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Oxycontin (Oxycodone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Oxycontin (Oxycodone) 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 (1088)
Death (202)
Life Threatening Events (31)
Disability (31)

Reports by Reaction Type

Drug Dependence (154)Pain (142)Drug Withdrawal Syndrome (101)Vomiting (75)Substance Abuse (68)Nausea (65)Drug Abuse (60)Death (58)Suicidal Ideation (56)Depression (53)Anxiety (52)Drug Ineffective (51)

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

Possible Oxycontin side effects in 79 year old female

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

Patient: 79 year old female

Reactions: Hallucination, Visual, Hallucination, Auditory, Drug Interaction, Toxicity To Various Agents, Somnolence, Crying

Drug(s) suspected as cause:
Lexapro
    Indication: Depression
    Start date: 2007-01-01

Lunesta
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Morphine
    Indication: Pain
    Start date: 2011-11-01
    End date: 2012-02-01

Oxycontin
    Indication: Pain

Oxycontin

Other drugs received by patient: Vicodin



Possible Oxycontin side effects in female

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

Patient: female

Reactions: Pain, Headache, Somnolence, Cardiac Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alprazolam

Lexapro

Oxycontin
    Dosage: 80 mg, unk

Roxicodone



Possible Oxycontin side effects in 35 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-24

Patient: 35 year old male

Reactions: Oedema Peripheral, Pain, Rash Vesicular, Erythema, Herpes Zoster

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lasix
    Dosage: unk
    Administration route: Oral
    Start date: 2012-06-01
    End date: 2012-06-02

Lidocaine
    Dosage: unk
    Administration route: Topical
    Indication: Pain
    Start date: 2012-05-24

Lyrica
    Dosage: unk
    Administration route: Oral
    Indication: Pain
    Start date: 2012-05-01
    End date: 2012-01-01

Lyrica
    Dosage: 75 mg, 2x/day
    Administration route: Oral
    End date: 2012-05-06

Nefopam
    Dosage: unk
    Administration route: Oral
    Start date: 2012-01-01

Nefopam
    Dosage: unk
    Indication: Pain
    Start date: 2012-05-22

Oxycodone Hydrochloride
    Dosage: unk
    Administration route: Oral
    Indication: Pain
    Start date: 2012-05-23
    End date: 2012-06-03

Oxycontin
    Dosage: unk
    Administration route: Oral
    Indication: Pain
    Start date: 2012-05-23

Pantoprazole Sodium
    Dosage: 40 mg, daily
    Administration route: Oral
    Start date: 2012-05-29
    End date: 2012-06-03

Remicade
    Dosage: 400 mg,1 in 8 wk
    Indication: Spondylitis
    Start date: 2009-03-01
    End date: 2012-04-18



Possible Oxycontin side effects in male

Reported by a physician from Japan on 2012-08-24

Patient: male

Reactions: Stomatitis, Alanine Aminotransferase Increased, Rash, Xeroderma, Constipation, Interstitial Lung Disease, Neoplasm Malignant, Cholangitis, Aspartate Aminotransferase Increased

Adverse event resulted in: death

Drug(s) suspected as cause:
Erlotinib Hydrochloride
    Dosage: 100 mg, uid/qd
    Administration route: Oral
    Start date: 2011-12-27
    End date: 2012-01-10

Erlotinib Hydrochloride
    Dosage: 100 mg, uid/qd
    Administration route: Oral
    Indication: Adenocarcinoma Pancreas
    Start date: 2011-11-28
    End date: 2011-12-21

Gemcitabine Hydrochloride
    Dosage: 1000 mg/m2, uid/qd
    Start date: 2012-02-13
    End date: 2012-02-13

Gemcitabine Hydrochloride
    Dosage: 1000 mg/m2, uid/qd
    Start date: 2012-01-04
    End date: 2012-01-04

Gemcitabine Hydrochloride
    Dosage: 1000 mg/m2, weekly
    Start date: 2011-12-19
    End date: 2011-12-26

Gemcitabine Hydrochloride
    Dosage: 1000 mg/m2, weekly 3 weeks administration and 1 week rest
    Start date: 2012-01-16
    End date: 2012-01-30

Gemcitabine Hydrochloride
    Dosage: 1000 mg/m2, weekly 2 weeks administration and 1 week rest
    Indication: Adenocarcinoma Pancreas
    Start date: 2011-11-28
    End date: 2011-12-05

Levofloxacin
    Dosage: 500 mg, uid/qd
    Administration route: Oral
    Indication: Cholangitis
    Start date: 2011-12-11
    End date: 2011-12-15

Oxycontin
    Dosage: 10 mg, tid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Levofloxacin; Loxonin; Morphine; Magmitt; Berizym; Pursennid; Lansoprazole



Possible Oxycontin side effects in female

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

Patient: female

Reactions: Foot Operation, Poor Peripheral Circulation, Neck Surgery

Drug(s) suspected as cause:
Oxycontin



Possible Oxycontin side effects in male

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

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Oxycontin



Possible Oxycontin side effects in female

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

Patient: female

Reactions: Fatigue, Insomnia, Mental Disorder, Depression

Drug(s) suspected as cause:
Abilify
    Indication: Mental Disorder

Abilify
    Dosage: unk
    Indication: Depression
    Start date: 2012-01-01

Oxycontin
    Dosage: 320 mg, hs
    Administration route: Oral

Oxycontin
    Dosage: 160 mg, pm
    Administration route: Oral

Oxycontin
    Dosage: 320 mg, am
    Administration route: Oral
    Indication: Pain



Possible Oxycontin side effects in 33 year old male

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

Patient: 33 year old male

Reactions: Euphoric Mood, Overdose, Suicide Attempt, Injury, Polysubstance Dependence, Drug Withdrawal Syndrome, Substance Abuse

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

Methamphetamine Hydrochloride
    Indication: Drug Abuse

Oxycontin
    Dosage: unk
    Indication: Pain
    Start date: 2008-08-01



Possible Oxycontin side effects in 63 year old female

Reported by a physician from Spain on 2012-08-24

Patient: 63 year old female

Reactions: Akathisia, Myoclonus, Feeling Jittery, Dyskinesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naloxolne HCL
    Indication: Rheumatoid Arthritis

Naloxolne HCL
    Dosage: 20 mg, q12h
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2012-05-10
    End date: 2012-05-11

Oxycontin
    Indication: Rheumatoid Arthritis

Oxycontin
    Dosage: unk
    Indication: Osteoarthritis

Other drugs received by patient: Prednisone TAB; Calcium Carbonate; Omeprazole; Duragesic-100; Abstral; Arava; Lormetazepam; Enalapril Maleate; Actonel; Metamizole



Possible Oxycontin side effects in female

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

Patient: female

Reactions: Gallbladder Operation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Oxycontin



Possible Oxycontin side effects in 57 year old male

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

Patient: 57 year old male, weighing 106.6 kg (234.5 pounds)

Reactions: Wrong Technique in Drug Usage Process, Deafness, Erythema, Abdominal Discomfort, Neurotoxicity, Brain Injury, Balance Disorder, Oedema Peripheral, Sensory Integrative Dysfunction, Unevaluable Event, Back Pain, Pain in Extremity, Inadequate Analgesia, Judgement Impaired, Drug Withdrawal Syndrome, Costochondritis, Decreased Interest, Apathy, Irritability, Affective Disorder, Euphoric Mood, Sleep Disorder, Major Depression, Nervous System Disorder, Disturbance in Attention, Drug Ineffective, Chills, Pain, Intentional Drug Misuse, Anhedonia, Fatigue, Neuropathy Peripheral, Neck Pain, Dizziness, Injury, Allodynia, Loss of Libido, Musculoskeletal Pain, Logorrhoea, Dysarthria, Anxiety, Hyperaesthesia, Arthralgia, Loss of Employment, Drug Dependence, Bradyphrenia, Depressed Mood

Drug(s) suspected as cause:
Oxycontin
    Dosage: 160 mg, bid
    End date: 2012-04-01

Oxycontin
    Dosage: 20 mg, see text

Oxycontin
    Dosage: 40 mg, unk

Oxycontin
    Dosage: 10 mg, see text
    Indication: Pain in Extremity
    Start date: 2002-01-01

Other drugs received by patient: Interferon / 05982601 /; Pegintron / 01543001 /; Neupogen; Clonazepam; Lortab; Lexapro; Flexeril; Fluticasone Propionate; Ribavirin



Possible Oxycontin side effects in 37 year old male

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-23

Patient: 37 year old male

Reactions: Dependence, Suicidal Ideation

Drug(s) suspected as cause:
Morphine
    Indication: Product Used FOR Unknown Indication

Oxycontin
    Indication: Product Used FOR Unknown Indication

Valium
    Indication: Product Used FOR Unknown Indication



Possible Oxycontin side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: male

Reactions: Concussion, Victim of Crime, Incorrect Dose Administered, Haematoma

Drug(s) suspected as cause:
Oxycontin



Possible Oxycontin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Hospitalisation, Gastrointestinal Disorder Therapy, Diabetes Mellitus, Gastrointestinal Disorder, Hypokalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Oxycontin
    Dosage: 40 mg, daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Oxycontin
    Dosage: 20 mg, bid
    Administration route: Oral
    Start date: 2012-01-01



Possible Oxycontin side effects in male

Reported by a physician from United States on 2012-08-21

Patient: male, weighing 62.1 kg (136.7 pounds)

Reactions: Complications of Transplanted Liver, Pain

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Oxycodone HCL
    Dosage: 15 mg, q4h
    Indication: Product Used FOR Unknown Indication

Oxycontin
    Dosage: 40 mg, q8h
    Administration route: Oral
    Indication: Pain
    Start date: 2010-01-01



Possible Oxycontin side effects in female

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

Patient: female

Reactions: Nausea, Pain, Inadequate Analgesia, Headache, Somnolence, Abdominal Pain Upper, Cardiac Disorder, Unevaluable Event

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Alprazolam
    Indication: Product Used FOR Unknown Indication

Cardiac Medication
    Indication: Product Used FOR Unknown Indication

Lexapro
    Indication: Product Used FOR Unknown Indication

Oxycontin
    Dosage: 80 mg, unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Roxicodone
    Indication: Product Used FOR Unknown Indication



Possible Oxycontin side effects in 57 year old female

Reported by a physician from United States on 2012-08-20

Patient: 57 year old female

Reactions: Chest Pain, Drug Hypersensitivity

Drug(s) suspected as cause:
Celexa
    Dosage: unk

Ciprofloxacin HCL
    Dosage: unk

Gabapentin
    Dosage: unk

Hydrocodone Bitartrate + Acetaminophen
    Dosage: unk

Iodine
    Dosage: unk

Morphine Sulfate
    Dosage: unk

Oxycontin
    Dosage: unk

Povidone-Iodine (Formula 47)
    Dosage: unk

Prozac
    Dosage: unk

Secretin INJ
    Dosage: unk

Seroquel
    Dosage: unk

Titanium Dioxide
    Dosage: unk

Zyprexa
    Dosage: unk



Possible Oxycontin side effects in female

Reported by a pharmacist from Japan on 2012-08-20

Patient: female

Reactions: Neoplasm Malignant, Pain

Drug(s) suspected as cause:
Oxycontin
    Indication: Cancer Pain
    Start date: 2012-07-24

Tramadol HCL
    Dosage: 1dfx4 per day
    Administration route: Oral
    Indication: Pain



Possible Oxycontin side effects in 25 year old male

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: 25 year old male, weighing 79.8 kg (175.6 pounds)

Reactions: Abdominal Pain, Gastrointestinal Pain, Amylase Increased, Abdominal Pain Upper

Drug(s) suspected as cause:
Oxycontin
    Dosage: 10mg, twice daily, po
    Administration route: Oral
    Indication: Joint Surgery
    Start date: 2012-05-01
    End date: 2012-08-15

Oxycontin
    Dosage: 10mg, twice daily, po
    Administration route: Oral
    Indication: Pain
    Start date: 2012-05-01
    End date: 2012-08-15



Possible Oxycontin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: female

Reactions: Lymphadenopathy, Vomiting, Drug Ineffective, Nausea, Haemoptysis, Musculoskeletal Pain, Headache, Constipation, Product Size Issue, Neoplasm Malignant, Unevaluable Event, Decreased Appetite

Adverse event resulted in: death

Drug(s) suspected as cause:
Oxycodone HCL
    Dosage: 10-20 mg q3-4 h prn
    Indication: Pain
    Start date: 2012-01-31

Oxycontin
    Dosage: 10 mg, q12h
    Indication: Pain
    Start date: 2012-01-31

Xalkori
    Dosage: 250 mg, bid
    Administration route: Oral
    Indication: Lung Neoplasm Malignant
    Start date: 2012-02-22
    End date: 2012-02-29

Other drugs received by patient: MS Contin; Tylenol (Caplet); Senokot; Zofran; Roxanol; Robitussin / 00048001 /; Klonopin; Sudafed S.a.; Chloraseptic; Vitamin B6; Vitamin B12 / 00056201 /; Tussionex; Viactiv / 00751501 /; Ambien; Fosamax



Possible Oxycontin side effects in 35 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-17

Patient: 35 year old male

Reactions: Oedema Peripheral, Pain, Rash Vesicular, Erythema, Herpes Zoster

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lasix
    Dosage: unk
    Administration route: Oral
    Indication: Oedema Peripheral
    Start date: 2012-06-01
    End date: 2012-06-02

Lidocaine
    Dosage: unk
    Administration route: Topical
    Indication: Pain
    Start date: 2012-05-24

Lyrica
    Dosage: unk
    Administration route: Oral
    Indication: Pain
    Start date: 2012-05-01
    End date: 2012-01-01

Lyrica
    Dosage: 75 mg, 2x/day
    Administration route: Oral
    End date: 2012-05-06

Nefopam
    Dosage: unk
    Indication: Pain
    Start date: 2012-05-22

Nefopam
    Dosage: unk
    Administration route: Oral
    Start date: 2012-01-01

Oxycodone Hydrochloride
    Dosage: unk
    Administration route: Oral
    Indication: Pain
    Start date: 2012-05-23
    End date: 2012-06-03

Oxycontin
    Dosage: unk
    Administration route: Oral
    Indication: Pain
    Start date: 2012-05-23

Pantoprazole Sodium
    Dosage: 40 mg, 1x/day
    Administration route: Oral
    Start date: 2012-05-29
    End date: 2012-06-03

Remicade
    Dosage: 400 mg,1 in 8 wk
    Indication: Spondylitis
    Start date: 2009-03-01
    End date: 2012-04-18



Possible Oxycontin side effects in male

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

Patient: male, weighing 64.0 kg (140.7 pounds)

Reactions: Negative Thoughts, Urinary Incontinence, Pain, Mental Status Changes, Suicidal Ideation, Abnormal Loss of Weight, Subcutaneous Abscess, Osteochondrosis, Anaemia, Drug Withdrawal Syndrome, Eating Disorder, Dysgeusia, Incoherent, Anxiety, Activities of Daily Living Impaired, Insomnia, Hypothyroidism, Parosmia, Mobility Decreased, Post Laminectomy Syndrome

Drug(s) suspected as cause:
Oxycontin
    Dosage: 80 mg, q12h
    Administration route: Oral

Oxycontin
    Dosage: 480 mg, q12h
    Indication: Pain

Other drugs received by patient: Valium; Synthroid; Zoloft; Unisom / 00000402 /; Valium; Neurontin



Possible Oxycontin side effects in male

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

Patient: male

Reactions: Pulmonary Haemorrhage, Scapula Fracture, Road Traffic Accident, Traumatic Lung Injury, Spinal Column Injury, RIB Fracture

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Oxycontin



Possible Oxycontin side effects in 35 year old male

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

Patient: 35 year old male

Reactions: Pain, General Physical Health Deterioration, Drug Withdrawal Syndrome, Hypoaesthesia, Pallor, Substance Abuse, Suicidal Ideation, Overweight, Euphoric Mood, Overdose, Cyanosis, Social Avoidant Behaviour, Depression, Drug Dependence

Drug(s) suspected as cause:
Alcohol
    Indication: Product Used FOR Unknown Indication

Cocaine
    Indication: Product Used FOR Unknown Indication

Marijuana
    Indication: Product Used FOR Unknown Indication

Oxycontin
    Dosage: 20 tablet, daily
    Indication: Product Used FOR Unknown Indication

Oxycontin
    Dosage: unk unk, daily
    Indication: Product Used FOR Unknown Indication

Percocet
    Indication: Product Used FOR Unknown Indication



Possible Oxycontin side effects in 65 year old male

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

Patient: 65 year old male

Reactions: Psychotic Disorder, Judgement Impaired, Somnambulism, Feeling Abnormal, Amnesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ativan
    Dosage: unk unk, see text
    Indication: Product Used FOR Unknown Indication

Haldol
    Dosage: 25 mg, see text
    Indication: Product Used FOR Unknown Indication

Oxycontin
    Dosage: 20 mg, unk
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Versed
    Dosage: unk unk, see text
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Oxycodone HCL; Xanax; Valium



Possible Oxycontin side effects in 62 year old male

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

Patient: 62 year old male

Reactions: Narcolepsy, Restless Legs Syndrome, Agoraphobia, Fatigue, Road Traffic Accident, Overdose, Dizziness, Depression, Hallucination, Nausea, Paranoia, Drug Withdrawal Syndrome, Renal Failure, Dehydration, Asthenia, Sleep Apnoea Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Oxycontin
    Dosage: dosing details unknown
    Indication: Product Used FOR Unknown Indication

Suboxone
    Indication: Drug Dependence
    Start date: 2008-01-01

Suboxone
    Dosage: tapered down to 16 mg daily
    Indication: Drug Dependence



Possible Oxycontin side effects in 58 year old female

Reported by a physician from France on 2012-08-16

Patient: 58 year old female

Reactions: Disturbance in Attention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amitriptyline Hydrochloride
    Indication: Product Used FOR Unknown Indication
    End date: 2012-06-21

Cetirizine HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-06-21

Clonazepam
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-06-21

Lyrica
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-06-21

Oxycodone Hydrochloride
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-06-21

Oxycontin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2012-06-21



Possible Oxycontin side effects in female

Reported by a pharmacist from Australia on 2012-08-15

Patient: female

Reactions: Death, Hospitalisation, Drug Administration Error

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Oxycontin



Possible Oxycontin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: female

Reactions: Drug Ineffective, Neoplasm Malignant

Drug(s) suspected as cause:
Oxycontin
    Dosage: 30 mg, q12h
    Indication: Cancer Pain

Oxycontin
    Dosage: 60 mg, tid



Possible Oxycontin side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-15

Patient: male

Reactions: Cellulitis, Restlessness, Tachycardia, Antibiotic Resistant Staphylococcus Test, Drug Abuse, Hyperhidrosis, Tremor, Anxiety, Psychotic Disorder, Skin Ulcer, Diarrhoea, Insomnia, Withdrawal Syndrome, Drug Dependence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipilimumab
    Dosage: 295 mg, unk
    Indication: Prostate Cancer
    Start date: 2011-12-06
    End date: 2012-05-29

Oxycodone HCL
    Dosage: 10 mg, prn
    Administration route: Oral
    Indication: Back Pain
    Start date: 2012-01-01

Oxycontin
    Dosage: 20 mg, bid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Placebo
    Dosage: unk
    Indication: Prostate Cancer
    Start date: 2011-12-06
    End date: 2012-05-29

Other drugs received by patient: Lisinopril; Humulin N; Sulfamethoxazole; Citalopram; Trazodone Hydrochloride; Aspirin; Buspar; Prednisone TAB; Paxil; Actos; Amaryl; Prednisone TAB; Zocor; Aleve; Celebrex; Metformin Hydrochloride; Titralac / 00183701 /; Triamcinolone; Humulin R; Novolin 70 / 30

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