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Opana (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 (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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