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 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 D02368
MeSH ID C056507
PubChem ID 60750
TTD Drug ID D03UVS
NDC Product Code 16729-391; 16729-426; 0143-9394; 62756-008; 62756-219; 62756-614; 62756-073; 0409-0183; 62756-321; 62756-438; 63323-102; 63323-126; 68001-350; 55111-687; 62756-533; 62756-974; 16729-423; 55111-686; 62756-102; 0409-0182; 81955-0006; 16729-419; 0143-9395; 63323-125; 0409-0181; 68001-359; 0409-0186; 50742-498; 65129-1235; 50742-497; 62756-746; 0409-0185; 0409-0187; 68001-342; 68001-348; 50742-496
UNII B76N6SBZ8R
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
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)
Metastases to central nervous system16.22.02.004; 17.02.10.0130.000224%-
Skin toxicity12.03.01.020; 23.03.03.0320.000112%-
Blood alkaline phosphatase increased13.04.02.004--
Recall phenomenon12.02.06.001; 23.03.07.005--
Embolism24.01.01.0090.000112%
Haematotoxicity01.05.01.007; 12.03.01.0250.000448%-
Inflammation08.01.05.007; 10.02.01.0890.000224%-
Ischaemic stroke17.08.01.018; 24.04.06.0100.000168%-
Neoplasm progression16.16.02.0050.002127%-
Poisoning12.03.01.004---
Decreased appetite08.01.09.028; 14.03.01.005--
Pulmonary toxicity12.03.01.013; 22.01.02.0070.000672%-
Hepatobiliary disease09.01.08.003---
Large intestinal obstruction07.13.03.0030.000358%
Metastasis16.22.01.0010.000224%-
Transaminases abnormal13.03.04.034---
Hypophagia07.01.06.010; 14.03.01.006; 19.09.01.0040.000280%-
Bone marrow failure01.03.03.0050.000504%
Cytopenia01.03.03.0120.000168%-
Liver injury09.01.07.022; 12.01.17.0120.000168%-
Hypertransaminasaemia09.01.02.0050.000112%-
Acute kidney injury20.01.03.0160.001903%
Posterior reversible encephalopathy syndrome17.13.02.0070.000224%
Autoimmune haemolytic anaemia01.06.01.004; 10.04.01.0050.000112%-
Multiple organ dysfunction syndrome08.01.03.0570.000280%
Cholangitis acute09.02.01.0060.000112%-
Pancreatic carcinoma metastatic07.21.09.006; 16.13.10.003---
Pulmonary artery thrombosis22.06.02.005; 24.01.06.0050.000112%-
Retinal pigment epitheliopathy06.09.03.0240.000112%-
Small intestinal haemorrhage07.12.03.002; 24.07.02.0190.000168%
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ADReCS-Target
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