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
FatigueEpidermal growth factor receptorP00533T5932826362459
FatigueReceptor tyrosine-protein kinase erbB-2P04626T1459726362459
Neoplasm related morbiditiesTumor necrosis factor receptor superfamily member 10BO14763T7006714716031; 15364135; 14977831; 14668933
Neoplasm related morbiditiesApoptosis regulator Bcl-2P10415T3130914716031; 15364135; 14977831; 14668933
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.0010.002664%
Abdominal pain07.01.05.0020.018116%
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.003--
Acanthosis nigricans23.01.04.001; 16.32.01.0030.000799%Not Available
Acute hepatic failure09.01.03.0010.000834%Not Available
Acute myeloid leukaemia16.01.05.001; 01.10.05.0010.000417%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.001--Not Available
Acute pulmonary oedema22.01.03.005; 02.05.02.0040.001865%Not Available
Acute respiratory distress syndrome22.01.03.0010.000417%
Acute respiratory failure22.02.06.001; 14.01.04.0040.000208%Not Available
Adenocarcinoma16.16.01.0040.000139%Not Available
Affective disorder19.04.04.001--Not Available
Agranulocytosis01.02.03.0010.002398%Not Available
Alanine aminotransferase increased13.03.01.003--
Alopecia23.02.02.001--
Alveolitis22.01.01.0010.000625%Not Available
Alveolitis allergic22.01.01.002; 10.01.03.0080.002131%Not Available
Amaurosis06.02.02.0080.000799%Not Available
Anaemia01.03.02.0010.039162%
Anaemia neonatal18.04.03.002; 01.03.02.0110.001066%Not Available
Anal fistula07.11.05.0020.000533%
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Anaphylactic shock24.06.02.004; 10.01.07.0020.001066%Not Available
Anastomotic ulcer12.02.03.001; 07.04.04.0030.000533%
Aneurysm24.02.01.0010.000208%Not Available
Anuria20.01.03.0020.000533%Not Available
Anxiety19.06.02.002--
Aortic thrombosis24.01.09.0010.000533%Not Available
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