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Rowasa Safety Reports

Total Rowasa reports: 8.
Rowasa FDA safety alerts: No.
   Reported hospitalizations: 6.
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Reported Rowasa Side Effects: insomnia, abdominal pain, diarrhoea, rectal cancer, intestinal perforation, eye oedema, rash morbilliform, lymphadenopathy, blood alkaline phosphatase increased, alanine aminotransferase increased, skin test positive.
Rowasa Usage.

Rowasa Side Effects Report #5230773-X
Health Professional from FRANCE reported ROWASA problem on Jan 17, 2007. Male patient, 74 years of age, was diagnosed with crohn's disease and was treated with ROWASA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, blood alkaline phosphatase increased, diarrhoea, eosinophilia, hypersensitivity, lymphadenopathy, rash morbilliform, skin lesion. ROWASA dosage: unknown. During the same period patient was treated with PENTASA, LANTUS, CIFLOX, RIFADIN, IMUREL, SOLUPRED, INIPOMP, ACTOS. Patient was hospitalized. Patient recovered.

Rowasa Side Effects Report #5233312-2
ROWASA problem was reported by a Physician from UNITED STATES on Jan 22, 2007. Male patient was treated with ROWASA. After drug was administered, patient experienced the following problems/side effects: abdominal pain, crying, diarrhoea, eye oedema, glomerulonephritis minimal lesion, insomnia, multiple allergies. ROWASA dosage: unknown. During the same period patient was treated with PREDNISONE, PENICILLIN, CALCIUM CARBONATE. Patient recovered.

Rowasa Side Effects Report #5097998-8
Consumer or non-health professional from UNITED STATES reported ROWASA problem on Aug 21, 2006. Female patient was diagnosed with colitis ulcerative and was treated with ROWASA. After drug was administered, patient experienced the following problems/side effects: chest discomfort, dyspnoea, haemorrhage. ROWASA dosage: unknown. During the same period patient was treated with ASACOL, HYDROCORTISONE ENEMA. Patient recovered.

Rowasa Side Effects Report #5129837-0
ROWASA problem was reported by a Consumer or non-health professional from ALBANIA on Sept 29, 2006. Male patient was treated with ROWASA. After drug was administered, patient experienced the following problems/side effects: abdominal distension, abdominal pain, allergy to animal, eye oedema, house dust allergy, insomnia. ROWASA dosage: unknown. During the same period patient was treated with PREDNISONE. Patient was hospitalized. Patient recovered.

Rowasa Side Effects Report #5129935-1
Consumer or non-health professional from UNITED STATES reported ROWASA problem on Sept 29, 2006. Male patient was diagnosed with colitis and was treated with ROWASA. After drug was administered, patient experienced the following problems/side effects: abdominal pain, insomnia, irritability, nausea, nephritic syndrome. ROWASA dosage: unknown. Patient was hospitalized. Patient recovered.

Rowasa Side Effects Report #5162046-8
ROWASA problem was reported by a Consumer or non-health professional from FRANCE on Nov 06, 2006. Female patient, 43 years of age, was diagnosed with enterocolitis haemorrhagic, rectal cancer and was treated with ROWASA. After drug was administered, patient experienced the following problems/side effects: anal fistula, anorectal disorder, candidiasis, diarrhoea, intestinal perforation, proctalgia, rectal cancer, sepsis, vaginal disorder. ROWASA dosage: 500 MG QDAY RC. During the same period patient was treated with XELODA. Patient was hospitalized. Patient recovered.

Rowasa Side Effects Report #5162189-9
Consumer or non-health professional from FRANCE reported ROWASA problem on Nov 06, 2006. Female patient, 43 years of age, was diagnosed with enterocolitis haemorrhagic, rectal cancer and was treated with ROWASA. After drug was administered, patient experienced the following problems/side effects: female genital tract fistula, intestinal perforation, rectal cancer. ROWASA dosage: 500 MILLIGRAM (S) RECTAL. During the same period patient was treated with XELODA, METEOXANE. Patient was hospitalized. Patient recovered.

Rowasa Side Effects Report #5177434-3
ROWASA problem was reported by a Health Professional from FRANCE on Nov 24, 2006. Male patient, 74 years of age, was diagnosed with crohn's disease and was treated with ROWASA. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, blood alkaline phosphatase increased, lymphadenopathy, rash morbilliform, skin test positive. ROWASA dosage: unknown. During the same period patient was treated with PENTASA, LANTUS, CIPROFLOXACIN, RIFADIN, IMUREL, SOLUPRED, INIPOMP, ACTOS. Patient was hospitalized. Patient recovered.


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ALABAMA
ALASKA
AMERICAN SAMOA
ARIZONA
ARKANSAS
CALIFORNIA
COLORADO
CONNECTICUT
DELAWARE
DISTRICT OF COLUMBIA
FEDERATED STATES OF MICRONESIA
FLORIDA
GEORGIA
GUAM
HAWAII
IDAHO
ILLINOIS
INDIANA
IOWA
KANSAS
KENTUCKY
LOUISIANA
MAINE
MARSHALL ISLANDS
MARYLAND
MASSACHUSETTS
MICHIGAN
MINNESOTA
MISSISSIPPI
MISSOURI
MONTANA
NEBRASKA
NEVADA
NEW HAMPSHIRE
NEW JERSEY
NEW MEXICO
NEW YORK
NORTH CAROLINA
NORTH DAKOTA
NORTHERN MARIANA ISLANDS
OHIO
OKLAHOMA
OREGON
PALAU
PENNSYLVANIA
PUERTO RICO
RHODE ISLAND
SOUTH CAROLINA
SOUTH DAKOTA
TENNESSEE
TEXAS
UTAH
VERMONT
VIRGIN ISLANDS
VIRGINIA
WASHINGTON
WEST VIRGINIA
WISCONSIN
WYOMING
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