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Oxynorm Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Disease Progression, Infusion Site Irritation, Infusion Site Mass, Injection Site Vesicles (5884103-0)
on Sep 05, 2008 Female from UNITED KINGDOM , 37 years of age, was diagnosed with
  • analgesia
  • anxiety
  • nausea
and was treated with Oxynorm Injection 10mg/ml. Directly after, patient experienced the unwanted or unexpected Oxynorm side effects: disease progression, infusion site irritation, infusion site mass, injection site vesicles. Oxynorm Injection 10mg/ml dosage: 180 Mg, Daily.
Associated medications used:
  • Midazolam Hcl (70 Mg, Daily)
  • Nozinan (6.25 Mg, Daily)
  • Clonazepam (.5 Mg, Daily)
  • Hyoscine (60 Mg, Daily)


Hallucination, Hyperkalaemia, Vomiting (5874070-8)
Patient was taking Oxynorm. Patient felt the following Oxynorm side effects: hallucination, hyperkalaemia, vomiting on Aug 29, 2008 from SWEDEN Additional patient health information: Male , 88 years of age, . Oxynorm dosage: N/A.
Multiple prescriptions taken:
  • Omeprazole
  • Simvastatin
  • Levothyroxine Sodium (100 Mcg, Unk)
  • Acetaminophen (500 Mg, Unk)
  • Propavan (25 Mg, Unk)
  • Betapred (.5 Mg, Unk)
  • Etalpha (.25 Mcg, Unk)
  • Aspirin (75 Mg, Unk)
Patient was hospitalized.

Disease Progression, Infusion Site Irritation, Infusion Site Mass, Injection Site Vesicles (5823341-X)
Adverse event was reported on Jul 16, 2008 by a Female taking Oxynorm Injection 10mg/ml (Dosage: 180 Mg, Daily) was diagnosed with
  • analgesia
  • anxiety
  • nausea
and. Location: UNITED KINGDOM , 37 years of age, After Oxynorm was administered, patient encountered several Oxynorm side effects: disease progression, infusion site irritation, infusion site mass, injection site vesicles.
Multiple concurrent drugs taken:
  • Midazolam Hcl (70 Mg, Daily)
  • Nozinan (6.25 Mg, Daily)
  • Clonazepam (.5 Mg, Daily)
  • Hyoscine (60 Mg, Daily)


Angioedema (5652896-3)
on Feb 27, 2008 Female from FRANCE , 66 years of age, was diagnosed with
  • pain
and was treated with Oxynorm Capsules 5 Mg. Directly after, patient experienced the unwanted or unexpected Oxynorm side effects: angioedema. Oxynorm Capsules 5 Mg dosage: 5 Mg, Unk.
Associated medications used:
  • Oxycontin (40 Mg, Daily)
  • Corticosteroids (Unk, Unk)



Nausea, Skin Reaction (5595811-3)
on Dec 20, 2007 Female from NETHERLANDS , 39 years of age, weighting 149.9 lb, was diagnosed with
  • pain
and was treated with Oxynorm Capsules. Patient felt the following Oxynorm side effects: nausea, skin reaction. Oxynorm Capsules dosage: Max 5 Capsules Of 5mg, Prn. Patient was hospitalized.

Atrial Fibrillation, Blood Pressure Abnormal (5578918-6)
Patient was taking Oxynorm Capsules 10 Mg. After Oxynorm was administered, patient encountered several Oxynorm side effects: atrial fibrillation, blood pressure abnormal on Dec 20, 2007 from UNITED KINGDOM Additional patient health information: Male , 50 years of age, weighting 169.8 lb, was diagnosed with
  • procedural pain
and. Oxynorm Capsules 10 Mg dosage: 10 Mg, Unk.

Coma, Respiratory Failure (5529412-X)
Adverse event was reported on Nov 19, 2007 by a Female taking Oxynorm Capsules 20 Mg (Dosage: 20 Mg, Qid) was diagnosed with
  • pain
and. Location: FRANCE , 89 years of age, Directly after, patient experienced the unwanted or unexpected Oxynorm side effects: coma, respiratory failure.
Associated medications used:
  • Duragesic-100 (100 Mcg, Daily)
Patient was hospitalized.

Acute Prerenal Failure (5490618-X)
on Oct 10, 2007 Female from , 83 years of age, was diagnosed with
  • cancer pain
and was treated with Oxynorm Capsules 10 Mg. Patient felt the following Oxynorm side effects: acute prerenal failure. Oxynorm Capsules 10 Mg dosage: Unk, Unk. Patient was hospitalized.

Acute Prerenal Failure (5482624-6)
on Sep 27, 2007 Female from , 83 years of age, was diagnosed with
  • pain
and was treated with Oxynorm Capsules 10 Mg. After Oxynorm was administered, patient encountered several Oxynorm side effects: acute prerenal failure. Oxynorm Capsules 10 Mg dosage: Unk, Unk. Patient was hospitalized.

Bronchial Secretion Retention, Respiratory Failure, Sopor (5443238-7)
Patient was taking Oxynorm Capsules 5 Mg. Directly after, patient experienced the unwanted or unexpected Oxynorm side effects: bronchial secretion retention, respiratory failure, sopor on Aug 23, 2007 from Additional patient health information: Female , 84 years of age, was diagnosed with
  • pain
and. Oxynorm Capsules 5 Mg dosage: 5 Mg, Daily.
Associated medications used:
  • Levothyrox (100 Mcg, Daily)
  • Xanax (.5 Mg, Unk)
  • Imovane (7.5 Mg, Unk)
  • Paroxetine Hcl (40 Mg, Unk)
  • Augmentin '125' (Unk, Unk)


Rash Maculo-papular, Renal Failure (5419709-6)
Adverse event was reported on Aug 08, 2007 by a Female taking Oxynorm Capsules 5 Mg (Dosage: 20 Mg, Daily) was diagnosed with
  • sciatica
and. Location: , 50 years of age, Patient felt the following Oxynorm side effects: rash maculo-papular, renal failure.
Multiple prescriptions taken:
  • Myolastan (3 Df, Daily)
  • Topalgic ^houde^ (400 Mg, Daily)
  • Lasix
  • Kayexalate
  • Speciafoldine
  • Tardyferon
  • Calcidia
  • Omeprazole
Patient was hospitalized.

Anxiety, Body Temperature Increased, Bronchitis, Bronchopneumonia, Depressed Level Of Consciousness, Dystonia, Hyperhidrosis, Muscle Rigidity, Respiratory Rate Decreased (5417984-5)
on Aug 06, 2007 Female from , child 6 years of age, was treated with Oxynorm Capsules. After Oxynorm was administered, patient encountered several Oxynorm side effects: anxiety, body temperature increased, bronchitis, bronchopneumonia, depressed level of consciousness, dystonia, hyperhidrosis, muscle rigidity, respiratory rate decreased. Oxynorm Capsules dosage: 32 Mg, Daily.
Multiple concurrent drugs taken:
  • Stesolid (15 Mg, Daily)
  • Catapres (16-32 Ml (20 Mcg/ml; 1 Mg/h))
  • Morphine (.8 Mg, Q1h)
  • Kavepenin
  • Baclofen (640-1600 Mcg Daily)
  • Lanexat
  • Midazolam Hcl (2 Ml, Q1h)
  • Nitrazepam (Unk, Unk)
Patient was hospitalized.

Fear, Hallucination, Auditory, Hallucination, Visual (5223934-7)
on Jan 19, 2007 Female from , 78 years of age, was diagnosed with
  • postoperative analgesia
and was treated with Oxynorm Capsules 5 Mg. Directly after, patient experienced the unwanted or unexpected Oxynorm side effects: fear, hallucination, auditory, hallucination, visual. Oxynorm Capsules 5 Mg dosage: 5 Mg, Prn.
Associated medications used:
  • Ketogan (5 Mg, Single)
  • Simvastatin
  • Panodil (500 Mg, Unk)
  • Cardizem (60 Mg, Unk)
  • Effexor (150 Mg, Unk)
  • Oxycontin Tablets 10 Mg (10 Mg, Daily)
Patient was hospitalized.

Confusional State, Hallucination, Insomnia, Lower Respiratory Tract Infection (5179240-2)
Patient was taking Oxynorm Capsules. Patient felt the following Oxynorm side effects: confusional state, hallucination, insomnia, lower respiratory tract infection on Sep 08, 2006 from Additional patient health information: Male , 66 years of age, was diagnosed with
  • cancer pain
and. Oxynorm Capsules dosage: 5-10 Mg, Prn.
Multiple prescriptions taken:
  • Diazepam (4 Mg, Prn)
  • Zopiclone (7.5 Mg, Prn)
  • Omeprazole (40 Mg, Daily)
  • Furosemide (20 Mg, Am)
  • Cefaclor (500 Mg, Tid)
  • Haloperidol (105 Mg, Nocte)
  • Nystatin (1 Ml, Bid)
  • Warfarin Sodium (1 Mg, Unk)


Disease Progression, Incorrect Dose Administered, Somnolence (5156368-4)
Adverse event was reported on Oct 21, 2006 by a Female taking Oxynorm Injection 10mg/ml (Dosage: 50 Mg, Single) was diagnosed with
  • cancer pain
and. Location: , 75 years of age, After Oxynorm was administered, patient encountered several Oxynorm side effects: disease progression, incorrect dose administered, somnolence. Patient was hospitalized.

Agitation, Coma, Pain (5116815-0)
on Aug 22, 2006 Male from , 61 years of age, was diagnosed with
  • breakthrough pain
and was treated with Oxynorm. Directly after, patient experienced the unwanted or unexpected Oxynorm side effects: agitation, coma, pain. Oxynorm dosage: 100 Mg, Q12h.

Incorrect Dose Administered (5028018-9)
on May 25, 2006 Male from UNITED KINGDOM , 70 years of age, was treated with Oxynorm Injection 10mg/ml(oxycodone Hydrochloride) Solution For Inject. Patient felt the following Oxynorm side effects: incorrect dose administered. Oxynorm Injection 10mg/ml(oxycodone Hydrochloride) Solution For Inject dosage: 80 Mg, Q24h, Iv Drip.

Accidental Overdose, Alanine Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Blood Pressure Decreased, Blood Pressure Increased, Incorrect Dose Administered, Renal Impairment, Sedation (5011004-2)
Patient was taking Oxynorm. After Oxynorm was administered, patient encountered several Oxynorm side effects: accidental overdose, alanine aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, blood pressure decreased, blood pressure increased, incorrect dose administered, renal impairment, sedation on May 08, 2006 from UNITED KINGDOM Additional patient health information: Male , 73 years of age, . Oxynorm dosage: 20 Ml, Oral.

Infusion Related Reaction, Injection Site Erythema, Injection Site Reaction, Injection Site Swelling, Neoplasm Malignant (5003535-6)
Adverse event was reported on Apr 25, 2006 by a Male taking Oxynorm (Dosage: See Image,subcutaneous) was diagnosed with
  • arthralgia
and. Location: SWEDEN , 84 years of age, Directly after, patient experienced the unwanted or unexpected Oxynorm side effects: infusion related reaction, injection site erythema, injection site reaction, injection site swelling, neoplasm malignant.

Skin Necrosis (4995831-3)
on Apr 18, 2006 Female from SWEDEN , 66 years of age, was treated with Oxynorm (oxycodone Hydrochloride). Patient felt the following Oxynorm side effects: skin necrosis. Oxynorm (oxycodone Hydrochloride) dosage: Oral.
Multiple prescriptions taken:
  • Absenor (valproic Acid) (300 Mg, Daily, Oral)
  • Fenantoin (phenytoin)
  • Sobril (oxazepam)
Patient was hospitalized.

Confusional State, Facial Bones Fracture, Fall, Hallucination, Visual, Somnolence (4931039-5)
on Feb 13, 2006 Female from FRANCE , 88 years of age, was treated with Oxynorm(oxycodone Hydrochloride). After Oxynorm was administered, patient encountered several Oxynorm side effects: confusional state, facial bones fracture, fall, hallucination, visual, somnolence. Oxynorm(oxycodone Hydrochloride) dosage: 1 Unit, Daily, Oral.
Multiple concurrent drugs taken:
  • Neurontin (300 Mg, Daily, Oral)
  • Coversyl (perindopril)
  • Ikorel (nicorandil)
  • Desloratadine (desloratadine) (1 Unit, Daily, Oral)
  • Paroxetine Hydrochloride (20 Mg, Daily, Oral)
  • Trinipatch (glyceryl Trinitrate)
  • Previscan (fluindione)
  • Iskedyl (dihydroergocristine Mesilate, Raubasine)
Patient was hospitalized.

Bradycardia, Bradypnoea, Hypotension, Respiratory Failure, Somnolence (4929492-6)
Patient was taking Oxynorm Liquid(oxycodone Hydrochloride) Oral Solution. Directly after, patient experienced the unwanted or unexpected Oxynorm side effects: bradycardia, bradypnoea, hypotension, respiratory failure, somnolence on Feb 13, 2006 from IRELAND Additional patient health information: Female , 75 years of age, . Oxynorm Liquid(oxycodone Hydrochloride) Oral Solution dosage: 5 Ml Bid.
Associated medications used:
  • Zydol
  • Augmentin '125'
  • Amoxicillin Trihydrate
  • Exelon
  • Senokot
  • Effexor Xr
  • Paralief
  • Risperdal


Accidental Overdose, Alanine Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Blood Bilirubin Increased, Blood Pressure Decreased, Blood Pressure Increased, Hyperhidrosis, Incorrect Dose Administered, Renal Impairment (4872081-2)
Adverse event was reported on Dec 21, 2005 by a Male taking Oxynorm Concentrate 10 Mg/ml (oxycodone Hydrochloride) Oral Solution (Dosage: 20 Ml, Oral) . Location: UNITED KINGDOM , 73 years of age, Patient felt the following Oxynorm side effects: accidental overdose, alanine aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, blood pressure decreased, blood pressure increased, hyperhidrosis, incorrect dose administered, renal impairment.

Accidental Overdose, Incorrect Dose Administered, Oxygen Saturation Decreased (4866044-0)
on Dec 05, 2005 Female from UNITED STATES , child 4 years of age, weighting 37.48 lb, was diagnosed with
  • procedural pain
and was treated with Oxynorm Concentrate 10 Mg/ml (oxycodone Hydrochloride) Oral Solution. After Oxynorm was administered, patient encountered several Oxynorm side effects: accidental overdose, incorrect dose administered, oxygen saturation decreased. Oxynorm Concentrate 10 Mg/ml (oxycodone Hydrochloride) Oral Solution dosage: 17 Mg, Single, Oral. Patient was hospitalized.

Accidental Overdose, Blood Pressure Decreased, Incorrect Dose Administered, Laboratory Test Abnormal, Miosis, Sedation (4851893-5)
on Nov 28, 2005 Male from UNITED STATES , 73 years of age, was treated with Oxynorm Concentrate 10 Mg/ Ml(oxycodone Hydrochloride) Oral Solution. Directly after, patient experienced the unwanted or unexpected Oxynorm side effects: accidental overdose, blood pressure decreased, incorrect dose administered, laboratory test abnormal, miosis, sedation. Oxynorm Concentrate 10 Mg/ Ml(oxycodone Hydrochloride) Oral Solution dosage: 20 Ml, Unk, Oral.

Showing 1-25 of 50 

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Oxynorm Information

More About Oxynorm

Side Effects reported to FDA: 50. View Oxynorm Adverse Reports

Oxynorm safety alerts: No

Reported deaths: 5

Reported hospitalizations: 7

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