This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS • Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1) , Use in Special Populations (8.1 , 8.3 )]. • Increased risk of development of lymphoma and other malignancies, particularly of the skin [see Warnings and Precautions (5.2) ]. • Increased susceptibility to bacterial, viral, fungal and protozoal infections, including opportunistic infections and viral reactivation of hepatitis B and C, which may lead to hospitalizations and fatal outcomes [see Warnings and Precautions (5.3) ]. WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS See full prescribing information for complete boxed warning • Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see War...
Mycophenolate mofetil capsules are indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1) ], heart [see Clinical Studies (14.2) ] or liver transplants [see Clinical Studies (14.3) ], in combination with other immunosuppressants. Mycophenolate Mofetil capsules are an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. ( 1 )
Mycophenolate mofetil capsule is contraindicated in patients with a history of hypersensitivity, including anaphylaxis, to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product [see Warnings and Precautions ( 5.8 )]. • History of hypersensitivity, including anaphylaxis, to mycophenolate mofetil, mycophenolic acid or any component of the drug product
• Blood Dyscrasias (Neutropenia, Red Blood Cell Aplasia): Monitor with blood tests; consider treatment interruption or dose reduction. ( 5.4 ) • Gastrointestinal Complications: Monitor for complications such as bleeding, ulceration and perforations, particularly in patients with underlying gastrointestinal disorders. ( 5.5 ) • Hypoxanthine-Guanine Phosphoribosyl-Transferase Deficiency: Avoid use of mycophenolate mofetil. ( 5.6 ) • Acute Inflammatory Syndrome Associated with Mycophenolate Products: Monitor for this paradoxical inflammatory reaction. ( 5.7 ) • Hypersensitivity Reactions: Discontinue mycophenolate mofetil; treat and monitor until signs and symptoms resolve. ( 5.8 ) • Immunizations: Avoid live attenuated vaccines. ( 5.9 ) • Blood Donation: Avoid during therapy and for 6 weeks thereafter. ( 5.12 ) • Semen Donation: Avoid during therapy and for 90 days thereafter. ( 5.13 ) • Potential Impairment on Driving and Use of Machinery: Mycophenolate mofetil may affect ability to drive or operate machinery. ( 5.15 ) 5.1 Embryofetal Toxicity Use of MMF during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malfor...
The 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) ] • H ypersensitivity 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 Hetero Labs Limited at 1-866-495-1995 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 r...
Warnings and Precautions (5.8) 05/2025
Source: FDA SPL label for Mycophenolate Mofetil (Camber Pharmaceuticals, Inc.), effective 20250802. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 9,984 | 10,438 | 9,917 | 10,160 | 11,147 | 14,277 | 14,311 | 6,708 |
67,450 reports blaming this drug for every million Medicare prescriptions filled, which is 24.4× the typical drug on this site. (34,966 reports in 2024–2026, against 518,400 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 08/2026 | Class II | Mylan Pharmaceuticals Inc | Failed Dissolution Specifications |
| 07/2026 | Class II | MYLAN PHARMACEUTICALS INC | Presence of precipitate |
| 04/2019 | Class I | Par Pharmaceutical, Inc. | Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $3,203 in payments to US physicians and hospitals tied to this drug across 9 transactions (mycophenolate mofetil $2,328, Myhibbin $875).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Mycophenolate Mofetil | 516,697 | $122 |
| Cellcept | 1,688 | $2,421 |
| Myhibbin | 15 | $847 |
No same-class alternatives found in RxClass.