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Lantus Side Effects Report #5661627-2
Consumer or non-health professional from BRAZIL reported LANTUS problem on Mar 06, 2008. Male patient, 76 years of age, weighting 172.0 lb, was treated with LANTUS. After drug was administered, patient experienced the following problems/side effects: off label use, somnolence, . LANTUS dosage: unknown. During the same period patient was treated with HUMALOG, PLAVIX, ANCORON, ALLOPURINOL, PROSCAR, DIGOXIN, LIPITOR, SERETIDE. Patient recovered.

Ortho Side Effects Report #5683825-4
ORTHO EVRA problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 17, 2008. Female patient, weighting 200.0 lb, was diagnosed with menometrorrhagia and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: off label use, peripheral ischaemia, venous thrombosis, . ORTHO EVRA dosage: unknown. During the same period patient was treated with ALTACE, PROTONIX. Patient was hospitalized. Patient recovered.

Ortho Side Effects Report #5621285-X
Consumer or non-health professional from UNITED STATES reported ORTHO EVRA problem on Jan 31, 2008. Female patient, 22 years of age, was diagnosed with menorrhagia and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: off label use, vaginal haemorrhage, withdrawal bleed, . ORTHO EVRA dosage: unknown. Patient recovered.

Simdax Side Effects Report #5628489-0
SIMDAX problem was reported by a Physician from SPAIN on Feb 11, 2008. Male patient, child 2 years of age, was diagnosed with congestive cardiomyopathy and was treated with SIMDAX. After drug was administered, patient experienced the following problems/side effects: off label use, ventricular tachycardia, . SIMDAX dosage: unknown. During the same period patient was treated with DOPAMINA, MILRINONA. Patient recovered.


Ortho Side Effects Report #5630195-3
Consumer or non-health professional from UNITED STATES reported ORTHO EVRA problem on Feb 06, 2008. Female patient, weighting 72.53 lb, was diagnosed with dysmenorrhoea and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: off label use, pleural effusion, respiratory failure, . ORTHO EVRA dosage: unknown. Patient died on 07/15/2005.

Duragesic Side Effects Report #5632738-2
DURAGESIC problem was reported by a Consumer or non-health professional from UNITED STATES on Feb 12, 2008. Male patient, 17 years of age, was diagnosed with toothache and was treated with DURAGESIC. After drug was administered, patient experienced the following problems/side effects: off label use, unevaluable event, . DURAGESIC dosage: unknown. Patient died.

Duragesic Side Effects Report #5634388-0
Consumer or non-health professional from UNITED STATES reported DURAGESIC problem on Feb 12, 2008. Male patient, weighting 120.0 lb, was diagnosed with pain in extremity and was treated with DURAGESIC. After drug was administered, patient experienced the following problems/side effects: off label use, overdose, . DURAGESIC dosage: unknown. During the same period patient was treated with TYLENOL. Patient was hospitalized. Patient died on 01/27/1993.

Fentanyl Side Effects Report #5640768-X
FENTANYL problem was reported by a Consumer or non-health professional from UNITED STATES on Feb 16, 2008. Male patient, 23 years of age, weighting 150.0 lb, was diagnosed with procedural pain and was treated with FENTANYL. After drug was administered, patient experienced the following problems/side effects: off label use, procedural pain, surgery, . FENTANYL dosage: unknown. Patient was hospitalized. Patient recovered.

Adartrel Side Effects Report #5583070-7
Health Professional from UNITED KINGDOM reported ADARTREL problem on Jan 03, 2008. Male patient was diagnosed with parkinson's disease and was treated with ADARTREL. After drug was administered, patient experienced the following problems/side effects: off label use, parkinson's disease, . ADARTREL dosage: 2MG PER DAY. During the same period patient was treated with REQUIP. Patient recovered.


Ortho Side Effects Report #5588908-5
ORTHO EVRA problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 04, 2008. Female patient, weighting 200.0 lb, was diagnosed with menometrorrhagia and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: off label use, peripheral ischaemia, venous thrombosis, . ORTHO EVRA dosage: unknown. During the same period patient was treated with ALTACE, PROTONIX. Patient was hospitalized. Patient recovered.

Avastin Side Effects Report #5606866-1
Health Professional from UNITED KINGDOM reported AVASTIN problem on Jan 14, 2008. Female patient, 41 years of age, was diagnosed with glaucoma and was treated with AVASTIN. After drug was administered, patient experienced the following problems/side effects: off label use, toe amputation, . AVASTIN dosage: 2.5 MG, UNK. Patient recovered.

Tracleer Side Effects Report #5574090-7
TRACLEER problem was reported by a Physician from FRANCE on Dec 14, 2007. Male patient, 68 years of age, was diagnosed with pulmonary hypertension and was treated with TRACLEER. After drug was administered, patient experienced the following problems/side effects: off label use, pneumonia, . TRACLEER dosage: 125 MG,BID,ORAL; 62.5 MG,BID,ORAL. During the same period patient was treated with DIURETICS. Patient died on 02/01/2007.

Hexabrix Side Effects Report #5575986-2
Health Professional from FRANCE reported HEXABRIX problem on Dec 17, 2007. Female patient was diagnosed with spinal myelogram and was treated with HEXABRIX. After drug was administered, patient experienced the following problems/side effects: off label use, status epilepticus, . HEXABRIX dosage: unknown. Patient recovered.

Lovaza Side Effects Report #5588544-0
LOVAZA problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 20, 2007. Male patient, 43 years of age, was diagnosed with blood cholesterol increased and was treated with LOVAZA. After drug was administered, patient experienced the following problems/side effects: off label use, therapeutic response unexpected, . LOVAZA dosage: unknown. Patient recovered.


Lovaza Side Effects Report #5588919-X
Consumer or non-health professional from UNITED STATES reported LOVAZA problem on Sept 05, 2007. Male patient, 73 years of age, was diagnosed with blood cholesterol, blood triglycerides increased and was treated with LOVAZA. After drug was administered, patient experienced the following problems/side effects: off label use, onychoclasis, . LOVAZA dosage: unknown. During the same period patient was treated with TRICOR. Patient recovered.

Lovaza Side Effects Report #5588930-9
LOVAZA problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 21, 2007. Female patient, 62 years of age, weighting 157.0 lb, was diagnosed with blood cholesterol increased and was treated with LOVAZA. After drug was administered, patient experienced the following problems/side effects: off label use, therapeutic response unexpected, . LOVAZA dosage: unknown. During the same period patient was treated with FOLIC ACID, KLONOPIN, PROZAC, NEXIUM, CRESTOR. Patient recovered.

Lovaza Side Effects Report #5588936-X
Consumer or non-health professional from UNITED STATES reported LOVAZA problem on Sept 27, 2007. Female patient, 65 years of age, weighting 132.0 lb, was diagnosed with blood cholesterol increased, blood pressure and was treated with LOVAZA. After drug was administered, patient experienced the following problems/side effects: off label use, weight increased, . LOVAZA dosage: unknown. During the same period patient was treated with TOPROL, FLAXSEED OIL. Patient recovered.

Vyvanse Side Effects Report #5597024-8
VYVANSE problem was reported by a Physician from UNITED STATES on Dec 14, 2007. Male patient, 15 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, tic, . VYVANSE dosage: 50 MG, 1X/DAY:QD, ORAL ; 50 MG, 1X/DAY:QD, ORAL. During the same period patient was treated with LAMICTAL, ALBUTEROL, KLONOPIN, SINGULAIR, TENEX. Patient recovered.

Vyvanse Side Effects Report #5597039-X
Consumer or non-health professional from UNITED STATES reported VYVANSE problem on Oct 15, 2007. Male patient was diagnosed with disturbance in attention, energy increased and was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, restlessness, . VYVANSE dosage: 50 MG. Patient recovered.


Vyvanse Side Effects Report #5597225-9
VYVANSE problem was reported by a Physician from UNITED STATES on Oct 23, 2007. Male patient, 16 years of age, was diagnosed with attention deficit/hyperactivity disorder and was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, vision blurred, . VYVANSE dosage: 30 MG, 1X/DAY:QD. Patient recovered.

Vyvanse Side Effects Report #5597245-4
Consumer or non-health professional from UNITED STATES reported VYVANSE problem on Oct 02, 2007. Male patient, child 5 years of age, weighting 50.04 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, tic, . VYVANSE dosage: 30 MG, 1X/DAY:QD, ORAL. Patient recovered.

Vyvanse Side Effects Report #5597276-4
VYVANSE problem was reported by a Health Professional from UNITED STATES on Nov 12, 2007. Male patient, child 5 years of age, weighting 54.90 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, vomiting, . VYVANSE dosage: 30 MG, 1X/DAY:QD, ORAL. During the same period patient was treated with SINGULAIR. Patient recovered.

Vyvanse Side Effects Report #5597335-6
Physician from UNITED STATES reported VYVANSE problem on Oct 05, 2007. Male patient, child 5 years of age, was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, psychotic disorder, . VYVANSE dosage: 30 MG, ORAL. During the same period patient was treated with ADDERALL. Patient recovered.

Vyvanse Side Effects Report #5597764-0
VYVANSE problem was reported by a Health Professional from UNITED STATES on Oct 02, 2007. Male patient, 45 years of age, weighting 205.0 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, vision blurred, . VYVANSE dosage: 30 MG, 1X/DAY:QD, ORAL. Patient recovered.

Singulair Side Effects Report #5511996-9
Physician from SPAIN reported SINGULAIR problem on Oct 30, 2007. Female patient, 40 years of age, was diagnosed with asthma, nasal polyps and was treated with SINGULAIR. After drug was administered, patient experienced the following problems/side effects: off label use, pulmonary eosinophilia, . SINGULAIR dosage: unknown. During the same period patient was treated with ALBUTEROL SULPHATE. Patient recovered.

Arimidex Side Effects Report #5518501-1
ARIMIDEX problem was reported by a Consumer or non-health professional from BRAZIL on Nov 07, 2007. Female patient, 65 years of age, weighting 114.6 lb, was diagnosed with ovarian cancer, bronchitis, hypertension, dyspepsia, nausea and was treated with ARIMIDEX. After drug was administered, patient experienced the following problems/side effects: off label use, vaginal haemorrhage, . ARIMIDEX dosage: unknown. During the same period patient was treated with CARDIZEM, MONOCORDIL, SOLMALGIN CARDIO, CELESTAMINE, NORVASC, OMEPRAZOLE, PLASIL. Patient recovered.

Fosamax Side Effects Report #5570808-8
Physician from UNITED STATES reported FOSAMAX problem on Apr 30, 2007. Female patient, 76 years of age, weighting 140.0 lb, was diagnosed with arthritis and was treated with FOSAMAX. After drug was administered, patient experienced the following problems/side effects: off label use, osteonecrosis, . FOSAMAX dosage: 70 MG/WKY/PO. During the same period patient was treated with NORVASC, TOPROL, ZOCOR, ZOLOFT. Patient recovered.

Arava Side Effects Report #5474391-7
ARAVA problem was reported by a Physician from TURKEY on Sept 21, 2007. Female patient, 75 years of age, weighting 165.3 lb, was diagnosed with hypertension and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: off label use, pruritus, wound, . ARAVA dosage: unknown. During the same period patient was treated with CALCIUM WITH VITAMIN D, FOSAMAX, DELTACORTRIL, TENSINOR, COZAAR, DIAMICRON, PROSEK, HYZAAR. Patient recovered.

Cytotec Side Effects Report #5475222-1
Consumer or non-health professional from NORWAY reported CYTOTEC problem on Sept 20, 2007. Female patient was diagnosed with abortion induced and was treated with CYTOTEC. After drug was administered, patient experienced the following problems/side effects: off label use, . CYTOTEC dosage: DAILY DOSE:.8MG-FREQ:ONCE. During the same period patient was treated with MIFEPRISTONE, CODEINE PHOSPHATE AND ACETAMINOPHEN. Patient was hospitalized. Patient recovered.

Cytotec Side Effects Report #5475223-3
CYTOTEC problem was reported by a Consumer or non-health professional from NORWAY on Sept 20, 2007. Female patient was diagnosed with abortion induced and was treated with CYTOTEC. After drug was administered, patient experienced the following problems/side effects: off label use, . CYTOTEC dosage: DAILY DOSE:.8MG-FREQ:ONCE. During the same period patient was treated with MIFEPRISTONE, CODEINE PHOSPHATE AND ACETAMINOPHEN. Patient was hospitalized. Patient recovered.

Cytotec Side Effects Report #5477495-8
Pharmacist from UNITED KINGDOM reported CYTOTEC problem on Sept 25, 2007. Female patient, weighting 198.4 lb, was diagnosed with abortion induced and was treated with CYTOTEC. After drug was administered, patient experienced the following problems/side effects: off label use, therapeutic response delayed, . CYTOTEC dosage: unknown. During the same period patient was treated with MIFEPRISTONE. Patient recovered.

Daytrana Side Effects Report #5490332-0
DAYTRANA problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 04, 2007. Male patient, child 4 years of age, weighting 42.99 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with DAYTRANA. After drug was administered, patient experienced the following problems/side effects: off label use, pneumonia, . DAYTRANA dosage: 15 MG, 1X/DAY:QD, TRANSDERMAL. During the same period patient was treated with SINGULAIR, NASONEX, ALBUTEROL, FLOVENT, STRATTERA, TENEX. Patient was hospitalized. Patient recovered.

Arava Side Effects Report #5499200-1
Physician from TURKEY reported ARAVA problem on Oct 18, 2007. Female patient, 75 years of age, weighting 165.3 lb, was diagnosed with hypertension and was treated with ARAVA. After drug was administered, patient experienced the following problems/side effects: off label use, pruritus, wound, . ARAVA dosage: unknown. During the same period patient was treated with CALCIUM WITH VITAMIN D, FOSAMAX, DELTACORTRIL, TENSINOR, COZAAR, DIAMICRON, PROSEK, HYZAAR. Patient recovered.

Vyvanse Side Effects Report #5501660-4
VYVANSE problem was reported by a Consumer or non-health professional from UNITED STATES on July 25, 2007. Female patient, 16 years of age, weighting 160.1 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, rash erythematous, . VYVANSE dosage: 30 MG, 1X/DAY;QD; ORAL. During the same period patient was treated with ABILIFY, LAMICTAL, FLUOXETINE. Patient recovered.

Vyvanse Side Effects Report #5501671-9
Consumer or non-health professional from UNITED STATES reported VYVANSE problem on Aug 06, 2007. Male patient, 13 years of age, weighting 50.04 lb, was diagnosed with attention deficit/hyperactivity disorder and was treated with VYVANSE. After drug was administered, patient experienced the following problems/side effects: off label use, somnolence, . VYVANSE dosage: 30 MG, 1X/DAY, QD; ORAL. During the same period patient was treated with PROPRANOLOL, RISPERDAL. Patient recovered.

Singulair Side Effects Report #5502424-8
SINGULAIR problem was reported by a Physician from SPAIN on Oct 23, 2007. Female patient, 41 years of age, was diagnosed with asthma, nasal polyps and was treated with SINGULAIR. After drug was administered, patient experienced the following problems/side effects: off label use, pulmonary eosinophilia, . SINGULAIR dosage: unknown. During the same period patient was treated with BUDESONIDE. Patient recovered.

Omacor Side Effects Report #5486518-1
Consumer or non-health professional from UNITED STATES reported OMACOR problem on July 09, 2007. Male patient was diagnosed with high density lipoprotein decreased and was treated with OMACOR. After drug was administered, patient experienced the following problems/side effects: off label use, pollakiuria, weight decreased, . OMACOR dosage: unknown. Patient recovered.

Biperiden Side Effects Report #5428370-6
BIPERIDEN HYDROCHLORIDE problem was reported by a Consumer or non-health professional from TURKEY on Aug 21, 2007. Male patient, 52 years of age, was diagnosed with psychotic disorder and was treated with BIPERIDEN HYDROCHLORIDE. After drug was administered, patient experienced the following problems/side effects: off label use, subcutaneous abscess, . BIPERIDEN HYDROCHLORIDE dosage: unknown. During the same period patient was treated with BIPERIDEN HYDROCHLORIDE. Patient was hospitalized. Patient recovered.

Ortho Side Effects Report #5395229-2
Physician from UNITED STATES reported ORTHO EVRA problem on May 18, 2007. Female patient, 31 years of age, weighting 118.0 lb, was diagnosed with menstruation irregular and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: off label use, pulmonary embolism, . ORTHO EVRA dosage: unknown. Patient was hospitalized. Patient recovered.

Fosamax Side Effects Report #5399708-3
FOSAMAX problem was reported by a Physician from JAPAN on July 19, 2007. Female patient, child 8 years of age, was diagnosed with osteogenesis imperfecta and was treated with FOSAMAX. After drug was administered, patient experienced the following problems/side effects: off label use, osteomyelitis, overdose, . FOSAMAX dosage: unknown. Patient recovered.

Ortho Side Effects Report #5403252-4
Health Professional from UNITED STATES reported ORTHO EVRA problem on May 01, 2007. Female patient, 44 years of age, weighting 185.2 lb, was diagnosed with uterine neoplasm and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: off label use, pulmonary embolism, . ORTHO EVRA dosage: unknown. During the same period patient was treated with SKELAXIN, PRILOSEC, MOTRIN, ALBUTEROL INHALER, ADVAIR DISKUS. Patient was hospitalized. Patient recovered.

Ortho Side Effects Report #5412466-9
ORTHO EVRA problem was reported by a Health Professional from UNITED STATES on May 16, 2007. Female patient, 27 years of age, weighting 220.0 lb, was diagnosed with menstruation irregular and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: off label use, pulmonary embolism, . ORTHO EVRA dosage: unknown. During the same period patient was treated with PREDNISONE. Patient was hospitalized. Patient recovered.

Ortho Side Effects Report #5412581-X
Health Professional from UNITED STATES reported ORTHO EVRA problem on Mar 06, 2007. Female patient, 27 years of age, weighting 192.0 lb, was diagnosed with amenorrhoea, contraception and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: off label use, pulmonary embolism, . ORTHO EVRA dosage: unknown. During the same period patient was treated with ORTHO EVRA. Patient was hospitalized. Patient recovered.

Ortho Side Effects Report #5414117-6
ORTHO EVRA problem was reported by a Physician from UNITED STATES on Mar 28, 2007. Female patient, 45 years of age, weighting 180.0 lb, was diagnosed with menopause, menstruation irregular and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: off label use, pulmonary embolism, . ORTHO EVRA dosage: unknown. During the same period patient was treated with ORTHO EVRA, SYNTHROID. Patient was hospitalized. Patient recovered.

Ortho Side Effects Report #5414175-9
Physician from UNITED STATES reported ORTHO EVRA problem on Jan 19, 2007. Female patient, 43 years of age, weighting 181.0 lb, was diagnosed with menometrorrhagia and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: off label use, pulmonary embolism, thrombophlebitis, . ORTHO EVRA dosage: unknown. During the same period patient was treated with IRON. Patient was hospitalized. Patient recovered.

Ortho Side Effects Report #5395229-2
ORTHO EVRA problem was reported by a Physician from UNITED STATES on May 18, 2007. Female patient, 31 years of age, weighting 118.0 lb, was diagnosed with menstruation irregular and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: off label use, pulmonary embolism, . ORTHO EVRA dosage: unknown. Patient was hospitalized. Patient recovered.

Fosamax Side Effects Report #5399708-3
Physician from JAPAN reported FOSAMAX problem on July 19, 2007. Female patient, child 8 years of age, was diagnosed with osteogenesis imperfecta and was treated with FOSAMAX. After drug was administered, patient experienced the following problems/side effects: off label use, osteomyelitis, overdose, . FOSAMAX dosage: unknown. Patient recovered.

Ortho Side Effects Report #5403252-4
ORTHO EVRA problem was reported by a Health Professional from UNITED STATES on May 01, 2007. Female patient, 44 years of age, weighting 185.2 lb, was diagnosed with uterine neoplasm and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: off label use, pulmonary embolism, . ORTHO EVRA dosage: unknown. During the same period patient was treated with SKELAXIN, PRILOSEC, MOTRIN, ALBUTEROL INHALER, ADVAIR DISKUS. Patient was hospitalized. Patient recovered.

Ortho Side Effects Report #5412466-9
Health Professional from UNITED STATES reported ORTHO EVRA problem on May 16, 2007. Female patient, 27 years of age, weighting 220.0 lb, was diagnosed with menstruation irregular and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: off label use, pulmonary embolism, . ORTHO EVRA dosage: unknown. During the same period patient was treated with PREDNISONE. Patient was hospitalized. Patient recovered.

Ortho Side Effects Report #5412581-X
ORTHO EVRA problem was reported by a Health Professional from UNITED STATES on Mar 06, 2007. Female patient, 27 years of age, weighting 192.0 lb, was diagnosed with amenorrhoea, contraception and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: off label use, pulmonary embolism, . ORTHO EVRA dosage: unknown. During the same period patient was treated with ORTHO EVRA. Patient was hospitalized. Patient recovered.

Ortho Side Effects Report #5414117-6
Physician from UNITED STATES reported ORTHO EVRA problem on Mar 28, 2007. Female patient, 45 years of age, weighting 180.0 lb, was diagnosed with menopause, menstruation irregular and was treated with ORTHO EVRA. After drug was administered, patient experienced the following problems/side effects: off label use, pulmonary embolism, . ORTHO EVRA dosage: unknown. During the same period patient was treated with ORTHO EVRA, SYNTHROID. Patient was hospitalized. Patient recovered.