Drug information for ORTHO EVRA
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
FILM, EXTENDED RELEASE; TRANSDERMAL
0.02MG/24HR;0.15MG/24HR
Prescription
(Reference Drug)
ETHINYL ESTRADIOL
;
NORELGESTROMIN
Ortho Evra
JANSSEN PHARMS
21180
2012-01-03 Letter
2011-12-28 Label
2011-08-12 Label
2011-07-28 Letter
2011-03-28 Label
2011-03-25 Letter
2010-04-19 Label
2010-04-19 Letter
2010-01-25 Letter
2009-12-02 Label
2009-11-10 Letter
2009-11-10 Letter
2009-09-17 Label
2009-08-13 Label
2008-11-07 Label
2008-11-07 Label
2008-11-07 Label
2008-11-03 Letter
2008-11-03 Letter
2008-11-03 Letter
2008-08-01 Review
2008-08-01 Review
2008-07-31 Review
2008-01-18 Label
2007-06-29 Review
2006-09-22 Other Important Information from FDA
2006-09-20 Letter
2006-09-20 Label
2006-07-11 Review
2006-07-11 Review
2006-05-21 Letter
2005-11-18 Letter
2005-11-10 Label
2005-05-17 Label
2005-05-17 Letter
2004-12-02 Letter
2004-03-02 Letter
2001-11-20 Review
2001-11-20 Label
2001-11-20 Letter
Drug Adverse Effects information for ORTHO EVRA
Role code
Indications
Reaction
# Reports
PS
ANTIINFLAMMATORY THERAPY
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION
1
PS
ANTIINFLAMMATORY THERAPY
MENSTRUATION IRREGULAR
1
PS
ANTIINFLAMMATORY THERAPY
TENDONITIS
1
PS
ASTHMA
ASTHMA
5
PS
ASTHMA
CONTUSION
3
PS
ASTHMA
DRUG DOSE OMISSION
2
PS
ASTHMA
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION
5
PS
ASTHMA
INCORRECT DOSE ADMINISTERED
2
PS
ASTHMA
INTERVERTEBRAL DISC DISPLACEMENT
3
PS
ASTHMA
MENSTRUATION DELAYED
2
PS
ASTHMA
PRESBYOPIA
3
PS
ASTHMA
PRODUCT ADHESION ISSUE
3
PS
ASTHMA
ROAD TRAFFIC ACCIDENT
3
PS
ASTHMA
WRONG TECHNIQUE IN DRUG USAGE PROCESS
3
PS
CONTRACEPTION
ABORTION
2
PS
CONTRACEPTION
ACNE
1
PS
CONTRACEPTION
ADNEXA UTERI PAIN
2
PS
CONTRACEPTION
ANAEMIA
3
PS
CONTRACEPTION
ANGER
1
PS
CONTRACEPTION
ARTHRITIS
1
PS
CONTRACEPTION
ARTHROPATHY
1
PS
CONTRACEPTION
ASTHMA
3
PS
CONTRACEPTION
CARDIAC VALVE DISEASE
1
PS
CONTRACEPTION
CONTUSION
1
PS
CONTRACEPTION
CONVULSION
1
PS
CONTRACEPTION
DEHYDRATION
1
PS
CONTRACEPTION
DEPRESSION
1
PS
CONTRACEPTION
DRUG DOSE OMISSION
3
PS
CONTRACEPTION
DRUG PRESCRIBING ERROR
1
PS
CONTRACEPTION
EPILEPSY
1
PS
CONTRACEPTION
EYELID OEDEMA
1
PS
CONTRACEPTION
FOOT FRACTURE
1
PS
CONTRACEPTION
GASTROENTERITIS VIRAL
1
PS
CONTRACEPTION
HAIR GROWTH ABNORMAL
1
PS
CONTRACEPTION
HYPERCOAGULATION
2
PS
CONTRACEPTION
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION
8
PS
CONTRACEPTION
INCORRECT DOSE ADMINISTERED
2
PS
CONTRACEPTION
INSOMNIA
1
PS
CONTRACEPTION
INTERVERTEBRAL DISC DISPLACEMENT
1
PS
CONTRACEPTION
INTRACARDIAC THROMBUS
2
PS
CONTRACEPTION
JOINT DISLOCATION
1
PS
CONTRACEPTION
MALAISE
2
PS
CONTRACEPTION
MATERNAL EXPOSURE DURING PREGNANCY
2
PS
CONTRACEPTION
MENSTRUATION DELAYED
2
PS
CONTRACEPTION
MENSTRUATION IRREGULAR
1
PS
CONTRACEPTION
METRORRHAGIA
2
PS
CONTRACEPTION
MIGRAINE
1
PS
CONTRACEPTION
OEDEMA PERIPHERAL
1
PS
CONTRACEPTION
OFF LABEL USE
5
PS
CONTRACEPTION
OVARIAN CYST
1
PS
CONTRACEPTION
PALLOR
1
PS
CONTRACEPTION
POLYMENORRHOEA
1
PS
CONTRACEPTION
PREGNANCY WITH CONTRACEPTIVE PATCH
2
PS
CONTRACEPTION
PRESBYOPIA
1
PS
CONTRACEPTION
PRODUCT ADHESION ISSUE
1
PS
CONTRACEPTION
PRODUCT QUALITY ISSUE
1
PS
CONTRACEPTION
PULMONARY EMBOLISM
4
PS
CONTRACEPTION
RIGHT VENTRICULAR FAILURE
2
PS
CONTRACEPTION
ROAD TRAFFIC ACCIDENT
1
PS
CONTRACEPTION
SEXUALLY TRANSMITTED DISEASE
1
PS
CONTRACEPTION
SUICIDAL IDEATION
1
PS
CONTRACEPTION
TENDONITIS
1
PS
CONTRACEPTION
THROMBOSIS
2
PS
CONTRACEPTION
TOXICITY TO VARIOUS AGENTS
1
PS
CONTRACEPTION
TREATMENT NONCOMPLIANCE
3
PS
CONTRACEPTION
VAGINAL HAEMORRHAGE
3
PS
CONTRACEPTION
VARICOSE VEIN
1
PS
CONTRACEPTION
WEIGHT INCREASED
1
PS
CONTRACEPTION
WITHDRAWAL BLEED
3
PS
CONTRACEPTION
WRONG TECHNIQUE IN DRUG USAGE PROCESS
3
PS
DYSMENORRHOEA
CARDIAC VALVE DISEASE
1
PS
DYSMENORRHOEA
MIGRAINE
1
PS
DYSMENORRHOEA
OFF LABEL USE
2
PS
DYSMENORRHOEA
PULMONARY EMBOLISM
2
PS
DYSMENORRHOEA
RIGHT VENTRICULAR FAILURE
2
PS
FATIGUE
ANGER
1
PS
FATIGUE
EPILEPSY
1
PS
FATIGUE
EYELID OEDEMA
1
PS
FATIGUE
INSOMNIA
1
PS
FATIGUE
MALAISE
1
PS
FATIGUE
OEDEMA PERIPHERAL
1
PS
FATIGUE
TREATMENT NONCOMPLIANCE
1
PS
GASTROINTESTINAL DISORDER THERAPY
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION
1
PS
GASTROINTESTINAL DISORDER THERAPY
MENSTRUATION IRREGULAR
1
PS
GASTROINTESTINAL DISORDER THERAPY
TENDONITIS
1
PS
HAEMORRHAGE
ARTHRITIS
1
PS
HAEMORRHAGE
ARTHROPATHY
1
PS
HAEMORRHAGE
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION
1
PS
HAEMORRHAGE
JOINT DISLOCATION
1
PS
HAEMORRHAGE
OFF LABEL USE
2
PS
HAEMORRHAGE
PRODUCT QUALITY ISSUE
1
PS
HORMONE THERAPY
CARDIAC VALVE DISEASE
1
PS
HORMONE THERAPY
MIGRAINE
1
PS
HORMONE THERAPY
OFF LABEL USE
1
PS
HORMONE THERAPY
PULMONARY EMBOLISM
1
PS
HORMONE THERAPY
RIGHT VENTRICULAR FAILURE
1
PS
ILL-DEFINED DISORDER
ADNEXA UTERI PAIN
2
PS
ILL-DEFINED DISORDER
POLYMENORRHOEA
1
PS
ILL-DEFINED DISORDER
TREATMENT NONCOMPLIANCE
2
PS
ILL-DEFINED DISORDER
WITHDRAWAL BLEED
1
PS
MENSTRUATION IRREGULAR
CHEST PAIN
1
PS
MENSTRUATION IRREGULAR
DYSPNOEA
1
PS
MENSTRUATION IRREGULAR
MUSCULOSKELETAL PAIN
1
PS
MENSTRUATION IRREGULAR
OFF LABEL USE
1
PS
MENSTRUATION IRREGULAR
OVARIAN CYST
1
PS
MENSTRUATION IRREGULAR
PAIN IN EXTREMITY
1
PS
MOOD SWINGS
CARDIAC VALVE DISEASE
1
PS
MOOD SWINGS
MIGRAINE
1
PS
MOOD SWINGS
OFF LABEL USE
2
PS
MOOD SWINGS
PULMONARY EMBOLISM
2
PS
MOOD SWINGS
RIGHT VENTRICULAR FAILURE
2
PS
MUSCLE SPASMS
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION
1
PS
MUSCLE SPASMS
MENSTRUATION IRREGULAR
1
PS
MUSCLE SPASMS
TENDONITIS
1
PS
PAIN
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION
1
PS
PAIN
MENSTRUATION IRREGULAR
1
PS
PAIN
TENDONITIS
1
PS
POLYCYSTIC OVARIES
OFF LABEL USE
1
PS
POLYCYSTIC OVARIES
VISUAL IMPAIRMENT
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
ACNE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
BURNING SENSATION
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
CYSTITIS
2
PS
PRODUCT USED FOR UNKNOWN INDICATION
DEATH
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
DEPRESSION
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
DYSPNOEA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
FATIGUE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
HEADACHE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
HOT FLUSH
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
HYPERCOAGULATION
3
PS
PRODUCT USED FOR UNKNOWN INDICATION
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
INFECTION
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
INTRACARDIAC THROMBUS
3
PS
PRODUCT USED FOR UNKNOWN INDICATION
KIDNEY ENLARGEMENT
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
METRORRHAGIA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
MOOD SWINGS
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
MUSCULOSKELETAL CHEST PAIN
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
NAUSEA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
NEPHROLITHIASIS
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
NEPHROTIC SYNDROME
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
PARAESTHESIA
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
PRURITUS
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
PULMONARY EMBOLISM
3
PS
PRODUCT USED FOR UNKNOWN INDICATION
SYNCOPE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
THROMBOSIS
3
PS
PRODUCT USED FOR UNKNOWN INDICATION
TREATMENT NONCOMPLIANCE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
VAGINAL HAEMORRHAGE
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
WITHDRAWAL BLEED
1
PS
PRODUCT USED FOR UNKNOWN INDICATION
WRONG TECHNIQUE IN DRUG USAGE PROCESS
1
SS
ASTHMA
ASTHMA
3
SS
ASTHMA
CONTUSION
3
SS
ASTHMA
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION
3
SS
ASTHMA
INTERVERTEBRAL DISC DISPLACEMENT
3
SS
ASTHMA
PRESBYOPIA
3
SS
ASTHMA
PRODUCT ADHESION ISSUE
3
SS
ASTHMA
ROAD TRAFFIC ACCIDENT
3
SS
ASTHMA
WRONG TECHNIQUE IN DRUG USAGE PROCESS
3
SS
CONTRACEPTION
ARTHRITIS
1
SS
CONTRACEPTION
ARTHROPATHY
1
SS
CONTRACEPTION
ASTHMA
1
SS
CONTRACEPTION
CARDIAC VALVE DISEASE
3
SS
CONTRACEPTION
CONTUSION
1
SS
CONTRACEPTION
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION
2
SS
CONTRACEPTION
INTERVERTEBRAL DISC DISPLACEMENT
1
SS
CONTRACEPTION
JOINT DISLOCATION
1
SS
CONTRACEPTION
MIGRAINE
3
SS
CONTRACEPTION
OFF LABEL USE
8
SS
CONTRACEPTION
OVARIAN CYST
1
SS
CONTRACEPTION
PRESBYOPIA
1
SS
CONTRACEPTION
PRODUCT ADHESION ISSUE
1
SS
CONTRACEPTION
PRODUCT QUALITY ISSUE
1
SS
CONTRACEPTION
PULMONARY EMBOLISM
5
SS
CONTRACEPTION
RIGHT VENTRICULAR FAILURE
5
SS
CONTRACEPTION
ROAD TRAFFIC ACCIDENT
1
SS
CONTRACEPTION
WRONG TECHNIQUE IN DRUG USAGE PROCESS
1
SS
DYSMENORRHOEA
CARDIAC VALVE DISEASE
3
SS
DYSMENORRHOEA
MIGRAINE
3
SS
DYSMENORRHOEA
OFF LABEL USE
5
SS
DYSMENORRHOEA
PULMONARY EMBOLISM
5
SS
DYSMENORRHOEA
RIGHT VENTRICULAR FAILURE
5
SS
FOETAL EXPOSURE DURING PREGNANCY
ANKYLOGLOSSIA CONGENITAL
2
SS
FOETAL EXPOSURE DURING PREGNANCY
FEEDING DISORDER NEONATAL
2
SS
FOETAL EXPOSURE DURING PREGNANCY
JAW DISORDER
2
SS
FOETAL EXPOSURE DURING PREGNANCY
LIP DISORDER
2
SS
HAEMORRHAGE
ARTHRITIS
1
SS
HAEMORRHAGE
ARTHROPATHY
1
SS
HAEMORRHAGE
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION
1
SS
HAEMORRHAGE
JOINT DISLOCATION
1
SS
HAEMORRHAGE
OFF LABEL USE
2
SS
HAEMORRHAGE
PRODUCT QUALITY ISSUE
1
SS
HORMONE THERAPY
CARDIAC VALVE DISEASE
3
SS
HORMONE THERAPY
MIGRAINE
3
SS
HORMONE THERAPY
OFF LABEL USE
3
SS
HORMONE THERAPY
PULMONARY EMBOLISM
3
SS
HORMONE THERAPY
RIGHT VENTRICULAR FAILURE
3
SS
MENSTRUATION IRREGULAR
OFF LABEL USE
1
SS
MENSTRUATION IRREGULAR
OVARIAN CYST
1
SS
MOOD SWINGS
CARDIAC VALVE DISEASE
3
SS
MOOD SWINGS
MIGRAINE
3
SS
MOOD SWINGS
OFF LABEL USE
5
SS
MOOD SWINGS
PULMONARY EMBOLISM
5
SS
MOOD SWINGS
RIGHT VENTRICULAR FAILURE
5
C
ACNE
ABDOMINAL PAIN
1
C
ACNE
BILE DUCT STONE
1
C
ACNE
CHOLECYSTITIS ACUTE
1
C
ACNE
CHOLECYSTITIS CHRONIC
1
C
ACNE
COLITIS ULCERATIVE
1
C
ACNE
DEPRESSION
1
C
ACNE
EMOTIONAL DISTRESS
1
C
ACNE
INFLAMMATORY BOWEL DISEASE
1
C
ACNE
IRRITABLE BOWEL SYNDROME
1
C
ACNE
NAUSEA
1
C
ACNE
PAIN
1
C
ACNE
PANIC ATTACK
1
C
ACNE
VOMITING
1
C
BACK PAIN
BILIARY DYSKINESIA
2
C
BACK PAIN
CHOLECYSTECTOMY
2
C
BACK PAIN
CHOLECYSTITIS CHRONIC
1
C
BACK PAIN
GALLBLADDER DISORDER
1
C
CONTRACEPTION
ABDOMINAL PAIN
3
C
CONTRACEPTION
ANXIETY
2
C
CONTRACEPTION
BILE DUCT STONE
1
C
CONTRACEPTION
CHOLECYSTITIS ACUTE
1
C
CONTRACEPTION
CHOLECYSTITIS CHRONIC
5
C
CONTRACEPTION
CHOLELITHIASIS
4
C
CONTRACEPTION
EMOTIONAL DISTRESS
2
C
CONTRACEPTION
INJURY
4
C
CONTRACEPTION
IRRITABILITY
2
C
CONTRACEPTION
MALAISE
2
C
CONTRACEPTION
MENSTRUATION IRREGULAR
1
C
CONTRACEPTION
MIGRAINE
2
C
CONTRACEPTION
NAUSEA
3
C
CONTRACEPTION
PAIN
5
C
CONTRACEPTION
VOMITING
1
C
MIGRAINE
ABDOMINAL PAIN
1
C
MIGRAINE
BILE DUCT STONE
1
C
MIGRAINE
CHOLECYSTITIS ACUTE
1
C
MIGRAINE
CHOLECYSTITIS CHRONIC
1
C
MIGRAINE
NAUSEA
1
C
MIGRAINE
PAIN
1
C
MIGRAINE
VOMITING
1
C
ORAL CONTRACEPTION
ABDOMINAL PAIN
1
C
ORAL CONTRACEPTION
BILE DUCT STONE
1
C
ORAL CONTRACEPTION
BILIARY DYSKINESIA
2
C
ORAL CONTRACEPTION
CHOLECYSTECTOMY
2
C
ORAL CONTRACEPTION
CHOLECYSTITIS ACUTE
1
C
ORAL CONTRACEPTION
CHOLECYSTITIS CHRONIC
2
C
ORAL CONTRACEPTION
GALLBLADDER DISORDER
1
C
ORAL CONTRACEPTION
NAUSEA
1
C
ORAL CONTRACEPTION
PAIN
1
C
ORAL CONTRACEPTION
VOMITING
1
C
POST COITAL CONTRACEPTION
MENSTRUATION IRREGULAR
1
C
PREMENSTRUAL SYNDROME
BILIARY DYSKINESIA
2
C
PREMENSTRUAL SYNDROME
CHOLECYSTECTOMY
2
C
PREMENSTRUAL SYNDROME
CHOLECYSTITIS CHRONIC
1
C
PREMENSTRUAL SYNDROME
GALLBLADDER DISORDER
1
C
SMOKING CESSATION THERAPY
IRRITABILITY
2
C
SMOKING CESSATION THERAPY
MALAISE
2
C
SMOKING CESSATION THERAPY
MIGRAINE
2
C
SMOKING CESSATION THERAPY
NAUSEA
2
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