrocardiogram QT prolonged Electrocardiogram QT prolonged x
Dry skin Dry skin x x
Interstitial lung disease Interstitial pneumonia x x
Cytomegalovirus chorioretinitis Cytomegalovirus retinitis x
Ketoacidosis Ketoacidosis x
Myalgia Myalgia x
Gait disturbance Unsteady gait x x
Tachypnoea Tachypnoea x x
Chest discomfort Chest tightness x x
Discomfort Discomfort x x x
Oedema peripheral Leg edema x
Muscle necrosis Muscle necrosis x
Skin exfoliation Skin exfoliation x x
Oesophageal candidiasis Oesophageal candidiasis x
Pulmonary congestion Pulmonary congestion x x
Respiratory tract congestion Pulmonary congestion x x
Azotaemia Azotaemia x x
Encephalitis viral Encephalitis viral x
Sepsis Sepsis x
Induration Induration x x
Oral herpes Oral herpes x
Vision blurred Vision blurred x x
Bradycardia Bradycardia x
Electrocardiogram ST segment Electrocardiogram ST segment x
Dysgeusia Bad taste x x x
Face oedema Face oedema x
Renal pain Renal pain x
Amnesia Memory loss x x
Local reaction Local reaction x
Insomnia Insomnia x x
Pneumocystis jirovecii infection Extrapulmonary pneumocystosis x
Psychotic disorder Paranoia x x
Paranoia Paranoia x x
Renal impairment Renal impairment x
Ageusia Ageusia x x
Hiatus hernia Hiatus hernia x


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


Side effects:120
Source:FDA Structured Product Label


Side effects:141
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