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 a chemotherapeutic agent used as monotherapy or in combination with other anticancer agents. In combination with [carboplatin], it is indicated for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.[L32950] Gemcitabine in combination with [paclitaxel] is indicated for the first-line treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.[L32950] In combination with [cisplatin], gemcitabine is indicated for the first-line treatment of patients with inoperable, locally advanced (Stage IIIA or IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC).[L32950] Dual therapy with cisplatin is also used to treat patients with Stage IV (locally advanced or metastatic) transitional cell carcinoma (TCC) of the bladder.[L32955] Gemcitabine is indicated as first-line treatment for patients with locally advanced (nonresectable Stage II or Stage III) or metastatic (Stage IV) adenocarcinoma of the pancreas. Gemcitabine is indicated for patients previously treated with [fluorouracil].[L32950]
Marketing Status approved
ATC Code L01BC05
DrugBank ID DB00441
KEGG ID D01155
MeSH ID C056507
PubChem ID 60749
TTD Drug ID D03UVS
NDC Product Code 63592-4075; 68554-0028; 16729-092; 25021-235; 70860-205; 71288-114; 54245-1091; 68083-148; 72485-221; 72485-222; 42385-748; 66529-0011; 16729-117; 67457-617; 67457-618; 67457-616; 58623-0019; 16729-118; 72485-223; 14593-892; 62128-0383; 25021-234; 68083-149; 53104-7689; 54893-0006; 71288-117; 13808-501; 55111-807; 65129-1091; 82920-701; 16714-909; 70860-204; 71288-113; 66529-0004; 16714-930
UNII U347PV74IL
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Acute respiratory distress syndrome24.03.02.034; 10.02.01.067; 22.01.03.001--
Agranulocytosis01.02.03.001--Not Available
Alanine aminotransferase13.03.04.002--Not Available
Alanine aminotransferase increased13.03.04.005--
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 aminotransferase13.03.04.008--Not Available
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001--Not Available
Azoospermia21.03.03.001--
Back pain15.03.04.005--
Blood alkaline phosphatase13.04.02.010--Not Available
Blood bilirubin13.03.04.015--Not Available
Blood bilirubin increased13.03.04.018--
Blood bilirubin normal13.03.04.019--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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