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)
Abdominal distension07.01.04.0010.000470%
Abdominal pain07.01.05.0020.001511%
Abdominal pain lower07.01.05.0100.000302%Not Available
Acute hepatic failure09.01.03.0010.000224%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.0010.000112%Not Available
Acute pulmonary oedema22.01.03.005; 02.05.02.0040.000224%Not Available
Acute respiratory distress syndrome10.02.01.067; 22.01.03.001; 24.03.02.0340.000112%
Acute respiratory failure22.02.06.001; 14.01.04.0040.000112%Not Available
Affective disorder19.04.04.001--Not Available
Agranulocytosis01.02.03.0010.000280%Not Available
Alanine aminotransferase increased13.03.04.005--
Alopecia23.02.02.001--
Anaemia01.03.02.0010.003022%
Aphasia19.21.01.001; 17.02.03.0010.000112%
Arrhythmia02.03.02.001--Not Available
Arthralgia15.01.02.001--
Ascites09.01.05.003; 02.05.04.002; 07.07.01.0010.001287%
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.0010.001511%Not Available
Atelectasis22.01.02.0010.000224%
Atrial fibrillation02.03.03.0020.000504%
Bladder dilatation20.03.01.0070.000112%Not Available
Blood bilirubin increased13.03.04.018--
Blood creatinine13.13.01.020--Not Available
Blood creatinine increased13.13.01.004--
Blood urea abnormal13.13.01.005--Not Available
Cachexia16.32.03.011; 14.03.02.001; 08.01.01.0090.000112%Not Available
Capillary leak syndrome24.06.03.001; 08.01.07.0120.001399%
Cardiac arrest02.03.04.0010.000392%
Cardiac failure02.05.01.0010.000895%
The 1th Page    1 2 3 4 5    Next   Last    Total 10 Pages
ADReCS-Target
Drug Name ADR Term Target
Tip:  Drug Name  ADR Term  Protein  Variation  Gene