Asacol HD Side Effects

Generic name: mesalamine

Medically reviewed by Philip Thornton, DipPharm. Last updated on Nov 4, 2024.

Note: This document provides detailed information about Asacol HD Side Effects associated with mesalamine. Some dosage forms listed on this page may not apply specifically to the brand name Asacol HD.

Applies to mesalamine: oral capsule delayed release, oral capsule extended release, oral tablet delayed release, oral tablet enteric coated.

Other dosage forms:

• rectal enema, rectal suppository

Precautions

It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Asacol® delayed-release tablet and Pentasa® extended-release capsule may cause serious kidney problems, including kidney stones. Check with your doctor right away if you have lower back or side pain, decreased frequency or amount of urine, bloody urine, increased thirst, loss of appetite, nausea, vomiting, unusual tiredness or weakness, swelling of the face, fingers, or lower legs, weight gain, or trouble breathing.

Check with your doctor right away if you have stomach pain, bloody diarrhea, cramps, fever, headache, or a rash while you are using this medicine. These may be symptoms of a condition called mesalamine-induced acute intolerance syndrome.

Call your doctor right away if you have difficulty breathing or swallowing, a fast heartbeat, itching, rash, or skin redness, or swelling of the face, throat, or tongue. These may be symptoms of an allergic reaction to this medicine.

This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may make you more sensitive to light and cause serious unwanted skin reaction. This is more likely if you have an existing skin problem (eg, atopic dermatitis, atopic eczema). Check with your doctor right away if you have increased sensitivity of the skin to sunlight, itching, redness or other discoloration of the skin, severe sunburn, or skin rash. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Do not take antacids (eg, Amphojel®, Maalox®, Mylanta®, Tums®) while you are using the Apriso® capsules. Using these medicines together may change the amount of medicine that is released in the body.

Make sure any doctor or dentist who treats you knows that you are using mesalamine (the active ingredient contained in Asacol HD) This medicine may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Asacol HD

Along with its needed effects, mesalamine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking mesalamine:

Other side effects of Asacol HD

Some side effects of mesalamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to mesalamine: compounding powder, oral capsule extended release, oral delayed release capsule, oral delayed release tablet, rectal enema, rectal kit, rectal suppository.

General adverse events

The most common adverse events were headache, eructation, and aggravation of ulcerative colitis.^[Ref]

Gastrointestinal

• Very common (10% or more): Eructation (up to 16%), ulcerative colitis aggravated (up to 15%)
• Common (1% to 10%): Abdominal pain/cramps/discomfort, diarrhea, flatulence, nausea, gastroenteritis, gastrointestinal hemorrhage, rectal disorder, stool abnormalities (color or texture change), urinary frequency, dyspepsia, vomiting, bloating, rectal distension, pain on insertion of tip (enema formulation), hemorrhoids, rectal pain, colitis, constipation, abdominal distension
• Uncommon (0.1% to 1%): Acute pancreatitis, melena (bloody diarrhea), rectal pain/soreness/burning, pancolitis, neonate diarrhea, anal discomfort, defecation urgency, colitis ulcer (proctitis ulcer), glossitis, rectal polyp, pancreatitis, application site irritation (rectal foam formulation), painful rectal tenesmus, rectal urgency
• Rare (less than 0.1%): Increased amylase
• Frequency not reported: Duodenal ulcer, dysphagia, esophageal ulcer, fecal incontinence, GI bleeding, mouth ulcer, oral candidiasis, rectal bleeding, rectal polyp, mild indigestion and cramping, bloody diarrhea, stomatitis, abdominal enlargement, lipase increase
• Postmarketing reports: Frequent bowel movements, mucus stools, painful defecation, proctalgia, rectal discharge, stomach discomfort, gastritis, dry mouth, oral ulcers, perforated peptic ulcer, amylase increased^[Ref]

Nervous system

• Very common (10% or more): Headache (up to 24%)
• Common (1% to 10%): Dizziness
• Uncommon (0.1% to 1%): Paresthesia, peripheral neuropathy, somnolence, tremor,
• Very rare (less than 0.01%): Vertigo
• Frequency not reported: Neuropathy, mild disorientation
• Postmarketing reports: Guillain-Barre syndrome, hypertonia, transverse myelitis, hyperesthesia, taste perversion, tinnitus^[Ref]

Other

• Very common (10% or more): Pain (up to 14%)
• Common (1% to 10%): Asthenia, fatigue, pyrexia, infection
• Uncommon (0.1% to 1%): Ear pain, peripheral edema
• Rare (less than 0.1%): Drug fever
• Frequency not reported: Malaise, mesalamine-induced acute intolerance syndrome, plugged ears, adenovirus infection, aching, decreased body mass index,
• Postmarketing reports: Medication residue, elevated alkaline phosphatase, elevated GGT, elevated LDH, ear congestion^[Ref]

Respiratory

• Very common (10% or more): Nasopharyngitis (up to 15%)
• Common (1% to 10%): Upper respiratory tract infection, influenza like symptoms, rhinitis, cold/sore throat
• Uncommon (0.1% to 1%): Allergic and fibrotic lung reactions, dyspnea, cough, bronchospasm, pleural effusion, alveolitis, pulmonary eosinophilia, lung infiltration, pneumonitis, pharyngolaryngeal pain
• Very rare (less than 0.01%): Eosinophilic pneumonia
• Frequency not reported: Hypersensitivity pneumonitis (including interstitial pneumonitis, allergic alveolitis, eosinophilic pneumonitis, stuffy head, interstitial pulmonary fibrosis, bronchiolitis obliterans, sinusitis
• Postmarketing reports: Fibrosing alveolitis, asthma exacerbation, pleuritis, bronchitis^[Ref]

Cardiovascular

• Common (1% to 10%): Hypertension, vasodilation,
• Uncommon (0.1% to 1%): Pericarditis, myocarditis, pericardial effusion, tachycardia, hypotension
• Frequency not reported: Chest pain, T-wave abnormalities, Kawasaki-like syndrome^[Ref]

Dermatologic

• Common (1% to 10%): Rash, alopecia, urticaria, pruritus, acne
• Uncommon (0.1% to 1%): Lupus erythematosus syndrome, allergic exanthema, increased sweating, angioedema, Stevens-Johnson syndrome, face edema
• Very rare (less than 0.01%): Reversible alopecia, bullous skin reactions including erythema multiforme
• Frequency not reported: Dry skin, eczema, erythema nodosum, nail disorder, photosensitivity, lichen planus, ecchymosis
• Postmarketing reports: Prurigo, erythema, psoriasis, pyoderma gangrenosum^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain, arthralgia, leg/joint pain
• Uncommon (0.1% to 1%): Myalgia, chills, myositis, arthritis
• Frequency not reported: Leg cramps, lower back discomfort, muscle cramps, neck pain
• Postmarketing reports: Joint disorder, rheumatoid arthritis^[Ref]

Hepatic

• Common (1% to 10%): Hepatic function abnormal, increased alanine aminotransferase
• Uncommon (0.1% to 1%): Hepatitis, increased liver enzymes (transaminase activity), intrahepatic cholestasis, increased bilirubin
• Very rare (less than 0.01%): Hepatotoxicity (including cirrhosis, hepatic failure), changes in liver function parameters
• Frequency not reported: GGTP increase, SGOT increase, SGPT increase, sclerosing cholangitis, increased alkaline phosphatase
• Postmarketing reports: Jaundice, cholestatic jaundice, liver necrosis, cholecystitis^[Ref]

Metabolic

• Common (1% to 10%): Anorexia
• Frequency not reported: Thirst, edema
• Postmarketing reports: Increased appetite, gout^[Ref]

Ocular

• Common (1% to 10%): Vision abnormalities
• Uncommon (0.1% to 1%): Conjunctivitis
• Postmarketing reports: Blurred vision, eye pain^[Ref]

Renal

• Uncommon (0.1% to 1%): Acute or chronic interstitial nephritis, renal insufficiency, renal failure, nephrotoxicity
• Very rare (less than 0.01%): Nephrotic syndrome, urine discoloration
• Frequency not reported: Creatinine clearance decreased
• Postmarketing reports: Minimal change nephropathy, elevated serum creatinine and BUN^[Ref]

Hematologic

• Uncommon (0.1% to 1%): Thrombocytopenia, aplastic anemia, hemolytic anemia, agranulocytosis, leukopenia, neutropenia, pancytopenia, platelet count decreased
• Very rare (less than 0.01%): Eosinophilia (as part of an allergic reaction), anemia, bone marrow depression
• Frequency not reported: Thrombocythemia
• Postmarketing reports: Granulocytopenia, lymphadenopathy^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Allergic reaction, anaphylactic reaction, drug reaction with eosinophilia and systemic symptoms (DRESS)
• Frequency not reported: Anaphylactic shock, angioedema^[Ref]

Genitourinary

• Uncommon (0.1% to 1%): Oligospermia (reversible), UTI/urinary burning
• Frequency not reported: Albuminuria, amenorrhea, breast pain, hematuria, hypomenorrhea, menorrhagia, metrorrhagia, urinary frequency
• Postmarketing reports: Dysuria, urinary urgency, epididymitis^[Ref]

Psychiatric

• Uncommon (0.1% to 1%): Insomnia
• Frequency not reported: Depression, anxiety, decreased libido
• Postmarketing reports: Nervousness, confusion, emotional lability, confusion^[Ref]

See also:

Frequently asked questions

• What are 7 mesalamine side effects to be aware of?

Further information

Asacol HD side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer