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)
Hepatic enzyme increased13.03.04.028--Not Available
Prostate cancer21.04.02.002; 16.25.01.001--Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Hormone level abnormal13.10.10.001--Not Available
Infestation23.11.01.002; 11.09.01.001--Not Available
Lymphoproliferative disorder16.21.02.001; 01.13.02.001--Not Available
Malnutrition14.03.02.004--Not Available
Mediastinal disorder22.09.03.001--Not Available
Mental disorder19.07.01.002--Not Available
Partial seizures17.12.03.010--Not Available
White blood cell disorder01.02.05.002--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Erectile dysfunction21.03.01.007; 19.08.04.001--
Ill-defined disorder08.01.03.049--Not Available
Lacrimal disorder06.08.02.005--Not Available
Polyp16.02.02.005; 08.01.06.010--Not Available
Blood disorder01.05.01.004--Not Available
Immunodeficiency10.03.02.002--Not Available
Atypical mycobacterial infection11.04.02.002--Not Available
Cytomegalovirus test13.08.03.004--Not Available
Disease recurrence08.01.03.050--Not Available
Drug intolerance08.06.01.013--Not Available
Psychotic disorder19.03.01.002--
Hepatobiliary disease09.01.08.003--Not Available
Infectious disease carrier11.07.03.002--Not Available
Hyperlipidaemia14.08.03.001--
Urine analysis abnormal13.13.02.008--Not Available
Renal impairment20.01.03.010--Not Available
Respiratory tract infection22.07.07.001; 11.01.08.017--Not Available
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