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Balsalazide Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Feb 16, 2023.

Applies to balsalazide: oral capsule.

Serious side effects of Balsalazide

Along with its needed effects, balsalazide 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 balsalazide:

More common

Less common


Incidence not known

Other side effects of Balsalazide

Some side effects of balsalazide 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

Less common


Incidence not known

For Healthcare Professionals

Applies to balsalazide: oral capsule, oral tablet.


Very common (10% or more): Abdominal pain upper (17%), vomiting (17%), abdominal pain (12%), diarrhea (11%)

Common (1% to 10%): Flatulence, dyspepsia, dry mouth, constipation, colitis ulcerative, hematochezia, nausea, stomatitis

Frequency not reported: Defecation urgency, hard feces, gastroesophageal reflux disease, gastroenteritis

Postmarketing reports: Pancreatitis[Ref]

Nervous system

Very common (10% or more): Headache (15%)

Frequency not reported: Dizziness, lethargy[Ref]


Very common (10% or more): Pyrexia (11%)

Common (1% to 10%): Fatigue, fever, flu-like disorder, pyrexia

Frequency not reported: Malaise, pain, pyrexia[Ref]


Common (1% to 10%): Arthralgia, musculoskeletal pain, myalgia, cramps

Frequency not reported: Back pain[Ref]


Common (1% to 10%): Pharyngolaryngeal pain, coughing

Postmarketing reports: Alveolitis, pleural effusion[Ref]


Frequency not reported: Increased aspartate aminotransferase

Postmarketing reports: Elevated liver enzymes (AST, ALT, GGT, LDH, alkaline phosphatase), elevated bilirubin, jaundice, cholestatic jaundice, cirrhosis, hepatocellular damage including liver necrosis and liver failure, Kawasaki-like syndrome including hepatic dysfunction[Ref]


Common (1% to 10%): Anemia[Ref]


Frequency not reported: Increased blood pressure, increased heart rate

Postmarketing reports: Myocarditis, pericarditis, vasculitis[Ref]


Postmarketing reports: Renal failure, interstitial nephritis[Ref]


Frequency not reported: Erythema nodosum, rash, face edema

Postmarketing reports: Alopecia, pruritus[Ref]


Common (1% to 10%): Nasopharyngitis, rhinitis, pharyngitis, urinary tract infection, influenza

Frequency not reported: Upper respiratory infection

Postmarketing reports: Pneumonia (with and without eosinophilia)[Ref]


Common (1% to 10%): Anorexia[Ref]


Common (1% to 10%): Insomnia[Ref]


Common (1% to 10%): Dysmenorrhea[Ref]


1. Product Information. Colazal (balsalazide). Salix Pharmaceuticals. 2001.

2. Product Information. Giazo (balsalazide). Valeant Pharmaceuticals. 2018.

Further information

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

Some side effects may not be reported. You may report them to the FDA.