Drug information for BEYAZ

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
TABLET; ORAL	3MG,N/A;0.02MG,N/A;0.451MG,0.451MG	Prescription	(Reference Drug)	DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM	beyaz	BAYER HLTHCARE	22532 2012-04-12 Letter 2012-04-10 Label 2012-02-21 Letter 2012-02-14 Label 2011-11-16 Other Important Information from FDA 2011-04-04 Review 2011-04-04 Summary Review 2010-09-29 Letter 2010-09-29 Label

Drug Adverse Effects information for BEYAZ

Role code	Indications	Reaction	# Reports
PS	ABDOMINAL PAIN LOWER	ABDOMINAL DISCOMFORT	1
PS	ABDOMINAL PAIN LOWER	NAUSEA	1
PS	ACNE	ACNE	1
PS	ACNE	BREAST ENLARGEMENT	1
PS	ACNE	CHEST PAIN	1
PS	ACNE	DRY SKIN	2
PS	ACNE	DYSPNOEA	2
PS	ACNE	EAR DISCOMFORT	1
PS	ACNE	HYPOACUSIS	1
PS	ACNE	PULMONARY EMBOLISM	2
PS	ACNE	RASH	2
PS	ACNE	WEIGHT INCREASED	1
PS	CONTRACEPTION	ABDOMINAL PAIN UPPER	1
PS	CONTRACEPTION	ABORTION THREATENED	1
PS	CONTRACEPTION	AMNESIA	1
PS	CONTRACEPTION	ANTEPARTUM HAEMORRHAGE	1
PS	CONTRACEPTION	BACK PAIN	1
PS	CONTRACEPTION	BLOOD POTASSIUM DECREASED	1
PS	CONTRACEPTION	BREAST PAIN	2
PS	CONTRACEPTION	BREAST TENDERNESS	1
PS	CONTRACEPTION	CEREBRAL THROMBOSIS	1
PS	CONTRACEPTION	CEREBROVASCULAR ACCIDENT	1
PS	CONTRACEPTION	CHEST PAIN	2
PS	CONTRACEPTION	CHOLELITHIASIS	2
PS	CONTRACEPTION	DEEP VEIN THROMBOSIS	3
PS	CONTRACEPTION	DYSPNOEA	2
PS	CONTRACEPTION	FUNGAL INFECTION	1
PS	CONTRACEPTION	GALLBLADDER ENLARGEMENT	1
PS	CONTRACEPTION	HYPERTENSION	1
PS	CONTRACEPTION	HYPOMENORRHOEA	3
PS	CONTRACEPTION	KIDNEY INFECTION	1
PS	CONTRACEPTION	MENSTRUATION DELAYED	2
PS	CONTRACEPTION	METRORRHAGIA	1
PS	CONTRACEPTION	NAUSEA	1
PS	CONTRACEPTION	NECK PAIN	1
PS	CONTRACEPTION	PAIN	1
PS	CONTRACEPTION	PALPITATIONS	1
PS	CONTRACEPTION	POLYMENORRHOEA	1
PS	CONTRACEPTION	PREGNANCY ON ORAL CONTRACEPTIVE	1
PS	CONTRACEPTION	PRODUCT SUBSTITUTION ISSUE	1
PS	CONTRACEPTION	PULMONARY EMBOLISM	4
PS	CONTRACEPTION	RASH	1
PS	CONTRACEPTION	RETINAL VASCULAR THROMBOSIS	1
PS	CONTRACEPTION	SWELLING	1
PS	CONTRACEPTION	TOXIC SHOCK SYNDROME	1
PS	CONTRACEPTION	VARICOSE VEIN	1
PS	CONTRACEPTION	VERTIGO	1
PS	CONTRACEPTION	VISUAL IMPAIRMENT	1
PS	DYSMENORRHOEA	AMNESIA	1
PS	DYSMENORRHOEA	BREAST PAIN	1
PS	MENORRHAGIA	ABDOMINAL DISCOMFORT	1
PS	MENORRHAGIA	NAUSEA	1
PS	MENSTRUAL CYCLE MANAGEMENT	MENORRHAGIA	1
PS	MENSTRUAL CYCLE MANAGEMENT	METRORRHAGIA	1
PS	MENSTRUAL CYCLE MANAGEMENT	POLYMENORRHOEA	1
PS	MENSTRUAL CYCLE MANAGEMENT	RASH	1
PS	MENSTRUAL CYCLE MANAGEMENT	RETINAL VEIN THROMBOSIS	1
PS	MENSTRUATION IRREGULAR	DRY SKIN	2
PS	MENSTRUATION IRREGULAR	RASH	2
PS	ORAL CONTRACEPTION	CHEST PAIN	1
PS	ORAL CONTRACEPTION	DEEP VEIN THROMBOSIS	1
PS	ORAL CONTRACEPTION	DYSPNOEA	2
PS	ORAL CONTRACEPTION	EMBOLISM VENOUS	1
PS	ORAL CONTRACEPTION	LOSS OF LIBIDO	1
PS	ORAL CONTRACEPTION	PULMONARY EMBOLISM	3
PS	OVARIAN CYST	COELIAC DISEASE	1
PS	OVARIAN CYST	NAUSEA	1
PS	OVARIAN CYST	PRODUCT SUBSTITUTION ISSUE	1
PS	OVARIAN CYST	VERTIGO	1
PS	POLYCYSTIC OVARIES	EAR DISCOMFORT	1
PS	POLYCYSTIC OVARIES	HYPOACUSIS	1
PS	PREMENSTRUAL SYNDROME	ABDOMINAL PAIN UPPER	1
PS	PREMENSTRUAL SYNDROME	ABNORMAL BEHAVIOUR	1
PS	PREMENSTRUAL SYNDROME	AMENORRHOEA	1
PS	PREMENSTRUAL SYNDROME	ASTHENIA	1
PS	PREMENSTRUAL SYNDROME	DECREASED APPETITE	1
PS	PREMENSTRUAL SYNDROME	DIARRHOEA	1
PS	PREMENSTRUAL SYNDROME	FATIGUE	1
PS	PREMENSTRUAL SYNDROME	IRRITABILITY	1
PS	PREMENSTRUAL SYNDROME	MIGRAINE	1
PS	PREMENSTRUAL SYNDROME	MOOD SWINGS	1
PS	PREMENSTRUAL SYNDROME	MUSCLE SPASMS	1
PS	PREMENSTRUAL SYNDROME	MUSCLE TIGHTNESS	1
PS	PREMENSTRUAL SYNDROME	NAUSEA	1
PS	PREMENSTRUAL SYNDROME	RASH	1
PS	PREMENSTRUAL SYNDROME	SUICIDE ATTEMPT	1
PS	PREMENSTRUAL SYNDROME	SWELLING	1
PS	PREMENSTRUAL SYNDROME	TEMPOROMANDIBULAR JOINT SYNDROME	1
PS	PREMENSTRUAL SYNDROME	VOMITING	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	DEEP VEIN THROMBOSIS	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	OEDEMA PERIPHERAL	1
PS	PRODUCT USED FOR UNKNOWN INDICATION	PULMONARY EMBOLISM	2
PS	PRODUCT USED FOR UNKNOWN INDICATION	VAGINAL HAEMORRHAGE	2
PS	WEIGHT ABNORMAL	HYPOMENORRHOEA	2
SS	ABDOMINAL PAIN LOWER	ABDOMINAL DISCOMFORT	1
SS	ABDOMINAL PAIN LOWER	NAUSEA	1
SS	ACNE	CHEST PAIN	1
SS	ACNE	DRY SKIN	2
SS	ACNE	DYSPNOEA	2
SS	ACNE	EAR DISCOMFORT	1
SS	ACNE	HYPOACUSIS	1
SS	ACNE	METRORRHAGIA	1
SS	ACNE	PULMONARY EMBOLISM	2
SS	ACNE	RASH	2
SS	CONTRACEPTION	AMNESIA	1
SS	CONTRACEPTION	BREAST PAIN	1
SS	CONTRACEPTION	METRORRHAGIA	1
SS	CONTRACEPTION	PREMENSTRUAL SYNDROME	1
SS	CONTRACEPTION	RASH	1
SS	CONTRACEPTION	SWELLING	1
SS	DYSMENORRHOEA	AMNESIA	1
SS	DYSMENORRHOEA	BREAST PAIN	1
SS	MENORRHAGIA	ABDOMINAL DISCOMFORT	1
SS	MENORRHAGIA	NAUSEA	1
SS	MENSTRUAL CYCLE MANAGEMENT	ANAEMIA	2
SS	MENSTRUAL CYCLE MANAGEMENT	HYPOMENORRHOEA	2
SS	MENSTRUAL CYCLE MANAGEMENT	MENORRHAGIA	2
SS	MENSTRUATION IRREGULAR	ABDOMINAL DISTENSION	1
SS	MENSTRUATION IRREGULAR	ASTHENIA	1
SS	MENSTRUATION IRREGULAR	DIARRHOEA	1
SS	MENSTRUATION IRREGULAR	DRY SKIN	2
SS	MENSTRUATION IRREGULAR	FEELING ABNORMAL	1
SS	MENSTRUATION IRREGULAR	MENORRHAGIA	1
SS	MENSTRUATION IRREGULAR	MYDRIASIS	1
SS	MENSTRUATION IRREGULAR	NO ADVERSE EVENT	1
SS	MENSTRUATION IRREGULAR	PALPITATIONS	1
SS	MENSTRUATION IRREGULAR	RASH	2
SS	MENSTRUATION IRREGULAR	SYNCOPE	1
SS	ORAL CONTRACEPTION	CHEST PAIN	1
SS	ORAL CONTRACEPTION	DYSPNOEA	2
SS	ORAL CONTRACEPTION	PULMONARY EMBOLISM	2
SS	POLYCYSTIC OVARIES	EAR DISCOMFORT	1
SS	POLYCYSTIC OVARIES	HYPOACUSIS	1
SS	PREMENSTRUAL SYNDROME	PREMENSTRUAL SYNDROME	1
SS	PREMENSTRUAL SYNDROME	RASH	1
SS	PREMENSTRUAL SYNDROME	SWELLING	1
C	ACNE	DRUG DOSE OMISSION	1
C	ACNE	METRORRHAGIA	1
C	ASTHMA EXERCISE INDUCED	ANXIETY	1
C	ASTHMA EXERCISE INDUCED	NIGHTMARE	1
C	CONTRACEPTION	DRUG DOSE OMISSION	1
C	CONTRACEPTION	METRORRHAGIA	1

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