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 For the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. Mycophenolate mofetil should be used concomitantly with cyclosporine and corticosteroids.
Marketing Status Prescription; Discontinued
ATC Code L04AA06
DrugBank ID DB00688
KEGG ID D00752
MeSH ID D009173
PubChem ID 5281078
TTD Drug ID D04FBR
NDC Product Code 0781-2067; 0904-7078; 70121-1584; 67877-230; 17478-422; 0093-7334; 71288-803; 70748-262; 70966-0015; 60429-070; 67877-266; 68254-0015; 69238-1595; 68254-2500; 51079-721; 16729-019; 68254-5000; 16714-345; 0378-4472; 65727-005; 17478-957; 66499-0006; 50090-2541; 55154-5382; 64380-725; 68382-669; 55486-1589; 0527-5160; 67877-225; 52972-0037; 72969-053; 78848-004; 0378-2250; 60429-059; 47848-019; 0004-0259; 0904-7074; 50090-4275; 70518-3068; 51079-379; 0004-0260; 0054-0166; 68254-0005; 64380-726; 68254-5003; 70748-186; 71052-317; 70518-2835; 0054-0163; 0004-0261; 70518-2767; 0781-5175; 42023-172; 60687-438; 70771-1084; 67457-386; 60687-494; 71610-033; 46014-1123; 65050-2101; 51927-5125; 66689-307; 16729-094; 55154-6262; 52076-6220
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
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Atrophy08.03.04.0010.001308%Not Available
Autoimmune hepatitis09.01.07.019; 10.04.09.0010.001308%Not Available
Azotaemia20.01.01.001--Not Available
B-cell lymphoma01.15.01.001; 16.28.01.0010.000341%Not Available
Back pain15.03.04.005--
Bacteraemia11.01.11.0010.002616%
Balanoposthitis21.09.03.001--Not Available
Basal cell carcinoma16.03.02.001; 23.08.02.0010.003269%Not Available
Benign intracranial hypertension17.07.02.0010.002616%Not Available
Benign neoplasm of skin16.26.01.006; 23.10.01.006--Not Available
Bladder neoplasm16.08.03.002; 20.03.04.002--Not Available
Bladder pain20.02.02.001--Not Available
Blepharitis06.04.04.001; 23.03.04.012--Not Available
Blindness06.02.02.001; 17.17.01.0030.003269%Not Available
Blood bilirubin increased13.03.01.0080.003923%
Blood creatinine increased13.13.01.0040.017001%
Blood gases abnormal13.02.01.0070.001308%Not Available
Blood glucose increased13.02.02.002--Not Available
Blood lactate dehydrogenase increased13.04.02.002--
Blood pressure increased13.14.03.005--Not Available
Blood urea increased13.13.01.0060.005885%Not Available
Blood uric acid increased13.02.04.001--Not Available
Body temperature increased13.15.01.001--Not Available
Bone pain15.02.01.001--
Bowen's disease16.03.02.004; 23.08.02.0040.001962%Not Available
Bradycardia02.03.02.002--Not Available
Brain abscess11.01.03.003; 17.06.07.0010.000853%Not Available
Breast pain21.05.05.003--
Bronchiectasis22.03.02.0050.007847%Not Available
Bronchitis11.01.09.001; 22.07.01.001--
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