Mycophenilic Acid side effects: what 20,594 FDA adverse event reports show

Mycophenilic Acid · Mycophenolic Acid · 1,202 reaction terms · 72,452 drug–reaction co-reports · data 2026-09-14

Drug class

Antimetabolite Immunosuppressant

FDA label (Established Pharmacologic Class)

Brand names

Mycophenolic Acid

openFDA label

Who reports

20,594 reports · 91% serious · 3,065 with death outcome · 47% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Mycophenolic acid delayed-release tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. ( 1.1 ) Use in combination with cyclosporine and corticosteroids.

FDA label, Indications and Usage

What it is

Mycophenolic acid delayed-release tablets, USP are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid is an immunosuppressive agent.

FDA label, Description section

Boxed warning

EMBRYO-FETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS WARNING: EMBRYO-FETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS Use during pregnancy is associated with increased risks of 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 (related wording) 5Lab value / disease marker 2Not in label — unassessed 33

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,162 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
Central nervous system abscess	13	395.3 208.1–750.9ROR 395.5 · χ² 3,390 / p <1e-300	200.6 EB05 124.8 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=13	no trial arm names this drug
Disseminated nocardiosis	22	319.9 198.0–516.9ROR 320.3 · χ² 5,064 / p <1e-300	200.7 EB05 139.7 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=22 · 100% clinician	no trial arm names this drug
Central nervous system lupus	44	259.7 186.5–361.7ROR 260.3 · χ² 8,803 / p <1e-300	189.6 EB05 147.1 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=44 · ♀ 100% (drug 47%)	no trial arm names this drug
Heart failure with preserved ejection fraction	50	241.2 177.2–328.3ROR 241.8 · χ² 9,450 / p <1e-300	181.3 EB05 142.9 · IC025 +5.6 3/3 methods agree	Labeled (related wording) related wording	serious n=50 · ♀ 100% (drug 47%)	no trial arm names this drug
Bacillary angiomatosis	25	226.0 146.5–348.7ROR 226.3 · χ² 4,389 / p <1e-300	162.0 EB05 115.4 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=25 · 100% clinician	no trial arm names this drug
Malacoplakia	69	217.7 167.9–282.3ROR 218.4 · χ² 12,054 / p <1e-300	170.7 EB05 139.5 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=69 · ♀ 16% (drug 47%) · 94% clinician	no trial arm names this drug
Cerebral nocardiosis	37	213.4 149.7–304.2ROR 213.7 · χ² 6,275 / p <1e-300	161.6 EB05 122.4 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious n=37 · 100% clinician	no trial arm names this drug
Body mass index abnormal	39	207.1 146.7–292.2ROR 207.4 · χ² 6,459 / p <1e-300	158.6 EB05 121.1 · IC025 +5.2 3/3 methods agree	Lab value / disease marker	serious n=39 · ♀ 100% (drug 47%)	no trial arm names this drug
Malacoplakia gastrointestinal	16	198.2 116.0–338.8ROR 198.4 · χ² 2,459 / p <1e-300	138.6 EB05 90.5 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=16	no trial arm names this drug
Gastroenteritis sapovirus	13	176.3 97.8–317.8ROR 176.4 · χ² 1,781 / p <1e-300	123.4 EB05 76.7 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=13	no trial arm names this drug
Angiosarcoma metastatic	17	164.0 98.2–273.8ROR 164.2 · χ² 2,229 / p <1e-300	122.1 EB05 80.7 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=17	no trial arm names this drug
Donor specific antibody present	20	155.6 97.1–249.1ROR 155.7 · χ² 2,527 / p <1e-300	119.7 EB05 81.8 · IC025 +4.2 3/3 methods agree	Lab value / disease marker	serious n=20	no trial arm names this drug
Apoptosis	40	149.8 107.5–208.7ROR 150.1 · χ² 5,014 / p <1e-300	122.9 EB05 94.1 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=40 · 100% clinician	no trial arm names this drug
Disseminated mucormycosis	49	147.2 109.1–198.6ROR 147.6 · χ² 6,078 / p <1e-300	122.5 EB05 96.3 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=49 · ♀ 0% (drug 47%) · 96% clinician	no trial arm names this drug
Rhodococcus infection	21	146.3 92.6–231.2ROR 146.5 · χ² 2,520 / p <1e-300	114.8 EB05 79.2 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=21	no trial arm names this drug
Pulmonary nocardiosis	102	145.2 118.0–178.6ROR 145.9 · χ² 12,633 / p <1e-300	124.0 EB05 105.1 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=102 · ♀ 22% (drug 47%) · 100% clinician	no trial arm names this drug
Amaurosis fugax	133	144.6 120.6–173.3ROR 145.5 · χ² 16,452 / p <1e-300	124.3 EB05 107.5 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=133 · 95% clinician	no trial arm names this drug
Pancreas transplant rejection	25	142.5 93.8–216.6ROR 142.7 · χ² 2,954 / p <1e-300	114.2 EB05 81.4 · IC025 +4.5 3/3 methods agree	Labeled (related wording) related wording	serious n=25	no trial arm names this drug
Polyomavirus viraemia	122	141.5 117.1–171.0ROR 142.4 · χ² 14,796 / p <1e-300	121.8 EB05 104.7 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=121 · 100% clinician	no trial arm names this drug
Human ehrlichiosis	24	138.4 90.3–212.0ROR 138.6 · χ² 2,757 / p <1e-300	111.2 EB05 78.6 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=24 · 100% clinician	no trial arm names this drug
Urinoma	17	131.2 79.2–217.5ROR 131.3 · χ² 1,829 / p <1e-300	103.0 EB05 68.1 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=17	no trial arm names this drug
Epidermodysplasia verruciformis	19	130.6 81.0–210.6ROR 130.7 · χ² 2,049 / p <1e-300	103.9 EB05 70.3 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=19	no trial arm names this drug
Renal-limited thrombotic microangiopathy	25	126.7 83.6–192.0ROR 126.8 · χ² 2,657 / p <1e-300	103.9 EB05 74.0 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=25 · 100% clinician	no trial arm names this drug
Trichodysplasia spinulosa	41	124.3 89.9–171.9ROR 124.5 · χ² 4,352 / p <1e-300	105.4 EB05 81.0 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=38 · 100% clinician	no trial arm names this drug
Acanthamoeba infection	20	119.5 75.2–189.9ROR 119.6 · χ² 1,995 / p <1e-300	97.2 EB05 66.4 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=20 · 100% clinician	no trial arm names this drug
Viral load	18	117.3 72.0–191.1ROR 117.4 · χ² 1,755 / p <1e-300	94.8 EB05 63.5 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=18	no trial arm names this drug
Disseminated strongyloidiasis	22	115.6 74.4–179.6ROR 115.7 · χ² 2,139 / p <1e-300	95.4 EB05 66.4 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=22 · 100% clinician	no trial arm names this drug
Gastrointestinal mucormycosis	16	113.9 67.9–190.9ROR 113.9 · χ² 1,508 / p <1e-300	91.5 EB05 59.7 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=16	no trial arm names this drug
West nile viral infection	73	113.7 89.3–144.8ROR 114.1 · χ² 7,226 / p <1e-300	99.7 EB05 81.9 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=73 · 100% clinician	no trial arm names this drug
Blastomycosis	48	113.3 84.1–152.7ROR 113.6 · χ² 4,701 / p <1e-300	98.0 EB05 76.9 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious n=48 · 100% clinician	no trial arm names this drug
Polyomavirus-associated nephropathy	223	108.0 94.1–123.9ROR 109.2 · χ² 21,247 / p <1e-300	96.8 EB05 86.6 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=223 · 97% clinician	no trial arm names this drug
Phaeohyphomycosis	44	107.9 79.1–147.3ROR 108.2 · χ² 4,113 / p <1e-300	93.7 EB05 72.7 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=44 · 100% clinician	no trial arm names this drug
Trichophytosis	20	105.1 66.3–166.5ROR 105.2 · χ² 1,773 / p <1e-300	87.5 EB05 59.8 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=19 · 100% clinician	no trial arm names this drug
Herpes simplex hepatitis	22	104.6 67.5–162.3ROR 104.7 · χ² 1,952 / p <1e-300	87.8 EB05 61.1 · IC025 +4.2 3/3 methods agree	Labeled (related wording) related wording	serious n=22 · 100% clinician	no trial arm names this drug
Renal transplant failure	91	103.2 83.2–128.0ROR 103.6 · χ² 8,257 / p <1e-300	91.9 EB05 77.1 · IC025 +5.6 3/3 methods agree	Labeled (related wording) related wording	serious n=91 · 96% clinician	no trial arm names this drug
Chronic allograft nephropathy	72	102.3 80.3–130.4ROR 102.7 · χ² 6,464 / p <1e-300	90.8 EB05 74.5 · IC025 +5.4 3/3 methods agree	Labeled (related wording) related wording	serious n=72 · 92% clinician	no trial arm names this drug
Disseminated cryptococcosis	67	102.0 79.4–131.1ROR 102.3 · χ² 5,992 / p <1e-300	90.4 EB05 73.6 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious n=67 · ♀ 20% (drug 47%) · 97% clinician	no trial arm names this drug
Parvovirus b19 infection	80	101.6 80.8–127.8ROR 102.0 · χ² 7,146 / p <1e-300	90.4 EB05 75.0 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=80 · 100% clinician	no trial arm names this drug
Disseminated mycobacterium avium complex infection	19	99.8 62.3–159.9ROR 99.9 · χ² 1,602 / p <1e-300	83.5 EB05 56.5 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=19	no trial arm names this drug
Cat scratch disease	35	97.6 69.0–138.0ROR 97.7 · χ² 2,961 / p <1e-300	85.0 EB05 63.9 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=35 · 94% clinician	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Mycophenilic Acid (searched MYCOPHENILIC ACID).

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)	2,225	2.6 2.5–2.7ROR 2.8 · χ² 2,305 / p <1e-300	2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 2.8	no trial arm names this drug
Drug ineffective (drug did not work)	1,498	1.2 1.1–1.2ROR 1.2 · χ² 34 / p 2e-9	1.2 EB05 1.1 · IC025 +0.1	Reporting / coding artifact	serious PRR 1.9	no trial arm names this drug
Diarrhoea (diarrhea)	1,055	1.7 1.6–1.8ROR 1.7 · χ² 292 / p 1e-65	1.7 EB05 1.6 · IC025 +0.6	Labeled adverse reaction exact term	serious PRR 1.6	no trial arm names this drug
Acute kidney injury (sudden kidney damage)	901	6.1 5.7–6.5ROR 6.3 · χ² 3,799 / p <1e-300	6.0 EB05 5.7 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.8 · 96% clinician	no trial arm names this drug
Covid-19	802	4.6 4.3–5.0ROR 4.8 · χ² 2,288 / p <1e-300	4.6 EB05 4.3 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 4.8	no trial arm names this drug
Product use in unapproved indication	758	3.2 3.0–3.4ROR 3.2 · χ² 1,130 / p 5e-248	3.2 EB05 3.0 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 3.9	no trial arm names this drug
Nausea	755	1.0 0.9–1.0ROR 1.0 · χ² 1 / p 0.236	1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 1.0	no trial arm names this drug
Pyrexia (fever)	749	2.2 2.1–2.4ROR 2.3 · χ² 499 / p 8e-111	2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.7	no trial arm names this drug
Drug interaction	732	4.7 4.4–5.1ROR 4.8 · χ² 2,144 / p <1e-300	4.7 EB05 4.4 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 3.2 · 96% clinician	no trial arm names this drug
Death	703	0.8 0.8–0.9ROR 0.8 · χ² 25 / p 3e-7	0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC	Outcome field, not a reaction	serious PRR 0.5	no trial arm names this drug
Fatigue (tiredness)	654	0.9 0.8–0.9ROR 0.9 · χ² 16 / p 3e-5	0.9 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 0.8	no trial arm names this drug
Headache	606	1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.362	1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 1.0 · ♀ 69% (drug 47%)	no trial arm names this drug
Pneumonia (lung infection)	604	1.9 1.8–2.1ROR 1.9 · χ² 262 / p 4e-59	1.9 EB05 1.8 · IC025 +0.8	Labeled — boxed warning synonym match	serious PRR 1.2	no trial arm names this drug
Cytomegalovirus infection	603	38.3 35.3–41.5ROR 39.4 · χ² 21,059 / p <1e-300	36.9 EB05 34.5 · IC025 +5.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 23.6 · 93% clinician	no trial arm names this drug
Dyspnoea (shortness of breath)	593	1.1 1.0–1.2ROR 1.1 · χ² 3 / p 0.057	1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 0.9	no trial arm names this drug

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.

Disseminated nocardiosis — n=22, PRR 319.9
Central nervous system lupus — n=44, PRR 259.7
Bacillary angiomatosis — n=25, PRR 226.0
Malacoplakia — n=69, PRR 217.7
Cerebral nocardiosis — n=37, PRR 213.4
Apoptosis — n=40, PRR 149.8
Disseminated mucormycosis — n=49, PRR 147.2
Rhodococcus infection — n=21, PRR 146.3
Pulmonary nocardiosis — n=102, PRR 145.2
Amaurosis fugax — n=133, PRR 144.6

✓ A hand-written Bradford Hill causality assessment exists for this drug: Zoledronic acid (bisphosphonates) ↔ Osteonecrosis of the jaw.

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 Mycophenilic Acid?

In FDA FAERS, the most frequently co-reported reaction terms for Mycophenilic Acid are diarrhoea, acute kidney injury, covid-19, nausea, pyrexia, fatigue. 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 Mycophenilic Acid have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: EMBRYO-FETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS WARNING: EMBRYO-FETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS Use during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. Avoid if safer treatment options are available.

Do FAERS signals prove that Mycophenilic Acid 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 30cb1078-929b-4c0f-be1d-49ef352dfab9, effective 20251229; matched on openfda.generic_name.exact:"MYCOPHENILIC ACID")
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, 1,202 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 MYCOPHENILIC ACID, results-bearing studies sorted by enrollment)

Page generated 2026-10-08. 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.