Should Dimethyl Fumarate Be Taken With Food?
Dimethyl fumarate can be taken with or without food according to the FDA label, but taking it with food is strongly recommended in clinical practice to reduce gastrointestinal adverse events. 1
FDA-Approved Administration Guidelines
- The FDA label explicitly states that dimethyl fumarate delayed-release capsules can be taken with or without food 1
- However, the FDA label notes that administration with food may reduce the incidence of flushing 1
- The capsules must be swallowed whole and intact—never crushed, chewed, or sprinkled on food 1
Clinical Practice Recommendations for Food Administration
Taking dimethyl fumarate with food is the primary strategy to prevent or reduce gastrointestinal adverse events, which occur in approximately 27% of patients. 2, 3
Specific Food Recommendations
- High-fat or protein-rich foods are most effective for reducing GI symptoms, with specific examples including sausage and peanut butter 2
- Most clinical sites (86%) routinely recommend that patients take dimethyl fumarate with food 3
- The American Academy of Dermatology guidelines support taking medication with food to reduce GI symptoms when switching between fumarate formulations 4
Evidence Supporting Food Co-Administration
- Sites that counseled patients to take dimethyl fumarate with food had lower discontinuation rates compared to sites that did not provide this recommendation 3
- A global Delphi consensus study found that 86% of MS nurses advised patients to take dimethyl fumarate with food, though patients were not always informed about the most appropriate types of food 5
- Real-world clinical experience demonstrates that food co-administration is one of the most effective strategies for managing GI adverse events 6, 7
Impact on Absorption and Tolerability
- While taking iron on an empty stomach maximizes absorption for that medication 8, the opposite approach applies to dimethyl fumarate where food improves tolerability without compromising efficacy 2
- The delayed-release formulation is designed to minimize GI effects, but food co-administration provides additional protection 2
Clinical Pitfall to Avoid
Do not advise patients to take dimethyl fumarate on an empty stomach despite the FDA label stating it "can" be taken without food—this significantly increases the risk of GI adverse events that lead to treatment discontinuation (5% of patients discontinue due to GI events within the first year). 3