This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Opana (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 (123)
Death (15)
Life Threatening Events (1)
Disability (2)
Reports by Reaction Type
Drug Abuse (22),
Drug Ineffective (20),
Insomnia (19),
Weight Decreased (15),
Drug Dependence (15),
Respiratory Depression (12),
Agitation (11),
Tinnitus (11),
Intentional Drug Misuse (11),
Pain (10),
Brain Injury (10),
Overdose (10)
Below are a few examples of reports where side effects / adverse reactions may be related to Opana (Oxymorphone). For a complete list or a specific selection of reports, please use the links above.
Possible Opana side effects in female
Reported by a pharmacist from United States on 2012-08-16
Patient: female
Reactions: Overdose
Adverse event resulted in: death
Drug(s) suspected as cause:
Opana
Possible Opana side effects in 50 year old male
Reported by a physician from United States on 2012-08-08
Patient: 50 year old male, weighing 81.0 kg (178.2 pounds)
Reactions: Weight Decreased, Regurgitation, Tinnitus, Depersonalisation, Hospitalisation, Malaise, Mood Altered, Feeling Hot, Unevaluable Event, Cold Sweat, Drug Withdrawal Syndrome, Convulsion, Tremor, Dehydration, Insomnia, Major Depression, Nervous System Disorder, Pain, Feeling Cold, Overdose, Drug Tolerance, Eye Disorder, Decreased Appetite, Nightmare, Vomiting, Nausea, Bruxism, Muscle Twitching, Amnesia, Discomfort, Diarrhoea, Drug Dependence, Feeling Abnormal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Oxycontin
Dosage: 20 mg, see text
Indication: Breakthrough Pain
Start date: 2012-01-18
End date: 2012-01-19
Oxycontin
Dosage: 30 mg, see text
Administration route: Oral
Indication: Back Pain
Oxycontin
Dosage: 80 mg, see text
Administration route: Oral
Indication: Neck Pain
Oxycontin
Dosage: 100 mg, see text
Administration route: Oral
Indication: Drug Withdrawal Syndrome
Opana
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Klonopin; Soma; Oxycodone HCL; Lyrica; Prozac; Percocet; Methadone Hydrochloride; Suboxone; Roxicodone; Ativan
Possible Opana side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-07
Patient: male, weighing 61.7 kg (135.7 pounds)
Reactions: Product Substitution Issue, Drug Effect Decreased, Renal Pain, Melaena, Constipation
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Opana
Dosage: 40 mg 2 x daily oral pill
Administration route: Oral
Indication: Pain in Extremity
Opana
Dosage: 40 mg 2 x daily oral pill
Administration route: Oral
Indication: Arthralgia
Opana
Dosage: 40 mg 2 x daily oral pill
Administration route: Oral
Indication: Back Pain
Opana
Dosage: 20 mg 2x daily oral pill
Administration route: Oral
Possible Opana side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-27
Patient: female
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Opana
Possible Opana side effects in 50 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26
Patient: 50 year old male, weighing 81.0 kg (178.2 pounds)
Reactions: Regurgitation, Weight Decreased, Tinnitus, Depersonalisation, Pain, Feeling Cold, Malaise, Hospitalisation, Drug Tolerance, Overdose, Mood Altered, Feeling Hot, Cold Sweat, Eye Disorder, Decreased Appetite, Vomiting, Nightmare, Nausea, Bruxism, Drug Withdrawal Syndrome, Amnesia, Muscle Twitching, Tremor, Convulsion, Diarrhoea, Dehydration, Insomnia, Nervous System Disorder, Major Depression, Drug Dependence, Feeling Abnormal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Oxycontin
Dosage: 80 mg, see text
Administration route: Oral
Indication: Neck Pain
Oxycontin
Dosage: 100 mg, see text
Administration route: Oral
Indication: Drug Withdrawal Syndrome
Oxycontin
Dosage: 20 mg, see text
Indication: Breakthrough Pain
Start date: 2012-01-18
End date: 2012-01-19
Opana
Indication: Product Used FOR Unknown Indication
Oxycontin
Dosage: 30 mg, see text
Administration route: Oral
Indication: Back Pain
Other drugs received by patient: Roxicodone; Methadone; Prozac; Klonopin; Soma; Suboxone; Percocet; Lyrica; Oxycodone HCL; Ativan
Possible Opana side effects in 30 year old male
Reported by a consumer/non-health professional from United States on 2012-07-11
Patient: 30 year old male, weighing 68.0 kg (149.7 pounds)
Reactions: Product Formulation Issue, Drug Ineffective, Medication Residue
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Opana
Possible Opana side effects in female
Reported by a pharmacist from United States on 2012-07-02
Patient: female
Reactions: Overdose
Adverse event resulted in: death
Drug(s) suspected as cause:
Opana
Possible Opana side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-28
Patient: female
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Opana
Possible Opana side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: male
Reactions: Unevaluable Event
Drug(s) suspected as cause:
Fentora
Opana
Possible Opana side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-08
Patient: female
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Opana
Other drugs received by patient: Opana ER
Possible Opana side effects in
Reported by a consumer/non-health professional from United States on 2012-06-07
Patient:
Reactions: Drug Ineffective, Neuralgia, Convulsion
Drug(s) suspected as cause:
Lyrica
Dosage: unk
Neurontin
Dosage: unk
Opana
Dosage: unk
Possible Opana side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-07
Patient: male
Reactions: Drug Dispensing Error
Drug(s) suspected as cause:
Opana
Possible Opana side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-06
Patient: male
Reactions: Withdrawal Syndrome, Drug Abuse
Drug(s) suspected as cause:
Opana
Dosage: 5 mg
Administration route: Oral
Indication: Pain
Opana
Administration route: Oral
Possible Opana side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-05
Patient: female
Reactions: Intentional Drug Misuse
Drug(s) suspected as cause:
Opana
Other drugs received by patient: Senna-Mint WAF; Opana ER; Amitiza; Lactulose; Nexium; Vitamin TAB
Possible Opana side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-05
Patient: male
Reactions: Drug Dispensing Error
Drug(s) suspected as cause:
Opana
Possible Opana side effects in female
Reported by a physician from United States on 2012-06-04
Patient: female
Reactions: Death, Intentional Drug Misuse
Adverse event resulted in: death
Drug(s) suspected as cause:
Butrans
Indication: Product Used FOR Unknown Indication
AN Unknown Medication
Indication: Product Used FOR Unknown Indication
Fentanyl-100
Indication: Product Used FOR Unknown Indication
Opana
Indication: Product Used FOR Unknown Indication
Possible Opana side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-04
Patient: male
Reactions: Back Pain, Arthralgia
Drug(s) suspected as cause:
Opana
Dosage: 20 mg, 3x/day
Administration route: Oral
Indication: Back Pain
End date: 2012-04-01
Benefix
Dosage: 3000 iu, 3 times a week
Indication: Factor IX Deficiency
Opana
Indication: Arthralgia
Other drugs received by patient: Allopurinol; Metformin; Colchicine; Imitrex; Trental; Celex; Neurontin; Ambien; Simvastatin; Lasix; Insulin; Naprosyn; Bactrim
Possible Opana side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-31
Patient: female
Reactions: White Blood Cell Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Opana
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Opana ER
Administration route: Oral
Opana ER
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Opana
Administration route: Oral
Possible Opana side effects in female
Reported by a physician from United States on 2012-05-31
Patient: female
Reactions: Drug Abuse
Drug(s) suspected as cause:
Fentanyl-100
Dosage: unknown
Indication: Drug Abuse
Butrans
Dosage: unknown
Indication: Product Used FOR Unknown Indication
Opana
Dosage: unknown
Administration route: Oral
Indication: Drug Abuse
Possible Opana side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-30
Patient: male
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Opana
Other drugs received by patient: Opana ER
Possible Opana side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-30
Patient: male
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Opana
Other drugs received by patient: Opana ER
Possible Opana side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-29
Patient: male
Reactions: Confusional State, Tinnitus, Neuropathy Peripheral, Drug Ineffective, Poor Peripheral Circulation, Condition Aggravated, Feeling Abnormal
Drug(s) suspected as cause:
Opana
Other drugs received by patient: Opana ER
Possible Opana side effects in female
Reported by a physician from United States on 2012-05-25
Patient: female
Reactions: Overdose, Wrong Technique in Drug Usage Process, Intentional Drug Misuse
Drug(s) suspected as cause:
Opana
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Opana ER
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Opana side effects in 35 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-25
Patient: 35 year old male, weighing 79.4 kg (174.6 pounds)
Reactions: Unresponsive To Stimuli, Drug Interaction, Accidental Death, Toxicity To Various Agents, Drug Abuse, Accidental Overdose, Alcohol Poisoning, Drug Diversion, Pulmonary Congestion, Pulmonary Oedema
Adverse event resulted in: death
Drug(s) suspected as cause:
Alcohol (Ethanol)
Indication: Drug Abuse
Opana
Dosage: oral
Administration route: Oral
Indication: Drug Diversion
Possible Opana side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-25
Patient: female
Reactions: Death, Drug Abuse
Adverse event resulted in: death
Drug(s) suspected as cause:
Fentanyl-100
Indication: Product Used FOR Unknown Indication
Opana
Indication: Product Used FOR Unknown Indication
Butrans
Indication: Product Used FOR Unknown Indication
Possible Opana side effects in 33 year old male
Reported by a consumer/non-health professional from United States on 2012-05-23
Patient: 33 year old male
Reactions: Drug Diversion, Prescription Form Tampering, Intentional Drug Misuse
Drug(s) suspected as cause:
Opana
Dosage: n/a
Indication: Drug Diversion
Heroin
Dosage: n/a
Indication: Drug Diversion
Possible Opana side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-22
Patient: female
Reactions: Weight Bearing Difficulty, Drug Ineffective, Abasia
Drug(s) suspected as cause:
Opana
Other drugs received by patient: Opana ER
Possible Opana side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-10
Patient: female
Reactions: Cellulitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Opana
Administration route: Oral
Indication: Breakthrough Pain
Start date: 2010-01-01
End date: 2012-03-01
Opana
Indication: Osteoarthritis
Opana
Indication: Cellulitis
Opana
Indication: Neuropathy Peripheral
Opana
Indication: Fibromyalgia
Opana
Indication: Rheumatoid Arthritis
Other drugs received by patient: Nucynta
Possible Opana side effects in 39 year old female
Reported by a consumer/non-health professional from United States on 2012-05-10
Patient: 39 year old female
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Opana
Possible Opana side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-08
Patient: female
Reactions: Drug Dependence
Drug(s) suspected as cause:
Opana
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