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Drug · FAERS side-effect profile with label screen

Mycophenolate Mofetil side effects: what 134,957 FDA adverse event reports show

Mycophenolate Mofetil · 1,379 reaction terms · 617,424 drug–reaction co-reports · data 2026-09-14

Drug class

Antimetabolite immunosuppressant

FDA label, Indications wording

Who reports

134,957 reports · 91% serious · 24,236 with death outcome · 50% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Mycophenolate mofetil (MMF) is 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.

FDA label, Indications and Usage

What it is

Mycophenolate mofetil is a carboxylic ester resulting from the formal condensation between the carboxylic acid group of mycophenolic acid and the hydroxy group of 2-(morpholin-4-yl)ethanol.

PubChem CID 5281078 (ChEBI)

Boxed 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.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 4Labeled (related wording) 8Likely indication confounding 7Not in label — unassessed 21

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,339 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Smooth muscle cell neoplasm	290	371.0 299.8–459.2ROR 371.8 · calibrated p 2e-12 ✓	107.9 EB05 97.9 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious n=289 · ♀ 82% (drug 50%) · 100% clinician	not reported in cached trials
Polyomavirus-associated nephropathy	1,471	271.8 249.6–295.9ROR 274.8 · calibrated p 2e-11 ✓	98.1 EB05 94.0 · IC025 +6.5 3/3 methods agree	Labeled adverse reaction exact term	serious n=1,471 · ♀ 28% (drug 50%) · 97% clinician	not reported in cached trials
Renal graft infection	144	257.9 197.3–337.2ROR 258.2 · calibrated p 8e-11 ✓	95.2 EB05 82.8 · IC025 +5.9 3/3 methods agree	Labeled (related wording) related wording	serious n=144 · 100% clinician	not reported in cached trials
Trichodysplasia spinulosa	233	255.2 206.9–314.8ROR 255.6 · calibrated p 7e-11 ✓	95.3 EB05 85.4 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=201 · 100% clinician	not reported in cached trials
Transplant dysfunction	1,030	221.5 201.3–243.7ROR 223.2 · calibrated p 2e-10 ✓	90.7 EB05 86.1 · IC025 +6.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=1,030 · 96% clinician	not reported in cached trials
Malacoplakia	227	216.0 176.5–264.4ROR 216.4 · calibrated p 3e-10 ✓	89.2 EB05 79.9 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=223 · 100% clinician	not reported in cached trials
Grip strength	134	214.8 165.1–279.3ROR 215.0 · calibrated p 4e-10 ✓	88.6 EB05 76.7 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=134 · ♀ 100% (drug 50%) · 100% clinician	not reported in cached trials
Polyomavirus viraemia	555	195.6 172.5–221.8ROR 196.4 · calibrated p 5e-10 ✓	85.9 EB05 80.1 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious n=551 · 97% clinician	not reported in cached trials
Chronic allograft nephropathy	434	192.1 166.8–221.3ROR 192.7 · calibrated p 6e-10 ✓	85.2 EB05 78.7 · IC025 +6.1 3/3 methods agree	Labeled (related wording) related wording	serious n=433 · 93% clinician	not reported in cached trials
Delayed graft function	389	191.7 165.1–222.5ROR 192.2 · calibrated p 7e-10 ✓	85.1 EB05 78.2 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=389 · 94% clinician	not reported in cached trials
C-reactive protein	494	187.1 164.0–213.4ROR 187.8 · calibrated p 8e-10 ✓	84.2 EB05 78.2 · IC025 +6.1 3/3 methods agree	Labeled adverse reaction exact term	serious n=494 · ♀ 100% (drug 50%) · 96% clinician	not reported in cached trials
Phaeohyphomycosis	245	179.3 149.1–215.7ROR 179.7 · calibrated p 1e-9 ✓	82.4 EB05 74.1 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=245 · ♀ 28% (drug 50%) · 100% clinician	not reported in cached trials
Heart transplant rejection	557	178.5 158.0–201.8ROR 179.3 · calibrated p 1e-9 ✓	82.5 EB05 76.9 · IC025 +6.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=556	NCT00300274: 26/268 (9.7%) on Mycophenolate Mofetil (serious AE)
Transplant rejection	4,103	164.3 157.3–171.7ROR 169.5 · calibrated p 2e-9 ✓	79.5 EB05 77.5 · IC025 +6.2 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 50.4 · 93% clinician	NCT00300274: 26/268 (9.7%) on Mycophenolate Mofetil (serious AE)
Swollen joint count	121	151.0 117.4–194.2ROR 151.1 · calibrated p 7e-9 ✓	75.4 EB05 64.8 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=121 · ♀ 100% (drug 50%) · 100% clinician	not reported in cached trials
Parvovirus b19 infection	429	148.1 129.7–169.1ROR 148.6 · calibrated p 6e-9 ✓	75.3 EB05 69.5 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=382 · 100% clinician	not reported in cached trials
Deep vein thrombosis postoperative	937	142.8 130.6–156.1ROR 143.8 · calibrated p 7e-9 ✓	74.1 EB05 70.2 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=937 · ♀ 100% (drug 50%) · 92% clinician	not reported in cached trials
Pancreas transplant rejection	96	139.2 105.5–183.6ROR 139.3 · calibrated p 2e-8 ✓	72.2 EB05 60.9 · IC025 +5.4 3/3 methods agree	Labeled (related wording) related wording	serious n=96 · ♀ 0% (drug 50%) · 100% clinician	not reported in cached trials
Complications of transplanted heart	100	134.7 103.0–176.3ROR 134.8 · calibrated p 2e-8 ✓	71.0 EB05 60.1 · IC025 +5.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=100 · ♀ 0% (drug 50%) · 100% clinician	NCT00300274: 2/268 (0.7%) on Mycophenolate Mofetil (serious AE)
Mycobacterium haemophilum infection	117	132.9 103.7–170.3ROR 133.0 · calibrated p 2e-8 ✓	70.6 EB05 60.5 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=117 · ♀ 0% (drug 50%) · 100% clinician	not reported in cached trials
Complications of transplanted kidney	1,019	131.1 120.6–142.6ROR 132.1 · calibrated p 1e-8 ✓	70.8 EB05 67.3 · IC025 +6.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=1,016 · 92% clinician	not reported in cached trials
Post transplant lymphoproliferative disorder	2,253	126.9 120.1–134.2ROR 129.1 · calibrated p 2e-8 ✓	69.6 EB05 67.3 · IC025 +6.0 3/3 methods agree	Labeled (related wording) related wording	serious n=2,250 · 98% clinician	not reported in cached trials
Alternaria infection	164	125.5 102.0–154.3ROR 125.6 · calibrated p 3e-8 ✓	68.7 EB05 60.3 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=162 · ♀ 0% (drug 50%) · 100% clinician	not reported in cached trials
Lupus vulgaris	520	120.9 107.7–135.6ROR 121.3 · calibrated p 3e-8 ✓	67.7 EB05 62.9 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=520 · ♀ 100% (drug 50%) · 95% clinician	not reported in cached trials
Human polyomavirus infection	227	120.8 101.5–143.8ROR 121.0 · calibrated p 3e-8 ✓	67.4 EB05 60.4 · IC025 +5.7 3/3 methods agree	Labeled (related wording) related wording	serious n=212 · 100% clinician	not reported in cached trials
Bk virus infection	1,455	119.7 111.8–128.2ROR 121.0 · calibrated p 3e-8 ✓	67.4 EB05 64.5 · IC025 +6.0 3/3 methods agree	Labeled adverse reaction exact term	serious n=1,403 · 97% clinician	NCT00300274: 1/279 (0.4%) on Mycophenolate Mofetil (serious AE)
Renal transplant failure	425	117.4 103.5–133.3ROR 117.8 · calibrated p 4e-8 ✓	66.5 EB05 61.4 · IC025 +5.8 3/3 methods agree	Labeled (related wording) related wording	serious n=424 · 94% clinician	not reported in cached trials
Chronic graft versus host disease in skin	372	107.5 94.1–122.7ROR 107.8 · calibrated p 7e-8 ✓	63.2 EB05 58.0 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=372 · 93% clinician	not reported in cached trials
Graft loss	295	104.7 90.3–121.4ROR 104.9 · calibrated p 9e-8 ✓	62.2 EB05 56.5 · IC025 +5.6 3/3 methods agree	Labeled adverse reaction exact term	serious n=293 · 100% clinician	not reported in cached trials
Complications of transplanted lung	120	100.9 80.1–127.1ROR 101.0 · calibrated p 1e-7 ✓	60.5 EB05 52.0 · IC025 +5.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=120 · ♀ 0% (drug 50%) · 100% clinician	not reported in cached trials
Graft dysfunction	114	100.9 79.6–127.9ROR 101.0 · calibrated p 2e-7 ✓	60.5 EB05 51.7 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=113 · ♀ 0% (drug 50%) · 100% clinician	not reported in cached trials
Kidney transplant rejection	1,880	99.5 93.9–105.4ROR 100.8 · calibrated p 1e-7 ✓	60.5 EB05 58.3 · IC025 +5.8 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=1,876	not reported in cached trials
Acute graft versus host disease in intestine	536	96.1 86.3–107.1ROR 96.5 · calibrated p 2e-7 ✓	59.2 EB05 55.1 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=535 · 100% clinician	not reported in cached trials
Acute graft versus host disease in skin	1,046	94.9 87.9–102.5ROR 95.6 · calibrated p 2e-7 ✓	58.8 EB05 55.9 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=1,043 · 96% clinician	not reported in cached trials
Acute graft versus host disease in liver	273	94.7 81.4–110.1ROR 94.9 · calibrated p 2e-7 ✓	58.5 EB05 52.9 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=273 · 100% clinician	not reported in cached trials
Lung transplant rejection	251	94.1 80.4–110.2ROR 94.3 · calibrated p 2e-7 ✓	58.3 EB05 52.5 · IC025 +5.5 3/3 methods agree	Labeled (related wording) related wording	serious n=251	not reported in cached trials
Cytomegalovirus gastrointestinal infection	113	94.0 74.4–118.8ROR 94.1 · calibrated p 3e-7 ✓	58.0 EB05 49.5 · IC025 +5.2 3/3 methods agree	Labeled (related wording) related wording	serious n=113 · 100% clinician	not reported in cached trials
Microtia	120	93.7 74.6–117.6ROR 93.8 · calibrated p 3e-7 ✓	57.9 EB05 49.7 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=119 · ♀ 100% (drug 50%) · 100% clinician	not reported in cached trials
Pulmonary mucormycosis	192	92.2 77.1–110.3ROR 92.3 · calibrated p 3e-7 ✓	57.5 EB05 51.0 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious n=192 · 100% clinician	not reported in cached trials
Chronic graft versus host disease in liver	133	91.2 73.6–113.1ROR 91.3 · calibrated p 3e-7 ✓	57.0 EB05 49.3 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=133 · 100% clinician	not reported in cached trials

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Opportunistic infection	8,753	10.610.4–10.8	signal
Interstitial lung disease	2,891	4.84.6–5.0	signal
Kidney injury	10,850	3.83.7–3.8	signal
Serious infection	15,449	3.23.1–3.2	signal
Liver injury	5,559	2.92.8–3.0	signal
Neutropenia / agranulocytosis	4,441	2.82.7–2.9	signal
Anaemia	4,123	2.22.1–2.2	signal
Thrombocytopenia	2,945	2.12.0–2.2	signal
Rhabdomyolysis / myopathy	1,083	2.12.0–2.2	raised
Pancreatitis	1,009	2.01.8–2.1	raised
Hyperglycaemia / diabetes	3,845	1.71.7–1.8	raised
Hyponatraemia	802	1.61.4–1.7	raised
Gi bleeding	1,610	1.41.3–1.4	raised
Osteonecrosis	479	1.31.2–1.4	raised
Heart failure	1,279	1.11.1–1.2	raised
Venous thromboembolism	1,483	1.11.0–1.1	raised

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Mycophenolate Mofetil as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (4 of 40 signal terms matched).

NCT00300274 — Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic Rejection (N=721, PHASE3; 599 AE terms posted; arms: Everolimus 1.5 mg; Everolimus 3.0 mg; Mycophenolate Mofetil)

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Off label use (used outside approved label)	19,548	3.6 3.5–3.6ROR 4.0 · calibrated p 0.379	3.5 EB05 3.5 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 3.0 · serious PRR 3.7	not reported in cached trials
Drug ineffective (drug did not work)	11,294	1.3 1.3–1.4ROR 1.4 · calibrated p 0.552	1.3 EB05 1.3 · IC025 +0.4	Reporting / coding artifact	age-adj. PRR 1.6 · serious PRR 2.2	not reported in cached trials
Product use in unapproved indication	7,290	4.7 4.6–4.9ROR 5.0 · calibrated p 0.239	4.6 EB05 4.5 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 4.4 · serious PRR 6.2 · 94% clinician	not reported in cached trials
Diarrhoea (diarrhea)	6,979	1.7 1.7–1.7ROR 1.7 · calibrated p 0.788	1.7 EB05 1.7 · IC025 +0.7	Labeled adverse reaction exact term	age-adj. PRR 1.6 · serious PRR 1.7	NCT00300274: 5/268 (1.9%) on Mycophenolate Mofetil (serious AE)
Pyrexia (fever)	5,700	2.6 2.5–2.7ROR 2.7 · calibrated p 0.750	2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.0 · serious PRR 2.0	NCT00300274: 1/167 (0.6%) on Mycophenolate Mofetil (serious AE)
Pneumonia (lung infection)	5,333	2.6 2.5–2.7ROR 2.7 · calibrated p 0.750	2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree	Labeled — boxed warning synonym match	age-adj. PRR 2.4 · serious PRR 1.7	NCT00300274: 1/279 (0.4%) on Mycophenolate Mofetil (serious AE)
Cytomegalovirus infection	4,929	65.3 63.2–67.5ROR 67.8 · calibrated p 2e-6 ✓	46.0 EB05 44.9 · IC025 +5.5 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 47.3 · serious PRR 29.0 · 95% clinician	NCT00300274: 10/268 (3.7%) on Mycophenolate Mofetil (serious AE)
Fatigue (tiredness)	4,593	0.9 0.9–0.9ROR 0.9 · calibrated p 0.252	0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Labeled (related wording) related wording	age-adj. PRR 0.8 · serious PRR 1.0 · ♀ 75% (drug 50%)	NCT00300274: 6/268 (2.2%) on Mycophenolate Mofetil (serious AE)
Nausea	4,551	0.9 0.9–0.9ROR 0.9 · calibrated p 0.238	0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	age-adj. PRR 0.7 · serious PRR 0.9 · ♀ 75% (drug 50%)	NCT00300274: 7/268 (2.6%) on Mycophenolate Mofetil (serious AE)
Condition aggravated	4,499	2.3 2.3–2.4ROR 2.4 · calibrated p 0.866	2.3 EB05 2.3 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 2.1 · serious PRR 2.2	not reported in cached trials
Dyspnoea (shortness of breath)	4,230	1.2 1.1–1.2ROR 1.2 · calibrated p 0.418	1.2 EB05 1.1 · IC025 +0.2	Labeled adverse reaction exact term	age-adj. PRR 1.1 · serious PRR 0.9	NCT00300274: 8/268 (3.0%) on Mycophenolate Mofetil (serious AE)
Transplant rejection	4,103	164.3 157.3–171.7ROR 169.5 · calibrated p 2e-9 ✓	79.5 EB05 77.5 · IC025 +6.2 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 50.4 · 93% clinician	NCT00300274: 26/268 (9.7%) on Mycophenolate Mofetil (serious AE)
Vomiting	4,099	1.4 1.3–1.4ROR 1.4 · calibrated p 0.557	1.4 EB05 1.3 · IC025 +0.4	Labeled adverse reaction exact term	age-adj. PRR 1.1 · serious PRR 1.2 · ♀ 74% (drug 50%)	NCT00300274: 5/268 (1.9%) on Mycophenolate Mofetil (serious AE)
Headache	3,991	1.0 1.0–1.0ROR 1.0 · calibrated p 0.300	1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	age-adj. PRR 0.8 · serious PRR 1.1 · ♀ 74% (drug 50%)	NCT00300274: 2/279 (0.7%) on Mycophenolate Mofetil (serious AE)
Infection	3,855	4.2 4.1–4.4ROR 4.3 · calibrated p 0.321	4.2 EB05 4.0 · IC025 +2.0 3/3 methods agree	Labeled — boxed warning exact term	age-adj. PRR 3.5 · serious PRR 3.2	NCT00300274: 1/167 (0.6%) on Mycophenolate Mofetil (serious AE)

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Smooth muscle cell neoplasm — n=290, PRR 371.0
Trichodysplasia spinulosa — n=233, PRR 255.2
Malacoplakia — n=227, PRR 216.0
Grip strength — n=134, PRR 214.8
Polyomavirus viraemia — n=555, PRR 195.6
Delayed graft function — n=389, PRR 191.7
Phaeohyphomycosis — n=245, PRR 179.3
Swollen joint count — n=121, PRR 151.0
Parvovirus b19 infection — n=429, PRR 148.1
Deep vein thrombosis postoperative — n=937, PRR 142.8

✓ A hand-written Bradford Hill causality assessment exists for this drug: Mycophenolate Mofetil Hydrochloride ↔ Cytomegalovirus Infection.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Mycophenolate Mofetil?

In FDA FAERS, the most frequently co-reported reaction terms for Mycophenolate Mofetil are diarrhoea, pyrexia, pneumonia, cytomegalovirus infection, fatigue, nausea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Mycophenolate Mofetil have an FDA boxed warning?

Yes. The current FDA label carries a boxed 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.

Do FAERS signals prove that Mycophenolate Mofetil causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 21ff53b0-b4ba-4473-91e4-76ef41681064, effective 20260527; matched on openfda.generic_name.exact:"MYCOPHENOLATE MOFETIL" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG")
PubChem CID 5281078 description (ChEBI)
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 1,379 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath
ClinicalTrials.gov API v2 (query MYCOPHENOLATE MOFETIL, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.