Understanding and Preventing ( N-Nitrosodimethylamine) NDMA Contamination of Medications

Ann Pharmacother. 2020 Jun;54(6):611-614. doi: 10.1177/1060028019892222. Epub 2019 Nov 26.


N-nitrosodimethylamine (NDMA) is a hepatotoxic agent and carcinogen contaminant in commonly used medications such as valsartan, losartan, irbesartan, and ranitidine. NDMA can be produced during manufacture, introduced from contaminated ingredients procured elsewhere, or introduced from contaminated solvents and catalysts. The Food and Drug Administration has established a maximum dose of NDMA that is permissible per tablet and guidance for manufacturers. However, many unanswered questions about NDMA contamination need rigorous investigation.

Keywords: FDA; NDMA; contamination; drug safety; manufacturing.

Publication types

  • Editorial

MeSH terms

  • Angiotensin Receptor Antagonists / standards*
  • Dimethylnitrosamine* / analysis
  • Dimethylnitrosamine* / toxicity
  • Drug Contamination / prevention & control*
  • Humans
  • Ranitidine / standards*
  • Tablets
  • United States
  • United States Food and Drug Administration


  • Angiotensin Receptor Antagonists
  • Tablets
  • Ranitidine
  • Dimethylnitrosamine