Olsalazine Side Effects

Medically reviewed by Drugs.com. Last updated on Apr 25, 2025.

Applies to olsalazine: oral capsule.

Precautions

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

This medicine 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.

Make sure any doctor or dentist who treats you knows that you are using mesalamine. This medicine may affect the results of certain medical tests.

Do not use this medicine for at least 6 weeks after receiving varicella vaccine to avoid the risk of having unwanted effects (eg, Reye's syndrome).

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 olsalazine

Along with its needed effects, olsalazine 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 olsalazine:

Incidence not know

• blistering, peeling, or loosening of the skin
• chest pain
• chills
• cough
• diarrhea
• 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
• swelling of the feet or lower legs
• unsteadiness or awkwardness
• weakness in the arms, hands, legs, or feet

Other side effects of olsalazine

Some side effects of olsalazine 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 olsalazine: oral capsule.

General adverse events

The most commonly reported side effects included diarrhea, abdominal pain, cramps, nausea, and headaches.^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (up to 17%), abdominal pain (up to 10.1%), cramps (10.1%)
• Common (1% to 10%): Bloating, heartburn, loose stools, nausea, rectal bleeding, stomatitis, upset stomach, vomiting
• Uncommon (0.1% to 1%): Dyspepsia
• Frequency not reported: Abdominal pain upper, diarrhea with dehydration, dry mouth, epigastric discomfort, exacerbation/flare in symptoms, flatulence, increased blood in stool, pancreatitis, rectal discomfort^[Ref]

Compared to patients given placebo, increased frequency and intensity of diarrhea was reported in patients given 500 mg orally 2 times a day who were also receiving pelvic radiation.^[Ref]

Nervous system

• Common (1% to 10%): Dizziness, headache, lightheadedness, vertigo
• Uncommon (0.1% to 1%): Paresthesia
• Frequency not reported: Drowsiness, lethargy, peripheral neuropathy, tremors^[Ref]

Dermatologic

• Common (1% to 10%): Itching, rash
• Uncommon (0.1% to 1%): Alopecia, photosensitivity/photosensitivity reaction, pruritus, urticaria
• Frequency not reported: Erythema, erythema nodosum^[Ref]

Psychiatric

• Common (1% to 10%): Depression, insomnia
• Frequency not reported: Irritability, mood swings^[Ref]

Musculoskeletal

• Common (1% to 10%): Arthralgia, joint pain
• Uncommon (0.1% to 1%): Myalgia
• Frequency not reported: Muscle cramps^[Ref]

Respiratory

• Common (1% to 10%): Upper respiratory infection
• Uncommon (0.1% to 1%): Dyspnea
• Frequency not reported: Bronchospasm, interstitial lung/pulmonary disease, shortness of breath^[Ref]

Metabolic

• Common (1% to 10%): Anorexia
• Postmarketing reports: Elevated lactate dehydrogenase (LDH)^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Hepatic enzyme increased
• Rare (0.01% to 0.1%): Granulomatous hepatitis, nonspecific, reactive hepatitis
• Frequency not reported: ALT elevated beyond normal range, AST elevated beyond normal range, hepatitis, increased bilirubin, mild cholestatic hepatitis
• Postmarketing reports: Cholestatic jaundice, cirrhosis, elevated alkaline phosphatase, elevated GGT, hepatic function changes, hepatocellular damage, hepatotoxicity, jaundice, liver failure, liver necrosis^[Ref]

Patients who developed granulomatous hepatitis, nonspecific, reactive hepatitis, or mild cholestatic hepatitis had complete recovery after treatment was withdrawn.^[Ref]

Hematologic

• Uncommon (0.1% to 1%): Thrombocytopenia
• Frequency not reported: Anemia, aplastic anemia, eosinophilia, granulocytopenia, hemolysis, hemolytic anemia, leukopenia, lymphopenia, neutropenia, pancytopenia, reticulocytosis^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Tachycardia
• Frequency not reported: Chest pains, heart block second degree, hot flashes, hypertension, myocarditis, orthostatic hypotension, palpitations, pericarditis, peripheral edema^[Ref]

A patient developed thyroid disease 9 days after starting treatment and was given propranolol radioactive iodine; the patient then developed nausea and shortness of breath and died 5 days later with signs/symptoms of acute diffuse myocarditis.^[Ref]

Other

• Uncommon (0.1% to 1%): Pyrexia
• Frequency not reported: Chills, fatigue, fever, miscellaneous side effects, rigors, tinnitus^[Ref]

Genitourinary

• Frequency not reported: Dysuria, frequency/urinary frequency, hematuria, impotence, menorrhagia, proteinuria^[Ref]

Ocular

• Frequency not reported: Blurred vision, dry eyes, watery eyes^[Ref]

Renal

• Frequency not reported: Interstitial nephritis, nephrotic syndrome^[Ref]

Hypersensitivity

• Frequency not reported: Angioneurotic edema^[Ref]

See also:

Further information

Olsalazine 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.

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