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Infliximab Side Effects Report #5636679-6
Health Professional from UNITED KINGDOM reported INFLIXIMAB problem on Feb 14, 2008. Male patient, weighting 121.3 lb, was diagnosed with rheumatoid arthritis and was treated with INFLIXIMAB. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, hypothermia, . INFLIXIMAB dosage: unknown. During the same period patient was treated with CLOPIDOGREL, CODEINE SUL, DICLOFENAC, LEFLUNOMIDE, PREDNISOLONE, AMITRIPTYLINE, BECLOMETHASONE DIPROPIONATE, FERROUS SULPHATE. Patient died on 10/16/2007.

Aspirin Side Effects Report #5491727-1
ASPIRIN problem was reported by a Health Professional from UNITED KINGDOM on Oct 15, 2007. Male patient, 82 years of age, weighting 176.4 lb, was treated with ASPIRIN. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, . ASPIRIN dosage: TOTAL DAILY DOSE: 75 MG. During the same period patient was treated with DICLOFENAC, ATORVASTATIN, DIGOXIN, FELODIPINE, FRUSEMIDE. Patient was hospitalized. Patient recovered.

Cisplatin Side Effects Report #5499189-5
Consumer or non-health professional from UNITED STATES reported CISPLATIN problem on Oct 24, 2007. Female patient, 54 years of age, weighting 105.8 lb, was diagnosed with c-reactive protein increased, insomnia and was treated with CISPLATIN. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, hyponatraemia, laryngeal oedema, lung infiltration, . CISPLATIN dosage: 75 MG/M 2. During the same period patient was treated with PEMETREXED DI, FOLIC ACID, VITAMIN B, AVELOX, XIMOVAN, NOVALGIN, KEVATRIL. Patient was hospitalized. Patient recovered.

Pemetrexed Side Effects Report #5502991-4
PEMETREXED problem was reported by a Physician from GERMANY on Oct 16, 2007. Female patient, weighting 106.9 lb, was diagnosed with prophylaxis, c-reactive protein increased, insomnia, pain, nausea, respiratory disorder and was treated with PEMETREXED. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, hyponatraemia, laryngeal oedema, lung infiltration, . PEMETREXED dosage: unknown. During the same period patient was treated with CISPLATIN, FOLIC ACID, VITAMIN B, AVELOX, XIMOVAN, NOVALGIN, KEVATRIL. Patient was hospitalized. Patient recovered.


Enbrel Side Effects Report #5404014-4
Physician from GERMANY reported ENBREL problem on July 26, 2007. Male patient was diagnosed with rheumatoid arthritis, arthralgia and was treated with ENBREL. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, . ENBREL dosage: 25 MG TWICE WEEKLY. During the same period patient was treated with DICLOFENAC, PREDNISOLONE. Patient was hospitalized. Patient recovered.

Diclofenac Side Effects Report #5406107-4
DICLOFENAC problem was reported by a Consumer or non-health professional from UNITED KINGDOM on July 25, 2007. Female patient, 91 years of age, was diagnosed with back pain and was treated with DICLOFENAC. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, peritonitis, . DICLOFENAC dosage: 50 MG; BID;. During the same period patient was treated with PARACETAMOL, TRAMADOL, CARBIMAZOLE. Patient was hospitalized. Patient died on 07/12/2007.

Infliximab Side Effects Report #5411151-7
Physician from JAPAN reported INFLIXIMAB problem on July 31, 2007. Female patient, weighting 92.59 lb, was diagnosed with rheumatoid arthritis, analgesia and was treated with INFLIXIMAB. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, peritonitis, pneumonia cryptococcal, septic shock, urinary tract infection, . INFLIXIMAB dosage: DOSE 3MG, 6MG, OR 10MG/KG. During the same period patient was treated with VOLTAREN, LORNOXICAM, PREDNISOLONE. Patient was hospitalized. Patient recovered.

Humira Side Effects Report #5417391-5
HUMIRA problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Aug 07, 2007. Female patient, weighting 116.8 lb, was diagnosed with rheumatoid arthritis and was treated with HUMIRA. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, . HUMIRA dosage: unknown. During the same period patient was treated with METHOTREXATE, AMITRIPTYLINE, FOLIC ACID. Patient was hospitalized. Patient recovered.

Diclofenac Side Effects Report #5441698-9
Consumer or non-health professional from DENMARK reported DICLOFENAC problem on Aug 02, 2007. Female patient was diagnosed with back pain and was treated with DICLOFENAC. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, . DICLOFENAC dosage: 100 MG (50 MG, 2 IN 1 D). Patient was hospitalized. Patient died.


Lasilix Side Effects Report #5392206-2
LASILIX problem was reported by a Consumer or non-health professional from on July 13, 2007. Female patient, 91 years of age, was diagnosed with hypertension, atrial fibrillation and was treated with LASILIX. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, peritonitis, . LASILIX dosage: unknown. During the same period patient was treated with KARDEGIC, COVERSYL, LERCAN. Patient recovered.

Arava Side Effects Report #5393808-X
Consumer or non-health professional from AUSTRALIA reported ARAVA problem on July 17, 2007. Male patient, 65 years of age, was diagnosed with rheumatoid arthritis, osteoporosis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, . ARAVA dosage: unknown. During the same period patient was treated with LANTUS, AUTOPEN INSULINECTION PEN, ACTONEL, PREDNISOLONE. Patient died on 05/26/2007.

Perindopril Side Effects Report #5397440-3
PERINDOPRIL ERBUMINE problem was reported by a Health Professional from FRANCE on July 16, 2007. Female patient, 91 years of age, was diagnosed with hypertension, atrial fibrillation and was treated with PERINDOPRIL ERBUMINE. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, intestinal obstruction, peritonitis, . PERINDOPRIL ERBUMINE dosage: DAILY DOSE: 4 MILLIGRAM(S). During the same period patient was treated with KARDEGIC, LASIX, LERCAN. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5401239-9
Physician from AUSTRALIA reported ARAVA problem on July 24, 2007. Male patient, 65 years of age, was diagnosed with rheumatoid arthritis, osteoporosis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, . ARAVA dosage: unknown. During the same period patient was treated with LANTUS, AUTOPEN INSULINECTION PEN, ACTONEL, PREDNISOLONE. Patient died on 05/26/2007.

Lasilix Side Effects Report #5392206-2
LASILIX problem was reported by a Consumer or non-health professional from on July 13, 2007. Female patient, 91 years of age, was diagnosed with hypertension, atrial fibrillation and was treated with LASILIX. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, peritonitis, . LASILIX dosage: unknown. During the same period patient was treated with KARDEGIC, COVERSYL, LERCAN. Patient recovered.


Arava Side Effects Report #5393808-X
Consumer or non-health professional from AUSTRALIA reported ARAVA problem on July 17, 2007. Male patient, 65 years of age, was diagnosed with rheumatoid arthritis, osteoporosis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, . ARAVA dosage: unknown. During the same period patient was treated with LANTUS, AUTOPEN INSULINECTION PEN, ACTONEL, PREDNISOLONE. Patient died on 05/26/2007.

Perindopril Side Effects Report #5397440-3
PERINDOPRIL ERBUMINE problem was reported by a Health Professional from FRANCE on July 16, 2007. Female patient, 91 years of age, was diagnosed with hypertension, atrial fibrillation and was treated with PERINDOPRIL ERBUMINE. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, intestinal obstruction, peritonitis, . PERINDOPRIL ERBUMINE dosage: DAILY DOSE: 4 MILLIGRAM(S). During the same period patient was treated with KARDEGIC, LASIX, LERCAN. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5401239-9
Physician from AUSTRALIA reported ARAVA problem on July 24, 2007. Male patient, 65 years of age, was diagnosed with rheumatoid arthritis, osteoporosis and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, . ARAVA dosage: unknown. During the same period patient was treated with LANTUS, AUTOPEN INSULINECTION PEN, ACTONEL, PREDNISOLONE. Patient died on 05/26/2007.

Ibandronic Side Effects Report #5793378-8
IBANDRONIC ACID problem was reported by a Physician from FRANCE on June 17, 2008. Female patient, weighting 108.0 lb, was diagnosed with osteoporosis postmenopausal and was treated with IBANDRONIC ACID. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, . IBANDRONIC ACID dosage: unknown. During the same period patient was treated with OROCAL, DEDROGYL, AVLOCARDYL, NEURONTIN, AMITRIPTYLINE HYDROCHLORIDE, MONOCRIXO. Patient was hospitalized. Patient recovered.

Arixtra Side Effects Report #5749497-5
Physician from JAPAN reported ARIXTRA problem on May 22, 2008. Female patient, 86 years of age, was diagnosed with thrombosis prophylaxis and was treated with ARIXTRA. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, haematoma, haemorrhage, impaired healing, . ARIXTRA dosage: 2.5MG PER DAY. During the same period patient was treated with MICARDIS, TORSEMIDE, FLUITRAN, SELBEX, MERISLON, VOLTAREN. Patient was hospitalized. Patient recovered.


Aspirin Side Effects Report #5708000-6
ASPIRIN problem was reported by a Health Professional from UNITED KINGDOM on Apr 11, 2008. Female patient, 54 years of age, was diagnosed with cardiovascular event prophylaxis, pain and was treated with ASPIRIN. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, . ASPIRIN dosage: unknown. During the same period patient was treated with DICLOFENAC, ATORVASTATIN, DIAZEPAM, DOXYCYCLINE, FELODIPINE, HALOPERIDOL, HUMULIN S, INSULIN GLARGINE. Patient was hospitalized. Patient recovered.

Fiorinal Side Effects Report #5713617-9
Physician from AUSTRALIA reported FIORINAL W problem on Apr 07, 2008. Female patient, 39 years of age, was treated with FIORINAL W. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, . FIORINAL W dosage: unknown. During the same period patient was treated with IBUPROFEN. Patient was hospitalized. Patient recovered.

Fiorinal Side Effects Report #5713619-2
FIORINAL W problem was reported by a Physician from AUSTRALIA on Apr 07, 2008. Male patient, 41 years of age, was treated with FIORINAL W. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, . FIORINAL W dosage: unknown. During the same period patient was treated with IBUPROFEN, PARACHOC, MICROLAX. Patient was hospitalized. Patient recovered.

Acetylsalicylic Side Effects Report #5716219-3
Consumer or non-health professional from UNITED KINGDOM reported ACETYLSALICYLIC ACID SRT problem on Apr 11, 2008. Female patient, 54 years of age, was diagnosed with cardiovascular event prophylaxis, pain and was treated with ACETYLSALICYLIC ACID SRT. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, . ACETYLSALICYLIC ACID SRT dosage: 75 MG, QD, ORAL. During the same period patient was treated with ATORVASTATIN CALCIUM, DIAZEPAM, DOXYCYCLINE, FELODIPINE, HALOPERIDOL, HUMULIN S, INSULIN GLARGINE. Patient recovered.

Bevacizumab Side Effects Report #5359503-8
BEVACIZUMAB problem was reported by a Health Professional from UNITED STATES on June 13, 2007. Female patient was diagnosed with breast cancer metastatic and was treated with BEVACIZUMAB. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, . BEVACIZUMAB dosage: 10 MG/KG, Q2W. During the same period patient was treated with HERCEPTIN, ACTONEL, PROTONIX, FOLIC ACID, CALCIUM SUPPLEMENT, PLE VITAMIN. Patient was hospitalized. Patient died on 04/25/2007.

Piroxicam Side Effects Report #5365039-0
Consumer or non-health professional from UNITED STATES reported PIROXICAM problem on Aug 29, 2006. Male patient, 78 years of age, was diagnosed with gout and was treated with PIROXICAM. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, . PIROXICAM dosage: (20 MG), ORAL. During the same period patient was treated with METHYLPREDNISOLONE, AGGRENOX. Patient was hospitalized. Patient recovered.

Bevacizumab Side Effects Report #5336896-9
BEVACIZUMAB problem was reported by a Physician from UNITED STATES on May 17, 2007. Female patient was diagnosed with breast cancer metastatic and was treated with BEVACIZUMAB. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, . BEVACIZUMAB dosage: 10 MG/KG, Q2W. During the same period patient was treated with HERCEPTIN, ACTONEL, PROTONIX, FOLIC ACID, CALCIUM SUPPLEMENT, PLE VITAMIN. Patient was hospitalized. Patient died on 04/25/2007.

Bonviva Side Effects Report #5301866-3
Pharmacist from IRELAND reported BONVIVA problem on Apr 13, 2007. Female patient, 88 years of age, was diagnosed with arthritis and was treated with BONVIVA. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, . BONVIVA dosage: unknown. During the same period patient was treated with KETOPROFEN. Patient was hospitalized. Patient recovered.

Bonviva Side Effects Report #5253337-0
BONVIVA problem was reported by a Pharmacist from IRELAND on Feb 20, 2007. Female patient, 88 years of age, was treated with BONVIVA. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, . BONVIVA dosage: unknown. During the same period patient was treated with PROTEIN. Patient was hospitalized. Patient recovered.

Methylprednisolo Side Effects Report #5275211-6
Physician from UNITED STATES reported METHYLPREDNISOLONE problem on Sept 21, 2006. Male patient, 78 years of age, was diagnosed with gout, cerebrovascular accident prophylaxis and was treated with METHYLPREDNISOLONE. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, . METHYLPREDNISOLONE dosage: (8 MG),ORAL. During the same period patient was treated with PIROXICAM, AGGRENOX. Patient was hospitalized. Patient recovered.

Aspirin Side Effects Report #5678290-7
ASPIRIN problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 11, 2008. Female patient, 41 years of age, was diagnosed with headache and was treated with ASPIRIN. After drug was administered, patient experienced the following problems/side effects: gastric infection, gastric ulcer perforation, malaise, . ASPIRIN dosage: unknown. Patient was hospitalized. Patient recovered.

Cisplatin Side Effects Report #5527575-3
Consumer or non-health professional from UNITED STATES reported CISPLATIN problem on Nov 27, 2007. Female patient, 54 years of age, weighting 105.8 lb, was diagnosed with c-reactive protein increased, insomnia and was treated with CISPLATIN. After drug was administered, patient experienced the following problems/side effects: circulatory collapse, gastric ulcer perforation, hyponatraemia, laryngeal oedema, lung infiltration, pneumonia, . CISPLATIN dosage: 75 MG/M 2. During the same period patient was treated with PEMETREXED DI, FOLIC ACID, VITAMIN B, AVELOX, XIMOVAN, NOVALGIN, KEVATRIL, ACETYLCYSTEINE. Patient was hospitalized. Patient died on 11/04/2007.

Naproxen Side Effects Report #5486944-0
NAPROXEN problem was reported by a Pharmacist from UNITED STATES on Oct 12, 2007. Male patient, 79 years of age, was diagnosed with arthritis and was treated with NAPROXEN. After drug was administered, patient experienced the following problems/side effects: gastric haemorrhage, gastric ulcer perforation, . NAPROXEN dosage: 250MG PRN PO. Patient died on 08/03/2007.

Diclofenac Side Effects Report #5500198-8
Consumer or non-health professional from UNITED KINGDOM reported DICLOFENAC problem on Oct 15, 2007. Male patient, 82 years of age, weighting 176.4 lb, was treated with DICLOFENAC. After drug was administered, patient experienced the following problems/side effects: gastric ulcer, gastric ulcer perforation, . DICLOFENAC dosage: 50 MG, TID, ORAL. During the same period patient was treated with ASPIRIN, ATORVASTATIN CALCIUM, DIGOXIN, FELODIPINE, FUROSEMIDE. Patient was hospitalized. Patient recovered.

Boniva Side Effects Report #5405074-7
BONIVA problem was reported by a Pharmacist from IRELAND on July 24, 2007. Female patient, 88 years of age, was diagnosed with osteoporosis prophylaxis, arthritis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: colitis, gastric ulcer perforation, . BONIVA dosage: unknown. During the same period patient was treated with KETOPROFEN. Patient was hospitalized. Patient recovered.

Diclofenac Side Effects Report #5405677-X
Physician from DENMARK reported DICLOFENAC problem on Aug 02, 2007. Female patient, 91 years of age, was diagnosed with back pain and was treated with DICLOFENAC. After drug was administered, patient experienced the following problems/side effects: abdominal distension, gastric ulcer perforation, peritonitis, . DICLOFENAC dosage: 50 MG, BID. During the same period patient was treated with PAMOL, DOLOL, NEO MERCAZOLE. Patient was hospitalized. Patient died on 07/12/2007.

Ibuprofen Side Effects Report #5735778-8
IBUPROFEN problem was reported by a Consumer or non-health professional from UNITED STATES on May 05, 2008. Female patient, weighting 150.0 lb, was diagnosed with pain and was treated with IBUPROFEN. After drug was administered, patient experienced the following problems/side effects: full blood count abnormal, gastric ulcer perforation, hypokalaemia, injury, loss of consciousness, . IBUPROFEN dosage: unknown. During the same period patient was treated with VISTORIL, HYDROCHLOROTHIAZIDE. Patient was hospitalized. Patient recovered.

Morphine Side Effects Report #5724052-1
Consumer or non-health professional from reported MORPHINE problem on Apr 29, 2008. Male patient, 41 years of age, was diagnosed with abdominal pain and was treated with MORPHINE. After drug was administered, patient experienced the following problems/side effects: gastric ulcer perforation, pyrexia, . MORPHINE dosage: unknown. During the same period patient was treated with NUROFEN PLUS. Patient recovered.

Ibuprofen Side Effects Report #5295658-1
IBUPROFEN problem was reported by a Pharmacist from UNITED STATES on Apr 10, 2007. Female patient, weighting 102.1 lb, was diagnosed with musculoskeletal pain and was treated with IBUPROFEN. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, gastric ulcer perforation, nausea, peritoneal disorder, vomiting, . IBUPROFEN dosage: 600 MG TID (PO). During the same period patient was treated with RISEDRONATE, LISINOPRIL, ATENOLOL, METOCLOPRAMIDE, TRIAMTERERE, OXYCODONE, OMEPRAZOLE. Patient was hospitalized. Patient recovered.

Fosamax Side Effects Report #5274072-9
Physician from JAPAN reported FOSAMAX problem on Mar 15, 2007. Female patient, 78 years of age, was diagnosed with osteoporosis, prophylaxis, dizziness, arrhythmia, hypercholesterolaemia, liver disorder and was treated with FOSAMAX. After drug was administered, patient experienced the following problems/side effects: duodenal ulcer perforation, gastric ulcer perforation, . FOSAMAX dosage: unknown. During the same period patient was treated with MERISLON, CALFINA, CIBENOL, LOCHOL, GOKUMISIN, OSPAIN, GASTROM. Patient was hospitalized and became disabled. Patient recovered.

Diclofenac Side Effects Report #5281941-2
DICLOFENAC problem was reported by a Physician from DENMARK on Mar 15, 2007. Female patient, 70 years of age, was diagnosed with osteoarthritis and was treated with DICLOFENAC. After drug was administered, patient experienced the following problems/side effects: abscess, gastric ulcer perforation, increased upper airway secretion, inflammation, multi-organ failure, no therapeutic response, peritoneal disorder, post procedural complication, pulmonary congestion, . DICLOFENAC dosage: unknown. Patient was hospitalized. Patient died on 10/06/2006.

Avonex Side Effects Report #5788081-4
Consumer or non-health professional from UNITED STATES reported AVONEX problem on June 13, 2008. Female patient, 37 years of age, was diagnosed with multiple sclerosis and was treated with AVONEX. After drug was administered, patient experienced the following problems/side effects: cognitive disorder, diarrhoea, gastric ulcer perforation, hypoaesthesia, multiple sclerosis, vomiting, . AVONEX dosage: unknown. Patient was hospitalized. Patient recovered.

Indocin Side Effects Report #5760691-X
INDOCIN problem was reported by a Consumer or non-health professional from CANADA on May 21, 2008. Male patient, 55 years of age, was diagnosed with back pain, pleuritic pain and was treated with INDOCIN. After drug was administered, patient experienced the following problems/side effects: depressed level of consciousness, gastric ulcer haemorrhage, gastric ulcer perforation, gastrointestinal fistula, hypovolaemic shock, ventricular fibrillation, . INDOCIN dosage: 75 MG/TID PO. During the same period patient was treated with MORPHINESO. Patient died.

Augmentin Side Effects Report #5315822-2
Consumer or non-health professional from FRANCE reported AUGMENTIN problem on Apr 27, 2007. Female patient, 42 years of age, was diagnosed with tooth disorder and was treated with AUGMENTIN. After drug was administered, patient experienced the following problems/side effects: abdominal pain, abdominal pain upper, gastric ulcer perforation, gastritis, infection, inflammation, intestinal obstruction, peritonitis, . AUGMENTIN dosage: 1000MG TWICE PER DAY. During the same period patient was treated with KETOPROFEN, NIFLURIL, ORELOX. Patient was hospitalized. Patient recovered.

Aleve Side Effects Report #5338747-5
ALEVE problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 20, 2006. Male patient, 49 years of age, weighting 210.0 lb, was diagnosed with pain in extremity and was treated with ALEVE. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, cardio-respiratory arrest, gastric ulcer perforation, haematemesis, haemoptysis, loss of consciousness, . ALEVE dosage: 220 MG, QD, ORAL. During the same period patient was treated with CYCLOBENZAPRINE. Patient was hospitalized. Patient recovered.