Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Gemcitabine hydrochloride
Drug ID BADD_D01010
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 D01155
MeSH ID C056507
PubChem ID 60749
TTD Drug ID D03UVS
NDC Product Code 25021-234; 54893-0006; 70860-204; 66529-0011; 54245-1091; 68083-149; 13808-501; 63759-7001; 16714-930; 16729-117; 53104-7689; 16729-118; 65129-1091; 67457-616; 71288-114; 68083-148; 72485-222; 70860-205; 63592-4075; 71288-113; 67457-617; 25021-235; 55111-807; 62128-0383; 16729-092; 66529-0004; 72485-223; 71288-117; 58623-0019; 16714-909; 72485-221; 68554-0028; 67457-618
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 C9H12ClF2N3O4
CAS Registry Number 122111-03-9
SMILES C1=CN(C(=O)N=C1N)C2C(C(C(O2)CO)O)(F)F.Cl
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
FatigueEpidermal growth factor receptorP00533T59328Not Available
FatigueReceptor tyrosine-protein kinase erbB-2P04626T14597Not Available
Neoplasm related morbiditiesTumor necrosis factor receptor superfamily member 10BO14763T70067Not Available
Neoplasm related morbiditiesApoptosis regulator Bcl-2P10415T31309Not Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Acute respiratory distress syndrome22.01.03.001--
Agranulocytosis01.02.03.001--Not Available
Alanine aminotransferase13.03.01.031--Not Available
Alanine aminotransferase increased13.03.01.003--
Alopecia23.02.02.001--
Anaemia01.03.02.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Arrhythmia02.03.02.001--Not Available
Arrhythmia supraventricular02.03.03.001--Not Available
Arthralgia15.01.02.001--
Aspartate aminotransferase13.03.01.032--Not Available
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.001--Not Available
Azoospermia21.03.03.001--
Back pain15.03.04.005--
Blood alkaline phosphatase13.04.02.010--Not Available
Blood bilirubin13.03.01.040--Not Available
Blood bilirubin increased13.03.01.008--
Blood bilirubin normal13.03.01.041--Not Available
Blood creatinine13.13.01.020--Not Available
Blood creatinine abnormal13.13.01.002--Not Available
Blood creatinine increased13.13.01.004--
Blood urea13.13.01.019--Not Available
Blood urea increased13.13.01.006--Not Available
Body temperature increased13.15.01.001--Not Available
Bone disorder15.02.04.004--Not Available
Bone pain15.02.01.001--
Breast cancer21.05.01.003; 16.10.01.001--Not Available
Bronchospasm22.03.01.004; 10.01.03.012--
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