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Index of reports
> Cases with Product Quality Issue (13)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Ortho Evra where reactions include product quality issue. The selected reports were submitted to the FDA during the sample period of about a year.
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 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 United States on 2012-06-22
Patient: female, weighing 86.2 kg (189.6 pounds)
Reactions: Product Quality Issue, Wrong Technique in Drug Usage Process, Upper Limb Fracture, Product Adhesion Issue, Convulsion, Application Site Pruritus, Skin Irritation
Drug(s) suspected as cause:
Ortho Evra
Other drugs received by patient: Cymbalta; Multi-Vitamins; Tramadol HCL; Antithyroid Drug, Unspecified; Adderall XR 10; Remeron; Paxil
Possible Ortho Evra side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-04
Patient: female, weighing 56.7 kg (124.7 pounds)
Reactions: Application Site Reaction, Product Quality Issue, Wrist Fracture, Application Site Erosion, Application Site Pain, Skin Irritation
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 2012-05-31
Patient: female, weighing 86.2 kg (189.6 pounds)
Reactions: Product Quality Issue, Wrong Technique in Drug Usage Process, Upper Limb Fracture, Skin Irritation, Application Site Pruritus
Drug(s) suspected as cause:
Ortho Evra
Other drugs received by patient: Multi-Vitamins; Cymbalta; Antithyroid Drug, Unspecified; Adderall XR 10
Possible Ortho Evra side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-18
Patient: female, weighing 68.0 kg (149.7 pounds)
Reactions: Off Label Use, Drug Dose Omission, Product Quality Issue, Withdrawal Bleed, Hyperhidrosis, Aggression
Drug(s) suspected as cause:
Ortho Evra
Indication: Haemorrhage
Start date: 2012-04-29
Ortho Evra
Start date: 2011-12-01
End date: 2012-04-01
Other drugs received by patient: ^vitamins^ (Nos)
Possible Ortho Evra side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-04
Patient: female, weighing 71.7 kg (157.7 pounds)
Reactions: Product Quality Issue, Inappropriate Schedule of Drug Administration, Wrong Technique in Drug Usage Process, Hypothyroidism
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 Brazil on 2012-04-27
Patient: 31 year old female, weighing 47.0 kg (103.4 pounds)
Reactions: Inappropriate Schedule of Drug Administration, Nephrolithiasis, Product Quality Issue, Wrong Technique in Drug Usage Process
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 2012-04-24
Patient: female, weighing 72.6 kg (159.7 pounds)
Reactions: Drug Dose Omission, Product Quality Issue, Wrong Technique in Drug Usage Process, Attention Deficit / Hyperactivity Disorder
Drug(s) suspected as cause:
Ortho Evra
Other drugs received by patient: Effexor XR
Possible Ortho Evra side effects in 31 year old female
Reported by a consumer/non-health professional from Brazil on 2012-04-06
Patient: 31 year old female, weighing 47.0 kg (103.4 pounds)
Reactions: Inappropriate Schedule of Drug Administration, Product Quality Issue, Nephrolithiasis, Wrong Technique in Drug Usage Process
Drug(s) suspected as cause:
Ortho Evra
Possible Ortho Evra side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-06
Patient: female
Reactions: Product Quality Issue, Wrong Technique in Drug Usage Process, Pregnancy With Contraceptive Patch, Maternal Exposure During Pregnancy, Abortion Induced
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ortho Evra
Possible Ortho Evra side effects in 26 year old female
Reported by a consumer/non-health professional from Brazil on 2012-03-26
Patient: 26 year old female, weighing 61.0 kg (134.2 pounds)
Reactions: Product Quality Issue, Wrong Technique in Drug Usage Process, 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 2011-10-12
Patient: female, weighing 63.5 kg (139.7 pounds)
Reactions: Off Label Use, Product Quality Issue, Inappropriate Schedule of Drug Administration, Joint Dislocation
Drug(s) suspected as cause:
Ortho Evra
Indication: Contraception
Start date: 2006-01-01
Ortho Evra
Indication: Haemorrhage
Start date: 2006-01-01
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