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Review Oroken Safety Reports submitted to FDA

Total Oroken reports: 20.
Oroken FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 17.
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FDA Reported Oroken Side Effects: tendonitis, condition aggravated, clostridium difficile colitis, asthenia, abortion spontaneous, pyrexia, purpura, pruritus, photosensitivity reaction, dermatitis bullous, conjunctival disorder.
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Oroken Side Effects Report #5657415-3
Physician from JAPAN reported OROKEN problem on Mar 03, 2008. Female patient, 55 years of age, was diagnosed with vaginal infection and was treated with OROKEN. After drug was administered, patient experienced the following problems/side effects: dyspnoea, fibrin d dimer increased, nausea. OROKEN dosage: 400MG DAILY. Patient was hospitalized. Patient recovered.

Oroken Side Effects Report #5626485-0
OROKEN problem was reported by a Health Professional from JAPAN on Feb 12, 2008. Female patient, child 3 years of age, was diagnosed with diarrhoea, ocular icterus and was treated with OROKEN. After drug was administered, patient experienced the following problems/side effects: renal failure acute. OROKEN dosage: unknown. Patient was hospitalized. Patient recovered.

Oroken Side Effects Report #5579460-9
Health Professional from JAPAN reported OROKEN problem on Dec 21, 2007. Female patient, child 3 years of age, was diagnosed with diarrhoea, ocular icterus and was treated with OROKEN. After drug was administered, patient experienced the following problems/side effects: hepatitis a, renal failure acute, renal tubular necrosis. OROKEN dosage: unknown. During the same period patient was treated with COTRIM. Patient was hospitalized. Patient recovered.

Oroken Side Effects Report #5546801-8
OROKEN problem was reported by a Health Professional from FRANCE on Dec 07, 2007. Male patient, child 4 years of age, was treated with OROKEN. After drug was administered, patient experienced the following problems/side effects: pallor, paraesthesia oral, syncope. OROKEN dosage: unknown. Patient was hospitalized. Patient recovered.

Oroken Side Effects Report #5509804-5
Health Professional from FRANCE reported OROKEN problem on Nov 02, 2007. Male patient, 73 years of age, was diagnosed with prostatitis, herpes virus infection and was treated with OROKEN. After drug was administered, patient experienced the following problems/side effects: telangiectasia, vascular purpura. OROKEN dosage: unknown. During the same period patient was treated with ZELITREX, HYTACAND, OXAZEPAM, VASTIN, ALLOPURINOL, PREVISCAN, CIFLOX, BUFLOMEDIL. Patient was hospitalized. Patient recovered.

Oroken Side Effects Report #5481230-7
OROKEN problem was reported by a Health Professional from JAPAN on Oct 05, 2007. Female patient, 23 years of age, was treated with OROKEN. After drug was administered, patient experienced the following problems/side effects: cardiogenic shock, cytolytic hepatitis, hepatic failure, intentional overdose, pancreatitis, renal failure. OROKEN dosage: unknown. During the same period patient was treated with ZOPICLONE, CITALOPRAM HYDROBROMIDE, PARACETAMOL, PROPRANOLOL. Patient was hospitalized. Patient recovered.

Oroken Side Effects Report #5502693-4
Consumer or non-health professional from FRANCE reported OROKEN problem on Oct 23, 2007. Female patient, 77 years of age, was diagnosed with urinary tract infection and was treated with OROKEN. After drug was administered, patient experienced the following problems/side effects: angioedema, dry mouth, erythema. OROKEN dosage: unknown. During the same period patient was treated with FURADANTIN. Patient recovered.

Oroken Side Effects Report #5466962-9
OROKEN problem was reported by a Health Professional from JAPAN on Sept 20, 2007. Female patient, 46 years of age, was diagnosed with urinary tract infection and was treated with OROKEN. After drug was administered, patient experienced the following problems/side effects: condition aggravated, tendonitis. OROKEN dosage: unknown. Patient recovered.

Oroken Side Effects Report #5386310-2
Health Professional from JAPAN reported OROKEN problem on July 06, 2007. Female patient, 25 years of age, was diagnosed with urinary tract infection and was treated with OROKEN. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous. OROKEN dosage: unknown. During the same period patient was treated with AMOXICILLIN, THIOCOLCHICOSIDE, PARACETAMOL, TRAMADOL, ATHYMIL. Patient was hospitalized. Patient recovered.

Oroken Side Effects Report #5401760-3
OROKEN problem was reported by a Health Professional from JAPAN on July 19, 2007. Male patient, 82 years of age, was diagnosed with renal colic, infection and was treated with OROKEN. After drug was administered, patient experienced the following problems/side effects: asthenia, clostridium difficile colitis. OROKEN dosage: 200 MG DAILY. During the same period patient was treated with NOROXIN, ROCEPHIN, ORELOX, DOLIPRANE, CORDARONE, ASPEGIC, AMLODIPINE, SPASFON. Patient was hospitalized. Patient recovered.

Oroken Side Effects Report #5386310-2
Health Professional from JAPAN reported OROKEN problem on July 06, 2007. Female patient, 25 years of age, was diagnosed with urinary tract infection and was treated with OROKEN. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous. OROKEN dosage: unknown. During the same period patient was treated with AMOXICILLIN, THIOCOLCHICOSIDE, PARACETAMOL, TRAMADOL, ATHYMIL. Patient was hospitalized. Patient recovered.

Oroken Side Effects Report #5401760-3
OROKEN problem was reported by a Health Professional from JAPAN on July 19, 2007. Male patient, 82 years of age, was diagnosed with renal colic, infection and was treated with OROKEN. After drug was administered, patient experienced the following problems/side effects: asthenia, clostridium difficile colitis. OROKEN dosage: 200 MG DAILY. During the same period patient was treated with NOROXIN, ROCEPHIN, ORELOX, DOLIPRANE, CORDARONE, ASPEGIC, AMLODIPINE, SPASFON. Patient was hospitalized. Patient recovered.

Oroken Side Effects Report #5777746-6
Health Professional from FRANCE reported OROKEN problem on June 12, 2008. Female patient, 76 years of age, was diagnosed with bronchitis and was treated with OROKEN. After drug was administered, patient experienced the following problems/side effects: clostridium difficile colitis, septic shock, staphylococcal infection. OROKEN dosage: unknown. Patient was hospitalized. Patient died on 02/29/2008.

Oroken Side Effects Report #5728992-9
OROKEN problem was reported by a Health Professional from JAPAN on Apr 25, 2008. Female patient, 76 years of age, was diagnosed with bronchitis and was treated with OROKEN. After drug was administered, patient experienced the following problems/side effects: haemoptysis, international normalised ratio increased. OROKEN dosage: unknown. During the same period patient was treated with HYPERIUM, MEDIATENSYL, DIFFU K, PREVISCAN, FLUDEX, DAONIL, MODOPAR. Patient was hospitalized. Patient recovered.

Oroken Side Effects Report #5739384-0
Health Professional from JAPAN reported OROKEN problem on May 06, 2008. Female patient, 76 years of age, was diagnosed with bronchitis and was treated with OROKEN. After drug was administered, patient experienced the following problems/side effects: haemoptysis, international normalised ratio increased, overdose. OROKEN dosage: unknown. During the same period patient was treated with HYPERIUM, MEDIATENSYL, DIFFU K, PREVISCAN, FLUDEX, DAONIL, MODOPAR. Patient was hospitalized. Patient recovered.

Oroken Side Effects Report #5747525-4
OROKEN problem was reported by a Consumer or non-health professional from FRANCE on May 16, 2008. Female patient, 33 years of age, was treated with OROKEN. After drug was administered, patient experienced the following problems/side effects: angioedema. OROKEN dosage: unknown. Patient was hospitalized. Patient recovered.

Oroken Side Effects Report #5752108-6
Health Professional from JAPAN reported OROKEN problem on May 22, 2008. Female patient, 76 years of age, was diagnosed with pyelonephritis and was treated with OROKEN. After drug was administered, patient experienced the following problems/side effects: international normalised ratio increased. OROKEN dosage: unknown. During the same period patient was treated with PLAVIX, DIACEREIN, LESCOL, NEBIVOLOL, PREVISCAN, INNOHEP. Patient recovered.

Oroken Side Effects Report #5753333-0
OROKEN problem was reported by a Health Professional from JAPAN on May 23, 2008. Male patient, 59 years of age, was diagnosed with bronchitis and was treated with OROKEN. After drug was administered, patient experienced the following problems/side effects: dermatitis bullous, photosensitivity reaction. OROKEN dosage: 400 MG /DAILY. During the same period patient was treated with RULID. Patient was hospitalized. Patient recovered.

Oroken Side Effects Report #5721516-1
Health Professional from JAPAN reported OROKEN problem on Apr 18, 2008. Female patient, 30 years of age, was treated with OROKEN. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, cholestasis. OROKEN dosage: unknown. During the same period patient was treated with TARDYFERON. Patient was hospitalized. Patient recovered.

Oroken Side Effects Report #5358605-X
OROKEN problem was reported by a Health Professional from FRANCE on June 13, 2007. Male patient, child 4 years of age, was treated with OROKEN. After drug was administered, patient experienced the following problems/side effects: angioedema, malaise. OROKEN dosage: unknown. Patient was hospitalized. Patient recovered.


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dyspnoea, fibrin d dimer increased, nausea, renal failure acute, hepatitis a, renal failure acute, renal tubular necrosis, , was diagnosed with vaginal infection and was diagnosed with diarrhoea, ocular icterus and was diagnosed with diarrhoea, ocular icterus and