Drug Levels and Effects:

Summary of Use during Lactation:

Mesalamine is poorly excreted into breastmilk. However, rather high levels of the mesalamine metabolite N-acetyl-5-ASA appear in breastmilk and its effects on breastfed infants are unknown. A few cases of diarrhea have been reported in infants exposed to mesalamine, although the rate is not high. European experts consider mesalamine derivatives to be safe during breastfeeding.[1] If mesalamine is required by the mother, it is not a reason to discontinue breastfeeding, but carefully observe breastfed infants for diarrhea during maternal use of mesalamine.

Drug Levels:

Mesalamine (5-aminosalicylic acid; 5-ASA) is metabolized to N-acetyl-5-ASA which is inactive in treating inflammatory bowel disease, but the metaqbolite's possible effects on the breastfed infant are unknown.

Maternal Levels.

One woman with ulcerative colitis (time postpartum not stated) was taking delayed-release tablets of mesalamine (Claversal) 500 mg orally 3 times daily. A single milk sample taken 5.25 hours after a dose contained 0.11 mg/L of mesalamine and 12.4 mg/L of N-acetyl-5-ASA.[2]

A woman with inactive ulcerative colitis was taking mesalamine (product not specified) 1 gram orally 3 times daily. A milk sample taken 1 week postpartum at 5 hours after a dose contained mesalamine 0.1 mg/L and N-acetyl-5-ASA 18.1 mg/L. Another milk sample taken 4 days later at 5 hours after a dose contained mesalamine 0.1 mg/L and N-acetyl-5-ASA 12.3 mg/L. The authors also report another mother taking 1 g of mesalamine daily (product not specified) who had a milk level of mesalamine that was undetectable and N-acetyl-5-ASA level of 2.2 mg/L (time of sampling and assay method not reported). The authors estimated that a fully breastfed infant whose mother was taking 1.5 grams of mesalamine daily would receive 0.015 mg/kg of mesalamine and 2.3 mg/kg of N-acetyl-5-ASA daily.[3]

Twelve women taking mesalamine in various oral dosage forms and one taking olsalazine capsules collected 1 to 8 breastmilk samples during one day 2 to 4 weeks postpartum. Mesalamine was undetectable (< 20 mcg/L) in most women, but detected in the milk of 3 women; one was taking Pentasa tablets 1 gram 3 times daily and one was taking Pentasa suppositories 1 gram at night and one was taking oral Asacol 400 mg twice daily plus Mesalal tablets 500 mg at night. Mesalamine milk levels ranged from 20 to 81 mcg/L. N-acetyl-5-ASA was detected in all milk samples, but there was no clear relationship between the dosages, times of the doses and the peak time in breastmilk. The individual average N-acetyl-5-ASA milk levels by product and dosage were Asacol tablets 800 mg daily, 0.24 mg/L (1 patient); Asacol tablets 800 mg daily plus Mesalal tablets 500 mg at night, 2.6 mg/L (1 patient); Mesalal tablets 500 mg daily, 0.75 mg/L (1 patient); Pentasa tablets 500 mg daily, 0.97 mg/L (1 patient); Pentasa tablets 1.5 grams daily, 2.8 to 6.5 mg/L (5 patients); Pentasa tablets 2 grams daily, 10.5 mg/L (1 patient); Pentasa tablets 3 grams daily, 10.2 mg/L (1 patient); Pentasa suppositories 1 gram daily, 1.9 mg/L (1 patient). Using the highest individual measured of 16.2 mg/L, the authors estimated that a fully breastfed infant would receive about 15 mg of N-acetyl-5-ASA daily, which is 1% ot the usual daily dosage (not weight-adjusted) of mesalamine.[4]

Four women with inflammatory bowel disease who were breastfeeding during mesalamine use had breastmilk samples taken. Specific dosages and mesalamine products were not reported nor were sampling times with respect to the doses. Mesalamine milk levels ranged from 4 to 40 mcg/L and N-acetyl-5-ASA milk levels ranged from 5 to 14.9 mg/L. The authors calculated a daily dosage of mesalamine of 0.6 to 6 mcg/kg daily in an exclusively breastfed infant. However, the N-acetyl-5-ASA dosage would be about 1000 times greater. The authors speculated that mesalamine might be metabolized in the breast to N-acetyl-5-ASA in the breast tissue, but provided no direct evidence of this happening.[5]

Infant Levels.

Relevant published information was not found as of the revision date.

Effects in Breastfed Infants:

A 6-week-old breastfed infant developed watery diarrhea 12 hours after the first maternal dose of mesalamine rectal suppositories 500 mg twice daily. The drug was stopped and reintroduced 4 times and each time the infant's diarrhea began 8 to 12 hours after the drug was started and ceased 8 to 12 hours after the drug was stopped. The infant's diarrhea was probably caused by mesalamine or it metabolite in breastmilk.[6]

A 4-month-old breastfed infant developed thrombosis of the superior saggital sinus following severe thrombocytosis. The infant's mother was receiving oral mesalamine in dosages averaging 1 to 1.5 grams daily throughout pregnancy and lactation. Breastfeeding had been stopped abruptly 1 week prior to the thrombotic event. The authors ruled out other causes of thrombosis and hypothesized that the abrupt discontinuation of long-term mesalamine exposure caused the thrombocytosis and thrombosis in the infant. They rated the reaction as possibly caused by the drug.[7]

In a prospective telephone follow-up study, 8 nursing mothers reported taking mesalamine (dosage and route unspecified). One mother reported diarrhea in her infant. No other adverse reactions were reported in the infants by their mothers.[8]

A small controlled study reported only in abstract form found no higher rate of diarrhea in the breastfed infants of mothers taking mesalamine or sulfasalazine than in control infants.[9]

Possible Effects on Lactation:

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider:



1. van der Woude CJ, Kolacek S, Dotan I et al. European evidenced-based consensus on reproduction in inflammatory bowel disease. J Crohn's Colitis. 2010;4:493-510. PMID:21122553
2. Jenss H, Weber P, Hartmann F. 5-Aminosalicylic acid and its metabolites in breast milk during lactation. Am J Gastroenterol. 1990;85:331. Letter. PMID:2309691
3. Klotz U, Harings-Kaim A. Negligible excretion of 5-aminosalicylic acid in breast milk. Lancet. 1993;342:618-9. Letter. PMID:8102746
4. Christensen LA , Rasmussen SN, Hansen SH. Disposition of 5-aminosalicylic acid and N-acetyl-5-aminosalicylic acid in fetal and maternal body fluids during treatment with different 5-aminosalicylic acid preparations. Acta Obstet Gynecol Scand. 1994;73:399-402. PMID:8009971
5. Silverman DA, Ford J, Shaw I et al. Is mesalazine really safe for use in breastfeeding mothers? Gut. 2005;54:170-1. PMID:15591526
6. Nelis GF. Diarrhoea due to 5-aminosalicylic acid in breast milk. Lancet. 1989;333:383. Letter. PMID:2563532
7. Barriuso LM, Yoldi-Petri ME, Olaciregui O et al. [Thrombosis of the superior sagittal sinus in a breast fed infant: secondary to prolonged exposure to mesalazine?]. Rev Neurol. 2003;36:1142-4. PMID:12833232
8. Ito S, Blajchman A, Stephenson M et al. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168:1393-9. PMID:8498418
9. Moretti ME, Spiczynski Y, Hashemi G et al. Prospective follow-up of infants exposed to 5-aminosalicylic acid containing drugs through maternal milk. J Clin Pharmacol. 1998;38 (Suppl):867. Abstract.

Substance Identification:

Substance Name:


CAS Registry Number:


Drug Class:

  • Gastrointestinal Agents

  • Anti-Inflammatory Agents, Non-Steroidal

  • Administrative Information:

    LactMed Record Number:


    Last Revision Date:

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