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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.0010.010462%Not Available
Abdominal distension07.01.04.0010.003923%
Abdominal pain07.01.05.0020.033349%
Abdominal pain lower07.01.05.0100.003269%Not Available
Abdominal pain upper07.01.05.003--
Abortion missed18.01.01.0020.002616%Not Available
Abortion spontaneous18.01.04.0010.028117%Not Available
Abscess11.01.08.001--Not Available
Acidosis14.01.03.002--
Acne23.02.01.0010.002616%Not Available
Activated partial thromboplastin time prolonged13.01.02.001--
Acute disseminated encephalomyelitis17.16.02.003; 10.04.10.0100.009154%Not Available
Acute hepatic failure09.01.03.0010.002388%Not Available
Acute myeloid leukaemia16.01.05.001; 01.10.05.0010.001365%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Acute respiratory distress syndrome22.01.03.0010.001706%
Acute respiratory failure22.02.06.001; 14.01.04.0040.000682%Not Available
Adenocarcinoma16.16.01.0040.000341%Not Available
Adenoma benign16.02.02.001--Not Available
Ageusia07.14.03.003; 17.02.07.001--Not Available
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.0010.006539%Not Available
Alanine aminotransferase increased13.03.01.003--
Albuminuria20.02.01.001--Not Available
Alkalosis14.01.02.001--
Alopecia23.02.02.0010.008501%
Altered state of consciousness19.07.01.003; 17.02.04.0010.002616%Not Available
Alveolar proteinosis22.01.02.0090.001194%Not Available
Amblyopia06.02.01.001--Not Available
Amenorrhoea21.01.02.001; 05.05.01.002--
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