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Review Oxygesic Safety Reports submitted to FDA

Total Oxygesic reports: 17.
Oxygesic FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 6.
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FDA Reported Oxygesic Side Effects: constipation, gait disturbance, nausea, dizziness, coronary artery stenosis, tooth loss, gingivitis, international normalised ratio increased, speech disorder, fall, intracranial pressure increased.
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Oxygesic Side Effects Report #5656903-3
Physician from GERMANY reported OXYGESIC problem on Mar 03, 2008. Male patient was diagnosed with back pain and was treated with OXYGESIC. After drug was administered, patient experienced the following problems/side effects: dental caries, gingivitis, neuritis, tooth loss. OXYGESIC dosage: 10 MG, TID. During the same period patient was treated with KATADOLON, SYNEUDON, METOPROLOL SUCCINATE. Patient recovered.

Oxygesic Side Effects Report #5638169-3
OXYGESIC problem was reported by a Health Professional from GERMANY on Feb 14, 2008. Male patient, 67 years of age, was diagnosed with pain and was treated with OXYGESIC. After drug was administered, patient experienced the following problems/side effects: stevens-johnson syndrome. OXYGESIC dosage: unknown. During the same period patient was treated with ANTRA, TAVOR, PRAXITEN, ACETYLSALICYLIC ACID, ULTRALAN, DOCITON, METHOTREXAT, AUGMENTIN. Patient was hospitalized. Patient recovered.

Oxygesic Side Effects Report #5557436-5
Physician from GERMANY reported OXYGESIC problem on Dec 04, 2007. Male patient was diagnosed with back pain and was treated with OXYGESIC. After drug was administered, patient experienced the following problems/side effects: dental caries, gingivitis, neuritis, tooth loss. OXYGESIC dosage: 10 MG, TID. During the same period patient was treated with KATADOLON, SYNEUDON, METOPROLOL SUCCINATE. Patient recovered.

Oxygesic Side Effects Report #5474968-9
OXYGESIC problem was reported by a Consumer or non-health professional from on Sept 18, 2007. Male patient was diagnosed with back pain and was treated with OXYGESIC. After drug was administered, patient experienced the following problems/side effects: dental caries, gingivitis, tooth loss. OXYGESIC dosage: 10 MG, TID. During the same period patient was treated with KATADOLON, SYNEUDON, METOPROLOL SUCCINATE. Patient recovered.


Oxygesic Side Effects Report #5503017-9
Consumer or non-health professional from reported OXYGESIC problem on Oct 23, 2007. Female patient was treated with OXYGESIC. After drug was administered, patient experienced the following problems/side effects: hepatitis. OXYGESIC dosage: 40 MG, BID. During the same period patient was treated with CALCIMAGON, DAFLON, IBUPROFEN, DAFALGAN. Patient was hospitalized. Patient recovered.

Oxygesic Side Effects Report #5443488-X
OXYGESIC problem was reported by a Consumer or non-health professional from on Aug 22, 2007. Female patient, 82 years of age, weighting 143.3 lb, was diagnosed with pain, depression, restless legs syndrome and was treated with OXYGESIC. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, nausea, respiratory arrest, ventricular fibrillation, vomiting. OXYGESIC dosage: 20 MG, BID. During the same period patient was treated with MIRTAZAPINE, MADOPAR, TORSEMIDE, ATACAND, BELOC, METOHEXAL. Patient recovered.

Oxygesic Side Effects Report #5409822-1
Consumer or non-health professional from reported OXYGESIC problem on July 25, 2007. Male patient was diagnosed with back pain and was treated with OXYGESIC. After drug was administered, patient experienced the following problems/side effects: gingivitis, tooth loss. OXYGESIC dosage: 10 MG, TID. During the same period patient was treated with KATADOLON, SYNEUDON, METOPROLOL SUCCINATE. Patient recovered.

Oxygesic Side Effects Report #5409840-3
OXYGESIC problem was reported by a Consumer or non-health professional from on Aug 01, 2007. Female patient, 49 years of age, weighting 202.8 lb, was diagnosed with pain and was treated with OXYGESIC. After drug was administered, patient experienced the following problems/side effects: angina pectoris, coronary artery stenosis. OXYGESIC dosage: unknown. During the same period patient was treated with LOKREN, CIPRALEX, DULCOLAX, OXYCODONE, TORVACARD. Patient was hospitalized. Patient recovered.

Oxygesic Side Effects Report #5415403-6
Consumer or non-health professional from reported OXYGESIC problem on Aug 03, 2007. Female patient was treated with OXYGESIC. After drug was administered, patient experienced the following problems/side effects: hepatitis. OXYGESIC dosage: 40 MG, BID. During the same period patient was treated with CALCIMAGON, DAFLON, BRUFEN, DAFALGAN. Patient was hospitalized. Patient recovered.


Oxygesic Side Effects Report #5429177-6
OXYGESIC problem was reported by a Consumer or non-health professional from on Aug 16, 2007. Male patient was diagnosed with back pain and was treated with OXYGESIC. After drug was administered, patient experienced the following problems/side effects: gingivitis, tooth loss. OXYGESIC dosage: 10 MG, TID. During the same period patient was treated with KATADOLON, SYNEUDON, METOPROLOL SUCCINATE. Patient recovered.

Oxygesic Side Effects Report #5384015-5
Consumer or non-health professional from reported OXYGESIC problem on June 28, 2007. Female patient, 76 years of age, weighting 167.6 lb, was diagnosed with back pain and was treated with OXYGESIC. After drug was administered, patient experienced the following problems/side effects: electrocardiogram change. OXYGESIC dosage: unknown. During the same period patient was treated with OXYGESIC KAPSELN, VERAPAMIL, TRIAMTERENE, ALLOPURINOL, ENALAPRIL MALEATE, AERODUR. Patient recovered.

Oxygesic Side Effects Report #5384015-5
OXYGESIC problem was reported by a Consumer or non-health professional from on June 28, 2007. Female patient, 76 years of age, weighting 167.6 lb, was diagnosed with back pain and was treated with OXYGESIC. After drug was administered, patient experienced the following problems/side effects: electrocardiogram change. OXYGESIC dosage: unknown. During the same period patient was treated with OXYGESIC KAPSELN, VERAPAMIL, TRIAMTERENE, ALLOPURINOL, ENALAPRIL MALEATE, AERODUR. Patient recovered.

Oxygesic Side Effects Report #5744063-X
Physician from GERMANY reported OXYGESIC problem on May 08, 2008. Female patient, 52 years of age, weighting 132.3 lb, was diagnosed with pain and was treated with OXYGESIC. After drug was administered, patient experienced the following problems/side effects: abnormal dreams, anorexia, balance disorder, bone pain, crying, diarrhoea, dizziness, feeling abnormal, myalgia. OXYGESIC dosage: 20 MG, TID. During the same period patient was treated with ESCITALOPRAM, CELEBREX, ISOPTIN, NEXIUM, SYMBICORT, AARANE. Patient recovered.

Oxygesic Side Effects Report #5347508-2
OXYGESIC problem was reported by a Consumer or non-health professional from on May 24, 2007. Male patient, 86 years of age, was diagnosed with pain and was treated with OXYGESIC. After drug was administered, patient experienced the following problems/side effects: confusional state, hypokinesia, somnolence. OXYGESIC dosage: 5 MG, BID. During the same period patient was treated with SINTROM, NEXIUM, MODURETIC, AMIODARON, TORASIS, ZOLOFT, DAFALGAN, SERESTA. Patient was hospitalized. Patient recovered.


Oxygesic Side Effects Report #5366831-9
Consumer or non-health professional from reported OXYGESIC problem on June 14, 2007. Female patient, 49 years of age, weighting 202.8 lb, was diagnosed with pain and was treated with OXYGESIC. After drug was administered, patient experienced the following problems/side effects: angina pectoris, coronary artery stenosis. OXYGESIC dosage: unknown. During the same period patient was treated with LOKREN, CIPRALEX, DULCOLAX, OXYCODONE, TORVACARD. Patient was hospitalized. Patient recovered.

Oxygesic Side Effects Report #5315718-6
OXYGESIC problem was reported by a Consumer or non-health professional from on Apr 18, 2007. Male patient, 82 years of age, was diagnosed with cancer pain and was treated with OXYGESIC. After drug was administered, patient experienced the following problems/side effects: intentional overdose, suicidal ideation. OXYGESIC dosage: unknown. Patient died on 03/01/2007.

Oxygesic Side Effects Report #5288015-5
Consumer or non-health professional from reported OXYGESIC problem on Mar 23, 2007. Male patient was diagnosed with pain and was treated with OXYGESIC. After drug was administered, patient experienced the following problems/side effects: constipation, dependence, euphoric mood, metal poisoning, tooth extraction. OXYGESIC dosage: 80 MG, TID. During the same period patient was treated with ANTIDOTES. Patient recovered.


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