Skip to Content

Asacol HD (Oral)

Generic Name: mesalamine (Oral route)

me-SAL-a-meen

Medically reviewed on Oct 31, 2018

Commonly used brand name(s)

See also: Entyvio

In the U.S.

  • Apriso
  • Asacol HD
  • Delzicol
  • Lialda
  • Pentasa

In Canada

  • Asacol 800

Available Dosage Forms:

  • Tablet, Delayed Release
  • Capsule, Delayed Release
  • Capsule, Extended Release

Therapeutic Class: Anti-Inflammatory

Chemical Class: Salicylate, Non-Aspirin

Uses For Asacol HD

Mesalamine is used to treat and prevent mild to moderately active ulcerative colitis (an inflammatory bowel disease). It works inside the bowels to reduce inflammation and other symptoms of the disease.

This medicine is available only with your doctor's prescription.

Before Using Asacol HD

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Delzicol® for the treatment of ulcerative colitis in children 5 years of age and older. Safety and efficacy have not been established in children younger than 5 years of age and for the prevention of ulcerative colitis in children.

Appropriate studies have not been performed on the relationship of age to the effects of Apriso™, Asacol® HD, Lialda®, or Pentasa® in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mesalamine in the elderly. However, elderly patients are more likely to have blood problems and age-related kidney disease, which may require caution and an adjustment in the dose for patients receiving mesalamine.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aceclofenac
  • Acemetacin
  • Amtolmetin Guacil
  • Bromfenac
  • Bufexamac
  • Celecoxib
  • Clonixin
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Dipyrone
  • Droxicam
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Ibuprofen
  • Indomethacin
  • Ketoprofen
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Mercaptopurine
  • Morniflumate
  • Nabumetone
  • Naproxen
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Phenylbutazone
  • Piketoprofen
  • Piroxicam
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Rofecoxib
  • Sulindac
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolfenamic Acid
  • Tolmetin
  • Valdecoxib
  • Varicella Virus Vaccine, Live

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Tamarind
  • Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergy to sulfasalazine (Azulfidine®) or
  • Skin problems (eg, atopic dermatitis, atopic eczema)—Use with caution. May cause side effects to become worse.
  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Liver disease—Use with caution. May make this condition worse.
  • Phenylketonuria (PKU)—The Apriso™ capsules contain aspartame, which may require caution in patients with PKU.

Proper Use of mesalamine

This section provides information on the proper use of a number of products that contain mesalamine. It may not be specific to Asacol HD. Please read with care.

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Do not stop using this medicine without checking first with your doctor.

Keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.

Swallow the capsule or tablet whole. Do not open, break, crush, or chew it.

Take the Asacol® HD tablet on an empty stomach, at least 1 hour before or 2 hours after a meal.

You should take the Lialda® tablets with food. All other brands of capsules and tablets can be taken with or without food.

If you have trouble swallowing the Delzicol® capsule, carefully open the capsule and take out the 4 tablets. Swallow the tablets whole and make sure all 4 are taken at the same time as one dose. Do not cut, break, crush, or chew them.

The contents of the Pentasa® capsule may be sprinkled onto soft foods (eg, applesauce or yogurt) if you have trouble swallowing the capsule. The mixture must be swallowed right away without chewing.

If you are taking the delayed-release capsule, extended-release capsule, or delayed-release tablet, part of the capsule or tablet may pass into your stool after your body has absorbed the medicine. Contact your doctor if this happens more often than 1 or 2 times.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For the treatment of ulcerative colitis:
    • For long-acting oral dosage form (delayed-release capsules):
      • Adults—800 milligrams (mg) 3 times a day.
      • Children 5 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually not more than 2400 mg per day, divided in 2 doses.
      • Children younger than 5 years of age—Use and dose must be determined by your doctor.
    • For long-acting oral dosage form (delayed-release tablets):
      • Adults—
        • For Asacol® HD: 1600 milligrams (mg) 3 times a day for 6 weeks.
        • For Lialda®: 2.4 to 4.8 grams (g) once a day.
      • Children—Use and dose must be determined by your doctor.
    • For long-acting oral dosage form (extended-release capsules):
      • Adults—
        • For Apriso™: 1.5 grams (g) once a day as a single dose in the morning.
        • For Pentasa®: 1 g (four 250 milligrams [mg] capsules or two 500 mg capsules) 4 times a day.
      • Children—Use and dose must be determined by your doctor.
  • For prevention of ulcerative colitis:
    • For long-acting oral dosage form (delayed-release capsules):
      • Adults—1600 milligrams (mg) per day, taken in divided doses.
      • Children—Use and dose must be determined by your doctor.
    • For long-acting oral dosage form (delayed-release tablets):
      • Adults—2.4 grams (g) once a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the delayed-release capsules and delayed-release tablets in a tightly-closed container to protect them from moisture.

Precautions While Using Asacol HD

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 or urine tests may be needed to check for unwanted effects.

Check with your doctor right away if you have abdominal or 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.

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.

Pentasa® extended-release capsules 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 Pentasa® extended-release capsules. 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.

Asacol HD Side Effects

Along with its needed effects, a medicine 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:

More common

  • Bloody diarrhea
  • rectal bleeding
  • stomach pain (severe)

Less common

  • Blurred vision
  • dizziness
  • fever
  • full or bloated feeling
  • headache (severe)
  • itching, skin rash
  • nervousness
  • pounding in the ears
  • pressure in the stomach
  • slow or fast heartbeat
  • stomach cramps (severe)
  • swelling of the abdominal or stomach area
  • unusual tiredness or weakness

Rare

  • Anxiety
  • back pain (severe)
  • blue or pale skin
  • chest pain, possibly moving to the left arm, neck, or shoulder
  • chills
  • nausea
  • vomiting
  • yellow eyes or skin

Incidence not known

  • Blistering, peeling, or loosening of the skin
  • bloody urine
  • change in the ability to see colors, especially blue or yellow
  • clay- colored stools
  • cough
  • dark urine
  • decreased frequency or amount of urine
  • diarrhea
  • general feeling of discomfort or illness
  • greatly increased frequency of urination or amount of urine
  • hair loss
  • headache
  • hives
  • increased blood pressure
  • increased thirst
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
  • loss of appetite
  • lower back or side pain
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomach pain or tenderness
  • swelling of the feet or lower legs
  • swollen glands
  • thickening of bronchial secretions
  • troubled breathing
  • weight gain

Some side effects 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:

More common

  • Diarrhea (mild)
  • runny or stuffy nose
  • sneezing

Less common

  • Acne
  • back pain
  • belching
  • difficulty with moving
  • excess air or gas in the stomach or bowels
  • hair loss or thinning of the hair
  • heartburn
  • indigestion
  • muscle stiffness
  • passing gas
  • stomach discomfort or upset

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide