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Mycophenolate Side Effects

The most commonly reported side effects of mycophenolate include off label use, product use in unapproved indication, and diarrhoea, based on 153,809 FDA adverse event reports from 2004 to 2025. 7.3% of reports found the drug to be ineffective.

Mycophenolate side effects

Percentages show how often each reaction appears relative to total reports for mycophenolate.

1
Off Label Use13.0%19,944
2
Drug Ineffective7.3%11,182
3
Product Use In Unapproved Indication5.0%7,645
4
Diarrhoea4.7%7,200
5
Pyrexia3.4%5,284
6
Pneumonia3.4%5,248
7
Fatigue3.0%4,664
8
Nausea2.9%4,533
9
Cytomegalovirus Infection2.9%4,470
10
Condition Aggravated2.8%4,381
11
Acute Kidney Injury2.8%4,341
12
Dyspnoea2.8%4,245
13
Headache2.7%4,108
14
Vomiting2.6%4,063
15
Transplant Rejection2.6%3,923

These are voluntary reports and do not establish that mycophenolate caused these reactions.

Report severity

89.7%Serious137,893 reports
38.8%Hospitalizations59,610 reports
17.1%Fatal26,307 reports

Seriousness is determined by the reporter, not by OpenClaim.

Mycophenolate drug interactions

Other drugs that appear in adverse event reports alongside mycophenolate. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Tacrolimus33.7%51,885
2
Prednisone18.1%27,900
3
Cyclosporine13.0%20,001
4
Prednisolone10.6%16,283
5
Rituximab9.8%15,017
6
Methylprednisolone9.1%14,008
7
Methotrexate6.3%9,657
8
Cyclophosphamide5.9%9,004
9
Azathioprine4.2%6,490
10
Hydroxychloroquine-sulfate4.1%6,278
11
Basiliximab3.9%6,015
12
Fludarabine-phosphate3.8%5,885
13
Sirolimus3.4%5,261
14
Adalimumab3.0%4,585
15
Infliximab2.9%4,517

Taken alongside

1
Prednisone15.8%24,236
2
Tacrolimus10.1%15,577
3
Methylprednisolone6.0%9,233
4
Acetaminophen5.7%8,709
5
Prednisolone5.5%8,507
6
Sulfamethoxazole5.3%8,109
7
Aspirin4.9%7,573
8
Furosemide4.8%7,441
9
Amlodipine4.6%7,025
10
Trimethoprim4.4%6,738
11
Pantoprazole-sodium4.4%6,736
12
Omeprazole4.3%6,546
13
Ergocalciferol4.2%6,517
14
Cyclosporine4.2%6,430
15
Ganciclovir4.0%6,182

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports mycophenolate side effects

42.7% of mycophenolate adverse event reports involve female patients and 44.1% involve male patients. The largest age group is adult at 70%. These figures reflect who reports side effects, not underlying risk.

Sex

Female42.7%
Male44.1%
Unknown13.2%

Age group

< 21.5%
2–115.6%
12–174.3%
18–6469.6%
65+19.0%

What is mycophenolate used for

Conditions and purposes for which patients were taking mycophenolate when the adverse event was reported.

1p36 Deletion SyndromeAbdominal DiscomfortAbdominal LymphadenopathyAbdominal PainAbo IncompatibilityAbo IncompatibilityAbscessAccidental OverdoseAcquired Epidermolysis BullosaAcquired Gene MutationAcquired HaemophiliaAcquired Haemophilia With Anti Fviii, Xi, Or XiiiAcute Biphenotypic LeukaemiaAcute Cutaneous Lupus ErythematosusAcute Disseminated Encephalomyelitis

Showing 15 of 2,202 indications

Mycophenolate brand names and reporting trend

Mycophenolate is sold under brand names including Cellcept, Myfortic.

Brand names

Cellcept141,007
Myfortic3,988

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking mycophenolate with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.