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Rowasa

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Rowasa

Rowasa

Rowasa Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Rowasa (mesalamine) Rectal Suspension Enema is used to treat ulcerative colitis, proctitis, and proctosigmoiditis, and is also used to prevent the symptoms of ulcerative colitis from recurring. It is an aminosalicylate anti-inflammatory drug. This medication is available in generic form. Common side effects include rectal pain, pain while inserting the bottle tip, gas, and joint/leg pain.

The usual dosage of Rowasa Rectal Suspension Enema in 60 ml units is one rectal instillation (4 grams) once a day, preferably at bedtime, and retained for approximately eight hours. Other drugs may interact with Rowasa rectal. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Rowasa should be used only when prescribed. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Our Rowasa (mesalamine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Rowasa in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using mesalamine rectal and call your doctor at once if you have severe stomach pain, cramping, fever, headache, and bloody diarrhea.

Less serious side effects may include:

  • mild nausea, vomiting, stomach cramps, diarrhea, gas;
  • fever, sore throat, or other flu symptoms;
  • rectal pain, constipation;
  • headache or dizziness;
  • tired feeling; or
  • skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Rowasa (Mesalamine Rectal Suspension Enema) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Rowasa Overview - Patient Information: Side Effects

SIDE EFFECTS: Rectal pain, pain while inserting the bottle tip, gas, and joint/leg pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Infrequently, this medication may make symptoms of your condition worse rather than better (acute intolerance syndrome or sensitivity reaction). Tell your doctor immediately if you experience any of these unlikely but serious side effects: worsening stomach pain/cramping, worsening bloody diarrhea, fever, severe/prolonged headache.

Tell your doctor immediately if any of these rare but very serious side effects occur: chest pain, trouble breathing, severe stomach/abdominal pain (especially if spreading to the back), change in the amount of urine, easy bruising/bleeding, signs of infection (such as fever, persistent sore throat).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Rowasa (Mesalamine Rectal Suspension Enema)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Rowasa FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Adverse Experience

ROWASA® (mesalamine) Rectal Suspension Enema is usually well tolerated. Most adverse effects have been mild and transient.

ADVERSE REACTIONS OCCURRING IN MORE THAN 0.1% OF ROWASA® (MESALAMINE) RECTAL SUSPENSION
ENEMA TREATED PATIENTS (COMPARISON TO PLACEBO)

  ROWASA® PLACEBO
N =815 N =128
SYMPTOM N % N %
Abdominal Pain/Cramps/Discomforl 66 8.10 10 7.81
Headache 53 6.50 16 12.50
Gas/Flatulence 50 6.13 5 3.91
Nausea 47 5.77 12 9.38
Flu 43 5.28 1 0.78
Tired/Weak/Malaise/Fatigue 28 3.44 8 6.25
Fever 26 3.19 0 0.00
Rash/Spots 23 2.82 4 3.12
Cold/Sore Throat 19 2.33 9 7.03
Diarrhea 17 2.09 5 3.91
Leg/Joint Pain 17 2.09 1 0.78
Dizziness 15 1.84 3 2.34
Bloating 12 1.47 2 1.56
Back Pain 11 1.35 1 0.78
Pain on Insertion of Enema Tip 11 1.35 1 0.78
Hemorrhoids 11 1.35 0 0.00
Itching 10 1.23 1 0.78
Rectal Pain 10 1.23 0 0.00
Constipation 3 0.98 4 3.12
Hair Loss 7 0.86 0 0.00
Peripheral Edema 5 0.61 11 8.59
UTI/Urinary Burning 5 0.61 4 3.12
Rectal Pain/Soreness/Burning 5 0.61 3 2.34
Asthenia 1 0.12 4 3.12
Insomnia 1 0.12 3 2.34

In addition, the following adverse events have been identified during post approval use of products which contain (or are metabolized to) mesalamine in clinical practice: nephrotoxicity, pancreatitis, fibrosing alveolitis and elevated liver enzymes. Cases of pancreatitis and fibrosing alveolitis have been reported as manifestations of inflammatory bowel disease as well. Published case reports and/or spontaneous post marketing surveillance have described rare instances of aplastic anemia, agranulocytosis, thrombocytopenia, eosinophilia, pancytopenia, neutropenia, oligospermia, and infertility in men. Anemia, leukocytosis, and thrombocytosis can be part of the clinical presentation of inflammatory bowel disease.

Hair Loss

Mild hair loss characterized by "more hair in the comb" but no withdrawal from clinical trials has been observed in 7 of 815 mesalamine patients but none of the placebo-treated patients. In the literature there are at least six additional patients with mild hair loss who received either mesalamine or sulfasalazine. Retreatment is not always associated with repeated hair loss.

Read the entire FDA prescribing information for Rowasa (Mesalamine Rectal Suspension Enema) »

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Rowasa - User Reviews

Rowasa User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Rowasa sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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