Drug information for QUALAQUIN

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
CAPSULE; ORAL	324MG	Prescription	(Reference Drug)	QUININE SULFATE	Quinine	AR HOLDING CO INC	21799 2011-04-19 Letter 2011-04-18 Label 2010-08-09 Other Important Information from FDA 2010-06-30 Other 2010-06-24 Medication Guide 2010-06-24 Label 2010-06-17 Letter 2010-02-23 Label 2010-01-29 Letter 2010-01-25 Letter 2009-12-31 Letter 2009-12-03 Medication Guide 2009-11-23 Label 2008-11-18 Letter 2008-11-17 Label 2008-07-09 Review 2007-10-10 Label 2007-10-04 Letter 2005-08-16 Letter 2005-08-15 Label

Drug Adverse Effects information for QUALAQUIN

Role code	Indications	Reaction	# Reports
PS	BLOOD CHOLESTEROL INCREASED	DIARRHOEA	1
PS	BLOOD CHOLESTEROL INCREASED	OFF LABEL USE	1
PS	CARDIAC FAILURE CONGESTIVE	OEDEMA PERIPHERAL	1
PS	CARDIAC FAILURE CONGESTIVE	OFF LABEL USE	1
PS	CONSTIPATION	ECCHYMOSIS	2
PS	CONSTIPATION	HYPOACUSIS	2
PS	CONSTIPATION	NERVOUSNESS	2
PS	CONSTIPATION	OFF LABEL USE	2
PS	CONSTIPATION	RESTLESSNESS	2
PS	DIABETES MELLITUS	OEDEMA PERIPHERAL	2
PS	DIABETES MELLITUS	OFF LABEL USE	3
PS	DIABETES MELLITUS	PRURITUS GENERALISED	1
PS	DIABETES MELLITUS	PURPURA	1
PS	EPILEPSY	ECCHYMOSIS	1
PS	EPILEPSY	HYPOACUSIS	1
PS	EPILEPSY	NERVOUSNESS	1
PS	EPILEPSY	OFF LABEL USE	1
PS	EPILEPSY	RESTLESSNESS	1
PS	HYPERSENSITIVITY	DIARRHOEA	1
PS	HYPERSENSITIVITY	OFF LABEL USE	1
PS	HYPERTENSION	ECCHYMOSIS	2
PS	HYPERTENSION	HYPOACUSIS	2
PS	HYPERTENSION	NERVOUSNESS	2
PS	HYPERTENSION	OEDEMA PERIPHERAL	2
PS	HYPERTENSION	OFF LABEL USE	4
PS	HYPERTENSION	RESTLESSNESS	2
PS	HYPOTHYROIDISM	OEDEMA PERIPHERAL	1
PS	HYPOTHYROIDISM	OFF LABEL USE	1
PS	MINERAL SUPPLEMENTATION	OFF LABEL USE	1
PS	MINERAL SUPPLEMENTATION	PRURITUS GENERALISED	1
PS	MINERAL SUPPLEMENTATION	PURPURA	1
PS	MUSCLE SPASMS	DIARRHOEA	1
PS	MUSCLE SPASMS	DRUG INEFFECTIVE	1
PS	MUSCLE SPASMS	HAEMATOCHEZIA	1
PS	MUSCLE SPASMS	INCREASED TENDENCY TO BRUISE	1
PS	MUSCLE SPASMS	MUSCLE SPASMS	1
PS	MUSCLE SPASMS	OEDEMA PERIPHERAL	2
PS	MUSCLE SPASMS	OFF LABEL USE	7
PS	MUSCLE SPASMS	PRURITUS	1
PS	MUSCLE SPASMS	PRURITUS GENERALISED	1
PS	MUSCLE SPASMS	PURPURA	1
PS	MUSCLE SPASMS	THROMBOTIC THROMBOCYTOPENIC PURPURA	1
PS	MUSCLE SPASMS	TINNITUS	1
PS	PAIN	OEDEMA PERIPHERAL	1
PS	PAIN	OFF LABEL USE	1
PS	PARKINSON'S DISEASE	OFF LABEL USE	1
PS	PARKINSON'S DISEASE	PRURITUS GENERALISED	1
PS	PARKINSON'S DISEASE	PURPURA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	OEDEMA PERIPHERAL	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	OFF LABEL USE	6
PS	PRODUCT USED FOR UNKNOWN INDICATION	PRURITUS GENERALISED	5
PS	PRODUCT USED FOR UNKNOWN INDICATION	PURPURA	5
PS	RESTLESS LEGS SYNDROME	ECCHYMOSIS	2
PS	RESTLESS LEGS SYNDROME	HYPOACUSIS	2
PS	RESTLESS LEGS SYNDROME	NERVOUSNESS	2
PS	RESTLESS LEGS SYNDROME	OFF LABEL USE	2
PS	RESTLESS LEGS SYNDROME	RESTLESSNESS	2
PS	ROCKY MOUNTAIN SPOTTED FEVER	HEARING IMPAIRED	2
PS	ROCKY MOUNTAIN SPOTTED FEVER	OFF LABEL USE	2
PS	ROSACEA	ECCHYMOSIS	2
PS	ROSACEA	HYPOACUSIS	2
PS	ROSACEA	NERVOUSNESS	2
PS	ROSACEA	OFF LABEL USE	2
PS	ROSACEA	RESTLESSNESS	2
PS	THROMBOSIS PROPHYLAXIS	OFF LABEL USE	1
PS	THROMBOSIS PROPHYLAXIS	PRURITUS GENERALISED	1
PS	THROMBOSIS PROPHYLAXIS	PURPURA	1
PS	VITAMIN SUPPLEMENTATION	ECCHYMOSIS	1
PS	VITAMIN SUPPLEMENTATION	HYPOACUSIS	1
PS	VITAMIN SUPPLEMENTATION	NERVOUSNESS	1
PS	VITAMIN SUPPLEMENTATION	OFF LABEL USE	1
PS	VITAMIN SUPPLEMENTATION	RESTLESSNESS	1
SS	INFECTION PARASITIC	DEAFNESS	3
SS	INFECTION PARASITIC	HYPOACUSIS	3
SS	INFECTION PARASITIC	TINNITUS	3
C	ADVERSE DRUG REACTION	ARTHRALGIA	2
C	ADVERSE DRUG REACTION	BIOPSY LIP	2
C	ADVERSE DRUG REACTION	CATARACT	2
C	ADVERSE DRUG REACTION	DRUG INEFFECTIVE	2
C	ADVERSE DRUG REACTION	FIBROMYALGIA	2
C	ADVERSE DRUG REACTION	HERPES ZOSTER	2
C	ADVERSE DRUG REACTION	IMMUNE SYSTEM DISORDER	2
C	ADVERSE DRUG REACTION	JOINT SWELLING	2
C	ADVERSE DRUG REACTION	MYOCARDIAL INFARCTION	2
C	ADVERSE DRUG REACTION	OEDEMA PERIPHERAL	2
C	ADVERSE DRUG REACTION	PAIN	2
C	ADVERSE DRUG REACTION	THYROID NEOPLASM	2
C	ADVERSE DRUG REACTION	UNEVALUABLE EVENT	2
C	DEHYDRATION	DEHYDRATION	2
C	DEHYDRATION	DERMATITIS ACNEIFORM	2
C	DEHYDRATION	ENTERITIS INFECTIOUS	1
C	DEHYDRATION	FALL	2
C	DEHYDRATION	FEMORAL HERNIA, OBSTRUCTIVE	1
C	DEHYDRATION	SMALL INTESTINAL OBSTRUCTION	1
C	DEHYDRATION	STOMATITIS	2
C	DEHYDRATION	TACHYCARDIA	2
C	DERMATITIS	DEHYDRATION	2
C	DERMATITIS	DERMATITIS ACNEIFORM	2
C	DERMATITIS	ENTERITIS INFECTIOUS	1
C	DERMATITIS	FALL	2
C	DERMATITIS	FEMORAL HERNIA, OBSTRUCTIVE	1
C	DERMATITIS	SMALL INTESTINAL OBSTRUCTION	1
C	DERMATITIS	STOMATITIS	2
C	DERMATITIS	TACHYCARDIA	2
C	HOT FLUSH	ARTHRALGIA	6
C	HOT FLUSH	BIOPSY LIP	6
C	HOT FLUSH	CATARACT	6
C	HOT FLUSH	DRUG INEFFECTIVE	6
C	HOT FLUSH	FIBROMYALGIA	6
C	HOT FLUSH	HERPES ZOSTER	6
C	HOT FLUSH	IMMUNE SYSTEM DISORDER	6
C	HOT FLUSH	JOINT SWELLING	6
C	HOT FLUSH	MYOCARDIAL INFARCTION	6
C	HOT FLUSH	OEDEMA PERIPHERAL	6
C	HOT FLUSH	PAIN	6
C	HOT FLUSH	THYROID NEOPLASM	6
C	HOT FLUSH	UNEVALUABLE EVENT	6
C	HYPERTENSION	DEHYDRATION	2
C	HYPERTENSION	DERMATITIS ACNEIFORM	2
C	HYPERTENSION	ENTERITIS INFECTIOUS	1
C	HYPERTENSION	FALL	2
C	HYPERTENSION	FEMORAL HERNIA, OBSTRUCTIVE	1
C	HYPERTENSION	SMALL INTESTINAL OBSTRUCTION	1
C	HYPERTENSION	STOMATITIS	2
C	HYPERTENSION	TACHYCARDIA	2
C	IMMUNISATION	ARTHRALGIA	12
C	IMMUNISATION	BIOPSY LIP	12
C	IMMUNISATION	CATARACT	12
C	IMMUNISATION	DRUG INEFFECTIVE	12
C	IMMUNISATION	FIBROMYALGIA	12
C	IMMUNISATION	HERPES ZOSTER	12
C	IMMUNISATION	IMMUNE SYSTEM DISORDER	12
C	IMMUNISATION	JOINT SWELLING	12
C	IMMUNISATION	MYOCARDIAL INFARCTION	12
C	IMMUNISATION	OEDEMA PERIPHERAL	12
C	IMMUNISATION	PAIN	12
C	IMMUNISATION	THYROID NEOPLASM	12
C	IMMUNISATION	UNEVALUABLE EVENT	12
C	INFECTION	DEHYDRATION	1
C	INFECTION	DERMATITIS ACNEIFORM	1
C	INFECTION	ENTERITIS INFECTIOUS	1
C	INFECTION	FALL	1
C	INFECTION	SMALL INTESTINAL OBSTRUCTION	1
C	INFECTION	STOMATITIS	1
C	INFECTION	TACHYCARDIA	1
C	NASAL CONGESTION	DEHYDRATION	1
C	NASAL CONGESTION	DERMATITIS ACNEIFORM	1
C	NASAL CONGESTION	ENTERITIS INFECTIOUS	1
C	NASAL CONGESTION	FALL	1
C	NASAL CONGESTION	SMALL INTESTINAL OBSTRUCTION	1
C	NASAL CONGESTION	STOMATITIS	1
C	NASAL CONGESTION	TACHYCARDIA	1
C	NAUSEA	DEHYDRATION	6
C	NAUSEA	DERMATITIS ACNEIFORM	6
C	NAUSEA	ENTERITIS INFECTIOUS	3
C	NAUSEA	FALL	6
C	NAUSEA	FEMORAL HERNIA, OBSTRUCTIVE	3
C	NAUSEA	SMALL INTESTINAL OBSTRUCTION	3
C	NAUSEA	STOMATITIS	6
C	NAUSEA	TACHYCARDIA	6
C	PAIN	DEHYDRATION	4
C	PAIN	DERMATITIS ACNEIFORM	4
C	PAIN	ENTERITIS INFECTIOUS	2
C	PAIN	FALL	4
C	PAIN	FEMORAL HERNIA, OBSTRUCTIVE	2
C	PAIN	SMALL INTESTINAL OBSTRUCTION	2
C	PAIN	STOMATITIS	4
C	PAIN	TACHYCARDIA	4
C	PNEUMONIA	DEHYDRATION	2
C	PNEUMONIA	DERMATITIS ACNEIFORM	2
C	PNEUMONIA	ENTERITIS INFECTIOUS	1
C	PNEUMONIA	FALL	2
C	PNEUMONIA	FEMORAL HERNIA, OBSTRUCTIVE	1
C	PNEUMONIA	SMALL INTESTINAL OBSTRUCTION	1
C	PNEUMONIA	STOMATITIS	2
C	PNEUMONIA	TACHYCARDIA	2
C	PREMEDICATION	DEHYDRATION	8
C	PREMEDICATION	DERMATITIS ACNEIFORM	8
C	PREMEDICATION	ENTERITIS INFECTIOUS	4
C	PREMEDICATION	FALL	8
C	PREMEDICATION	FEMORAL HERNIA, OBSTRUCTIVE	4
C	PREMEDICATION	SMALL INTESTINAL OBSTRUCTION	4
C	PREMEDICATION	STOMATITIS	8
C	PREMEDICATION	TACHYCARDIA	8
C	PRODUCT USED FOR UNKNOWN INDICATION	ARTHRALGIA	90
C	PRODUCT USED FOR UNKNOWN INDICATION	BIOPSY LIP	90
C	PRODUCT USED FOR UNKNOWN INDICATION	CATARACT	90
C	PRODUCT USED FOR UNKNOWN INDICATION	DRUG INEFFECTIVE	90
C	PRODUCT USED FOR UNKNOWN INDICATION	FIBROMYALGIA	90
C	PRODUCT USED FOR UNKNOWN INDICATION	HERPES ZOSTER	90
C	PRODUCT USED FOR UNKNOWN INDICATION	IMMUNE SYSTEM DISORDER	90
C	PRODUCT USED FOR UNKNOWN INDICATION	JOINT SWELLING	90
C	PRODUCT USED FOR UNKNOWN INDICATION	MYOCARDIAL INFARCTION	90
C	PRODUCT USED FOR UNKNOWN INDICATION	OEDEMA PERIPHERAL	90
C	PRODUCT USED FOR UNKNOWN INDICATION	PAIN	90
C	PRODUCT USED FOR UNKNOWN INDICATION	THYROID NEOPLASM	90
C	PRODUCT USED FOR UNKNOWN INDICATION	UNEVALUABLE EVENT	90
C	PROPHYLAXIS	DEHYDRATION	2
C	PROPHYLAXIS	DERMATITIS ACNEIFORM	2
C	PROPHYLAXIS	ENTERITIS INFECTIOUS	1
C	PROPHYLAXIS	FALL	2
C	PROPHYLAXIS	FEMORAL HERNIA, OBSTRUCTIVE	1
C	PROPHYLAXIS	SMALL INTESTINAL OBSTRUCTION	1
C	PROPHYLAXIS	STOMATITIS	2
C	PROPHYLAXIS	TACHYCARDIA	2
C	RHEUMATOID ARTHRITIS	ARTHRALGIA	12
C	RHEUMATOID ARTHRITIS	BIOPSY LIP	12
C	RHEUMATOID ARTHRITIS	CATARACT	12
C	RHEUMATOID ARTHRITIS	DRUG INEFFECTIVE	12
C	RHEUMATOID ARTHRITIS	FIBROMYALGIA	12
C	RHEUMATOID ARTHRITIS	HERPES ZOSTER	12
C	RHEUMATOID ARTHRITIS	IMMUNE SYSTEM DISORDER	12
C	RHEUMATOID ARTHRITIS	JOINT SWELLING	12
C	RHEUMATOID ARTHRITIS	MYOCARDIAL INFARCTION	12
C	RHEUMATOID ARTHRITIS	OEDEMA PERIPHERAL	12
C	RHEUMATOID ARTHRITIS	PAIN	12
C	RHEUMATOID ARTHRITIS	THYROID NEOPLASM	12
C	RHEUMATOID ARTHRITIS	UNEVALUABLE EVENT	12
C	SEASONAL ALLERGY	DEHYDRATION	6
C	SEASONAL ALLERGY	DERMATITIS ACNEIFORM	6
C	SEASONAL ALLERGY	ENTERITIS INFECTIOUS	3
C	SEASONAL ALLERGY	FALL	6
C	SEASONAL ALLERGY	FEMORAL HERNIA, OBSTRUCTIVE	3
C	SEASONAL ALLERGY	SMALL INTESTINAL OBSTRUCTION	3
C	SEASONAL ALLERGY	STOMATITIS	6
C	SEASONAL ALLERGY	TACHYCARDIA	6

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