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Rowasa adverse events reported to FDA.

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Summary

FDA Adverse Reports: 18. View All

Rowasa FDA safety alerts: No

Reported hospitalizations: 8

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Often additional risks of using a medication, such as Rowasa, become known after product is used by a larger number of patients, for a longer period of time, and by patients with different health characteristics from those studied before drug approval. This page allows You to Find answers and discuss health symptoms with other Rowasa users, Learn more about unwanted side effects & find ways to reduce them. Browse Rowasa Adverse Reports reported to FDA and participate in Rowasa discussion, find alternative treatments and find ways to avoid or reduce risks associated with using Rowasa. You can also Post a question to users community or Ask a Doctor. PatientsVille.com is Your Complete Guide to all common, undocumented and undisclosed side effects associated with drugs and vaccines. Browse More Drug Reports Here: A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z

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Rowasa Adverse Effect Reports (FDA)

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7026959-4 | Caesarean Section, Foetal Distress Syndrome
on Sep 16, 2010 Female patient from FRANCE , weighting 6.17 lb, was treated with Rowasa (View Usage). Patient experienced the following unwanted or unexpected effects: caesarean section, foetal distress syndrome. Rowasa dosage: (df Transplacental). During the same period patient was treated with IMUREL /00001501/ (IMUREL) (NOT SPECIFIED) ((df Transplacental)) (View Imurel /00001501/ (imurel) (not Specified) Review and Imurel /00001501/ (imurel) (not Specified) Label ), PENTASA ((df Transplacental)) (View Pentasa Review and Pentasa Label ).

6962567-9 | Hallucination, Off Label Use
Patient was taking Rowasa (View Usage). Patient had the following side effects: hallucination, off label use on Aug 16, 2010 from UNITED STATES Additional patient health information: Male patient , 14 years of age, was diagnosed with colitis ulcerative and. Rowasa dosage: (df Rectal). During the same period patient was treated with APRISO (View Apriso Review and Apriso Label ).

6600005-6 | Bone Marrow Failure, Colitis Ulcerative, Pallor
Adverse event was reported on Feb 02, 2010 by a Male patient taking Rowasa (View Usage) (Dosage: (500 Mg Qid Rectal)) was diagnosed with colitis ulcerative and. Location: ALGERIA , 61 years of age, After Rowasa was administered, patient had the following side effects: bone marrow failure, colitis ulcerative, pallor. During the same period patient was treated with METFORMIN HCL (View Metformin Hcl Review and Metformin Hcl Label ).

5934938-0 | Arthralgia, Gait Disturbance, Myalgia, Neuropathy Peripheral, Sensory Loss, Tremor
on Oct 10, 2008 Male patient from FRANCE , 76 years of age, was diagnosed with crohn's disease (What is crohn's disease?) and was treated with Rowasa (View Usage). Patient experienced the following unwanted or unexpected effects: arthralgia, gait disturbance, myalgia, neuropathy peripheral, sensory loss, tremor. Rowasa dosage: 1 G Qd Oral. During the same period patient was treated with PREVISCAN (View Previscan Review and Previscan Label ), HYDROCORTISONE (View Hydrocortisone Review and Hydrocortisone Label ).


5674077-X | Diarrhoea, Gastrointestinal Haemorrhage, Rectal Ulcer
on Oct 02, 2007 Female patient from UNITED STATES , 66 years of age, was diagnosed with gastrointestinal haemorrhage and was treated with Rowasa (View Usage). Patient had the following side effects: diarrhoea, gastrointestinal haemorrhage, rectal ulcer. Rowasa dosage: (4 G Bid Rectal). During the same period patient was treated with NOVOLOG (View Novolog Review and Novolog Label ), TOPROL XL (View Toprol-xl Review and Toprol-xl Label ), NITROGLYCERIN (View Nitroglycerin Review and Nitroglycerin Label ), LASIX (View Lasix Review and Lasix Label ). Patient was hospitalized.

5491383-2 | Abdominal Pain Upper, Lipase Increased
Patient was taking Rowasa (View Usage). After Rowasa was administered, patient had the following side effects: abdominal pain upper, lipase increased on Oct 04, 2007 from FRANCE Additional patient health information: Female patient , 16 years of age, . Rowasa dosage: (2000 Mg Oral). During the same period patient was treated with DELURSAN (View Delursan Review and Delursan Label ).

5230773-X | Alanine Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Diarrhoea, Eosinophilia, Hypersensitivity, Lymphadenopathy, Rash Morbilliform, Skin Lesion
Adverse event was reported on Jan 17, 2007 by a Male patient taking Rowasa (View Usage) (Dosage: 1.5 G Qday Po) was diagnosed with crohn's disease (What is crohn's disease?) and. Location: FRANCE , 74 years of age, Patient experienced the following unwanted or unexpected effects: alanine aminotransferase increased, blood alkaline phosphatase increased, diarrhoea, eosinophilia, hypersensitivity, lymphadenopathy, rash morbilliform, skin lesion. During the same period patient was treated with PENTASA (View Pentasa Review and Pentasa Label ), LANTUS (View Lantus Review and Lantus Label ), CIFLOX /00697201/ (View Ciflox /00697201/ Review and Ciflox /00697201/ Label ), RIFADIN (View Rifadin Review and Rifadin Label ), IMUREL (View Imurel Review and Imurel Label ), SOLUPRED /00016209/ (View Solupred /00016209/ Review and Solupred /00016209/ Label ), INIPOMP (View Inipomp Review and Inipomp Label ), ACTOS (View Actos Review and Actos Label ). Patient was hospitalized.

5177434-3 | Alanine Aminotransferase Increased, Blood Alkaline Phosphatase Increased, Lymphadenopathy, Rash Morbilliform, Skin Test Positive
on Nov 24, 2006 Male patient from FRANCE , 74 years of age, was diagnosed with crohn's disease (What is crohn's disease?) and was treated with Rowasa (View Usage). Patient had the following side effects: alanine aminotransferase increased, blood alkaline phosphatase increased, lymphadenopathy, rash morbilliform, skin test positive. Rowasa dosage: 1.5 G Qday Po. During the same period patient was treated with PENTASA (View Pentasa Review and Pentasa Label ), LANTUS (View Lantus Review and Lantus Label ), CIPROFLOXACIN (View Ciprofloxacin Review and Ciprofloxacin Label ), RIFADIN (View Rifadin Review and Rifadin Label ), IMUREL (View Imurel Review and Imurel Label ), SOLUPRED (View Solupred Review and Solupred Label ), INIPOMP (View Inipomp Review and Inipomp Label ), ACTOS (View Actos Review and Actos Label ). Patient was hospitalized.

5162189-9 | Female Genital Tract Fistula, Intestinal Perforation, Rectal Cancer
on Nov 06, 2006 Female patient from FRANCE , 43 years of age, was diagnosed with enterocolitis haemorrhagic, rectal cancer and was treated with Rowasa (View Usage). After Rowasa was administered, patient had the following 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 (2900 Milligram (s),) (View Xeloda Review and Xeloda Label ), METEOXANE (SIMETICONE, PHLOROGLUCINOL) (View Meteoxane (simeticone, Phloroglucinol) Review and Meteoxane (simeticone, Phloroglucinol) Label ). Patient was hospitalized.

5162046-8 | Anal Fistula, Anorectal Disorder, Candidiasis, Diarrhoea, Intestinal Perforation, Proctalgia, Rectal Cancer, Sepsis, Vaginal Disorder
Patient was taking Rowasa (View Usage). Patient experienced the following unwanted or unexpected effects: anal fistula, anorectal disorder, candidiasis, diarrhoea, intestinal perforation, proctalgia, rectal cancer, sepsis (What is sepsis?), vaginal disorder on Nov 06, 2006 from FRANCE Additional patient health information: Female patient , 43 years of age, was diagnosed with enterocolitis haemorrhagic, rectal cancer and. Rowasa dosage: 500 Mg Qday Rc. During the same period patient was treated with XELODA (2900 Mg) (View Xeloda Review and Xeloda Label ). Patient was hospitalized.

4978351-1 | Pancreatitis Acute
Adverse event was reported on Apr 28, 2005 by a Female patient taking Rowasa (View Usage) (Dosage: 500 Milligram(s) Oral Daily Dose: 3 Gram(s)) was diagnosed with crohn's disease (What is crohn's disease?), abscess intestinal and. Location: FRANCE , 25 years of age, weighting 138.9 lb, Patient had the following side effects: pancreatitis acute. During the same period patient was treated with IMURAN (50 Milligram(s) Daily Oral Daily Dose: 50 Milligram(s)) (View Imuran Review and Imuran Label ), ENTOCORT (BUDESONIDE) (View Entocort (budesonide) Review and Entocort (budesonide) Label ). Patient was hospitalized.

4674323-5 | Small Intestinal Obstruction
on May 19, 2005 Female patient from , weighting 123.5 lb, was diagnosed with ill-defined disorder and was treated with Rowasa (View Usage). After Rowasa was administered, patient had the following side effects: small intestinal obstruction. Rowasa dosage: Daily Dose: 8 Gram(s).

4650864-1 | Anal Discomfort
on Apr 29, 2005 Female patient from , 13 years of age, weighting 99.00 lb, was diagnosed with colitis and was treated with Rowasa (View Usage). Patient experienced the following unwanted or unexpected effects: anal discomfort. Rowasa dosage: 1/2 Pr Bid.

4643640-7 | Deep Vein Thrombosis
Patient was taking Rowasa (View Usage). Patient had the following side effects: deep vein thrombosis (What is deep vein thrombosis?) on Jul 20, 2004 from Additional patient health information: Female patient , weighting 155.0 lb, was diagnosed with crohn's disease (What is crohn's disease?) and. Rowasa dosage: Daily Dose: 4 Gram(s). During the same period patient was treated with ASACOL (Daily Dose: 3600 Milligram(s)) (View Asacol Review and Asacol Label ), PREDNISONE (Daily Dose: 60 Milligram(s)) (View Prednisone Review and Prednisone Label ). Patient was hospitalized.

4619884-7 | Blood Creatinine Increased, Foetal Growth Retardation, Premature Baby
Adverse event was reported on Mar 18, 2005 by a Female patient taking Rowasa (View Usage) (Dosage: Daily Dose: 2 Gram(s)) was diagnosed with colitis ulcerative and. Location: , weighting 1.65 lb, After Rowasa was administered, patient had the following side effects: blood creatinine increased, foetal growth retardation, premature baby. During the same period patient was treated with PENTASA (Daily Dose: 2 Gram(s)) (View Pentasa Review and Pentasa Label ).

4617610-9 | Growth Retardation, Oligohydramnios, Premature Baby
on Mar 10, 2005 Female patient from , 25 years of age, was diagnosed with colitis ulcerative and was treated with Rowasa (View Usage). Patient experienced the following unwanted or unexpected effects: growth retardation, oligohydramnios, premature baby. Rowasa dosage: Daily Dose: 2 Gram(s). During the same period patient was treated with PENTASA (Daily Dose: 2 Gram(s)) (View Pentasa Review and Pentasa Label ).

4617461-5 | Foetal Growth Retardation, Oligohydramnios
on Mar 10, 2005 Female patient from , 25 years of age, was diagnosed with colitis and was treated with Rowasa (View Usage). Patient had the following side effects: foetal growth retardation, oligohydramnios. Rowasa dosage: Daily Dose: 2 Gram(s). During the same period patient was treated with PENTASA (Daily Dose: 2 Gram(s)) (View Pentasa Review and Pentasa Label ).

4555497-3 | Abdominal Pain Upper, Gallbladder Disorder, Vomiting
Patient was taking Rowasa (View Usage). After Rowasa was administered, patient had the following side effects: abdominal pain upper, gallbladder disorder, vomiting on Jan 10, 2005 from Additional patient health information: Female patient , weighting 133.4 lb, was diagnosed with ill-defined disorder and. Rowasa dosage: Daily Dose: 4 Gram(s) Once. Patient was hospitalized.


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To find out about documented side effects or safety concerns read either the drug label or the drug's package insert. You may also want to speak with your pharmacist or healthcare provider. All medicines have benefits and risks. The risks are the chances that something unwanted or unexpected could happen to you when you use them. You can protect yourself by searching summaries of recent safety alerts, adverse reports. Sometimes there are risks that only come to light after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval.

Be aware of the following potential Rowasa risks to be aware of: 1. Watch for any Serious adverse events, such as life-threatening situation, which can require an admission to hospital or longer-than-expected hospital stay, permanent disability, birth defect, miscarriage, stillbirth, or birth with serious disease requires medical care to prevent permanent damage
2. Any potential Rowasa quality problem: suspected counterfeit product, potentially contaminated product indicated by suspicious odor or unusual color, inaccurate or unreadable product labeling
3. Potential Rowasa use error: mixing up products with similar drug names or packaging, taking wrong dose of a drug because of confusing dosing instructions on label
4. When applicable, Problems with different manufacturer of same medicine: not getting same results from a generic drug as a brand name drug, or from another generic

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Rowasa Reactions
Abdominal Pain Upper
Alanine Aminotransferase Increased
Anal Discomfort
Anal Fistula
Anorectal Disorder
Arthralgia
Blood Alkaline Phosphatase Increased
Blood Creatinine Increased
Bone Marrow Failure
Caesarean Section
Candidiasis
Colitis Ulcerative
Deep Vein ThrombosisWhat is Deep vein thrombosis?
Diarrhoea
Eosinophilia
Female Genital Tract Fistula
Foetal Distress Syndrome
Foetal Growth Retardation
Gait Disturbance
Gallbladder Disorder
Gastrointestinal Haemorrhage
Growth Retardation
Hallucination
Hypersensitivity
Intestinal Perforation
Lymphadenopathy
Oligohydramnios
Premature Baby
Rash Morbilliform
Rectal Cancer
Rowasa Side Effects Notice - The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. PatientsVille.com does not provide medical advice, diagnosis or treatment. The information regarding Rowasa adverse reports, reviews and polls contained on PatientsVille.com site has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of adverse drug reactions or for establishing or changing of patient treatments. Thank you for visiting Patientsville.com!