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Opana ER (Oxymorphone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Opana ER (Oxymorphone) 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 (455)
Death (20)
Life Threatening Events (1)
Disability (1)

Reports by Reaction Type

Drug Ineffective (127)Drug Abuse (99)Intentional Drug Misuse (71)Wrong Technique in Drug Usage Process (51)Drug Effect Decreased (42)Inappropriate Schedule of Drug Administration (40)Withdrawal Syndrome (37)Medication Residue (33)Foreign Body (26)Nausea (24)Drug Diversion (24)Drug Dependence (21)

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

Possible Opana ER side effects in male

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

Patient: male

Reactions: Dysphagia

Drug(s) suspected as cause:
Opana ER



Possible Opana ER side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male, weighing 147.6 kg (324.6 pounds)

Reactions: Drug Ineffective, Intentional Drug Misuse, Headache, Medication Residue, Muscle Spasms

Drug(s) suspected as cause:
Opana ER
    Indication: Crush Injury
    Start date: 2012-03-28
    End date: 2012-04-01

Opana ER
    Indication: Pain
    Start date: 2012-04-01
    End date: 2012-01-01



Possible Opana ER side effects in 54 year old female

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

Patient: 54 year old female, weighing 86.2 kg (189.6 pounds)

Reactions: Malaise, Chest Pain, Heart Rate Abnormal

Drug(s) suspected as cause:
Opana ER



Possible Opana ER side effects in male

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

Patient: male

Reactions: Death, Wrong Technique in Drug Usage Process, Drug Abuse

Drug(s) suspected as cause:
Opana ER



Possible Opana ER side effects in 24 year old female

Reported by a physician from United States on 2012-08-22

Patient: 24 year old female

Reactions: Incorrect Route of Drug Administration, Wrong Technique in Drug Usage Process, Microangiopathic Haemolytic Anaemia, Thrombocytopenic Purpura, Drug Abuse, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Opana ER



Possible Opana ER side effects in female

Reported by a physician from United States on 2012-08-22

Patient: female

Reactions: Incorrect Route of Drug Administration, Wrong Technique in Drug Usage Process, Microangiopathic Haemolytic Anaemia, Thrombocytopenic Purpura, Drug Abuse, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Opana ER



Possible Opana ER side effects in female

Reported by a physician from United States on 2012-08-22

Patient: female

Reactions: Incorrect Route of Drug Administration, Wrong Technique in Drug Usage Process, Thrombocytopenic Purpura, Microangiopathic Haemolytic Anaemia, Drug Abuse, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Opana ER



Possible Opana ER side effects in female

Reported by a physician from United States on 2012-08-22

Patient: female

Reactions: Incorrect Route of Drug Administration, Wrong Technique in Drug Usage Process, Thrombocytopenic Purpura, Microangiopathic Haemolytic Anaemia, Endocarditis, Drug Abuse, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Opana ER



Possible Opana ER side effects in male

Reported by a physician from United States on 2012-08-22

Patient: male

Reactions: Incorrect Route of Drug Administration, Wrong Technique in Drug Usage Process, Microangiopathic Haemolytic Anaemia, Thrombocytopenic Purpura, Drug Abuse, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Opana ER



Possible Opana ER side effects in female

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

Patient: female, weighing 68.1 kg (149.8 pounds)

Reactions: Drug Effect Decreased, Wrong Technique in Drug Usage Process, Drug Ineffective, Foreign Body

Drug(s) suspected as cause:
Opana ER

Other drugs received by patient: Opana ER



Possible Opana ER side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: female

Reactions: Wrong Technique in Drug Usage Process, Drug Ineffective, Withdrawal Syndrome

Drug(s) suspected as cause:
Opana ER
    Administration route: Oral
    Indication: Back Pain
    Start date: 2012-01-01

Opana ER
    Indication: Pain in Extremity

Other drugs received by patient: Opana ER; Opana ER



Possible Opana ER side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: female

Reactions: Drug Ineffective, Drug Screen Negative

Drug(s) suspected as cause:
Opana ER
    Administration route: Oral
    Indication: Pain
    End date: 2012-01-01

Opana ER
    Administration route: Oral
    End date: 2012-01-01



Possible Opana ER side effects in 38 year old female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: 38 year old female

Reactions: Pruritus, Chest Discomfort

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Opana ER

Other drugs received by patient: Opana ER



Possible Opana ER side effects in female

Reported by a pharmacist from United States on 2012-08-15

Patient: female

Reactions: Wrong Technique in Drug Usage Process, Drug Abuse, Thrombocytopenia

Drug(s) suspected as cause:
Opana ER



Possible Opana ER side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: female

Reactions: Drug Effect Decreased, Diarrhoea, Foreign Body, Drug Effect Delayed, Constipation, Abdominal Pain Upper

Drug(s) suspected as cause:
Opana ER

Other drugs received by patient: Opana ER



Possible Opana ER side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: male

Reactions: Intestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Opana ER
    Dosage: 40 mg
    Administration route: Oral
    Start date: 2012-01-01

Opana ER
    Dosage: 20 mg
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01



Possible Opana ER side effects in male

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

Patient: male

Reactions: Gastrointestinal Ulcer, Gastrointestinal Disorder, Medication Residue

Drug(s) suspected as cause:
Opana ER
    Administration route: Oral
    Start date: 2012-01-01
    End date: 2012-01-01

Opana ER
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01
    End date: 2012-01-01



Possible Opana ER side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-03

Patient: female

Reactions: Vomiting, Nausea, Drug Ineffective, Choking, Depression

Drug(s) suspected as cause:
Opana ER
    Administration route: Oral
    Indication: Arthritis
    Start date: 2012-05-01

Opana ER
    Administration route: Oral
    Indication: Intervertebral Disc Degeneration
    Start date: 2012-05-01

Other drugs received by patient: Opana ER; Opana ER



Possible Opana ER side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-03

Patient: female

Reactions: Drug Effect Decreased

Drug(s) suspected as cause:
Opana ER



Possible Opana ER side effects in female

Reported by a individual with unspecified qualification from United States on 2012-08-02

Patient: female, weighing 79.5 kg (174.8 pounds)

Reactions: Dysphagia, Gingival Recession, Gingival Erythema, Gingival Infection, Oropharyngeal Blistering

Drug(s) suspected as cause:
Opana ER
    Administration route: Oral
    Indication: Pain
    Start date: 2012-05-22
    End date: 2012-05-28

Opana ER
    Indication: Back Pain

Opana ER
    Indication: Pain in Extremity

Other drugs received by patient: Opana ER; Opana ER; Opana ER; Percocet



Possible Opana ER side effects in male

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

Patient: male, weighing 99.9 kg (219.7 pounds)

Reactions: Drug Ineffective, Depression, Intentional Drug Misuse

Drug(s) suspected as cause:
Opana ER



Possible Opana ER side effects in female

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

Patient: female, weighing 68.1 kg (149.8 pounds)

Reactions: Drug Effect Decreased, Drug Ineffective

Drug(s) suspected as cause:
Opana ER

Other drugs received by patient: Opana ER



Possible Opana ER side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: female

Reactions: Drug Effect Decreased, Diarrhoea, Foreign Body, Drug Effect Delayed, Constipation, Abdominal Pain Upper

Drug(s) suspected as cause:
Opana ER

Other drugs received by patient: Opana ER



Possible Opana ER side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: female

Reactions: Abdominal Discomfort, Sudden Visual Loss, Pain in Extremity, Drug Ineffective, Chest Pain, Presyncope

Drug(s) suspected as cause:
Opana ER

Other drugs received by patient: Opana ER



Possible Opana ER side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: male

Reactions: Wrong Technique in Drug Usage Process

Drug(s) suspected as cause:
Opana ER



Possible Opana ER side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-27

Patient: female

Reactions: Accidental Exposure

Drug(s) suspected as cause:
Opana ER



Possible Opana ER side effects in 36 year old male

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: 36 year old male

Reactions: Drug Diversion, Drug Dependence

Drug(s) suspected as cause:
Opana ER



Possible Opana ER side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-26

Patient: female

Reactions: Drug Ineffective, Drug Screen Negative

Drug(s) suspected as cause:
Opana ER
    Administration route: Oral

Opana ER
    Administration route: Oral
    Indication: Pain
    End date: 2012-01-01



Possible Opana ER side effects in female

Reported by a physician from United States on 2012-07-26

Patient: female, weighing 61.7 kg (135.8 pounds)

Reactions: Drug Ineffective, Drug Abuse

Drug(s) suspected as cause:
Heroin
    Dosage: unknown
    Indication: Drug Abuse

Methadone
    Dosage: unknown
    Indication: Drug Abuse

Opana ER
    Administration route: Oral
    Indication: Pain
    Start date: 2012-04-27
    End date: 2012-05-09

Other drugs received by patient: Adderall XR 10; Miralax; Valium; Adderall 5; Oxycodone HCL; Loestrin 1.5 / 30; Oxycodone HCL; Bupropion HCL; Bupropion HCL; Opana; Phenytoin



Possible Opana ER side effects in 31 year old male

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: 31 year old male, weighing 95.3 kg (209.6 pounds)

Reactions: Product Formulation Issue, Malaise, Vomiting, Abdominal Pain Upper

Drug(s) suspected as cause:
Opana ER

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