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)
Neonatal respiratory distress syndrome22.11.02.010; 18.04.10.0030.001308%Not Available
Neonatal respiratory failure22.11.02.011; 18.04.17.0030.000512%Not Available
Pulmonary haemosiderosis22.01.02.024; 14.13.03.0060.001962%Not Available
Renal tubular atrophy20.05.03.0220.001962%Not Available
Urinary bladder haemorrhage24.07.01.086; 20.03.01.0230.001308%Not Available
Visceral leishmaniasis11.06.08.0020.001308%Not Available
Cytomegalovirus enteritis11.05.01.011; 07.19.01.0190.002616%Not Available
Ankyloglossia congenital03.04.09.002; 07.14.01.0100.001308%Not Available
Intestinal villi atrophy07.11.03.0100.005231%Not Available
Beta haemolytic streptococcal infection11.02.06.0060.001308%Not Available
Small intestinal haemorrhage24.07.02.019; 07.12.03.0020.001308%
Iris coloboma03.01.08.002; 06.13.03.0030.000853%Not Available
Cytomegalovirus gastrointestinal infection11.05.01.014; 07.19.02.0160.004577%Not Available
Microsporidia infection11.06.03.0020.000512%Not Available
Clostridium difficile infection11.02.02.0090.004577%Not Available
External auditory canal atresia04.01.01.005; 03.13.01.0050.000682%Not Available
Necrotising oesophagitis07.04.05.0060.003923%Not Available
Choroidal coloboma06.13.01.004; 03.01.08.0010.000341%Not Available
Biliary sepsis11.01.18.005; 09.02.01.0050.000682%Not Available
Cerebral toxoplasmosis17.06.11.001; 11.06.01.0020.000853%Not Available
Gastrointestinal oedema07.11.01.0120.001962%Not Available
Klebsiella bacteraemia11.02.03.0050.001962%Not Available
Foetal malformation03.02.01.012; 18.03.02.0160.000512%Not Available
Klebsiella infection11.02.03.0030.003269%Not Available
Papilloma viral infection11.05.07.0050.001962%Not Available
Extranodal marginal zone B-cell lymphoma (MALT type)01.15.07.001; 16.28.07.0010.000341%Not Available
Immunosuppressant drug level decreased13.17.01.0310.001962%Not Available
Small intestinal stenosis07.13.06.0080.001962%
Congenital cyst16.02.02.012; 08.03.05.007; 03.02.01.0100.001308%Not Available
Congenital nose malformation22.10.02.003; 03.16.04.0010.001308%Not Available
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