Drug information for ROGAINE EXTRA STRENGTH (FOR MEN)

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
SOLUTION; TOPICAL	5%	Over The Counter	(Reference Drug)	MINOXIDIL	Minoxidil	JOHNSON AND JOHNSON	20834 2006-09-20 Letter 2005-06-07 Letter 2004-06-30 Letter 2003-08-08 Review 2003-05-29 Label 2003-02-14 Letter

Drug Adverse Effects information for ROGAINE EXTRA STRENGTH (FOR MEN)

Role code	Indications	Reaction	# Reports
PS	ALOPECIA	ALOPECIA	3
PS	ALOPECIA	APPLICATION SITE PRURITUS	2
PS	ALOPECIA	BLISTER	2
PS	ALOPECIA	BLOOD PRESSURE INCREASED	1
PS	ALOPECIA	HAIR TEXTURE ABNORMAL	1
PS	ALOPECIA	HEPATITIS A	2
PS	ALOPECIA	MALAISE	1
PS	ALOPECIA	MIGRAINE	1
PS	ALOPECIA	MUSCLE SPASMS	1
PS	ALOPECIA	NERVE COMPRESSION	1
PS	ALOPECIA	OFF LABEL USE	1
PS	ALOPECIA	PALPITATIONS	1
PS	ALOPECIA	PLEURAL EFFUSION	1
PS	ALOPECIA	PNEUMONITIS	1
PS	ALOPECIA	PRODUCT QUALITY ISSUE	3
PS	ALOPECIA	PRURITUS	2
PS	ALOPECIA	UNDERDOSE	3
PS	ALOPECIA	WRONG DRUG ADMINISTERED	4
PS	ANXIETY	ALOPECIA	1
PS	ANXIETY	APPLICATION SITE PRURITUS	1
PS	ANXIETY	DIZZINESS	2
PS	ANXIETY	DYSPNOEA	2
PS	ANXIETY	HEPATITIS A	1
PS	ANXIETY	TINNITUS	2
PS	BLOOD CHOLESTEROL INCREASED	ALOPECIA	1
PS	BLOOD CHOLESTEROL INCREASED	HAIR TEXTURE ABNORMAL	1
PS	BLOOD CHOLESTEROL INCREASED	MIGRAINE	1
PS	BLOOD CHOLESTEROL INCREASED	OFF LABEL USE	1
PS	BLOOD CHOLESTEROL INCREASED	WRONG DRUG ADMINISTERED	1
PS	BLOOD PRESSURE INCREASED	BLOOD PRESSURE INCREASED	1
PS	BLOOD PRESSURE INCREASED	MALAISE	1
PS	BLOOD PRESSURE INCREASED	MUSCLE SPASMS	1
PS	BLOOD PRESSURE INCREASED	PRODUCT QUALITY ISSUE	1
PS	BLOOD PRESSURE INCREASED	UNDERDOSE	1
PS	BLOOD PRESSURE INCREASED	WRONG DRUG ADMINISTERED	1
PS	DIVERTICULUM	BLOOD PRESSURE INCREASED	1
PS	DIVERTICULUM	MALAISE	1
PS	DIVERTICULUM	MUSCLE SPASMS	1
PS	DIVERTICULUM	PRODUCT QUALITY ISSUE	1
PS	DIVERTICULUM	UNDERDOSE	1
PS	DIVERTICULUM	WRONG DRUG ADMINISTERED	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	ALOPECIA	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	HAIR TEXTURE ABNORMAL	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	MIGRAINE	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	OFF LABEL USE	1
PS	GASTROOESOPHAGEAL REFLUX DISEASE	WRONG DRUG ADMINISTERED	1
PS	NERVE INJURY	BLOOD PRESSURE INCREASED	1
PS	NERVE INJURY	MALAISE	1
PS	NERVE INJURY	MUSCLE SPASMS	1
PS	NERVE INJURY	PRODUCT QUALITY ISSUE	1
PS	NERVE INJURY	UNDERDOSE	1
PS	NERVE INJURY	WRONG DRUG ADMINISTERED	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	ALOPECIA	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	APPLICATION SITE PRURITUS	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	BLOOD PRESSURE INCREASED	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	DIZZINESS	4
PS	PRODUCT USED FOR UNKNOWN INDICATION	DYSPNOEA	4
PS	PRODUCT USED FOR UNKNOWN INDICATION	HEPATITIS A	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	MALAISE	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	MUSCLE SPASMS	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	PLEURAL EFFUSION	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	PNEUMONITIS	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	PRODUCT QUALITY ISSUE	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	TINNITUS	4
PS	PRODUCT USED FOR UNKNOWN INDICATION	UNDERDOSE	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	WRONG DRUG ADMINISTERED	2
PS	SLEEP DISORDER THERAPY	ALOPECIA	1
PS	SLEEP DISORDER THERAPY	APPLICATION SITE PRURITUS	1
PS	SLEEP DISORDER THERAPY	HEPATITIS A	1
SS	ALOPECIA	ALOPECIA	11
SS	ALOPECIA	AMENORRHOEA	8
SS	ALOPECIA	APPLICATION SITE PRURITUS	2
SS	ALOPECIA	BLISTER	2
SS	ALOPECIA	BLOOD PRESSURE INCREASED	3
SS	ALOPECIA	BREAST CANCER	8
SS	ALOPECIA	HAIR COLOUR CHANGES	8
SS	ALOPECIA	HAIR TEXTURE ABNORMAL	1
SS	ALOPECIA	HEPATITIS A	2
SS	ALOPECIA	HYPOTENSION	8
SS	ALOPECIA	MALAISE	3
SS	ALOPECIA	MIGRAINE	1
SS	ALOPECIA	MUSCLE SPASMS	3
SS	ALOPECIA	NERVE COMPRESSION	1
SS	ALOPECIA	OFF LABEL USE	9
SS	ALOPECIA	PALPITATIONS	1
SS	ALOPECIA	PLEURAL EFFUSION	1
SS	ALOPECIA	PNEUMONITIS	1
SS	ALOPECIA	PRODUCT QUALITY ISSUE	5
SS	ALOPECIA	PRURITUS	10
SS	ALOPECIA	UNDERDOSE	5
SS	ALOPECIA	WRONG DRUG ADMINISTERED	14
SS	ANXIETY	ALOPECIA	3
SS	ANXIETY	AMENORRHOEA	2
SS	ANXIETY	APPLICATION SITE PRURITUS	1
SS	ANXIETY	BREAST CANCER	2
SS	ANXIETY	DIZZINESS	2
SS	ANXIETY	DYSPNOEA	2
SS	ANXIETY	HAIR COLOUR CHANGES	2
SS	ANXIETY	HEPATITIS A	1
SS	ANXIETY	HYPOTENSION	2
SS	ANXIETY	OFF LABEL USE	2
SS	ANXIETY	PRURITUS	2
SS	ANXIETY	TINNITUS	2
SS	ANXIETY	WRONG DRUG ADMINISTERED	2
SS	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	ALOPECIA	2
SS	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	AMENORRHOEA	2
SS	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	BREAST CANCER	2
SS	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	HAIR COLOUR CHANGES	2
SS	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	HYPOTENSION	2
SS	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	OFF LABEL USE	2
SS	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	PRURITUS	2
SS	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	WRONG DRUG ADMINISTERED	2
SS	BLOOD CHOLESTEROL INCREASED	ALOPECIA	5
SS	BLOOD CHOLESTEROL INCREASED	AMENORRHOEA	4
SS	BLOOD CHOLESTEROL INCREASED	BREAST CANCER	4
SS	BLOOD CHOLESTEROL INCREASED	HAIR COLOUR CHANGES	4
SS	BLOOD CHOLESTEROL INCREASED	HAIR TEXTURE ABNORMAL	1
SS	BLOOD CHOLESTEROL INCREASED	HYPOTENSION	4
SS	BLOOD CHOLESTEROL INCREASED	MIGRAINE	1
SS	BLOOD CHOLESTEROL INCREASED	OFF LABEL USE	5
SS	BLOOD CHOLESTEROL INCREASED	PRURITUS	4
SS	BLOOD CHOLESTEROL INCREASED	WRONG DRUG ADMINISTERED	5
SS	BLOOD PRESSURE INCREASED	BLOOD PRESSURE INCREASED	3
SS	BLOOD PRESSURE INCREASED	MALAISE	3
SS	BLOOD PRESSURE INCREASED	MUSCLE SPASMS	3
SS	BLOOD PRESSURE INCREASED	PRODUCT QUALITY ISSUE	3
SS	BLOOD PRESSURE INCREASED	UNDERDOSE	3
SS	BLOOD PRESSURE INCREASED	WRONG DRUG ADMINISTERED	3
SS	DIABETES MELLITUS	ALOPECIA	2
SS	DIABETES MELLITUS	AMENORRHOEA	2
SS	DIABETES MELLITUS	BREAST CANCER	2
SS	DIABETES MELLITUS	HAIR COLOUR CHANGES	2
SS	DIABETES MELLITUS	HYPOTENSION	2
SS	DIABETES MELLITUS	OFF LABEL USE	2
SS	DIABETES MELLITUS	PRURITUS	2
SS	DIABETES MELLITUS	WRONG DRUG ADMINISTERED	2
SS	DIVERTICULUM	BLOOD PRESSURE INCREASED	3
SS	DIVERTICULUM	MALAISE	3
SS	DIVERTICULUM	MUSCLE SPASMS	3
SS	DIVERTICULUM	PRODUCT QUALITY ISSUE	3
SS	DIVERTICULUM	UNDERDOSE	3
SS	DIVERTICULUM	WRONG DRUG ADMINISTERED	3
SS	GASTROOESOPHAGEAL REFLUX DISEASE	ALOPECIA	1
SS	GASTROOESOPHAGEAL REFLUX DISEASE	HAIR TEXTURE ABNORMAL	1
SS	GASTROOESOPHAGEAL REFLUX DISEASE	MIGRAINE	1
SS	GASTROOESOPHAGEAL REFLUX DISEASE	OFF LABEL USE	1
SS	GASTROOESOPHAGEAL REFLUX DISEASE	WRONG DRUG ADMINISTERED	1
SS	HORMONE REPLACEMENT THERAPY	ALOPECIA	2
SS	HORMONE REPLACEMENT THERAPY	AMENORRHOEA	2
SS	HORMONE REPLACEMENT THERAPY	BREAST CANCER	2
SS	HORMONE REPLACEMENT THERAPY	HAIR COLOUR CHANGES	2
SS	HORMONE REPLACEMENT THERAPY	HYPOTENSION	2
SS	HORMONE REPLACEMENT THERAPY	OFF LABEL USE	2
SS	HORMONE REPLACEMENT THERAPY	PRURITUS	2
SS	HORMONE REPLACEMENT THERAPY	WRONG DRUG ADMINISTERED	2
SS	HYPERTENSION	ALOPECIA	2
SS	HYPERTENSION	AMENORRHOEA	2
SS	HYPERTENSION	BREAST CANCER	2
SS	HYPERTENSION	HAIR COLOUR CHANGES	2
SS	HYPERTENSION	HYPOTENSION	2
SS	HYPERTENSION	OFF LABEL USE	2
SS	HYPERTENSION	PRURITUS	2
SS	HYPERTENSION	WRONG DRUG ADMINISTERED	2
SS	MEDICAL DIET	ALOPECIA	6
SS	MEDICAL DIET	AMENORRHOEA	6
SS	MEDICAL DIET	BREAST CANCER	6
SS	MEDICAL DIET	HAIR COLOUR CHANGES	6
SS	MEDICAL DIET	HYPOTENSION	6
SS	MEDICAL DIET	OFF LABEL USE	6
SS	MEDICAL DIET	PRURITUS	6
SS	MEDICAL DIET	WRONG DRUG ADMINISTERED	6
SS	NERVE INJURY	BLOOD PRESSURE INCREASED	3
SS	NERVE INJURY	MALAISE	3
SS	NERVE INJURY	MUSCLE SPASMS	3
SS	NERVE INJURY	PRODUCT QUALITY ISSUE	3
SS	NERVE INJURY	UNDERDOSE	3
SS	NERVE INJURY	WRONG DRUG ADMINISTERED	3
SS	PRODUCT USED FOR UNKNOWN INDICATION	ALOPECIA	2
SS	PRODUCT USED FOR UNKNOWN INDICATION	APPLICATION SITE PRURITUS	2
SS	PRODUCT USED FOR UNKNOWN INDICATION	BLOOD PRESSURE INCREASED	6
SS	PRODUCT USED FOR UNKNOWN INDICATION	DIZZINESS	4
SS	PRODUCT USED FOR UNKNOWN INDICATION	DYSPNOEA	4
SS	PRODUCT USED FOR UNKNOWN INDICATION	HEPATITIS A	2
SS	PRODUCT USED FOR UNKNOWN INDICATION	MALAISE	6
SS	PRODUCT USED FOR UNKNOWN INDICATION	MUSCLE SPASMS	6
SS	PRODUCT USED FOR UNKNOWN INDICATION	PLEURAL EFFUSION	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	PNEUMONITIS	1
SS	PRODUCT USED FOR UNKNOWN INDICATION	PRODUCT QUALITY ISSUE	6
SS	PRODUCT USED FOR UNKNOWN INDICATION	TINNITUS	4
SS	PRODUCT USED FOR UNKNOWN INDICATION	UNDERDOSE	6
SS	PRODUCT USED FOR UNKNOWN INDICATION	WRONG DRUG ADMINISTERED	6
SS	SLEEP DISORDER THERAPY	ALOPECIA	1
SS	SLEEP DISORDER THERAPY	APPLICATION SITE PRURITUS	1
SS	SLEEP DISORDER THERAPY	HEPATITIS A	1

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