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Avelox Side Effects Report #5656748-4
Health Professional from CANADA reported AVELOX problem on Feb 25, 2008. Female patient, 56 years of age, weighting 189.6 lb, was treated with AVELOX. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . AVELOX dosage: TOTAL DAILY DOSE: 400 MG UNIT DOSE: 400 MG. During the same period patient was treated with ACTONEL, IMURAN, PREDNISONE, SEPTRA DS, ZANTAC. Patient recovered.

Avelox Side Effects Report #5660815-9
AVELOX problem was reported by a Health Professional from CANADA on Feb 25, 2008. Female patient, 56 years of age, weighting 189.6 lb, was treated with AVELOX. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . AVELOX dosage: TOTAL DAILY DOSE: 400 MG UNIT DOSE: 400 MG. During the same period patient was treated with ACTONEL, IMURAN, PREDNISONE, SEPTRA DS, ZANTAC. Patient recovered.

Augmentin Side Effects Report #5661255-9
Consumer or non-health professional from FRANCE reported AUGMENTIN problem on Feb 29, 2008. Male patient, 82 years of age, was treated with AUGMENTIN. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, respiratory distress, . AUGMENTIN dosage: unknown. During the same period patient was treated with GENTAMICIN, PIPERACILLIN AND TAZOBACTAM, TAVANIC, VANCOMYCIN. Patient was hospitalized. Patient recovered.

Nexavar Side Effects Report #5618376-6
NEXAVAR problem was reported by a Health Professional from UNITED KINGDOM on Feb 05, 2008. Male patient, 63 years of age, weighting 154.3 lb, was diagnosed with renal cell carcinoma and was treated with NEXAVAR. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, pruritus, renal failure, . NEXAVAR dosage: TOTAL DAILY DOSE: 800 MG. Patient was hospitalized. Patient died.


Omnic Side Effects Report #5623592-3
Health Professional from NETHERLANDS reported OMNIC CAPSULE problem on Feb 07, 2008. Male patient, weighting 132.3 lb, was diagnosed with benign prostatic hyperplasia and was treated with OMNIC CAPSULE. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . OMNIC CAPSULE dosage: unknown. During the same period patient was treated with PREDNISOLONE, SERETIDE, SPIRIVA, ACTOKIT COMBINATIEVERPAKKING, MOVICOL. Patient was hospitalized. Patient recovered.

Enbrel Side Effects Report #5627973-3
ENBREL problem was reported by a Physician from UNITED STATES on Feb 04, 2008. Female patient, 50 years of age, was diagnosed with rheumatoid arthritis and was treated with ENBREL. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . ENBREL dosage: unknown. Patient was hospitalized. Patient recovered.

Fluoxetine Side Effects Report #5636067-2
Health Professional from UNITED KINGDOM reported FLUOXETINE problem on Oct 26, 2007. Female patient, 45 years of age, was diagnosed with depression and was treated with FLUOXETINE. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . FLUOXETINE dosage: unknown. During the same period patient was treated with PROPRANOLOL. Patient recovered.

Januvia Side Effects Report #5655171-6
JANUVIA problem was reported by a Physician from UNITED STATES on Nov 15, 2007. Male patient, 71 years of age, was treated with JANUVIA. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . JANUVIA dosage: unknown. During the same period patient was treated with ACTOS, COUMADIN, DIOVAN, FORTAMET. Patient recovered.

Omnic Side Effects Report #5592652-8
Health Professional from NETHERLANDS reported OMNIC CAPSULE problem on Jan 07, 2008. Male patient, weighting 132.3 lb, was diagnosed with benign prostatic hyperplasia and was treated with OMNIC CAPSULE. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . OMNIC CAPSULE dosage: unknown. During the same period patient was treated with PREDNISOLONE, SERETIDE, SPIRIVA, ACTOKIT COMBINATIEVERPAKKING, MOVICOL. Patient was hospitalized. Patient recovered.


Exjade Side Effects Report #5602125-1
EXJADE problem was reported by a Health Professional from UNITED STATES on Jan 17, 2008. Male patient was diagnosed with iron overload and was treated with EXJADE. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . EXJADE dosage: 20/MG/KG/DAY. Patient recovered.

Avelox Side Effects Report #5535235-8
Health Professional from CANADA reported AVELOX problem on Aug 10, 2007. Female patient, 56 years of age, was treated with AVELOX. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . AVELOX dosage: unknown. During the same period patient was treated with ACTONEL, IMURAN, PREDNISONE, SEPTRA DS, ZANTAC. Patient recovered.

Avelox Side Effects Report #5537052-1
AVELOX problem was reported by a Health Professional from CANADA on Aug 10, 2007. Female patient, 56 years of age, was treated with AVELOX. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . AVELOX dosage: unknown. During the same period patient was treated with ACTONEL, IMURAN, PREDNISONE, SEPTRA DS, ZANTAC. Patient recovered.

Crestor Side Effects Report #5563606-2
Physician from UNITED STATES reported CRESTOR problem on July 13, 2007. Female patient, 64 years of age, was treated with CRESTOR. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . CRESTOR dosage: unknown. During the same period patient was treated with LOPID, ALCOHOL. Patient recovered.

Tracleer Side Effects Report #5569964-7
TRACLEER problem was reported by a Health Professional from GERMANY on Dec 05, 2007. Female patient, 46 years of age, weighting 110.2 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . TRACLEER dosage: 125 MG, BID, ORAL : 62.5 MG, BID, ORAL. During the same period patient was treated with SILDENAFIL CITRATE, LEVOTHYROXINE, ALLOPURINOL, DIGOXIN, TORSEMIDE, NEXIUM. Patient was hospitalized. Patient recovered.


Seropram Side Effects Report #5572442-2
Consumer or non-health professional from FRANCE reported SEROPRAM problem on Dec 04, 2007. Male patient, 69 years of age, weighting 149.9 lb, was diagnosed with depression and was treated with SEROPRAM. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . SEROPRAM dosage: unknown. During the same period patient was treated with RISPERDAL, OXAZEPAM, GLUCOPHAGE. Patient recovered.

Zetia Side Effects Report #5575530-X
ZETIA problem was reported by a Physician from AUSTRALIA on Dec 24, 2007. Male patient, 71 years of age, weighting 149.9 lb, was diagnosed with hyperlipidaemia and was treated with ZETIA. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . ZETIA dosage: unknown. Patient recovered.

Nexavar Side Effects Report #5509833-1
Health Professional from UNITED KINGDOM reported NEXAVAR problem on Nov 06, 2007. Male patient, 63 years of age, weighting 154.3 lb, was treated with NEXAVAR. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, pruritus, renal failure, . NEXAVAR dosage: TOTAL DAILY DOSE: 800 MG. Patient was hospitalized. Patient died.

Fluoxetine Side Effects Report #5516839-5
FLUOXETINE problem was reported by a Health Professional from UNITED KINGDOM on Oct 26, 2007. Female patient, 45 years of age, was diagnosed with depression and was treated with FLUOXETINE. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . FLUOXETINE dosage: unknown. During the same period patient was treated with PROPRANOLOL. Patient recovered.

Tracleer Side Effects Report #5531504-6
Physician from GERMANY reported TRACLEER problem on Nov 14, 2007. Female patient, 46 years of age, weighting 110.2 lb, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, liver injury, . TRACLEER dosage: 125 MG, BID, ORAL; 62.5 MG, BID, ORAL. During the same period patient was treated with SILDENAFIL CITRATE, LEVOTHYROXINE, ALLOPURINOL, DIGOXIN, TORSEMIDE, NEXIUM. Patient was hospitalized. Patient recovered.


Simvastatin Side Effects Report #5487720-5
SIMVASTATIN problem was reported by a Physician from UNITED STATES on Oct 15, 2007. Female patient was diagnosed with low density lipoprotein increased and was treated with SIMVASTATIN. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . SIMVASTATIN dosage: 80 MG 1 X /DAY PO. Patient was hospitalized. Patient recovered.

Cipro Side Effects Report #5488608-6
Physician from UNITED STATES reported CIPRO problem on Jan 30, 2007. Male patient was treated with CIPRO. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . CIPRO dosage: 500 MG, BID, ORAL. Patient recovered.

Nexium Side Effects Report #5497101-6
NEXIUM problem was reported by a Physician from AUSTRALIA on Oct 16, 2007. Male patient, weighting 132.3 lb, was diagnosed with gastrooesophageal reflux disease, hypertension and was treated with NEXIUM. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . NEXIUM dosage: unknown. During the same period patient was treated with CARDIZEM, TRITACE. Patient recovered.

Kelnor Side Effects Report #5444620-4
Health Professional from UNITED STATES reported KELNOR problem on Sept 04, 2007. Female patient, weighting 154.3 lb, was diagnosed with oral contraception and was treated with KELNOR. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . KELNOR dosage: unknown. Patient was hospitalized. Patient recovered.

Sorafenib Side Effects Report #5447548-9
SORAFENIB problem was reported by a Physician from CHINA on Sept 07, 2007. Male patient, 40 years of age, weighting 145.5 lb, was diagnosed with hepatic neoplasm malignant, hepatitis b, diabetes mellitus, hepatic function abnormal and was treated with SORAFENIB. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . SORAFENIB dosage: TOTAL DAILY DOSE: 800 MG. During the same period patient was treated with HEPTODIN, METFORMIN, DIAMICRON, METHIONINE. Patient was hospitalized. Patient recovered.

Nexavar Side Effects Report #5449980-6
Health Professional from UNITED KINGDOM reported NEXAVAR problem on Sept 07, 2007. Male patient, 65 years of age, was treated with NEXAVAR. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, pruritus, . NEXAVAR dosage: TOTAL DAILY DOSE: 800 MG. Patient recovered.

Seroquel Side Effects Report #5460061-8
SEROQUEL problem was reported by a Physician from UNITED STATES on May 09, 2007. Male patient, 92 years of age, was treated with SEROQUEL. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . SEROQUEL dosage: unknown. During the same period patient was treated with ARICEPT, TEMAZEPAM. Patient recovered.

Revlimid Side Effects Report #5407837-0
Physician from UNITED STATES reported REVLIMID problem on July 26, 2007. Female patient, 58 years of age, was diagnosed with multiple myeloma and was treated with REVLIMID. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, oedema peripheral, pancytopenia, white blood cell count decreased, . REVLIMID dosage: 15 MG, BIW, ORAL; 25 MG, 1 IN 1 D, ORAL. During the same period patient was treated with AUGMENTIN, ACYCLOVIR, BACTRIM DS, DECADRON, PLAVIX, ASPIRIN, ALLOPURINOL. Patient was hospitalized. Patient recovered.

Revlimid Side Effects Report #5423056-6
REVLIMID problem was reported by a Physician from UNITED STATES on Aug 14, 2007. Female patient, 58 years of age, was diagnosed with multiple myeloma and was treated with REVLIMID. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, oedema peripheral, pancytopenia, . REVLIMID dosage: 15 MG, BIW, ORAL; 25 MG, 1 IN 1 D, ORAL. During the same period patient was treated with DEXAMETHASONE, AMIODARONE, AUGMENTIN, ACYCLOVIR, BACTRIM DS, PLAVIX, ASPIRIN. Patient was hospitalized and became disabled. Patient recovered.

Bevacizumab Side Effects Report #5379466-9
Consumer or non-health professional from UNITED KINGDOM reported BEVACIZUMAB problem on June 21, 2007. Male patient, weighting 163.1 lb, was diagnosed with non-small cell lung cancer and was treated with BEVACIZUMAB. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . BEVACIZUMAB dosage: 15 MG/KG, Q3W. During the same period patient was treated with CARBOPLATIN, PACLITAXEL, NIFEDIPINE. Patient was hospitalized. Patient recovered.

Augmentin Side Effects Report #5385541-5
AUGMENTIN problem was reported by a Consumer or non-health professional from UNITED KINGDOM on July 05, 2007. Male patient, 44 years of age, weighting 185.2 lb, was diagnosed with urinary tract infection and was treated with AUGMENTIN. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, malaise, . AUGMENTIN dosage: unknown. During the same period patient was treated with ASPIRIN, ATENOLOL, CLOPIDOGREL, GLYCERYL TRINITRATE, METFORMIN, PERINDOPRIL, SIMVASTATIN. Patient was hospitalized and became disabled. Patient recovered.

Augmentin Side Effects Report #5385544-0
Consumer or non-health professional from UNITED KINGDOM reported AUGMENTIN problem on July 05, 2007. Male patient, 44 years of age, weighting 185.2 lb, was diagnosed with urinary tract infection and was treated with AUGMENTIN. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, malaise, . AUGMENTIN dosage: unknown. During the same period patient was treated with ASPIRIN, ATENOLOL, CLOPIDOGREL, METFORMIN, PERINDOPRIL, SIMVASTATIN. Patient was hospitalized and became disabled. Patient recovered.

Celebrex Side Effects Report #5396465-1
CELEBREX problem was reported by a Physician from UNITED STATES on Nov 28, 2006. Female patient was treated with CELEBREX. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . CELEBREX dosage: 200 MG (200 MG, 1 IN 1 D). Patient recovered.

Bevacizumab Side Effects Report #5379466-9
Consumer or non-health professional from UNITED KINGDOM reported BEVACIZUMAB problem on June 21, 2007. Male patient, weighting 163.1 lb, was diagnosed with non-small cell lung cancer and was treated with BEVACIZUMAB. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . BEVACIZUMAB dosage: 15 MG/KG, Q3W. During the same period patient was treated with CARBOPLATIN, PACLITAXEL, NIFEDIPINE. Patient was hospitalized. Patient recovered.

Augmentin Side Effects Report #5385541-5
AUGMENTIN problem was reported by a Consumer or non-health professional from UNITED KINGDOM on July 05, 2007. Male patient, 44 years of age, weighting 185.2 lb, was diagnosed with urinary tract infection and was treated with AUGMENTIN. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, malaise, . AUGMENTIN dosage: unknown. During the same period patient was treated with ASPIRIN, ATENOLOL, CLOPIDOGREL, GLYCERYL TRINITRATE, METFORMIN, PERINDOPRIL, SIMVASTATIN. Patient was hospitalized and became disabled. Patient recovered.

Augmentin Side Effects Report #5385544-0
Consumer or non-health professional from UNITED KINGDOM reported AUGMENTIN problem on July 05, 2007. Male patient, 44 years of age, weighting 185.2 lb, was diagnosed with urinary tract infection and was treated with AUGMENTIN. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, malaise, . AUGMENTIN dosage: unknown. During the same period patient was treated with ASPIRIN, ATENOLOL, CLOPIDOGREL, METFORMIN, PERINDOPRIL, SIMVASTATIN. Patient was hospitalized and became disabled. Patient recovered.

Celebrex Side Effects Report #5396465-1
CELEBREX problem was reported by a Physician from UNITED STATES on Nov 28, 2006. Female patient was treated with CELEBREX. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . CELEBREX dosage: 200 MG (200 MG, 1 IN 1 D). Patient recovered.

Revlimid Side Effects Report #5794254-7
Physician from UNITED STATES reported REVLIMID problem on June 18, 2008. Male patient, 65 years of age, was diagnosed with myelodysplastic syndrome and was treated with REVLIMID. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . REVLIMID dosage: 10 MG, 1 IN 1, ORAL. Patient died on 04/17/2008.

Alimta Side Effects Report #5691839-3
ALIMTA problem was reported by a Physician from MEXICO on Mar 24, 2008. Male patient, 57 years of age, weighting 125.7 lb, was diagnosed with mesothelioma and was treated with ALIMTA. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, malignant neoplasm progression, peripheral sensory neuropathy, . ALIMTA dosage: 500 MG/M2, OTHER. During the same period patient was treated with CISPLATIN, DEXAMETHASONE, FOLIC ACID, VITAMIN B. Patient died on 03/17/2008.

Nafcillin Side Effects Report #5693019-4
Pharmacist from UNITED STATES reported NAFCILLIN problem on Apr 01, 2008. Male patient, 73 years of age, weighting 81.40 lb, was diagnosed with staphylococcal abscess and was treated with NAFCILLIN. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . NAFCILLIN dosage: unknown. Patient recovered.

Sevoflurane Side Effects Report #5693989-4
SEVOFLURANE problem was reported by a Pharmacist from UNITED KINGDOM on Mar 26, 2008. Female patient, 40 years of age, was treated with SEVOFLURANE. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . SEVOFLURANE dosage: unknown. During the same period patient was treated with CEFUROXIME. Patient recovered.

Ancef Side Effects Report #5699213-0
Physician from UNITED STATES reported ANCEF problem on Apr 07, 2008. Male patient, 73 years of age, was treated with ANCEF. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, liver injury, weight decreased, . ANCEF dosage: unknown. During the same period patient was treated with SAW PALMETTO, GINKO BILOBA, SELENIUM, CALCIUM, MAGNESIUM, VITAMIN CAP, SYNTHROID, ASPIRIN. Patient recovered.

Maxaquin Side Effects Report #5354848-X
MAXAQUIN problem was reported by a Health Professional from ITALY on June 05, 2007. Female patient was diagnosed with hyperpyrexia, arthralgia and was treated with MAXAQUIN. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . MAXAQUIN dosage: DAILY DOSE:400MG. During the same period patient was treated with ARCOXIA, LOBIVON, VITAMIN D3. Patient was hospitalized. Patient recovered.

Levofloxacin Side Effects Report #5366472-3
Health Professional from UNITED KINGDOM reported LEVOFLOXACIN problem on June 13, 2007. Female patient, 75 years of age, was diagnosed with urinary tract infection, transient ischaemic attack, hypertension, muscle spasms and was treated with LEVOFLOXACIN. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, liver function test abnormal, malaise, . LEVOFLOXACIN dosage: unknown. During the same period patient was treated with ASPIRIN, ATENOLOL, BENDROFLUMETHIAZIDE, CANDESARTAN, CLOPIDOGREL, NITROFURANTOIN, QUININE BISULPHATE, SIMVASTATIN. Patient recovered.

Capecitabine Side Effects Report #5369194-8
CAPECITABINE problem was reported by a Health Professional from UNITED STATES on June 14, 2007. Female patient, 40 years of age, was diagnosed with colorectal cancer and was treated with CAPECITABINE. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, nausea, neoplasm progression, vomiting, . CAPECITABINE dosage: unknown. Patient was hospitalized. Patient recovered.

Methimazole Side Effects Report #5374584-3
Physician from UNITED STATES reported METHIMAZOLE problem on June 21, 2006. Female patient, 75 years of age, was diagnosed with hyperthyroidism and was treated with METHIMAZOLE. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . METHIMAZOLE dosage: 40MG (10 MG, 4 IN 1 D);. Patient was hospitalized. Patient recovered.

Methimazole Side Effects Report #5374586-7
METHIMAZOLE problem was reported by a Physician from UNITED STATES on June 21, 2006. Female patient, 74 years of age, was diagnosed with hyperthyroidism and was treated with METHIMAZOLE. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . METHIMAZOLE dosage: 40MG (10 MG, 4 IN 1 D);. Patient was hospitalized. Patient recovered.

Methimazole Side Effects Report #5374592-2
Physician from UNITED STATES reported METHIMAZOLE problem on June 21, 2006. Male patient, 68 years of age, was diagnosed with hyperthyroidism and was treated with METHIMAZOLE. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . METHIMAZOLE dosage: 60MG (20MG, 3 IN 1 D);. Patient was hospitalized. Patient recovered.

Methimazole Side Effects Report #5374594-6
METHIMAZOLE problem was reported by a Physician from UNITED STATES on June 21, 2006. Female patient, 43 years of age, was diagnosed with hyperthyroidism and was treated with METHIMAZOLE. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . METHIMAZOLE dosage: 30MG (10 MG, 3 IN 1 D);. During the same period patient was treated with PROPRANOLOL, AMLODIPINE. Patient was hospitalized. Patient recovered.

Methimazole Side Effects Report #5374596-X
Physician from UNITED STATES reported METHIMAZOLE problem on June 21, 2006. Female patient, 58 years of age, was diagnosed with hyperthyroidism and was treated with METHIMAZOLE. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . METHIMAZOLE dosage: 20MG (20 MG, 1 IN 1 D);. Patient was hospitalized. Patient recovered.

Methimazole Side Effects Report #5374597-1
METHIMAZOLE problem was reported by a Physician from UNITED STATES on June 21, 2006. Female patient, 62 years of age, was diagnosed with hyperthyroidism and was treated with METHIMAZOLE. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . METHIMAZOLE dosage: 40 MG (10 MG, 4 IN 1 D);. Patient was hospitalized. Patient recovered.

Methimazole Side Effects Report #5374599-5
Physician from UNITED STATES reported METHIMAZOLE problem on June 21, 2006. Female patient, 36 years of age, was diagnosed with hyperthyroidism and was treated with METHIMAZOLE. After drug was administered, patient experienced the following problems/side effects: jaundice cholestatic, . METHIMAZOLE dosage: 60MG (15 MG, 4 IN 1 D);. Patient was hospitalized. Patient recovered.