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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