What the label lists and what reports show
Mycophenolate mofetil side effects
Mycophenolate mofetil's FDA label: “The most common adverse reactions in clinical trials (20 % or greater) include diarrhea, leukopenia, infection, vomiting, and there is evidence of a higher frequency of certain types of infections e.g., opportunistic infection.” FAERS holds 135,260 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (6,997 reports).
- Generic listed
- Boxed warning
Check it at the source: the mycophenolate mofetil FDA label on DailyMed (effective August 5, 2026, Genentech, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of CELLCEPT?CELLCEPT may cause serious side effects, including: See " What is the most important information I should know about CELLCEPT? " Low blood cell counts. People taking high doses of CELLCEPT each day may have a decrease in blood counts, including: white blood cells, especially neutrophils. Neutrophils fight against bacterial infections. You have a higher chance of getting an infection when your white blood cell count is low. This is most common from 1 month to 6 months after your transplant. red blood cells. Red blood cells carry oxygen to your body tissues. You have a higher chance of getting severe anemia when your red blood cell count is low. platelets. Platelets help with blood clotting. Your doctor will do blood tests before you start taking CELLCEPT and during treatment with CELLCEPT to check your blood cell counts. […]
Source: FDA drug label, NDA050722 (Roche Palo), as published by Genentech, Inc., effective August 5, 2026 (SPL set 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions in clinical trials (20 % or greater) include diarrhea, leukopenia, infection, vomiting, and there is evidence of a higher frequency of certain types of infections e.g., opportunistic infection.
Table 5 Adverse Reactions in Controlled Studies of De Novo Kidney, Heart or Liver Transplantation Reported in ≥20% of Patients in the CELLCEPT Group
| System Organ Class | CellCept 2g/day (n=501) or 3g/day (n=490) (n=991) % | AZA 1 to 2 mg/kg/day or 100 to 150 mg/day (n=326) % | Placebo (n=166) % | CellCept 3g/day (n=289) % | AZA 1.5 to 3 mg/kg/day (n=289) % | CellCept 3g/day (n=277) % | AZA 1 to 2 mg/kg/day (n=287) % |
|---|---|---|---|---|---|---|---|
| Bacterial infections | 39.9 | 33.7 | 37.3 | - | - | 27.4 | 26.5 |
| Anemia | 20.0 | 23.6 | 2.4 | 45.0 | 47.1 | 43.0 | 53.0 |
| Leukopenia | 28.6 | 24.8 | 4.2 | 34.3 | 43.3 | 45.8 | 39.0 |
| Hypertension | 27.5 | 32.2 | 19.3 | 78.9 | 74.0 | 62.1 | 59.6 |
| Abdominal pain | 22.4 | 23.0 | 11.4 | 41.9 | 39.4 | 62.5 | 51.2 |
| Diarrhea | 30.4 | 20.9 | 13.9 | 52.6 | 39.4 | 51.3 | 49.8 |
| Edema "Edema" includes peripheral edema, facial edema, scrotal edema. | 21.0 | 28.2 | 8.4 | 67.5 | 55.7 | 48.4 | 47.7 |
| Pain "Pain" includes musculoskeletal pain (myalgia, neck pain, back pain). | 24.8 | 32.2 | 9.6 | 79.2 | 77.5 | 74.0 | 77.5 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in greater detail in other sections of the label: Embryofetal Toxicity [see Warnings and Precautions (5.1) ] Lymphomas and Other Malignancies [see Warnings and Precautions 5.2) ] Serious Infections [see Warnings and Precautions (5.3) ] Blood Dyscrasias: Neutropenia, Pure Red Cell Aplasia [see Warnings and Precautions (5.4) ] Gastrointestinal Complications [see Warnings and Precautions (5.5) ] Acute Inflammatory Syndrome Associated with Mycophenolate Products [see Warnings and Precautions (5.7) ] Hypersensitivity Reactions [see Warnings and Precautions (5.8) ] The most common adverse reactions in clinical trials (20 % or greater) include diarrhea, leukopenia, infection, vomiting, and there is evidence of a higher frequency of certain types of infections e.g., opportunistic infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, NDA050722 (Roche Palo), as published by Genentech, Inc., effective August 5, 2026 (SPL set 37241e87-4af4-4dc3-a1aa-ea6f20d8dc40), via openFDA; the full label on DailyMed
What do FAERS reports show?
135,260 reports list mycophenolate mofetil among the medicines taken, each a report of something that happened, not proof the medicine caused it; 24,305 are coded as a death and 51,893 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 13 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Mycophenolate mofetil: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions