What the label lists and what reports show
Mycophenolic acid side effects
Mycophenolic acid's FDA label: “Most common adverse reactions (≥ 20%): anemia, leukopenia, constipation, nausea, diarrhea, vomiting, dyspepsia, urinary tract infection, CMV infection, insomnia, and postoperative pain.” FAERS holds 31,820 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 (1,969 reports).
- Generic listed
- Boxed warning
Check it at the source: the mycophenolic acid FDA label on DailyMed (effective July 29, 2026, Novartis Pharmaceuticals Corporation); 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 Myfortic?Myfortic can cause serious side effects, including. See "What is the most important information I should know about Myfortic?" Stomach problems. Stomach and intestinal bleeding can happen in people who take Myfortic. Bleeding can be severe and you may have to be hospitalized for treatment. Inflammatory reactions. Some people taking Myfortic may have an inflammatory reaction with fever, joint stiffness, joint pain, and muscle pain. Some of these reactions may require hospitalization. This reaction could happen within weeks to months after you start treatment with Myfortic or if your dose is increased. Call your doctor right away if you experience these symptoms. Allergic (hypersensitivity) reactions. Allergic reactions, including a severe allergic reaction called anaphylaxis, can happen after taking Myfortic. […]
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective July 29, 2026 (SPL set eed26501-890d-4ff6-88e7-6dbea4726e53), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥ 20%): anemia, leukopenia, constipation, nausea, diarrhea, vomiting, dyspepsia, urinary tract infection, CMV infection, insomnia, and postoperative pain.
Table 2: Adverse Reactions (%) Reported in ≥ 10% of De novo Kidney Transplant Patients in Either Treatment Group
| Reaction | Myfortic 1.44 grams per day (n = 213) (%) | Mycophenolate mofetil (MMF) 2 grams per day (n = 210) (%) |
|---|---|---|
| Anemia | 22 | 22 |
| Leukopenia | 19 | 21 |
| Constipation | 38 | 40 |
| Nausea | 29 | 27 |
| Diarrhea | 24 | 25 |
| Vomiting | 23 | 20 |
| Dyspepsia | 23 | 19 |
| Abdominal pain upper | 14 | 14 |
| Flatulence | 10 | 13 |
| Edema | 17 | 18 |
| Edema lower limb | 16 | 17 |
| Pyrexia | 13 | 19 |
| Increased blood creatinine | 15 | 10 |
| Urinary tract infection | 29 | 33 |
| CMV infection | 20 | 18 |
| Hypocalcemia | 11 | 15 |
| Hyperuricemia | 13 | 13 |
| Hyperlipidemia | 12 | 10 |
| Hypokalemia | 13 | 9 |
| Hypophosphatemia | 11 | 9 |
| Back pain | 12 | 6 |
| Arthralgia | 7 | 11 |
| Insomnia | 24 | 24 |
| Tremor | 12 | 14 |
| Headache | 13 | 11 |
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. Embryo-Fetal Toxicity [see Boxed Warning, Warnings and Precautions (5.1)] Lymphomas and Other Malignancies [see Boxed Warning, Warnings and Precautions (5.3)] Serious Infections [see Boxed Warning, Warnings and Precautions (5.4)] New or Reactivated Viral Infections [see Warnings and Precautions (5.5)] Blood Dyscrasias, Including Pure Red Cell Aplasia [see Warnings and Precautions (5.6)] Serious GI Tract Complications [see Warnings and Precautions (5.7)] Acute Inflammatory Syndrome Associated with Mycophenolate Products [see Warnings and Precautions (5.8)] Hypersensitivity Reactions [see Warnings and Precautions (5.9)] Rare Hereditary Deficiencies [see Warnings and Precautions (5.11)] Most common adverse reactions (≥ 20%): anemia, leukopenia, constipation, nausea, diarrhea, vomiting, dyspepsia, urinary tract infection, CMV infection, insomnia, and postoperative pain. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective July 29, 2026 (SPL set eed26501-890d-4ff6-88e7-6dbea4726e53), via openFDA; the full label on DailyMed
What do FAERS reports show?
31,820 reports list mycophenolic acid among the medicines taken, each a report of something that happened, not proof the medicine caused it; 4,426 are coded as a death and 13,782 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 20 reactions below, 14 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?
- Mycophenolic acid: 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