Drug information for MOTRIN IB

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
TABLET; ORAL	200MG	Over The Counter	(Reference Drug)	IBUPROFEN	Ibuprofen	MCNEIL	19012 2012-03-27 Label 2010-10-26 Letter 2009-05-01 Letter 2007-11-26 Letter 2006-12-28 Letter 2006-02-22 Letter 2003-10-31 Letter 2003-04-16 Label 2002-05-14 Review 2000-02-25 Label 2000-02-25 Letter

Drug Adverse Effects information for MOTRIN IB

Role code	Indications	Reaction	# Reports
PS	CARDIAC OPERATION	COLONIC POLYP	3
PS	CARDIAC OPERATION	INCORRECT DOSE ADMINISTERED	3
PS	CARDIAC OPERATION	INTENTIONAL DRUG MISUSE	3
PS	CARDIAC OPERATION	LARGE INTESTINAL ULCER	3
PS	CARDIAC OPERATION	OVERDOSE	3
PS	CONVULSION	HEADACHE	1
PS	CONVULSION	PYREXIA	1
PS	CONVULSION	RENAL FAILURE ACUTE	1
PS	CONVULSION	RENAL TUBULAR NECROSIS	1
PS	HEADACHE	HEADACHE	2
PS	HEADACHE	PYREXIA	2
PS	HEADACHE	RENAL FAILURE ACUTE	2
PS	HEADACHE	RENAL TUBULAR NECROSIS	2
PS	KNEE ARTHROPLASTY	COLONIC POLYP	3
PS	KNEE ARTHROPLASTY	INCORRECT DOSE ADMINISTERED	3
PS	KNEE ARTHROPLASTY	INTENTIONAL DRUG MISUSE	3
PS	KNEE ARTHROPLASTY	LARGE INTESTINAL ULCER	3
PS	KNEE ARTHROPLASTY	OVERDOSE	3
PS	PREMENSTRUAL SYNDROME	ALOPECIA	1
PS	PREMENSTRUAL SYNDROME	ASTHENIA	1
PS	PREMENSTRUAL SYNDROME	DIARRHOEA	1
PS	PREMENSTRUAL SYNDROME	DIZZINESS	1
PS	PREMENSTRUAL SYNDROME	HYPERSENSITIVITY	1
PS	PREMENSTRUAL SYNDROME	HYPONATRAEMIA	1
PS	PREMENSTRUAL SYNDROME	JAUNDICE	1
PS	PREMENSTRUAL SYNDROME	LIVER FUNCTION TEST ABNORMAL	1
PS	PREMENSTRUAL SYNDROME	NAUSEA	1
PS	PREMENSTRUAL SYNDROME	PRODUCT QUALITY ISSUE	1
PS	PREMENSTRUAL SYNDROME	RASH	1
PS	PREMENSTRUAL SYNDROME	RENAL FAILURE ACUTE	1
PS	PREMENSTRUAL SYNDROME	THROMBOCYTOPENIA	1
PS	PREMENSTRUAL SYNDROME	URINARY TRACT INFECTION	1
PS	PREMENSTRUAL SYNDROME	VASCULITIS	1
PS	PREMENSTRUAL SYNDROME	VOMITING	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	ACCIDENTAL DRUG INTAKE BY CHILD	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	ANAEMIA HAEMOLYTIC AUTOIMMUNE	4
PS	PRODUCT USED FOR UNKNOWN INDICATION	CONVULSION	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	FALL	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	LOSS OF CONSCIOUSNESS	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	NAUSEA	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	PAIN IN EXTREMITY	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	PRODUCT ODOUR ABNORMAL	3
PS	PRODUCT USED FOR UNKNOWN INDICATION	THIRST	1
PS	PYREXIA	HEADACHE	1
PS	PYREXIA	PYREXIA	1
PS	PYREXIA	RENAL FAILURE ACUTE	1
PS	PYREXIA	RENAL TUBULAR NECROSIS	1
PS	SINUSITIS	HEADACHE	1
PS	SINUSITIS	PYREXIA	1
PS	SINUSITIS	RENAL FAILURE ACUTE	1
PS	SINUSITIS	RENAL TUBULAR NECROSIS	1
SS	CARDIAC OPERATION	COLONIC POLYP	3
SS	CARDIAC OPERATION	INCORRECT DOSE ADMINISTERED	3
SS	CARDIAC OPERATION	INTENTIONAL DRUG MISUSE	3
SS	CARDIAC OPERATION	LARGE INTESTINAL ULCER	3
SS	CARDIAC OPERATION	OVERDOSE	3
SS	CONVULSION	HEADACHE	2
SS	CONVULSION	PYREXIA	2
SS	CONVULSION	RENAL FAILURE ACUTE	2
SS	CONVULSION	RENAL TUBULAR NECROSIS	2
SS	HEADACHE	HEADACHE	4
SS	HEADACHE	PYREXIA	4
SS	HEADACHE	RENAL FAILURE ACUTE	4
SS	HEADACHE	RENAL TUBULAR NECROSIS	4
SS	KNEE ARTHROPLASTY	COLONIC POLYP	3
SS	KNEE ARTHROPLASTY	INCORRECT DOSE ADMINISTERED	3
SS	KNEE ARTHROPLASTY	INTENTIONAL DRUG MISUSE	3
SS	KNEE ARTHROPLASTY	LARGE INTESTINAL ULCER	3
SS	KNEE ARTHROPLASTY	OVERDOSE	3
SS	PREMENSTRUAL SYNDROME	ALOPECIA	1
SS	PREMENSTRUAL SYNDROME	ASTHENIA	1
SS	PREMENSTRUAL SYNDROME	DIARRHOEA	1
SS	PREMENSTRUAL SYNDROME	DIZZINESS	1
SS	PREMENSTRUAL SYNDROME	HYPERSENSITIVITY	1
SS	PREMENSTRUAL SYNDROME	HYPONATRAEMIA	1
SS	PREMENSTRUAL SYNDROME	JAUNDICE	1
SS	PREMENSTRUAL SYNDROME	LIVER FUNCTION TEST ABNORMAL	1
SS	PREMENSTRUAL SYNDROME	NAUSEA	1
SS	PREMENSTRUAL SYNDROME	PRODUCT QUALITY ISSUE	1
SS	PREMENSTRUAL SYNDROME	RASH	1
SS	PREMENSTRUAL SYNDROME	RENAL FAILURE ACUTE	1
SS	PREMENSTRUAL SYNDROME	THROMBOCYTOPENIA	1
SS	PREMENSTRUAL SYNDROME	URINARY TRACT INFECTION	1
SS	PREMENSTRUAL SYNDROME	VASCULITIS	1
SS	PREMENSTRUAL SYNDROME	VOMITING	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	ABDOMINAL PAIN	40
SS	PRODUCT USED FOR UNKNOWN INDICATION	ACCIDENTAL DRUG INTAKE BY CHILD	2
SS	PRODUCT USED FOR UNKNOWN INDICATION	ANAEMIA HAEMOLYTIC AUTOIMMUNE	4
SS	PRODUCT USED FOR UNKNOWN INDICATION	BACK PAIN	40
SS	PRODUCT USED FOR UNKNOWN INDICATION	FALL	3
SS	PRODUCT USED FOR UNKNOWN INDICATION	JAUNDICE	40
SS	PRODUCT USED FOR UNKNOWN INDICATION	LOSS OF CONSCIOUSNESS	3
SS	PRODUCT USED FOR UNKNOWN INDICATION	MALAISE	40
SS	PRODUCT USED FOR UNKNOWN INDICATION	MUSCULOSKELETAL STIFFNESS	40
SS	PRODUCT USED FOR UNKNOWN INDICATION	NAUSEA	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	PAIN IN EXTREMITY	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	PANCREATIC CARCINOMA	40
SS	PRODUCT USED FOR UNKNOWN INDICATION	PRODUCT ODOUR ABNORMAL	3
SS	PRODUCT USED FOR UNKNOWN INDICATION	THIRST	1
SS	PYREXIA	HEADACHE	2
SS	PYREXIA	PYREXIA	2
SS	PYREXIA	RENAL FAILURE ACUTE	2
SS	PYREXIA	RENAL TUBULAR NECROSIS	2
SS	SINUSITIS	HEADACHE	2
SS	SINUSITIS	PYREXIA	2
SS	SINUSITIS	RENAL FAILURE ACUTE	2
SS	SINUSITIS	RENAL TUBULAR NECROSIS	2
C	HEPATITIS C	DERMATITIS EXFOLIATIVE	3
C	LUNG CARCINOMA CELL TYPE UNSPECIFIED STAGE 0	DISEASE PROGRESSION	1
C	PRODUCT USED FOR UNKNOWN INDICATION	DISEASE PROGRESSION	2

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