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Ortho Evra (Norelgestromin / Estradiol Transdermal) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Ortho Evra and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (135)
Death (8)
Life Threatening Events (12)
Disability (2)

Reports by Reaction Type

Pulmonary Embolism (22)Off Label Use (16)Inappropriate Schedule of Drug Administration (14)Product Quality Issue (13)Wrong Technique in Drug Usage Process (11)Migraine (10)Vaginal Haemorrhage (9)Headache (8)Anaemia (8)Asthma (7)Drug Dose Omission (7)Dizziness (7)

Below are a few examples of reports where side effects / adverse reactions may be related to Ortho Evra. For a complete list or a specific selection of reports, please use the links above.

Possible Ortho Evra side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Off Label Use, Product Quality Issue, Endometriosis

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in female

Reported by a consumer/non-health professional from Portugal on 2012-08-27

Patient: female

Reactions: Off Label Use, Drug Dose Omission, Menstruation Irregular, Breast Swelling, Breast Cyst, Pollakiuria, Vasodilatation

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in female

Reported by a physician from Mexico on 2012-08-27

Patient: female

Reactions: Off Label Use, Neoplasm

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in

Reported by a consumer/non-health professional from United Kingdom on 2012-08-27

Patient:

Reactions: Pulmonary Thrombosis

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in 26 year old female

Reported by a physician from Poland on 2012-08-27

Patient: 26 year old female

Reactions: Pregnancy With Contraceptive Patch, Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in female

Reported by a lawyer from United States on 2012-08-24

Patient: female

Reactions: Asthma, Atelectasis, Migraine, Pneumonia, Iron Deficiency Anaemia, Pleural Effusion, Pulmonary Embolism

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female

Reactions: Product Quality Issue, Off Label Use, Endometriosis

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in female

Reported by a consumer/non-health professional from Taiwan, Province of China on 2012-08-23

Patient: female

Reactions: Ovarian Cyst

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female, weighing 83.9 kg (184.6 pounds)

Reactions: Migraine, Asthma, Lung Disorder, Pulmonary Embolism

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient:

Reactions: LOW Birth Weight Baby, Cerebral Palsy, Premature Baby

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female

Reactions: Pregnancy With Contraceptive Patch, Maternal Exposure During Pregnancy, Premature Labour

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient:

Reactions: LOW Birth Weight Baby, Cerebral Palsy, Premature Baby

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in female

Reported by a consumer/non-health professional from Canada on 2012-08-20

Patient: female, weighing 45.4 kg (99.8 pounds)

Reactions: Off Label Use, Paranoia, Therapeutic Response Unexpected, Drug Prescribing Error

Drug(s) suspected as cause:
Ortho Evra
    Dosage: for 3 months then off 1 week
    Indication: Muscle Spasms
    Start date: 2012-01-01

Ortho Evra
    Dosage: for 3 months then off 1 week
    Indication: Contraception
    Start date: 2012-01-01



Possible Ortho Evra side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female

Reactions: Anaemia, Pulmonary Embolism, Menorrhagia, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in

Reported by a individual with unspecified qualification from United States on 2012-08-08

Patient:

Reactions: Pulmonary Thrombosis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in female

Reported by a lawyer from United States on 2012-08-08

Patient: female, weighing 66.7 kg (146.7 pounds)

Reactions: Incorrect Route of Drug Administration, Pulmonary Embolism, Cardiac Arrest

Adverse event resulted in: death

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient: female, weighing 63.5 kg (139.7 pounds)

Reactions: Off Label Use, Menstruation Delayed, Stress, Feeling Abnormal, Convulsion

Drug(s) suspected as cause:
Ortho Evra
    Indication: Menstruation Irregular
    Start date: 2012-02-01

Ortho Evra
    Indication: Contraception
    Start date: 2012-02-01

Zoloft
    Administration route: Oral
    Indication: Depression
    Start date: 2012-01-01

Other drugs received by patient: Ibuprofen; Trazodone Hydrochloride; Zonegran; Citalopram Hydrobromide



Possible Ortho Evra side effects in

Reported by a individual with unspecified qualification from United States on 2012-08-03

Patient:

Reactions: Pulmonary Thrombosis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in 24 year old female

Reported by a physician from Poland on 2012-08-01

Patient: 24 year old female

Reactions: Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in 16 year old female

Reported by a physician from United States on 2012-08-01

Patient: 16 year old female

Reactions: Lyme Disease

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in 31 year old female

Reported by a consumer/non-health professional from Israel on 2012-07-31

Patient: 31 year old female

Reactions: Blood Iron Decreased

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-27

Patient: female

Reactions: Dysphagia, Visual Field Defect, Dizziness, Depression, Hemiplegia, Cognitive Disorder, Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ortho Evra

Other drugs received by patient: Maxalt; Norvasc



Possible Ortho Evra side effects in 26 year old female

Reported by a consumer/non-health professional from Mexico on 2012-07-24

Patient: 26 year old female, weighing 50.0 kg (110.0 pounds)

Reactions: Salmonellosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ortho Evra

Other drugs received by patient: Omeprazole; Amikacin



Possible Ortho Evra side effects in female

Reported by a consumer/non-health professional from Spain on 2012-07-12

Patient: female

Reactions: Vomiting, Pain in Extremity, Anaemia, Headache, Pyrexia, Arrhythmia, Eye Pain, Fatigue, Chest Pain, Vision Blurred

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-05

Patient: female, weighing 81.7 kg (179.6 pounds)

Reactions: Menstruation Delayed, Postpartum Depression

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-05

Patient: female, weighing 97.5 kg (214.5 pounds)

Reactions: Pulmonary Embolism, Deep Vein Thrombosis

Adverse event resulted in: death

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in 25 year old female

Reported by a pharmacist from France on 2012-07-02

Patient: 25 year old female

Reactions: Feeling Hot, Hypoaesthesia, Feeling Abnormal

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-25

Patient: female

Reactions: Breast Cyst, Vaginal Haemorrhage

Drug(s) suspected as cause:
Ortho Evra



Possible Ortho Evra side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-25

Patient: female, weighing 65.8 kg (144.7 pounds)

Reactions: Off Label Use, Inappropriate Schedule of Drug Administration, Dyspnoea, Musculoskeletal Pain, Migraine With Aura

Drug(s) suspected as cause:
Depo-Provera
    Indication: Acne Cystic
    Start date: 2011-01-01
    End date: 2012-05-01

Depo-Provera
    Indication: Contraception
    Start date: 2011-01-01
    End date: 2012-05-01

Ortho Evra
    Start date: 2012-06-04

Ortho Evra
    Dosage: initiated about 8 years ago
    Indication: Acne Cystic

Ortho Evra
    Start date: 2012-06-04

Ortho Evra
    Indication: Contraception
    Start date: 2012-06-04

Ortho Evra
    Dosage: initiated about 8 years ago

Ortho Evra
    Dosage: initiated about 8 years ago
    Indication: Product Used FOR Unknown Indication



Possible Ortho Evra side effects in 26 year old female

Reported by a individual with unspecified qualification from United States on 2012-06-25

Patient: 26 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Parosmia, Anosmia

Drug(s) suspected as cause:
Ortho Evra

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