Recommended Topic Related To:

Asacol

"The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.

Simponi works by blocking tumor necrosis factor (TNF), which plays an important"...

Asacol

Asacol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Asacol (mesalamine) 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 anti-inflammatory drug. Common side effects include mild nausea, vomiting, stomach cramps, diarrhea, gas, fever, sore throat, flu-like symptoms, constipation, headache or dizziness, tired feeling, or skin rash.

For the treatment of mildly to moderately active ulcerative colitis the usual adult dosage of Asacol is two 400-mg tablets to be taken three times a day for a total daily dose of 2.4 grams for a duration of 6 weeks. For the maintenance of remission of ulcerative colitis the recommended dosage in adults is 1.6 grams daily, in divided doses. Treatment duration is usually 6 months. Asacol may interact with azathioprine or mercaptopurine, pentamidine, tacrolimus, amphotericin B, antibiotics, antiviral medicines, cancer medicine, or aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs). Tell your doctor all medications you use. Asacol is not expected to be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This medication can pass into breast milk and may harm a nursing baby. Consult your doctor before breast-feeding.

Our Asacol (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.

Asacol 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 taking mesalamine and call your doctor at once if you have a serious side effect such as:

  • 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;
  • constipation;
  • headache or dizziness;
  • tired feeling; or
  • skin rash.

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.

Read the entire detailed patient monograph for Asacol (Mesalamine Delayed-Release Tablets) »

What is Prescribing information?

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

Asacol FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Asacol (mesalamine delayed-release tablets) tablets have been evaluated in 3685 inflammatory bowel disease patients (most patients with ulcerative colitis) in controlled and open-label studies. Adverse events seen in clinical trials with Asacol (mesalamine delayed-release tablets) tablets have generally been mild and reversible. Adverse events presented in the following sections may occur regardless of length of therapy and similar events have been reported in short- and long-term studies and in the post-marketing setting.

In two short-term (6 weeks) placebo-controlled clinical studies involving 245 patients, 155 of whom were randomized to Asacol (mesalamine delayed-release tablets) tablets, five (3.2%) of the Asacol (mesalamine delayed-release tablets) patients discontinued Asacol (mesalamine delayed-release tablets) therapy because of adverse events as compared to two (2.2%) of the placebo patients. Adverse reactions leading to withdrawal from Asacol (mesalamine delayed-release tablets) tablets included (each in one patient): diarrhea and colitis flare; dizziness, nausea, joint pain, and headache; rash, lethargy and constipation; dry mouth, malaise, lower back discomfort, mild disorientation, mild indigestion and cramping; headache, nausea, aching, vomiting, muscle cramps, a stuffy head, plugged ears, and fever.

Adverse events occurring in Asacol (mesalamine delayed-release tablets) -treated patients at a frequency of 2% or greater in the two short-term, double-blind, placebo-controlled trials mentioned above are listed in Table 1 below. Overall, the incidence of adverse events seen with Asacol (mesalamine delayed-release tablets) tablets was similar to placebo.

Table 1 : Frequency (%) of Common Adverse Events Reported in Ulcerative Colitis Patients Treated with Asacol (mesalamine delayed-release tablets) Tablets or Placebo in Short-Term (6-Week) Double-Blind Controlled Studies

Event Percent of Patients with Adverse Events
Placebo
(n = 87)
Asacol tablets
(n = 152)
Headache 36 35
Abdominal pain 14 18
Eructation 15 16
Pain 8 14
Nausea 15 13
Pharyngitis 9 11
Dizziness 8 8
Asthenia 15 7
Diarrhea 9 7
Back pain 5 7
Fever 8 6
Rash 3 6
Dyspepsia 1 6
Rhinitis 5 5
Arthralgia 3 5
Hypertonia 3 5
Vomiting 2 5
Constipation 1 5
Flatulence 7 3
Dysmenorrhea 3 3
Chest pain 2 3
Chills 2 3
Flu syndrome 2 3
Peripheral edema 2 3
Myalgia 1 3
Sweating 1 3
Colitis exacerbation 0 3
Pruritus 0 3
Acne 1 2
Increased cough 1 2
Malaise 1 2
Arthritis 0 2
Conjunctivitis 0 2
Insomnia 0 2

Of these adverse events, only rash showed a consistently higher frequency with increasing Asacol (mesalamine delayed-release tablets) dose in these studies.

In a 6-month placebo-controlled maintenance trial involving 264 patients, 177 of whom were randomized to Asacol (mesalamine delayed-release tablets) tablets, six (3.4%) of the Asacol (mesalamine delayed-release tablets) patients discontinued Asacol (mesalamine delayed-release tablets) therapy because of adverse events, as compared to four (4.6%) of the placebo patients. Adverse reactions leading to withdrawal from Asacol (mesalamine delayed-release tablets) tablets included (each in one patient): anxiety; headache; pruritus; decreased libido; rheumatoid arthritis; and stomatitis and asthenia.

In the 6-month placebo-controlled maintenance trial, the incidence of adverse events seen with Asacol (mesalamine delayed-release tablets) tablets was similar to that seen with placebo. In addition to events listed in Table 1, the following adverse events occurred in Asacol (mesalamine delayed-release tablets) -treated patients at a frequency of 2% or greater in this study: abdominal enlargement, anxiety, bronchitis, ear disorder, ear pain, gastroenteritis, gastrointestinal hemorrhage, infection, joint disorder, migraine, nervousness, paresthesia, rectal disorder, rectal hemorrhage, sinusitis, stool abnormalities, tenesmus, urinary frequency, vasodilation, and vision abnormalities.

In 3342 patients in uncontrolled clinical studies, the following adverse events occurred at a frequency of 5% or greater and appeared to increase in frequency with increasing dose: asthenia, fever, flu syndrome, pain, abdominal pain, back pain, flatulence, gastrointestinal bleeding, arthralgia, and rhinitis.

In addition to the adverse events listed above, the following events have been reported in clinical studies, literature reports, and postmarketing use of products which contain (or have been metabolized to) mesalamine. Because many of these events were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to their seriousness or potential causal connection to mesalamine:

Body as a Whole: Neck pain, facial edema, edema, lupus-like syndrome, drug fever (rare).

Cardiovascular: Pericarditis (rare), myocarditis (rare).

Gastrointestinal: Anorexia, pancreatitis, gastritis, increased appetite, cholecystitis, dry mouth, oral ulcers, perforated peptic ulcer (rare), bloody diarrhea. There have been rare reports of hepatotoxicity including, jaundice, cholestatic jaundice, hepatitis, and possible hepatocellular damage including liver necrosis and liver failure. Some of these cases were fatal. Asymptomatic elevations of liver enzymes which usually resolve during continued use or with discontinuation of the drug have also been reported. One case of Kawasaki-like syndrome which included changes in liver enzymes was also reported.

Hematologic: Agranulocytosis (rare), aplastic anemia (rare), thrombocytopenia, eosinophilia, leukopenia, anemia, lymphadenopathy.

Musculoskeletal: Gout.

Nervous: Depression, somnolence, emotional lability, hyperesthesia, vertigo, confusion, tremor, peripheral neuropathy (rare), transverse myelitis (rare), Guillain-Barré syndrome (rare).

Respiratory/Pulmonary: Eosinophilic pneumonia, interstitial pneumonitis, asthma exacerbation, pleuritis.

Skin: Alopecia, psoriasis (rare), pyoderma gangrenosum (rare), dry skin, erythema nodosum, urticaria.

Special Senses: Eye pain, taste perversion, blurred vision, tinnitus.

Urogenital: Renal Failure (rare), interstitial nephritis, minimal change nephropathy (See also Renal subsection in PRECAUTIONS). Dysuria, urinary urgency, hematuria, epididymitis, menorrhagia.

Laboratory Abnormalities: Elevated AST (SGOT) or ALT (SGPT), elevated alkaline phosphatase, elevated GGT, elevated LDH, elevated bilirubin, elevated serum creatinine and BUN.

Drug Abuse And Dependency

Abuse

None reported.

Dependency

Drug dependence has not been reported with chronic administration of mesalamine.

Read the entire FDA prescribing information for Asacol (Mesalamine Delayed-Release Tablets) »

A A A

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.


Women's Health

Find out what women really need.


NIH talks about Ebola on WebMD