Balsalazide

Chemical formula: C₁₇H₁₅N₃O₆  Molecular mass: 357.318 g/mol  PubChem compound: 6335412

Pregnancy

Human experience with balsalazide is limited, therefore it should not be given to pregnant women.

Nursing mothers

Balsalazide should not be given to breast feeding women as the active metabolite mesalazine has produced adverse effects in nursing infants.

Carcinogenesis, mutagenesis and fertility

Fertility

Animal studies on fertility and reproductive function did not reveal adverse effects of balsalazide.

Effects on ability to drive and use machines

Balsalazide has no or negligible influence on the ability to drive and use machines.

Adverse reactions


The adverse effects are expected to be those of mesalazine.

Reactions reported during treatment with oral mesalazine are listed in the table below.

Organ groupAdverse Event
Blood and lymphatic system disordersBlood dyscrasias
Aplastic anaemia Leucopenia
Neutropenia Agranulocytosis
Thrombocytopenia
Nervous system disordersHeadache
Neuropathy
Cardiac disordersMyocarditis
Pericarditis
Respiratory, thoracic and mediastinal disordersBronchospasm
Allergic alveolitis
Eosinophilic pneumonia
Gastrointestinal disordersAbdominal pain
Diarrhoea
Nausea, vomiting
Aggravation of ulcerative colitis
Acute pancreatitis
Hepatobiliary disordersHepatitis
Cholelithiasis
Skin and subcutaneous tissue disordersAlopecia
Angioedema
Rash
Musculoskeletal and connective tissue disordersSystemic lupus erythematosus-like syndrome
Arthralgia
Myalgia
Renal and urinary disordersInterstitial nephritis
Acute renal failure
Renal insufficiency
Renal impairment
Immune system disordersHypersensitivity

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