Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Mycophenolate mofetil
Drug ID BADD_D01507
Description Mycophenolate mofetil, also known as MMF or CellCept, is a prodrug of mycophenolic acid, and classified as a reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH).[A180805] This drug is an immunosuppressant combined with drugs such as [Cyclosporine] and corticosteroids to prevent organ rejection after hepatic, renal, and cardiac transplants.[L7363] It is marketed by Roche Pharmaceuticals and was granted FDA approval for the prophylaxis of transplant rejection in 1995.[A180826] In addition to the above uses, mycophenolate mofetil has also been studied for the treatment of nephritis and other complications of autoimmune diseases. Unlike another immunosuppressant class, the calcineurin inhibitors, MMF generally does not cause nephrotoxicity or fibrosis.[A180799,A180805] Previously, mycophenolic acid (MPA) was administered to individuals with autoimmune diseases beginning in the 1970s, but was discontinued due to gastrointestinal effects and concerns over carcinogenicity.[A180826] The new semi-synthetic 2-morpholinoethyl ester of MPA was synthesized to avoid the gastrointestinal effects associated with the administration of MPA. It demonstrates an increased bioavailability, a higher efficacy, and reduced gastrointestinal effects when compared to MPA.[A180826]
Indications and Usage Mycophenolate mofetil is indicated for the prophylaxis of organ rejection in patients undergoing allogeneic renal, hepatic, or cardiac transplants. It should be used with cyclosporine and corticosteroids.[L7363] Mycophenolate mofetil may also be used off-label as a second-line treatment for autoimmune hepatitis that has not responded adequately to first-line therapy.[A180814] Other off-label uses of this drug include lupus-associated nephritis and dermatitis in children.[A180817]
Marketing Status approved; investigational
ATC Code L04AA06
DrugBank ID DB00688
KEGG ID D00752
MeSH ID D009173
PubChem ID 5281078
TTD Drug ID D04FBR
NDC Product Code 0904-7074; 0904-7078; 47848-019; 52076-6220; 0004-0260; 60687-494; 64380-725; 67457-386; 68254-5000; 70518-2835; 52972-0037; 55486-1589; 16729-019; 23155-830; 50268-557; 51079-721; 55154-6262; 68254-5003; 70748-186; 70966-0015; 17478-422; 23155-836; 42023-172; 51079-379; 60429-070; 0054-0166; 69238-1595; 66689-307; 0480-1175; 0527-5160; 70518-2767; 70771-1084; 65050-2101; 50268-558; 64380-726; 0378-2250; 0054-0163; 72485-415; 0781-5175; 83270-000; 46014-1123; 68254-0015; 71052-317; 67877-266; 70121-1584; 70518-3068; 70748-262; 0004-0259; 17478-957; 0093-7334; 60687-438; 63629-9582; 67877-230; 0480-3571; 71288-803; 71610-033; 0781-2067; 81293-000; 51927-5125; 65727-005; 66499-0006; 68254-2500; 0004-0261; 16714-345; 16729-094; 55154-5382; 0378-4472; 67877-225; 68382-669; 68254-0005; 78848-004; 50090-4275; 55154-3571; 60219-2135; 60429-059
UNII 9242ECW6R0
Synonyms Mycophenolic Acid | Mycophenolate Mofetil | Mofetil, Mycophenolate | Mycophenolic Acid Morpholinoethyl Ester | Cellcept | Mycophenolate Sodium | Sodium Mycophenolate | Mycophenolate, Sodium | Myfortic | Mycophenolate Mofetil Hydrochloride | Mofetil Hydrochloride, Mycophenolate | RS 61443 | RS-61443 | RS61443
Chemical Information
Molecular Formula C23H31NO7
CAS Registry Number 128794-94-5
SMILES CC1=C2COC(=O)C2=C(C(=C1OC)CC=C(C)CCC(=O)OCCN3CCOCC3)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Increased bronchial secretion22.12.01.002--Not Available
Urethritis noninfective20.07.02.002--Not Available
Cystitis noninfective20.03.02.001--
Vulvovaginal mycotic infection21.14.02.004; 11.03.05.004--Not Available
Ulcerative keratitis10.02.01.021; 06.04.02.004--
Polyomavirus-associated nephropathy12.02.09.037; 20.01.09.003; 11.05.05.002--Not Available
Bone marrow failure01.03.03.005--
Cytopenia01.03.03.012--Not Available
Treatment failure08.06.01.017--Not Available
Liver injury12.01.17.012; 09.01.07.022--Not Available
X-linked lymphoproliferative syndrome16.21.02.003; 11.05.10.005; 10.03.01.003; 03.17.01.002; 01.13.02.003--Not Available
Microvillous inclusion disease07.11.04.003; 03.04.04.001--Not Available
Acute kidney injury20.01.03.016--
Posterior reversible encephalopathy syndrome17.13.02.007--
Lacrimal structural disorder06.06.04.013--Not Available
Pneumocystis jirovecii infection11.03.07.004--Not Available
Candida infection11.03.03.021--
Aspergillus infection11.03.01.004--Not Available
Renal transplant failure12.02.09.017; 10.02.03.006; 20.01.02.014--Not Available
Anal incontinence17.05.01.021; 07.01.06.029--
Depersonalisation/derealisation disorder19.14.01.004--Not Available
Acute graft versus host disease in skin23.07.04.020; 12.02.09.022; 10.02.01.053--Not Available
Chronic graft versus host disease in skin23.07.04.022; 12.02.09.025; 10.02.01.057--Not Available
Graft versus host disease in gastrointestinal tract12.02.09.028; 10.02.01.059; 07.11.01.027--Not Available
Neuromyelitis optica spectrum disorder06.04.08.003; 17.16.02.005; 10.04.10.015--Not Available
Drug ineffective for unapproved indication12.09.02.002; 08.06.01.038--Not Available
Gait inability17.02.05.069; 08.01.02.011--Not Available
Intermenstrual bleeding21.01.01.015--Not Available
Therapeutic product ineffective08.06.01.057--Not Available
Therapeutic response changed08.06.01.059--Not Available
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