Slideshows Images Quizzes

Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. See additional information.

Asacol HD

Last reviewed on RxList: 5/7/2018
Asacol HD Side Effects Center

Last reviewed on RxList 5/7/2018

Asacol HD (mesalamine) Delayed-Release Tablet is an anti-inflammatory drug used to treat ulcerative colitis, proctitis, and proctosigmoiditis, and is also used to prevent the symptoms of ulcerative colitis from recurring. Common side effects of Asacol HD include:

Tell your doctor if you have serious side effects of Asacol HD including:

  • severe stomach pain and cramping, and
  • bloody diarrhea.

For the treatment of mildly to moderately active ulcerative colitis the usual adult dosage of Asacol is two 800-mg tablets to be taken three times a day for a total daily dose of 4.8 grams for a duration of 6 weeks. Asacol may interact with azathioprine or mercaptopurine, pentamidine, tacrolimus, amphotericin B, antibiotics, antiviral medicines, cancer medicine, or aspirin or other NSAIDs (nonsteroidal anti-inflammatory drugs). Tell your doctor all medications you use. During pregnancy, Asacol HD should be used only if prescribed. This medication passes into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

Our Asacol HD (mesalamine) Delayed-Release Tablet 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.

QUESTION

Ulcerative colitis affects the colon. The colon is also referred to as the... See Answer
Asacol HD Consumer Information

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

Stop using mesalamine and call your doctor at once if you have:

  • severe stomach pain, stomach cramping, bloody diarrhea;
  • fever, headache, skin rash;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath; or
  • liver problems--loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • nausea, vomiting, stomach pain, diarrhea, indigestion, gas;
  • headache;
  • rash; or
  • abnormal liver function tests.

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 HD (Mesalamine Delayed-Release Tablets, Oral)

SLIDESHOW

Inflammatory Bowel Disease (IBD) Causes, Symptoms, Treatment See Slideshow
Asacol HD Professional Information

SIDE EFFECTS

The most serious adverse reactions seen in Asacol HD clinical trials or with other products that contain mesalamine or are metabolized to mesalamine were:

  • Renal Impairment [see WARNINGS AND PRECAUTIONS]
  • Mesalamine-Induced Acute Intolerance Syndrome [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Hepatic Failure [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Asacol HD has been evaluated in 896 patients with ulcerative colitis in controlled studies. Three six-week, active-controlled studies were conducted comparing Asacol HD 4.8 grams per day with mesalamine-delayed release tablets 2.4 grams per day in patients with mildly to moderately active ulcerative colitis. In these studies, 727 patients were dosed with Asacol HD tablets and 732 patients were dosed with mesalamine delayed-release tablets.

The most common reactions reported in the Asacol HD group were headache (4.7%), nausea (2.8%), nasopharyngitis (2.5%), abdominal pain (2.3%), diarrhea (1.7%), and dyspepsia (1.7%); Table 1 enumerates adverse reactions that occurred in the three studies. The most common reactions in patients with moderately active ulcerative colitis (602 patients dosed with Asacol HD and 618 patients dosed with mesalamine delayed-release 400 mg) were the same as all treated patients.

Discontinuations due to adverse reactions occurred in 3.9% of patients in the Asacol HD group and in 4.2% of patients in the mesalamine delayed-release tablet comparator group. The most common cause for discontinuation was gastrointestinal symptoms associated with ulcerative colitis.

Serious adverse reactions occurred in 0.8% of patients in the Asacol HD group and in 1.8% of patients in the mesalamine delayed-release tablet comparator group. The majority involved the gastrointestinal system.

Table 1: Adverse Reactions Occurring in ≥1% of All Treated Patients (Three studies combined)

Adverse Reaction Mesalamine delayed-release 2.4 grams per day (400 mg Tablet)
(N = 732)
Asacol HD 4.8 grams per day (800 mg Tablet)
(N = 727)
Headache 4.9 % 4.7 %
Nausea 2.9 % 2.8 %
Nasopharyngitis 1.4 % 2.5 %
Abdominal pain 2.3 % 2.3 %
Diarrhea 1.9 % 1.7 %
Dyspepsia 0.8 % 1.7 %
Vomiting 1.6 % 1.4 %
Flatulence 0.7 % 1.2 %
Influenza 1.2 % 1.0 %
Pyrexia 1.2 % 0.7 %
Cough 1.4 % 0.3 %
N = number of patients within specified treatment group
Percent = percentage of patients in category and treatment group

Postmarketing Experience

In addition to the adverse reactions reported above in clinical trials involving the Asacol HD tablet, the adverse events listed below have been reported in postmarketing experience with other mesalamine-containing products or products that are metabolized to mesalamine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Body as a Whole: Facial edema, edema, peripheral edema, asthenia, chills, infection, malaise, pain, neck pain, chest pain, back pain, abdominal enlargement, lupus-like syndrome, drug fever (rare).

Cardiovascular: Pericarditis (rare) and myocarditis (rare) [see WARNINGS AND PRECAUTIONS], pericardial effusion, vasodilation, migraine.

Endocrine: Nephrogenic diabetes insipidus.

Gastrointestinal: Dry mouth, stomatitis, oral ulcers, anorexia, increased appetite, eructation, pancreatitis, cholecystitis, gastritis, gastroenteritis, gastrointestinal bleeding, perforated peptic ulcer (rare), constipation, hemorrhoids, rectal hemorrhage, bloody diarrhea, tenesmus, stool abnormality.

Hepatic: 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, that included changes in liver enzymes, was also reported [see WARNINGS AND PRECAUTIONS].

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

Musculoskeletal: Gout, rheumatoid arthritis, arthritis, arthralgia, joint disorder, myalgia, hypertonia.

Neurological/Psychiatric: Anxiety, depression, somnolence, insomnia, nervousness, confusion, emotional lability, dizziness, vertigo, tremor, paresthesia, hyperesthesia, peripheral neuropathy (rare), Guillain-Barre syndrome (rare), transverse myelitis (rare), and intracranial hypertension.

Respiratory/Pulmonary: Sinusitis, rhinitis, pharyngitis, asthma exacerbation, pleuritis, bronchitis, eosinophilic pneumonia, interstitial pneumonitis.

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

Special Senses: Ear pain, tinnitus, ear congestion, ear disorder, conjunctivitis, eye pain, blurred vision, vision abnormality, taste perversion.

Renal/Urogenital: Renal failure (rare), interstitial nephritis, minimal change nephropathy [see WARNINGS AND PRECAUTIONS], dysuria, urinary frequency and urgency, hematuria, epididymitis, decreased libido, dysmenorrhea, menorrhagia.

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

Read the entire FDA prescribing information for Asacol HD (Mesalamine Delayed-Release Tablets, Oral)

Related Resources for Asacol HD

© Asacol HD Patient Information is supplied by Cerner Multum, Inc. and Asacol HD Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

Ulcerative colitis affects the colon. The colon is also referred to as the... See Answer

Health Solutions From Our Sponsors

CONTINUE SCROLLING FOR RELATED SLIDESHOW