Olsalazine Side Effects

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

Applies to olsalazine: oral capsule.

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:

More common side effects

• agitation
• bloody diarrhea
• blood in the urine
• coma
• confusion
• dark-colored urine
• decreased urine output
• depression
• dizziness
• fever
• general feeling of tiredness or weakness
• headache
• hostility
• increased sensitivity of the skin to sunlight
• irritability
• itching, skin rash
• lethargy
• light-colored stools
• muscle twitching
• nausea
• pain in the groin or genitals
• rapid weight gain
• redness or other discoloration of the skin
• seizures
• severe sunburn
• sharp back pain just below ribs
• stomach pain
• swelling of the face, ankles, or hands
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

Less common side effects

• pale skin
• trouble breathing
• unusual bleeding or bruising

Rare side effects

• back pain
• fast heartbeat
• swelling of the stomach

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:

More common side effects

• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• loss of appetite

Less common side effects

• aching joints and muscles
• acid or sour stomach
• acne
• anxiety
• belching
• bloated or full feeling
• body aches or pain
• bone pain
• congestion
• constipation
• coughing
• cramps
• difficulty with moving
• dizziness or drowsiness
• heartburn
• hoarseness
• indigestion
• muscle stiffness
• passing of gas
• shivering
• sleeplessness
• sneezing
• stomach discomfort or upset
• sweating
• swelling or inflammation of the mouth
• swollen joints
• tender, swollen glands in the neck
• trouble with sleeping
• trouble with swallowing
• unable to sleep
• voice changes
• weight loss

Rare side effects

• decreased interest in sexual intercourse
• flushing, redness of the skin
• hair loss or thinning of the hair
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• unusually warm skin

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]

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.

Medical Disclaimer