Drug information for MALARONE

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL 250MG;100MG Prescription AB (Reference Drug) ATOVAQUONE; PROGUANIL HYDROCHLORIDE malarone GLAXOSMITHKLINE 21078
2009-11-09 Letter
2009-01-02 Label
2008-12-29 Letter
2008-06-12 Label
2008-05-09 Letter
2008-01-09 Letter
2006-07-10 Review
2006-07-10 Review
2006-07-10 Review
2006-07-10 Review
2005-03-03 Letter
2005-03-03 Letter
2005-03-03 Label
2005-03-03 Label
2004-12-03 Label
2004-12-02 Letter
2004-09-07 Letter
2004-09-07 Label
2003-12-08 Letter
2003-12-08 Label
2003-06-16 Label
2003-06-16 Letter
2003-06-16 Review
2002-08-02 Letter
2002-08-02 Label
2002-02-28 Letter

Drug Adverse Effects information for MALARONE

Role code Indications Reaction # Reports
PS CONTRACEPTION DRUG INTERACTION 1
PS CONTRACEPTION PREGNANCY 2
PS CONTRACEPTION UNINTENDED PREGNANCY 2
PS FOREIGN TRAVEL NEUROPATHY PERIPHERAL 1
PS FOREIGN TRAVEL PARAESTHESIA 1
PS HYPERTENSION ABDOMINAL PAIN 1
PS HYPERTENSION ERYTHEMA 1
PS HYPERTENSION HYPERSENSITIVITY 1
PS HYPERTENSION PARAESTHESIA 1
PS HYPERTENSION PRURITUS 1
PS HYPERTENSION RASH 1
PS HYPERTENSION SWELLING FACE 1
PS IMMUNISATION DRUG INTERACTION 1
PS IMMUNISATION PREGNANCY 2
PS IMMUNISATION UNINTENDED PREGNANCY 2
PS MALARIA ASTHENIA 2
PS MALARIA C-REACTIVE PROTEIN INCREASED 2
PS MALARIA OVERDOSE 2
PS MALARIA THROMBOCYTOPENIA 2
PS MALARIA PROPHYLAXIS ABASIA 1
PS MALARIA PROPHYLAXIS ABDOMINAL PAIN 1
PS MALARIA PROPHYLAXIS ABDOMINAL PAIN UPPER 2
PS MALARIA PROPHYLAXIS ABNORMAL DREAMS 3
PS MALARIA PROPHYLAXIS ACUTE HEPATIC FAILURE 1
PS MALARIA PROPHYLAXIS AMENORRHOEA 1
PS MALARIA PROPHYLAXIS ASCITES 1
PS MALARIA PROPHYLAXIS CHOLECYSTITIS 1
PS MALARIA PROPHYLAXIS COLD SWEAT 2
PS MALARIA PROPHYLAXIS COORDINATION ABNORMAL 1
PS MALARIA PROPHYLAXIS DIARRHOEA 3
PS MALARIA PROPHYLAXIS DIARRHOEA HAEMORRHAGIC 1
PS MALARIA PROPHYLAXIS DIPLOPIA 1
PS MALARIA PROPHYLAXIS DISCOMFORT 1
PS MALARIA PROPHYLAXIS DIZZINESS 3
PS MALARIA PROPHYLAXIS DYSPEPSIA 1
PS MALARIA PROPHYLAXIS ERYTHEMA 1
PS MALARIA PROPHYLAXIS FLATULENCE 1
PS MALARIA PROPHYLAXIS HALLUCINATION 2
PS MALARIA PROPHYLAXIS HEADACHE 2
PS MALARIA PROPHYLAXIS HYPERSENSITIVITY 1
PS MALARIA PROPHYLAXIS HYPERTRIGLYCERIDAEMIA 2
PS MALARIA PROPHYLAXIS INSOMNIA 1
PS MALARIA PROPHYLAXIS INTERNATIONAL NORMALISED RATIO INCREASED 1
PS MALARIA PROPHYLAXIS LETHARGY 2
PS MALARIA PROPHYLAXIS MALAISE 2
PS MALARIA PROPHYLAXIS MOBILITY DECREASED 1
PS MALARIA PROPHYLAXIS MOTION SICKNESS 1
PS MALARIA PROPHYLAXIS MUSCULOSKELETAL STIFFNESS 1
PS MALARIA PROPHYLAXIS MYALGIA 1
PS MALARIA PROPHYLAXIS NAUSEA 1
PS MALARIA PROPHYLAXIS OEDEMA PERIPHERAL 1
PS MALARIA PROPHYLAXIS PALLOR 2
PS MALARIA PROPHYLAXIS PARAESTHESIA 1
PS MALARIA PROPHYLAXIS PNEUMONIA 1
PS MALARIA PROPHYLAXIS PRESYNCOPE 1
PS MALARIA PROPHYLAXIS PRURITUS 1
PS MALARIA PROPHYLAXIS PSYCHOTIC DISORDER 1
PS MALARIA PROPHYLAXIS PYREXIA 2
PS MALARIA PROPHYLAXIS RASH 1
PS MALARIA PROPHYLAXIS RENAL FAILURE ACUTE 1
PS MALARIA PROPHYLAXIS SOMNOLENCE 1
PS MALARIA PROPHYLAXIS SWELLING FACE 1
PS MALARIA PROPHYLAXIS SYNCOPE 2
PS MALARIA PROPHYLAXIS THROMBOCYTOPENIA 1
PS MALARIA PROPHYLAXIS TREATMENT NONCOMPLIANCE 1
PS MALARIA PROPHYLAXIS TYPE IV HYPERLIPIDAEMIA 2
PS PRODUCT USED FOR UNKNOWN INDICATION AMENORRHOEA 1
PS PRODUCT USED FOR UNKNOWN INDICATION APHASIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION ASTHENIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION CHOLECYSTITIS 2
PS PRODUCT USED FOR UNKNOWN INDICATION DIZZINESS 1
PS PRODUCT USED FOR UNKNOWN INDICATION HEADACHE 1
PS PRODUCT USED FOR UNKNOWN INDICATION MOBILITY DECREASED 1
PS PRODUCT USED FOR UNKNOWN INDICATION MUSCULOSKELETAL STIFFNESS 1
PS PRODUCT USED FOR UNKNOWN INDICATION MYALGIA 1
PS PRODUCT USED FOR UNKNOWN INDICATION RESPIRATORY DISORDER 1
PS PRODUCT USED FOR UNKNOWN INDICATION TREMOR 1
PS PRODUCT USED FOR UNKNOWN INDICATION VOMITING 1
PS PROPHYLAXIS ABDOMINAL DISCOMFORT 1
PS PROPHYLAXIS ABNORMAL BEHAVIOUR 1
PS PROPHYLAXIS AMENORRHOEA 1
PS PROPHYLAXIS ANXIETY 1
PS PROPHYLAXIS APATHY 1
PS PROPHYLAXIS COLITIS 1
PS PROPHYLAXIS CONFUSIONAL STATE 1
PS PROPHYLAXIS CRYING 1
PS PROPHYLAXIS DECREASED APPETITE 1
PS PROPHYLAXIS DEHYDRATION 1
PS PROPHYLAXIS DELUSION 1
PS PROPHYLAXIS DEPRESSED MOOD 1
PS PROPHYLAXIS DEPRESSION 2
PS PROPHYLAXIS DIARRHOEA 1
PS PROPHYLAXIS DISSOCIATION 1
PS PROPHYLAXIS DIZZINESS 1
PS PROPHYLAXIS EYE MOVEMENT DISORDER 1
PS PROPHYLAXIS FATIGUE 1
PS PROPHYLAXIS FEAR 1
PS PROPHYLAXIS FEELING HOT 1
PS PROPHYLAXIS GENERAL SYMPTOM 1
PS PROPHYLAXIS HALLUCINATION 1
PS PROPHYLAXIS HEADACHE 2
PS PROPHYLAXIS HYPERSENSITIVITY 1
PS PROPHYLAXIS JAUNDICE 1
PS PROPHYLAXIS LOSS OF CONSCIOUSNESS 1
PS PROPHYLAXIS MALAISE 2
PS PROPHYLAXIS MOBILITY DECREASED 1
PS PROPHYLAXIS MUSCULOSKELETAL STIFFNESS 1
PS PROPHYLAXIS MYALGIA 1
PS PROPHYLAXIS NAUSEA 3
PS PROPHYLAXIS NIGHTMARE 1
PS PROPHYLAXIS OCULAR ICTERUS 1
PS PROPHYLAXIS OROPHARYNGEAL PAIN 1
PS PROPHYLAXIS PALLOR 1
PS PROPHYLAXIS PANIC ATTACK 1
PS PROPHYLAXIS PYREXIA 3
PS PROPHYLAXIS SOMNOLENCE 1
PS PROPHYLAXIS SUICIDAL IDEATION 2
PS PROPHYLAXIS THROMBOCYTOPENIA 1
PS PROPHYLAXIS URTICARIA THERMAL 1
PS PROPHYLAXIS VOMITING 3
PS PROPHYLAXIS WEIGHT DECREASED 2
PS PSORIASIS ACUTE HEPATIC FAILURE 2
PS PSORIASIS ASCITES 1
PS PSORIASIS INTERNATIONAL NORMALISED RATIO INCREASED 2
PS PSORIASIS OEDEMA PERIPHERAL 1
PS PSORIASIS PNEUMONIA 1
PS PSORIASIS RENAL FAILURE ACUTE 1
PS PSORIASIS THROMBOCYTOPENIA 1
SS PRODUCT USED FOR UNKNOWN INDICATION DERMATITIS ACNEIFORM 8
SS PRODUCT USED FOR UNKNOWN INDICATION DRUG INTERACTION 8
C CONTRACEPTION ANHEDONIA 4
C CONTRACEPTION ANXIETY 4
C CONTRACEPTION CEREBROVASCULAR ACCIDENT 4
C CONTRACEPTION CEREBROVASCULAR DISORDER 4
C CONTRACEPTION GENERAL PHYSICAL HEALTH DETERIORATION 4
C CONTRACEPTION INJURY 4
C CONTRACEPTION PAIN 4
C HYPERLIPIDAEMIA ANHEDONIA 2
C HYPERLIPIDAEMIA ANXIETY 2
C HYPERLIPIDAEMIA CEREBROVASCULAR ACCIDENT 2
C HYPERLIPIDAEMIA CEREBROVASCULAR DISORDER 2
C HYPERLIPIDAEMIA GENERAL PHYSICAL HEALTH DETERIORATION 2
C HYPERLIPIDAEMIA INJURY 2
C HYPERLIPIDAEMIA PAIN 2
C SEPTIC SHOCK APLASIA PURE RED CELL 12
C SEPTIC SHOCK THROMBOCYTOPENIA 12
I MALARIA PROPHYLAXIS DERMATITIS ACNEIFORM 1
I MALARIA PROPHYLAXIS DRUG INTERACTION 1
I PRODUCT USED FOR UNKNOWN INDICATION DERMATITIS ACNEIFORM 3
I PRODUCT USED FOR UNKNOWN INDICATION DRUG INTERACTION 3
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