Drug information for STAXYN

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
TABLET, ORALLY DISINTEGRATING; ORAL	10MG	Prescription	(Reference Drug)	VARDENAFIL HYDROCHLORIDE	vardenafil	BAYER HLTHCARE	200179 2011-01-04 Review 2010-06-24 Label 2010-06-21 Letter

Drug Adverse Effects information for STAXYN

Role code	Indications	Reaction	# Reports
PS	APHRODISIAC THERAPY	DRUG INEFFECTIVE	2
PS	BLOOD CHOLESTEROL INCREASED	DRUG INEFFECTIVE	1
PS	BLOOD PRESSURE ABNORMAL	THERAPEUTIC RESPONSE UNEXPECTED	1
PS	DIABETES MELLITUS	DRUG INEFFECTIVE	1
PS	DIABETES MELLITUS	ERECTILE DYSFUNCTION	1
PS	DISTURBANCE IN SEXUAL AROUSAL	DRUG INEFFECTIVE	1
PS	ERECTILE DYSFUNCTION	BACK PAIN	1
PS	ERECTILE DYSFUNCTION	DEAFNESS	1
PS	ERECTILE DYSFUNCTION	DRUG INEFFECTIVE	4
PS	ERECTILE DYSFUNCTION	ERECTILE DYSFUNCTION	8
PS	ERECTILE DYSFUNCTION	EYE PAIN	1
PS	ERECTILE DYSFUNCTION	HEADACHE	3
PS	ERECTILE DYSFUNCTION	HEART RATE INCREASED	1
PS	ERECTILE DYSFUNCTION	NASAL CONGESTION	1
PS	ERECTILE DYSFUNCTION	PHOTOPSIA	1
PS	ERECTILE DYSFUNCTION	RHINORRHOEA	1
PS	ERECTILE DYSFUNCTION	THERAPEUTIC RESPONSE UNEXPECTED	1
PS	HYPERTENSION	DRUG INEFFECTIVE	2
PS	HYPERTENSION	ERECTILE DYSFUNCTION	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	CHEST PAIN	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	FEELING ABNORMAL	1
SS	ERECTILE DYSFUNCTION	BLOOD PRESSURE DECREASED	2
SS	ERECTILE DYSFUNCTION	DISORIENTATION	2
SS	ERECTILE DYSFUNCTION	DYSARTHRIA	2
SS	ERECTILE DYSFUNCTION	ERECTILE DYSFUNCTION	8
SS	ERECTILE DYSFUNCTION	TINNITUS	2
C	ERECTILE DYSFUNCTION	ABDOMINAL DISCOMFORT	2

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