Mycophenolate Mofetil vs Mycophenolic Acid: side effects in FDA adverse event reports
At a glance
| Mycophenolate Mofetil | Mycophenolic Acid | |
|---|---|---|
| Drug class | – | – |
| Brand names | – | – |
| FAERS reports | 32,904 | 31,810 |
| Serious | 84% | 88% |
| Death outcome | 4,489 | 4,426 |
| Boxed warning | Yes EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenit | Yes EMBRYO-FETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS WARNING: EMBRYO-FETAL TOXICITY, MALIGNANCIES, and SERIOUS INFECTIONS See full prescribing informatio |
Signals both drugs share
| Reaction | Mycophenolate Mofetil | Mycophenolic Acid | Label screen (A / B) |
|---|---|---|---|
| Polyomavirus-associated nephropathy | 1,473 · PRR 272.3 | 274 · PRR 88.0 | Labeled adverse reaction / Not in label — unassessed |
| Renal transplant failure | 425 · PRR 117.2 | 132 · PRR 101.5 | Labeled (related wording) / Labeled (related wording) |
| Chronic allograft nephropathy | 435 · PRR 192.7 | 120 · PRR 118.4 | Labeled (related wording) / Labeled (related wording) |
| Delayed graft function | 389 · PRR 191.3 | 133 · PRR 152.8 | Not in label — unassessed / Labeled (related wording) |
| Renal graft infection | 144 · PRR 257.5 | 25 · PRR 79.6 | Labeled (related wording) / Labeled (related wording) |
| Pancreas transplant rejection | 96 · PRR 139.0 | 34 · PRR 132.2 | Labeled (related wording) / Labeled (related wording) |
| Transplant rejection | 4,106 · PRR 164.3 | 722 · PRR 65.3 | Likely indication confounding / Likely indication confounding |
| Kidney transplant rejection | 1,880 · PRR 99.3 | 713 · PRR 114.5 | Likely indication confounding / Likely indication confounding |
| Complications of transplanted kidney | 1,019 · PRR 130.9 | 349 · PRR 122.3 | Likely indication confounding / Likely indication confounding |
| Transplant dysfunction | 1,031 · PRR 221.6 | 172 · PRR 71.3 | Likely indication confounding / Likely indication confounding |
| Polyomavirus viraemia | 557 · PRR 196.9 | 127 · PRR 95.9 | Not in label — unassessed / Not in label — unassessed |
| Parvovirus b19 infection | 430 · PRR 148.5 | 83 · PRR 68.5 | Not in label — unassessed / Not in label — unassessed |
| Malacoplakia | 227 · PRR 215.6 | 78 · PRR 163.9 | Not in label — unassessed / Not in label — unassessed |
| Phaeohyphomycosis | 245 · PRR 179.0 | 44 · PRR 69.9 | Not in label — unassessed / Not in label — unassessed |
| Trichodysplasia spinulosa | 234 · PRR 257.7 | 50 · PRR 100.8 | Not in label — unassessed / Not in label — unassessed |
Labeled signals distinctive to Mycophenolate Mofetil
- Post transplant lymphoproliferative disorder — n=2,254, PRR 126.8 Labeled (related wording)
- Bk virus infection — n=1,455, PRR 119.5 Labeled adverse reaction
- Graft loss — n=296, PRR 105.1 Labeled adverse reaction
- Lung transplant rejection — n=251, PRR 94.0 Labeled (related wording)
- Human polyomavirus infection — n=227, PRR 120.6 Labeled (related wording)
- Cytomegalovirus gastrointestinal infection — n=113, PRR 93.8 Labeled (related wording)
Labeled signals distinctive to Mycophenolic Acid
- Lymphocele — n=82, PRR 92.1 Labeled adverse reaction
- Heart failure with preserved ejection fraction — n=50, PRR 156.1 Labeled (related wording)
- Herpes simplex hepatitis — n=22, PRR 67.7 Labeled (related wording)
Common questions
Which has more reported side effects, Mycophenolate Mofetil or Mycophenolic Acid?
Mycophenolate Mofetil has 32,904 FAERS reports and Mycophenolic Acid 31,810. More reports does not mean more dangerous: volume follows how widely and how long a drug has been used, prescription vs over-the-counter status, and publicity. The seriousness share (84% vs 88%) is a better like-for-like signal of the kind of problems reported.
Which side effects do Mycophenolate Mofetil and Mycophenolic Acid share?
Both drugs carry disproportionality signals for polyomavirus-associated nephropathy, renal transplant failure, chronic allograft nephropathy, delayed graft function, renal graft infection. Shared signals often reflect a shared drug class or the condition both are used for.
Is Mycophenolate Mofetil or Mycophenolic Acid safer?
FAERS cannot answer that: it has no denominator and no comparator. Use this page to see which risks are already on each label and which signals are unlabeled, then check the prescribing information and your clinician for your situation.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, openFDA count queries for seriousness and deaths. Pair chosen because it is a commonly searched comparison. Generated 2026-10-08.