Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Gemcitabine
Drug ID BADD_D01009
Description Gemcitabine is a nucleoside analog and a chemotherapeutic agent. It was originally investigated for its antiviral effects, but it is now used as an anticancer therapy for various cancers.[A233135] Gemcitabine is a cytidine analog with two fluorine atoms replacing the hydroxyl on the ribose.[A233145] As a prodrug, gemcitabine is transformed into its active metabolites that work by replacing the building blocks of nucleic acids during DNA elongation, arresting tumour growth and promoting apoptosis of malignant cells.[L32960] The structure, metabolism, and mechanism of action of gemcitabine are similar to [cytarabine], but gemcitabine has a wider spectrum of antitumour activity.[A233140] Gemcitabine is marketed as Gemzar and it is available as intravenous injection. It is approved by the FDA to treat advanced ovarian cancer in combination with [carboplatin], metastatic breast cancer in combination with [paclitaxel], non-small cell lung cancer in combination with [cisplatin], and pancreatic cancer as monotherapy.[L32950] It is also being investigated in other cancer and tumour types.
Indications and Usage Gemcitabine is indicated for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy; metastatic ovarian cancer; inoperable, locally advanced (Stage IIIA or IIIB), or metastatic (Stage IV) non-small cell lung cancer; and locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas.
Marketing Status Prescription; Discontinued
ATC Code L01BC05
DrugBank ID DB00441
KEGG ID D02368
MeSH ID C056507
PubChem ID 60750
TTD Drug ID D03UVS
NDC Product Code 0409-0182; 0409-0185; 65129-1235; 16729-419; 0409-0181; 63323-102; 55111-687; 62756-008; 63323-125; 62756-321; 0143-9395; 16729-426; 62756-073; 68001-342; 16729-391; 63323-126; 68001-350; 16729-423; 0409-0187; 62756-219; 62756-533; 62756-974; 68001-348; 68001-359; 62756-438; 62756-102; 0409-0186; 55111-686; 0409-0183; 62756-614; 0143-9394; 62756-746
Synonyms gemcitabine | 2',2'-difluoro-2'-deoxycytidine | gemicitabine | 2'-deoxy-2'-difluorocytidine | dFdCyd | 2',2'-DFDC | 2',2'-difluorodeoxycytidine | gemcitabine hydrochloride | LY 188011 | LY-188011 | gemcitabine, (beta-D-threo-pentafuranosyl)-isomer | gemcitabine, (D-threo-pentafuranosyl)-isomer | Gemzar | 2'-deoxy-2',2''-difluorocytidine-5'-O-monophosphate | gemcitabine, (alpha-D-threo-pentofuranosyl)-isomer
Chemical Information
Molecular Formula C9H11F2N3O4
CAS Registry Number 95058-81-4
SMILES C1=CN(C(=O)N=C1N)C2C(C(C(O2)CO)O)(F)F
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
FatigueReceptor tyrosine-protein kinase erbB-2P04626T1459726362459
FatigueEpidermal growth factor receptorP00533T5932826362459
Neoplasm related morbiditiesApoptosis regulator Bcl-2P10415T3130914716031; 15364135; 14977831; 14668933
Neoplasm related morbiditiesTumor necrosis factor receptor superfamily member 10BO14763T7006714716031; 15364135; 14977831; 14668933
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Vascular pseudoaneurysm ruptured24.03.02.031; 12.02.01.0290.000139%Not Available
Clostridium difficile infection11.02.02.0090.000799%Not Available
Breast cancer metastatic16.10.01.008; 21.05.01.0160.000139%Not Available
Subacute cutaneous lupus erythematosus15.06.02.012; 10.04.03.012; 23.03.02.0200.002664%Not Available
Hypertensive emergency24.08.01.0040.001598%Not Available
Gastrointestinal ischaemia24.04.08.007; 07.15.02.0050.000533%Not Available
Platelet toxicity12.03.01.057; 01.08.03.0040.000556%Not Available
Trousseau's syndrome24.01.01.033; 16.32.03.0280.000347%Not Available
Escherichia infection11.02.10.0040.000139%Not Available
Biliary tract infection11.01.18.003; 09.02.01.0040.001332%
Fistula of small intestine07.11.05.0100.000533%
Stress cardiomyopathy24.04.04.026; 02.04.01.0120.000533%Not Available
Ovarian cancer recurrent21.11.01.014; 16.12.04.0050.000799%Not Available
Acute lung injury22.01.03.0100.000139%Not Available
Subretinal fluid12.01.04.031; 06.09.03.0270.000799%Not Available
Enterococcus test positive13.08.01.0080.000799%Not Available
Staphylococcus test positive13.08.01.0150.000799%Not Available
Refractory cancer16.16.01.0160.002398%Not Available
Pseudocellulitis23.03.04.0400.006927%Not Available
Cholangitis infective11.01.18.006; 09.02.01.0070.000139%Not Available
Steatohepatitis14.08.04.020; 09.01.07.0240.000208%Not Available
End stage renal disease20.01.03.0190.002931%Not Available
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