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Enbrel Side Effects Report #5662757-1
Health Professional from UNITED KINGDOM reported ENBREL problem on Feb 28, 2008. Female patient, weighting 194.0 lb, was diagnosed with rheumatoid arthritis, prophylaxis, type 2 diabetes mellitus, oedema, hypothyroidism, hypertension and was treated with ENBREL. After drug was administered, patient experienced the following problems/side effects: infected skin ulcer, pseudomonas infection, . ENBREL dosage: unknown. During the same period patient was treated with ASPIRIN, PREDNISOLONE, METFORMIN, ALENDRONATE, ADCAL D, FUROSEMIDE, LEVOTHYROXINE, ATENOLOL. Patient recovered.

Orlistat Side Effects Report #5673332-7
ORLISTAT problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Mar 11, 2008. Male patient, 76 years of age, weighting 264.6 lb, was diagnosed with obesity, hypertension, hyperthyroidism, unevaluable event and was treated with ORLISTAT. After drug was administered, patient experienced the following problems/side effects: infected skin ulcer, jaundice, . ORLISTAT dosage: unknown. During the same period patient was treated with PREGABALIN, SIMVASTATIN, BISOPROLOL FUMARATE, BUMETANIDE, AMIODARONE, CARBIMAZOLE, HUMULIN R, ADCAL. Patient was hospitalized. Patient recovered.

Zemplar Side Effects Report #5575215-X
Physician from GREECE reported ZEMPLAR problem on Dec 17, 2007. Male patient, 71 years of age, weighting 154.3 lb, was diagnosed with hyperparathyroidism secondary and was treated with ZEMPLAR. After drug was administered, patient experienced the following problems/side effects: infected skin ulcer, septic shock, . ZEMPLAR dosage: unknown. During the same period patient was treated with EVATON AMP, INTELECTA AMP, FOLIC ACID, ATORVASTATIN CALCIUM, CLOPIDOGREL BISULPHATE, ISOSORBIDE MONONITRATE, PENTOXIFYLLINE, EPOETIN BETA. Patient died on 10/20/2007.

Zemplar Side Effects Report #5505622-2
ZEMPLAR problem was reported by a Consumer or non-health professional from GREECE on Oct 29, 2007. Male patient, 71 years of age, weighting 154.3 lb, was diagnosed with hyperparathyroidism secondary and was treated with ZEMPLAR. After drug was administered, patient experienced the following problems/side effects: infected skin ulcer, septic shock, . ZEMPLAR dosage: unknown. Patient died on 10/20/2007.


Paclitaxel Side Effects Report #5515385-2
Consumer or non-health professional from UNITED KINGDOM reported PACLITAXEL problem on Oct 26, 2007. Female patient, 65 years of age, was diagnosed with breast cancer and was treated with PACLITAXEL. After drug was administered, patient experienced the following problems/side effects: infected skin ulcer, lymphoedema, . PACLITAXEL dosage: unknown. Patient recovered.

Humira Side Effects Report #5398475-7
HUMIRA problem was reported by a Health Professional from UNITED KINGDOM on July 18, 2007. Male patient, weighting 167.6 lb, was diagnosed with rheumatoid arthritis and was treated with HUMIRA. After drug was administered, patient experienced the following problems/side effects: infected skin ulcer, staphylococcal infection, . HUMIRA dosage: unknown. During the same period patient was treated with METHOTREXATE, PREDNISOLONE, AMLODIPINE, FOLIC ACID, NAPROXEN, OMEPRAZOLE, TRAMADOL. Patient was hospitalized. Patient recovered.

Humira Side Effects Report #5398475-7
Health Professional from UNITED KINGDOM reported HUMIRA problem on July 18, 2007. Male patient, weighting 167.6 lb, was diagnosed with rheumatoid arthritis and was treated with HUMIRA. After drug was administered, patient experienced the following problems/side effects: infected skin ulcer, staphylococcal infection, . HUMIRA dosage: unknown. During the same period patient was treated with METHOTREXATE, PREDNISOLONE, AMLODIPINE, FOLIC ACID, NAPROXEN, OMEPRAZOLE, TRAMADOL. Patient was hospitalized. Patient recovered.

Temodar Side Effects Report #5764310-8
TEMODAR problem was reported by a Health Professional from UNITED STATES on June 02, 2008. Male patient, 48 years of age, was diagnosed with glioblastoma multiforme and was treated with TEMODAR. After drug was administered, patient experienced the following problems/side effects: infected skin ulcer, sepsis, . TEMODAR dosage: unknown. Patient died on 04/02/2008.

Fentanyl Side Effects Report #5716187-4
Consumer or non-health professional from UNITED STATES reported FENTANYL TRANSDERMAL SYSTEM problem on Apr 15, 2008. Male patient, weighting 275.0 lb, was diagnosed with neuralgia and was treated with FENTANYL TRANSDERMAL SYSTEM. After drug was administered, patient experienced the following problems/side effects: infected skin ulcer, osteomyelitis, . FENTANYL TRANSDERMAL SYSTEM dosage: unknown. Patient was hospitalized. Patient recovered.


Humira Side Effects Report #5592280-4
HUMIRA problem was reported by a Physician from UNITED STATES on Jan 15, 2008. Female patient, weighting 200.2 lb, was diagnosed with colitis ulcerative and was treated with HUMIRA. After drug was administered, patient experienced the following problems/side effects: accidental exposure, infected skin ulcer, pharyngolaryngeal pain, rectal haemorrhage, streptococcal infection, wound drainage, . HUMIRA dosage: unknown. During the same period patient was treated with PREDNISONE, ONDANSETRON. Patient was hospitalized. Patient recovered.

Humira Side Effects Report #5558096-X
Physician from UNITED STATES reported HUMIRA problem on Dec 04, 2007. Female patient, weighting 200.2 lb, was diagnosed with colitis ulcerative and was treated with HUMIRA. After drug was administered, patient experienced the following problems/side effects: accidental exposure, infected skin ulcer, pharyngolaryngeal pain, rectal haemorrhage, streptococcal infection, . HUMIRA dosage: unknown. During the same period patient was treated with PREDNISONE, ONDANSETRON. Patient was hospitalized. Patient recovered.

Prograf Side Effects Report #5517883-4
PROGRAF problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 26, 2007. Male patient, 59 years of age, was diagnosed with prophylaxis against transplant rejection and was treated with PROGRAF. After drug was administered, patient experienced the following problems/side effects: gangrene, infected skin ulcer, . PROGRAF dosage: 4 MG, BID, ORAL. During the same period patient was treated with MYCOPHENOLATE MOFETIL, PREDNISONE, NYSTATIN, BACTRIM DS, VALCYTE, PROTONIX, LIPITOR, ASPIRIN. Patient was hospitalized. Patient recovered.

Avonex Side Effects Report #5519911-9
Consumer or non-health professional from UNITED STATES reported AVONEX problem on Nov 06, 2007. Male patient, 57 years of age, was diagnosed with multiple sclerosis and was treated with AVONEX. After drug was administered, patient experienced the following problems/side effects: cholelithiasis, infected skin ulcer, osteomyelitis, . AVONEX dosage: unknown. Patient was hospitalized. Patient recovered.

Amevive Side Effects Report #5531762-8
AMEVIVE problem was reported by a Physician from UNITED STATES on Nov 14, 2007. Female patient, 62 years of age, weighting 285.1 lb, was diagnosed with psoriasis and was treated with AMEVIVE. After drug was administered, patient experienced the following problems/side effects: cellulitis, infected skin ulcer, insomnia, insulin-requiring type ii diabetes mellitus, leukocytoclastic vasculitis, venous stasis, . AMEVIVE dosage: 15 MG, WEEKLY, INTRAMUSCULAR. During the same period patient was treated with SPIRIVA, NEURONTIN, ULTRAM, LANTUS. Patient was hospitalized. Patient recovered.


Remicade Side Effects Report #5462909-X
Physician from ITALY reported REMICADE problem on Sept 11, 2007. Male patient, 51 years of age, was diagnosed with colitis ulcerative and was treated with REMICADE. After drug was administered, patient experienced the following problems/side effects: atypical mycobacterial infection, infected skin ulcer, leukopenia, neutropenia, pyrexia, . REMICADE dosage: unknown. During the same period patient was treated with AZATHOPRINE. Patient was hospitalized. Patient recovered.

Remicade Side Effects Report #5404891-7
REMICADE problem was reported by a Physician from ITALY on July 23, 2007. Male patient, 51 years of age, was diagnosed with colitis ulcerative and was treated with REMICADE. After drug was administered, patient experienced the following problems/side effects: atypical mycobacterial infection, infected skin ulcer, leukopenia, neutropenia, pyrexia, . REMICADE dosage: unknown. During the same period patient was treated with AZATHOPRINE. Patient was hospitalized. Patient recovered.

Tysabri Side Effects Report #5760440-5
Health Professional from UNITED STATES reported TYSABRI problem on May 22, 2008. Female patient, 45 years of age, was diagnosed with multiple sclerosis and was treated with TYSABRI. After drug was administered, patient experienced the following problems/side effects: decubitus ulcer, infected skin ulcer, pyrexia, urinary tract infection, . TYSABRI dosage: 300 MG;QM;IV. During the same period patient was treated with PROTONIX. Patient was hospitalized. Patient recovered.

Oxycodone Side Effects Report #5776284-4
OXYCODONE problem was reported by a Pharmacist from UNITED STATES on June 17, 2008. Female patient, 62 years of age, weighting 156.5 lb, was diagnosed with pain and was treated with OXYCODONE. After drug was administered, patient experienced the following problems/side effects: confusional state, infected skin ulcer, mental status changes, pain, . OXYCODONE dosage: 5-10 MG Q6H PRN PO CHRONIC. During the same period patient was treated with AMITRIPTYLINE, PROZAC, EVISTA, ASPIRIN, PEPCID, AMAGRELIDE, ELAVIL, NEURONTIN. Patient was hospitalized. Patient recovered.

Tracleer Side Effects Report #5713871-3
Health Professional from GERMANY reported TRACLEER problem on Apr 07, 2008. Female patient, 74 years of age, was diagnosed with skin ulcer and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: c-reactive protein increased, infected skin ulcer, leukocytosis, pain, pain in extremity, superinfection, . TRACLEER dosage: 62.5 MG, BID, ORAL. During the same period patient was treated with URBASON, HYDROCHLOROTHIAZIDE, TRENTAL, SULFASALAZINE, TENORMIN, FLUOXETINE. Patient recovered.


Natalizumab Side Effects Report #5375716-3
NATALIZUMAB problem was reported by a Consumer or non-health professional from UNITED STATES on June 18, 2007. Male patient, 63 years of age, was diagnosed with multiple sclerosis and was treated with NATALIZUMAB. After drug was administered, patient experienced the following problems/side effects: decubitus ulcer, infected skin ulcer, . NATALIZUMAB dosage: unknown. Patient was hospitalized. Patient recovered.

Duragesic Side Effects Report #5627338-4
Consumer or non-health professional from UNITED STATES reported DURAGESIC problem on Feb 06, 2008. Male patient, weighting 300.0 lb, was diagnosed with pain in extremity, breakthrough pain, muscle spasms, anxiety, diabetes mellitus, blood pressure, medical diet, blood cholesterol and was treated with DURAGESIC. After drug was administered, patient experienced the following problems/side effects: inadequate analgesia, infected skin ulcer, . DURAGESIC dosage: unknown. During the same period patient was treated with PERCOCET, XANAX, HUMALOG, LISINOPRIL, MAGNESIUM, ZOCOR, GLUCOPHAGE. Patient recovered.

Amevive Side Effects Report #5502822-2
AMEVIVE problem was reported by a Physician from UNITED STATES on Oct 12, 2007. Female patient, 62 years of age, weighting 285.1 lb, was diagnosed with psoriasis and was treated with AMEVIVE. After drug was administered, patient experienced the following problems/side effects: blood glucose increased, cellulitis, infected skin ulcer, insomnia, leukocytoclastic vasculitis, oedema peripheral, pain, pco2 increased, rash, . AMEVIVE dosage: 15 MG, WEEKLY, INTRAMUSCULAR. Patient was hospitalized. Patient recovered.

Humira Side Effects Report #5399719-8
Consumer or non-health professional from GERMANY reported HUMIRA problem on July 19, 2007. Female patient, weighting 138.9 lb, was diagnosed with rheumatoid arthritis, diabetes mellitus, hypertension, hyperlipidaemia, myocardial infarction and was treated with HUMIRA. After drug was administered, patient experienced the following problems/side effects: coronary artery disease, impaired healing, infected skin ulcer, pneumonia, . HUMIRA dosage: unknown. During the same period patient was treated with PREDNISOLONE, INSULIN, METOPROLOL SUCCINATE, TORSEMIDE, HYDROCHLOROTHIAZIDE, SIMVASTATIN, ASPIRIN. Patient was hospitalized. Patient recovered.

Humira Side Effects Report #5399719-8
HUMIRA problem was reported by a Consumer or non-health professional from GERMANY on July 19, 2007. Female patient, weighting 138.9 lb, was diagnosed with rheumatoid arthritis, diabetes mellitus, hypertension, hyperlipidaemia, myocardial infarction and was treated with HUMIRA. After drug was administered, patient experienced the following problems/side effects: coronary artery disease, impaired healing, infected skin ulcer, pneumonia, . HUMIRA dosage: unknown. During the same period patient was treated with PREDNISOLONE, INSULIN, METOPROLOL SUCCINATE, TORSEMIDE, HYDROCHLOROTHIAZIDE, SIMVASTATIN, ASPIRIN. Patient was hospitalized. Patient recovered.

Byetta Side Effects Report #5733825-0
Physician from UNITED STATES reported BYETTA problem on Apr 28, 2008. Female patient was diagnosed with type 2 diabetes mellitus, arthritis, hypersensitivity, insomnia and was treated with BYETTA. After drug was administered, patient experienced the following problems/side effects: blood glucose decreased, blood glucose increased, infected skin ulcer, injection site abscess, pollakiuria, sepsis, skin disorder, . BYETTA dosage: unknown. During the same period patient was treated with INSULIN, MOBIC, COUMADIN, ALLEGRA, FLEXERIL, AMBIEN, HYDROCODONE BITARTRATE. Patient was hospitalized. Patient recovered.

Tysabri Side Effects Report #5752034-2
TYSABRI problem was reported by a Consumer or non-health professional from UNITED STATES on May 14, 2008. Female patient, 53 years of age, weighting 115.0 lb, was diagnosed with multiple sclerosis and was treated with TYSABRI. After drug was administered, patient experienced the following problems/side effects: decubitus ulcer, herpes zoster, infected skin ulcer, infection, rash, stomach discomfort, . TYSABRI dosage: 300 MG;QM;IV. Patient was hospitalized. Patient recovered.

Byetta Side Effects Report #5690990-1
Consumer or non-health professional from UNITED STATES reported BYETTA problem on Mar 25, 2008. Female patient was diagnosed with diabetes mellitus, arthritis, hypersensitivity, insomnia and was treated with BYETTA. After drug was administered, patient experienced the following problems/side effects: blood glucose decreased, blood glucose increased, infected skin ulcer, pollakiuria, sepsis, skin disorder, . BYETTA dosage: unknown. During the same period patient was treated with INSULIN, MOBIC, COUMADIN, ALLEGRA, FLEXERIL, AMBIEN, HYDROCODONE BITARTRATE. Patient was hospitalized. Patient recovered.