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Drug reference

Balsalazide

Aminosalicylate · Inflammatory bowel disease

Also known as Balsalazide sodium, Balsalazide disodium

AminosalicylateInflammatory bowel disease
CDSCO approved
EXCRETION
—
not curated
INTERACTIONS
12 major
SEVERE in our sources
PREGNANCY
Manufacturer advises avoid.
FDA category + note
Top interactionssee all 12 →
  • CidofovirSevereDatabaseDDInter
  • DeferasiroxSevereDatabaseDDInter
  • DiatrizoateSevereDatabaseDDInter
  • Human Cytomegalovirus Immune GlobulinSevereDatabaseDDInter

Mechanism

Balsalazide sodium is a pro-drug of 5-aminosalicylic acid (5-ASA). It acts as a carrier to deliver 5-ASA to the colonic site of action. 5-ASA exerts local anti-inflammatory effects in the bowel.

Indications

Treatment of mild to moderate ulcerative colitis, acute attackMaintenance of remission of ulcerative colitisInflammatory bowel diseaseinduction and maintenance of remission in mild-to-moderate ulcerative colitissevere ulcerative colitis (in combination with glucocorticoids)

Dosing

Adult
Treatment of mild to moderate ulcerative colitis, acute attack: 2.25 g 3 times a day until remission occurs or for up to a maximum of 12 weeks. Maintenance of remission of ulcerative colitis: 1.5 g twice daily, adjusted according to response.
Renal adjustment
Avoid in moderate to severe impairment. Renal function should be monitored more frequently.
Hepatic adjustment
Caution; avoid in severe impairment (no information available).
Max dose
6.75 g per day

Contraindications

  • Salicylate hypersensitivity
  • Severe hepatic impairment
  • Moderate to severe renal impairment
  • History of asthma

Side effects

Common
ArthralgiaCoughDiarrhoeaDizzinessFeverGastrointestinal discomfortHeadacheLeucopeniaNauseaSkin reactionsVomitingdyspepsiaskin rash
Serious
  • Alopecia
  • Depression
  • Dyspnoea
  • Myalgia
  • Photosensitivity reaction
  • Thrombocytopenia
  • Agranulocytosis
  • Bone marrow disorders
  • Cardiac inflammation
  • Hepatitis
  • Neutropenia
  • Pancreatitis
  • Peripheral neuropathy
  • Renal impairment
  • Respiratory disorders
  • Angioedema
  • Eosinophilia
  • Haemolytic anaemia
  • Nephritis tubulointerstitial
  • Oligozoospermia (reversible)
  • Ulcerative colitis aggravated
  • Cholelithiasis
  • Lupus-like syndrome
  • nephrotoxicity (interstitial nephritis)
  • pericarditis
  • pleuritis

Pregnancy & lactation

Pregnancy

Manufacturer advises avoid.

Lactation

Diarrhoea may develop in the infant. Monitor breast-fed infants for diarrhoea.

Drug interactions

Cidofovir
Severe
Database

Clinical effect not specified

Source: DDInter

Deferasirox
Severe
Database

Drug interaction classified as: synergy

Source: DDInter

Diatrizoate
Severe
Database

Clinical effect not specified

Source: DDInter

Human Cytomegalovirus Immune Globulin
Severe
Database

Clinical effect not specified

Source: DDInter

Inotersen
Severe
Database

Clinical effect not specified

Source: DDInter

Iodipamide
Severe
Database

Clinical effect not specified

Source: DDInter

Iodixanol
Severe
Database

Clinical effect not specified

Source: DDInter

Iohexol
Severe
Database

Drug interaction classified as: synergy

Source: DDInter

Iopamidol
Severe
Database

Drug interaction classified as: synergy

Source: DDInter

Iopromide
Severe
Database

Clinical effect not specified

Source: DDInter

Iothalamic Acid
Severe
Database

Clinical effect not specified

Source: DDInter

Ioversol
Severe
Database

Clinical effect not specified

Source: DDInter

Related guidelines

Other Aminosalicylate drugs

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Textbook-sourced·Sources: Goodman & Gilman 14e, Katzung, BNF, Nelson·Updated: 2026-05-10