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Oxynorm Side Effects

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Oxynorm Safety Reports submitted to FDA

Total Oxynorm reports: 6.
Oxynorm FDA safety alerts: No.
Reported deaths: 4    Reported hospitalizations: 3.
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Reported Oxynorm Side Effects: death, hallucination, auditory, sopor, respiratory failure, bronchial secretion retention, renal failure, rash maculo-papular, respiratory rate decreased, muscle rigidity, hyperhidrosis, dystonia.
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Oxynorm Side Effects Report #5223934-7
Consumer or non-health professional from reported OXYNORM problem on Jan 19, 2007. Female patient, 78 years of age, was diagnosed with postoperative analgesia, pain and was treated with OXYNORM. After drug was administered, patient experienced the following problems/side effects: fear, hallucination, auditory, hallucination, visual. OXYNORM dosage: 5 MG, PRN. During the same period patient was treated with KETOGAN, SIMVASTATIN, PANODIL, CARDIZEM, EFFEXOR, OXYCONTIN. Patient was hospitalized. Patient recovered.

Oxynorm Side Effects Report #5116815-0
OXYNORM problem was reported by a Consumer or non-health professional from on Aug 22, 2006. Male patient, 61 years of age, was diagnosed with breakthrough pain, agitation and was treated with OXYNORM. After drug was administered, patient experienced the following problems/side effects: agitation, coma, pain. OXYNORM dosage: 100 MG, Q12H. During the same period patient was treated with MIDAZOLAM. Patient died on 06/30/2006.

Oxynorm Side Effects Report #5179240-2
Consumer or non-health professional from reported OXYNORM problem on Sept 08, 2006. Male patient, 66 years of age, was diagnosed with cancer pain and was treated with OXYNORM. After drug was administered, patient experienced the following problems/side effects: confusional state, hallucination, insomnia, lower respiratory tract infection. OXYNORM dosage: 5-10 MG, PRN. During the same period patient was treated with DIAZEPAM, ZOPICLONE, OMEPRAZOLE, FUROSEMIDE, CEFACLOR, HALOPERIDOL, NYSTATIN, WARFARIN. Patient died on 06/20/2006.

Oxynorm Side Effects Report #5417984-5
OXYNORM problem was reported by a Consumer or non-health professional from on Aug 06, 2007. Female patient, child 6 years of age, was diagnosed with tonsillitis and was treated with OXYNORM. After drug was administered, patient experienced the following problems/side effects: anxiety, body temperature increased, bronchitis, bronchopneumonia, depressed level of consciousness, dystonia, hyperhidrosis, muscle rigidity, respiratory rate decreased. OXYNORM dosage: 32 MG, DAILY. During the same period patient was treated with STESOLID, CATAPRES, MORPHINE, KAVEPENIN, BACLOFEN, LANEXAT, MIDAZOLAM, NITRAZEPAM. Patient was hospitalized. Patient died on 04/29/2007.

Oxynorm Side Effects Report #5419709-6
Consumer or non-health professional from reported OXYNORM problem on Aug 08, 2007. Female patient, 50 years of age, was diagnosed with sciatica and was treated with OXYNORM. After drug was administered, patient experienced the following problems/side effects: rash maculo-papular, renal failure. OXYNORM dosage: 20 MG, DAILY. During the same period patient was treated with MYOLASTAN, TOPALGIC, LASIX, KAYEXALATE, SPECIAFOLDINE, TARDYFERON, CALCIDIA, OMEPRAZOLE. Patient was hospitalized. Patient recovered.

Oxynorm Side Effects Report #5443238-7
OXYNORM problem was reported by a Consumer or non-health professional from on Aug 23, 2007. Female patient, 84 years of age, was diagnosed with pain and was treated with OXYNORM. After drug was administered, patient experienced the following problems/side effects: bronchial secretion retention, respiratory failure, sopor. OXYNORM dosage: 5 MG, DAILY. During the same period patient was treated with LEVOTHYROX, XANAX, IMOVANE, PAROXETINE, AUGMENTIN. Patient died on 10/24/2006.


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fear, hallucination, auditory, hallucination, visual agitation, coma, pain confusional state, hallucination, insomnia, lower respiratory tract infection, was diagnosed with postoperative analgesia, pain and was diagnosed with breakthrough pain, agitation and