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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

Ask House about Balsalazide

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Sources: Goodman & Gilman 14e, Katzung, BNF, Nelson·Verified: 2026-05-10 · House clinical team