Acute mycophenolate overdose: case series and systematic literature analysis

Expert Opin Drug Saf. 2014 May;13(5):525-34. doi: 10.1517/14740338.2014.903032. Epub 2014 Mar 21.


Background: Literature regarding acute human toxicity of mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS) is limited.

Objectives: Our objectives were to describe all cases of overdose with MMF or EC-MPS reported to the Swiss Toxicological Information Centre (STIC) or in the literature between 1995 and 2013. Therefore, we performed an observational case-series and systematic literature search to determine circumstances, magnitude, management and outcome of overdose with MMF or EC-MPS.

Results: Of 152,762 reports to STIC, 15 (7 pediatric) involved overdose with MMF (n = 13) or EC-MPS (n = 2). Three cases from other centers were identified from a systematic literature search. The magnitude of overdose ranged from 1.2 to 16.7 (median 2.9) times usual dose. Six (33%) MMF overdoses had attributable symptoms, which included abdominal pain, vomiting, headache and dizziness. The majority of findings were minor, although a 9-fold MMF overdose caused hypotension 8 h after ingestion and a 12.5-fold overdose caused leukopenia after 5 days. Symptoms did not occur in patients who took 2.5 times or less of their usual MMF dose. Gastrointestinal decontamination measures with activated charcoal were undertaken in one-third of cases.

Conclusions: Acute MMF and EC-MPS overdoses had a favorable outcome in all cases reported to STIC and in the literature.

Publication types

  • Meta-Analysis
  • Observational Study
  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Adolescent
  • Adult
  • Antidotes / therapeutic use
  • Charcoal / therapeutic use
  • Child
  • Child, Preschool
  • Drug Overdose / epidemiology
  • Drug Overdose / therapy*
  • Female
  • Humans
  • Immunosuppressive Agents / adverse effects*
  • Immunosuppressive Agents / pharmacokinetics
  • Immunosuppressive Agents / toxicity
  • Male
  • Middle Aged
  • Mycophenolic Acid / adverse effects
  • Mycophenolic Acid / analogs & derivatives*
  • Mycophenolic Acid / pharmacokinetics
  • Mycophenolic Acid / toxicity
  • Treatment Outcome
  • Young Adult


  • Antidotes
  • Immunosuppressive Agents
  • Charcoal
  • Mycophenolic Acid