gemcitabine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
nucleosides antiviral or antineoplastic agents, cytarabine or azacitidine derivatives	1283	95058-81-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: gemcitabine gamcitabine gemcitabine hydrochloride gemcitabine HCl	Gemcitabine kills cells undergoing DNA synthesis and blocks the progression of cells through the G1/S-phase boundary. Gemcitabine is metabolized by nucleoside kinases to diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. Gemcitabine diphosphate inhibits ribonucleotide reductase, an enzyme responsible for catalyzing the reactions that generate deoxynucleoside triphosphates for DNA synthesis, resulting in reductions in deoxynucleotide concentrations, including dCTP. Gemcitabine triphosphate competes with dCTP for incorporation into DNA. The reduction in the intracellular concentration of dCTP by the action of the diphosphate enhances the incorporation of gemcitabine triphosphate into DNA (selfpotentiation). After the gemcitabine nucleotide is incorporated into DNA, only one additional nucleotide is added to the growing DNA strands, which eventually results in the initiation of apoptotic cell death. Molecular weight: 263.20 Formula: C9H11F2N3O4 CLOGP: -0.41 LIPINSKI: 0 HAC: 7 HDO: 3 TPSA: 108.38 ALOGS: -1.07 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

gemcitabine
gamcitabine
gemcitabine hydrochloride
gemcitabine HCl

Gemcitabine kills cells undergoing DNA synthesis and blocks the progression of cells through the G1/S-phase boundary. Gemcitabine is metabolized by nucleoside kinases to diphosphate (dFdCDP) and triphosphate (dFdCTP) nucleosides. Gemcitabine diphosphate inhibits ribonucleotide reductase, an enzyme responsible for catalyzing the reactions that generate deoxynucleoside triphosphates for DNA synthesis, resulting in reductions in deoxynucleotide concentrations, including dCTP. Gemcitabine triphosphate competes with dCTP for incorporation into DNA. The reduction in the intracellular concentration of dCTP by the action of the diphosphate enhances the incorporation of gemcitabine triphosphate into DNA (selfpotentiation). After the gemcitabine nucleotide is incorporated into DNA, only one additional nucleotide is added to the growing DNA strands, which eventually results in the initiation of apoptotic cell death.

Molecular weight: 263.20
Formula: C9H11F2N3O4
CLOGP: -0.41
LIPINSKI: 0
HAC: 7
HDO: 3
TPSA: 108.38
ALOGS: -1.07
ROTB: 2

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	15 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	8 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	93.90 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution)	1.50 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	32 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	1 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	1 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
May 15, 1996	FDA	LILLY
June 18, 2019	PMDA	Eli Lilly Japan K.K.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Malignant neoplasm progression	818.78	16.32	530	33370	67594	50503630
Thrombocytopenia	730.08	16.32	636	33264	127037	50444187
Disease progression	658.17	16.32	531	33369	95335	50475889
Neutropenia	549.02	16.32	581	33319	147384	50423840
Thrombotic microangiopathy	371.27	16.32	159	33741	8632	50562592
Neoplasm progression	362.33	16.32	232	33668	28925	50542299
Metastases to liver	303.16	16.32	181	33719	19923	50551301
Anaemia	279.49	16.32	558	33342	251898	50319326
Off label use	249.57	16.32	789	33111	473637	50097587
Myelosuppression	201.93	16.32	121	33779	13396	50557828
Metastases to lung	194.69	16.32	110	33790	10910	50560314
Haematotoxicity	184.80	16.32	95	33805	7800	50563424
Pleural effusion	179.57	16.32	246	33654	81208	50490016
Metastases to bone	170.30	16.32	121	33779	17874	50553350
Platelet count decreased	165.56	16.32	265	33635	100461	50470763
Metastases to lymph nodes	162.90	16.32	84	33816	6940	50564284
Pyrexia	162.86	16.32	591	33309	379612	50191612
Death	158.55	16.32	528	33372	324851	50246373
Pancytopenia	157.59	16.32	235	33665	83795	50487429
Diffuse large B-cell lymphoma recurrent	155.02	16.32	53	33847	1542	50569682
Leukopenia	150.39	16.32	205	33695	67323	50503901
Ascites	147.17	16.32	149	33751	35712	50535512
Recall phenomenon	138.15	16.32	38	33862	518	50570706
Febrile neutropenia	132.62	16.32	236	33664	97431	50473793
Acute myeloid leukaemia	130.40	16.32	96	33804	14978	50556246
Neutrophil count decreased	121.54	16.32	152	33748	45874	50525350
Bone marrow failure	121.12	16.32	119	33781	27505	50543719
Posterior reversible encephalopathy syndrome	117.84	16.32	90	33810	14838	50556386
Second primary malignancy	116.70	16.32	67	33833	6847	50564377
Joint swelling	116.17	16.32	14	33886	245272	50325952
Capillary leak syndrome	113.42	16.32	44	33856	1846	50569378
Arthralgia	109.17	16.32	81	33819	438621	50132603
Biliary tract infection	108.99	16.32	30	33870	410	50570814
Haemolytic uraemic syndrome	108.06	16.32	45	33855	2274	50568950
Drug ineffective	107.63	16.32	245	33655	819088	49752136
Metastases to peritoneum	102.57	16.32	46	33854	2787	50568437
Cholangitis	98.28	16.32	52	33848	4527	50566697
Neuropathy peripheral	97.31	16.32	206	33694	96551	50474673
Neurotoxicity	95.23	16.32	79	33821	14661	50556563
Fall	93.89	16.32	54	33846	334878	50236346
Mucosal inflammation	89.52	16.32	122	33778	40020	50531204
Abdominal pain	87.42	16.32	351	33549	235877	50335347
Product dose omission issue	85.77	16.32	11	33889	183827	50387397
Vomiting	83.19	16.32	560	33340	460198	50111026
Sepsis	82.41	16.32	235	33665	132690	50438534
Palmar-plantar erythrodysaesthesia syndrome	81.50	16.32	83	33817	20015	50551209
Therapy partial responder	80.69	16.32	52	33848	6539	50564685
Contraindicated product administered	79.95	16.32	5	33895	148953	50422271
Maternal exposure during pregnancy	78.43	16.32	8	33892	159770	50411454
Hypertransaminasaemia	71.87	16.32	39	33861	3572	50567652
Weight increased	71.69	16.32	23	33877	201868	50369356
Metastases to central nervous system	69.84	16.32	59	33841	11223	50560001
Hepatic failure	68.79	16.32	96	33804	32187	50539037
Cytokine release syndrome	68.02	16.32	52	33848	8582	50562642
Systemic lupus erythematosus	66.58	16.32	8	33892	140614	50430610
PIK3CA-activated mutation	63.73	16.32	23	33877	787	50570437
Pulmonary embolism	63.19	16.32	180	33720	101524	50469700
Sinusitis	63.13	16.32	18	33882	170540	50400684
Nasopharyngitis	61.71	16.32	26	33874	192901	50378323
Diffuse large B-cell lymphoma refractory	61.52	16.32	24	33876	1022	50570202
Cytopenia	60.81	16.32	49	33851	8726	50562498
Headache	60.28	16.32	159	33741	506376	50064848
Drug hypersensitivity	60.19	16.32	48	33852	250962	50320262
Abdominal discomfort	59.80	16.32	41	33859	231600	50339624
Musculoskeletal stiffness	59.15	16.32	8	33892	128473	50442751
Ovarian cancer recurrent	58.18	16.32	22	33878	860	50570364
Myositis	56.54	16.32	45	33855	7875	50563349
Swelling	55.33	16.32	33	33867	200839	50370385
Breast cancer recurrent	54.05	16.32	33	33867	3775	50567449
Pericardial effusion	52.89	16.32	75	33825	25514	50545710
Metastases to skin	51.81	16.32	23	33877	1360	50569864
Neutropenic sepsis	51.22	16.32	55	33845	14092	50557132
Myelodysplastic syndrome	49.88	16.32	56	33844	15076	50556148
Small intestinal obstruction	48.81	16.32	57	33843	16011	50555213
Thrombotic thrombocytopenic purpura	48.17	16.32	30	33870	3555	50567669
Wound	47.73	16.32	7	33893	105787	50465437
Therapeutic product effect decreased	47.39	16.32	16	33884	136034	50435190
Dehydration	47.37	16.32	215	33685	152234	50418990
Peripheral swelling	47.35	16.32	41	33859	205895	50365329
Bile duct stenosis	47.19	16.32	20	33880	1056	50570168
Product use in unapproved indication	46.72	16.32	177	33723	115642	50455582
General physical health deterioration	46.61	16.32	204	33696	142230	50428994
Hepatotoxicity	46.53	16.32	73	33827	27153	50544071
Injection site pain	46.43	16.32	9	33891	111015	50460209
Tumour lysis syndrome	46.32	16.32	39	33861	7382	50563842
Arthropathy	46.28	16.32	24	33876	157882	50413342
Haemoglobin decreased	46.12	16.32	188	33712	127028	50444196
BRCA2 gene mutation	43.82	16.32	10	33890	59	50571165
Pain	43.51	16.32	220	33680	578683	49992541
Metastases to pleura	43.47	16.32	20	33880	1286	50569938
Pancreatic carcinoma metastatic	43.29	16.32	23	33877	2019	50569205
Disease recurrence	43.20	16.32	60	33840	20021	50551203
Embolism	42.22	16.32	36	33864	6932	50564292
Pneumonitis	42.18	16.32	73	33827	29437	50541787
Interstitial lung disease	40.99	16.32	102	33798	53074	50518150
Drug interaction	40.93	16.32	44	33856	199577	50371647
Exposure during pregnancy	40.82	16.32	15	33885	121000	50450224
Erythema	40.74	16.32	200	33700	146214	50425010
Cholestasis	40.52	16.32	66	33834	25335	50545889
Asthma	40.09	16.32	6	33894	89331	50481893
Pancreatic fistula	39.84	16.32	7	33893	6	50571218
Lower respiratory tract infection	39.21	16.32	8	33892	95193	50476031
Hormone receptor positive breast cancer	38.99	16.32	14	33886	472	50570752
Capillary permeability increased	38.92	16.32	8	33892	26	50571198
White blood cell count decreased	38.80	16.32	168	33732	116554	50454670
Injection site erythema	38.78	16.32	3	33897	74933	50496291
Hypoalbuminaemia	38.66	16.32	40	33860	9820	50561404
Alopecia	38.16	16.32	66	33834	244981	50326243
Asthenia	38.14	16.32	353	33547	318689	50252535
Urinary tract obstruction	37.93	16.32	20	33880	1728	50569496
Overdose	37.86	16.32	10	33890	99717	50471507
Hepatic enzyme increased	37.21	16.32	23	33877	137357	50433867
Polyneuropathy	36.79	16.32	43	33857	12088	50559136
Arthritis	36.32	16.32	7	33893	86714	50484510
Nausea	36	16.32	667	33233	704731	49866493
Insomnia	35.34	16.32	39	33861	174826	50396398
EGFR gene mutation	34.99	16.32	11	33889	244	50570980
Product use issue	34.05	16.32	30	33870	149445	50421779
Breast cancer metastatic	33.55	16.32	38	33862	10326	50560898
Subacute cutaneous lupus erythematosus	33.51	16.32	20	33880	2195	50569029
Drug resistance	32.56	16.32	51	33849	18938	50552286
Carcinoembryonic antigen increased	32.37	16.32	17	33883	1457	50569767
Toxic erythema of chemotherapy	32.36	16.32	9	33891	128	50571096
Cardiac cirrhosis	32.24	16.32	9	33891	130	50571094
Memory impairment	32.00	16.32	7	33893	79353	50491871
Somnolence	31.94	16.32	34	33866	154951	50416273
Proteinuria	31.89	16.32	47	33853	16550	50554674
Bronchitis	31.76	16.32	15	33885	104144	50467080
Acquired gene mutation	31.71	16.32	14	33886	817	50570407
Microangiopathic haemolytic anaemia	31.14	16.32	12	33888	494	50570730
Pseudocellulitis	30.64	16.32	6	33894	14	50571210
Carbohydrate antigen 19-9 increased	30.60	16.32	9	33891	158	50571066
Metastases to meninges	30.09	16.32	18	33882	1984	50569240
Contusion	30.07	16.32	19	33881	112164	50459060
Muscle spasms	30.06	16.32	24	33876	125529	50445695
Jaundice	29.75	16.32	59	33841	26370	50544854
Condition aggravated	29.64	16.32	101	33799	296957	50274267
Thrombophlebitis migrans	29.57	16.32	8	33892	102	50571122
Metastasis	29.40	16.32	24	33876	4351	50566873
Carbohydrate antigen 125 increased	29.06	16.32	19	33881	2448	50568776
Metastases to chest wall	28.23	16.32	11	33889	467	50570757
Skin mass	28.03	16.32	25	33875	5110	50566114
Pericarditis	27.83	16.32	9	33891	78680	50492544
Sleep disorder	27.75	16.32	3	33897	57280	50513944
Epistaxis	27.66	16.32	100	33800	63854	50507370
Gait disturbance	27.59	16.32	36	33864	149969	50421255
Performance status decreased	26.84	16.32	20	33880	3175	50568049
Suicidal ideation	26.57	16.32	3	33897	55382	50515842
Feeling abnormal	26.45	16.32	27	33873	125465	50445759
Gastrointestinal toxicity	25.99	16.32	23	33877	4654	50566570
Metastases to bone marrow	25.90	16.32	9	33891	275	50570949
Haemoglobinaemia	25.79	16.32	6	33894	39	50571185
Influenza	25.64	16.32	14	33886	89524	50481700
Deep vein thrombosis	25.49	16.32	107	33793	73197	50498027
Oedema peripheral	25.39	16.32	187	33713	157774	50413450
Cerebral ischaemia	25.04	16.32	25	33875	5883	50565341
Cholangitis infective	24.89	16.32	8	33892	191	50571033
Loss of personal independence in daily activities	24.80	16.32	8	33892	70042	50501182
Device occlusion	24.64	16.32	25	33875	5998	50565226
Pulmonary toxicity	24.44	16.32	24	33876	5538	50565686
Migraine	24.27	16.32	10	33890	75270	50495954
Metastatic neoplasm	23.99	16.32	20	33880	3734	50567490
Urticaria	23.92	16.32	31	33869	129530	50441694
Catabolic state	23.69	16.32	6	33894	58	50571166
Decreased appetite	23.30	16.32	221	33679	200702	50370522
Atypical haemolytic uraemic syndrome	23.26	16.32	10	33890	547	50570677
Laryngospasm	22.97	16.32	17	33883	2671	50568553
Mediastinum neoplasm	22.83	16.32	6	33894	68	50571156
Peripheral sensory neuropathy	22.77	16.32	25	33875	6566	50564658
Granulocyte count decreased	22.70	16.32	11	33889	795	50570429
Inappropriate schedule of product administration	22.43	16.32	10	33890	71821	50499403
Gastric neoplasm	22.38	16.32	8	33892	266	50570958
Hypocalcaemia	22.32	16.32	53	33847	26763	50544461
Pancreatic carcinoma	22.21	16.32	24	33876	6190	50565034
Peritoneal disorder	21.91	16.32	9	33891	439	50570785
Leukaemic lymphoma	21.66	16.32	6	33894	84	50571140
Metastases to bladder	21.59	16.32	7	33893	172	50571052
Metastases to diaphragm	21.56	16.32	5	33895	32	50571192
Depression	21.08	16.32	50	33850	165373	50405851
Injection site reaction	21.03	16.32	4	33896	50028	50521196
Discomfort	20.98	16.32	25	33875	108355	50462869
Anxiety	20.84	16.32	56	33844	177550	50393674
Dizziness	20.42	16.32	142	33758	346227	50224997
Injury	20.37	16.32	4	33896	48921	50522303
Biliary obstruction	20.15	16.32	15	33885	2378	50568846
Vena cava thrombosis	20.06	16.32	14	33886	2007	50569217
Blood lactate dehydrogenase increased	20.04	16.32	42	33858	19520	50551704
Intestinal metastasis	20.01	16.32	6	33894	113	50571111
Neutrophil count abnormal	19.78	16.32	15	33885	2444	50568780
Generalised oedema	19.66	16.32	34	33866	13697	50557527
Metastases to spleen	19.58	16.32	6	33894	122	50571102
Chills	19.44	16.32	121	33779	96566	50474658
Lymphoedema	19.23	16.32	27	33873	9095	50562129
Bronchostenosis	19.14	16.32	8	33892	408	50570816
Left ventricular dysfunction	19.11	16.32	29	33871	10477	50560747
Colitis	19.05	16.32	63	33837	38466	50532758
Ureteric fistula	19.01	16.32	4	33896	15	50571209
Renal salt-wasting syndrome	19.00	16.32	7	33893	254	50570970
Hyperpyrexia	18.98	16.32	16	33884	3033	50568191
Portal vein occlusion	18.93	16.32	3	33897	0	50571224
TP53 gene mutation	18.93	16.32	3	33897	0	50571224
Paresis cranial nerve	18.93	16.32	3	33897	0	50571224
Pseudosepsis	18.93	16.32	3	33897	0	50571224
Gastrointestinal perforation	18.93	16.32	16	33884	3045	50568179
Dermatitis acneiform	18.75	16.32	18	33882	4039	50567185
IIIrd nerve paralysis	18.73	16.32	9	33891	638	50570586
Wrong technique in product usage process	18.51	16.32	7	33893	55503	50515721
Injection site swelling	18.29	16.32	3	33897	41770	50529454
Mobility decreased	18.25	16.32	16	33884	79932	50491292
Cardiotoxicity	18.20	16.32	23	33877	7004	50564220
Postictal state	18.18	16.32	10	33890	940	50570284
Metastases to adrenals	18.13	16.32	9	33891	685	50570539
Neoplasm recurrence	18.07	16.32	14	33886	2355	50568869
Renal vein thrombosis	17.99	16.32	7	33893	296	50570928
Osteoarthritis	17.86	16.32	12	33888	68594	50502630
Myocardial infarction	17.81	16.32	20	33880	89007	50482217
Tachycardia	17.70	16.32	121	33779	99642	50471582
Post thrombotic syndrome	17.50	16.32	8	33892	507	50570717
Metastases to stomach	17.16	16.32	6	33894	187	50571037
Impaired healing	17.13	16.32	13	33887	69773	50501451
Cardiomyopathy acute	16.92	16.32	6	33894	195	50571029
Infusion site thrombosis	16.78	16.32	5	33895	92	50571132
Folliculitis	16.77	16.32	3	33897	39222	50532002
Lymphangitis	16.72	16.32	9	33891	811	50570413
Cardiomyopathy	16.59	16.32	34	33866	15552	50555672
Haemoptysis	16.58	16.32	46	33854	25527	50545697
Ejection fraction abnormal	16.44	16.32	9	33891	838	50570386
Obstruction gastric	16.42	16.32	9	33891	840	50570384
Oroticaciduria	16.39	16.32	3	33897	4	50571220

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Thrombocytopenia	536.83	17.94	669	29207	134154	29410497
Disease progression	481.45	17.94	498	29378	81418	29463233
Thrombotic microangiopathy	352.11	17.94	173	29703	8508	29536143
Neutropenia	285.31	17.94	491	29385	131220	29413431
Malignant neoplasm progression	239.35	17.94	332	29544	73527	29471124
Anaemia	233.24	17.94	579	29297	200372	29344279
Myelosuppression	212.52	17.94	140	29736	12087	29532564
Off label use	210.56	17.94	723	29153	300077	29244574
Neoplasm progression	210.37	17.94	164	29712	18448	29526203
Pancytopenia	184.88	17.94	314	29562	82854	29461797
Cholangitis	183.57	17.94	107	29769	7430	29537221
Pyrexia	149.30	17.94	629	29247	286993	29257658
Diffuse large B-cell lymphoma recurrent	143.13	17.94	64	29812	2533	29542118
Leukopenia	131.33	17.94	215	29661	54988	29489663
General physical health deterioration	124.78	17.94	302	29574	102555	29442096
Febrile neutropenia	121.96	17.94	316	29560	111924	29432727
Haemolytic uraemic syndrome	109.30	17.94	49	29827	1951	29542700
Pneumonitis	98.10	17.94	131	29745	27913	29516738
Haematotoxicity	98.05	17.94	69	29807	6630	29538021
Therapy partial responder	89.02	17.94	59	29817	5140	29539511
Platelet count decreased	85.56	17.94	266	29610	104406	29440245
Pseudocellulitis	85.34	17.94	17	29859	24	29544627
Interstitial lung disease	83.73	17.94	182	29694	57536	29487115
Neuropathy peripheral	82.26	17.94	205	29671	70822	29473829
Diffuse large B-cell lymphoma refractory	82.13	17.94	32	29844	890	29543761
Neutrophil count decreased	81.85	17.94	153	29723	43414	29501237
Neutropenic sepsis	80.92	17.94	78	29798	11649	29533002
Bacteraemia	75.94	17.94	88	29788	16235	29528416
Biliary tract infection	73.46	17.94	25	29851	467	29544184
Product dose omission issue	72.08	17.94	7	29869	96376	29448275
Drug interaction	70.11	17.94	58	29818	197327	29347324
Pulmonary embolism	64.81	17.94	197	29679	76337	29468314
Bone marrow failure	63.97	17.94	106	29770	27343	29517308
Capillary leak syndrome	62.82	17.94	33	29843	1866	29542785
Liver abscess	59.87	17.94	39	29837	3299	29541352
Pancreatic carcinoma metastatic	59.37	17.94	36	29840	2685	29541966
Pleural effusion	56.17	17.94	180	29696	71728	29472923
Overdose	54.24	17.94	8	29868	79811	29464840
Atypical haemolytic uraemic syndrome	52.58	17.94	15	29861	151	29544500
Product use in unapproved indication	51.89	17.94	199	29677	86676	29457975
Peripheral ischaemia	51.17	17.94	42	29834	5077	29539574
Arthralgia	50.81	17.94	40	29836	139577	29405074
Neurotoxicity	50.68	17.94	68	29808	14545	29530106
Immune-mediated hepatitis	48.99	17.94	26	29850	1501	29543150
Metastases to liver	47.09	17.94	59	29817	11797	29532854
Pancreatic carcinoma	46.41	17.94	46	29830	7104	29537547
Biliary obstruction	45.25	17.94	29	29847	2385	29542266
Ascites	44.79	17.94	108	29768	36511	29508140
Vomiting	44.50	17.94	366	29510	211894	29332757
Nausea	44.21	17.94	466	29410	288789	29255862
Myositis	43.79	17.94	53	29823	10230	29534421
Fall	41.61	17.94	72	29804	177106	29367545
Deep vein thrombosis	41.50	17.94	140	29736	57259	29487392
Metastases to lung	41.05	17.94	45	29831	7810	29536841
Sepsis	40.76	17.94	265	29611	142417	29402234
Chills	39.06	17.94	159	29717	71141	29473510
Asthenia	38.78	17.94	359	29517	214891	29329760
Seizure	38.76	17.94	23	29853	93100	29451551
Recall phenomenon	38.75	17.94	16	29860	519	29544132
Right ventricular ejection fraction decreased	38.64	17.94	9	29867	36	29544615
Nasopharyngitis	38.25	17.94	7	29869	59658	29484993
Cytokine release syndrome	37.99	17.94	56	29820	13063	29531588
Drug hypersensitivity	37.95	17.94	11	29865	68395	29476256
Headache	37.93	17.94	74	29802	173933	29370718
Pulmonary toxicity	36.54	17.94	34	29842	4856	29539795
Decreased appetite	36.19	17.94	261	29615	145081	29399570
Cytopenia	35.91	17.94	47	29829	9812	29534839
Hepatocellular injury	34.26	17.94	70	29806	21173	29523478
Feeling abnormal	33.61	17.94	7	29869	54438	29490213
Device occlusion	32.61	17.94	34	29842	5574	29539077
Disease recurrence	32.53	17.94	58	29818	15856	29528795
Abdominal pain	32.50	17.94	241	29635	135116	29409535
Hyperpyrexia	31.97	17.94	23	29853	2287	29542364
Extremity necrosis	31.90	17.94	20	29856	1583	29543068
Metastases to central nervous system	30.76	17.94	37	29839	7094	29537557
Depression	30.19	17.94	25	29851	85122	29459529
Myalgia	29.80	17.94	19	29857	74000	29470651
Skin toxicity	29.69	17.94	27	29849	3744	29540907
Mucosal inflammation	29.25	17.94	84	29792	31511	29513140
Histiocytic necrotising lymphadenitis	28.81	17.94	6	29870	12	29544639
Hospitalisation	28.20	17.94	6	29870	45982	29498669
Chronic coronary syndrome	28.00	17.94	7	29869	40	29544611
Insomnia	27.99	17.94	29	29847	88732	29455919
Anxiety	27.94	17.94	27	29849	85338	29459313
Dehydration	27.93	17.94	205	29671	114543	29430108
Dermatitis acneiform	27.90	17.94	31	29845	5460	29539191
Second primary malignancy	27.64	17.94	34	29842	6671	29537980
Muscle spasms	27.18	17.94	16	29860	65066	29479585
Vena cava thrombosis	26.23	17.94	15	29861	1003	29543648
White blood cell count decreased	25.73	17.94	158	29718	83204	29461447
Urosepsis	25.70	17.94	42	29834	10704	29533947
Embolism	25.31	17.94	33	29843	6863	29537788
Tumour lysis syndrome	25.10	17.94	48	29828	13836	29530815
Pancreatic enzyme abnormality	25.01	17.94	6	29870	28	29544623
Acute myeloid leukaemia	24.97	17.94	53	29823	16460	29528191
Biliary sepsis	24.82	17.94	12	29864	568	29544083
Erythropenia	24.78	17.94	9	29867	205	29544446
Coronary artery disease	24.70	17.94	7	29869	44183	29500468
Blood pressure increased	24.55	17.94	23	29853	73780	29470871
Weight increased	24.23	17.94	25	29851	76642	29468009
Vascular purpura	24.20	17.94	16	29860	1387	29543264
Joint swelling	24.04	17.94	10	29866	49620	29495031
Agitation	23.81	17.94	11	29865	51293	29493358
Discontinued product administered	23.69	17.94	5	29871	11	29544640
Electrocardiogram QT prolonged	23.68	17.94	4	29872	36133	29508518
Hypophosphataemia	23.19	17.94	34	29842	7890	29536761
Ill-defined disorder	23.15	17.94	42	29834	11636	29533015
Cardiac failure congestive	23.06	17.94	26	29850	76555	29468096
Hypertransaminasaemia	23.03	17.94	23	29853	3583	29541068
Tremor	22.10	17.94	25	29851	73513	29471138
Lung opacity	21.92	17.94	15	29861	1377	29543274
Oedema peripheral	21.85	17.94	179	29697	103378	29441273
Metabolic disorder	20.76	17.94	22	29854	3673	29540978
Lymphadenopathy	20.72	17.94	64	29812	24985	29519666
Toxicity to various agents	20.47	17.94	98	29778	173563	29371088
Granulocyte-colony stimulating factor level increased	20.36	17.94	4	29872	5	29544646
Toxic erythema of chemotherapy	20.08	17.94	6	29870	72	29544579
Bradycardia	20.06	17.94	22	29854	65607	29479044
Jaundice cholestatic	20.01	17.94	23	29853	4203	29540448
Vascular pseudoaneurysm ruptured	19.71	17.94	6	29870	77	29544574
Tumour necrosis	19.69	17.94	13	29863	1124	29543527
Somnolence	19.55	17.94	41	29835	93914	29450737
Fistula of small intestine	19.44	17.94	9	29867	386	29544265
Molluscum contagiosum	19.33	17.94	8	29868	261	29544390
Nephropathy toxic	19.21	17.94	37	29839	10719	29533932
Myocardial infarction	19.10	17.94	53	29823	110243	29434408
Cardiac disorder	18.88	17.94	7	29869	37256	29507395
Haemoglobin decreased	18.57	17.94	179	29697	108196	29436455
Palpitations	18.52	17.94	5	29871	32599	29512052
Muscle necrosis	18.42	17.94	11	29865	798	29543853
Injection site pain	18.39	17.94	5	29871	32441	29512210
Disseminated intravascular coagulation	18.37	17.94	53	29823	19927	29524724
Gastroenteritis radiation	18.34	17.94	8	29868	298	29544353
Hypercalcaemia of malignancy	18.33	17.94	7	29869	184	29544467
Flank pain	18.29	17.94	26	29850	5867	29538784
Carbohydrate antigen 19-9 increased	18.26	17.94	7	29869	186	29544465
Thrombophlebitis	18.24	17.94	18	29858	2765	29541886
Memory impairment	18.23	17.94	7	29869	36463	29508188
Enterocolitis infectious	18.22	17.94	13	29863	1276	29543375
Splenic infarction	18.19	17.94	15	29861	1824	29542827
Cystoid macular oedema	18.09	17.94	10	29866	626	29544025
Duodenal stenosis	18.09	17.94	7	29869	191	29544460
Transitional cell carcinoma recurrent	18.06	17.94	4	29872	12	29544639

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Thrombocytopenia	1192.90	15.01	1174	51967	222627	64222964
Disease progression	833.94	15.01	786	52355	140894	64304697
Thrombotic microangiopathy	743.66	15.01	333	52808	16322	64429269
Malignant neoplasm progression	729.43	15.01	660	52481	112211	64333380
Neutropenia	712.28	15.01	929	52212	238695	64206896
Anaemia	469.53	15.01	990	52151	377690	64067901
Neoplasm progression	429.80	15.01	318	52823	40646	64404945
Myelosuppression	385.93	15.01	242	52899	23588	64422003
Pancytopenia	299.90	15.01	471	52670	142838	64302753
Pyrexia	289.65	15.01	1062	52079	557582	63888009
Cholangitis	263.15	15.01	143	52998	10659	64434932
Off label use	255.75	15.01	1113	52028	631693	63813898
Leukopenia	230.29	15.01	346	52795	100896	64344695
Haematotoxicity	229.19	15.01	139	53002	12757	64432834
Diffuse large B-cell lymphoma recurrent	221.33	15.01	87	53054	3059	64442532
Platelet count decreased	220.41	15.01	450	52691	167261	64278330
Metastases to liver	218.26	15.01	171	52970	23770	64421821
Febrile neutropenia	212.59	15.01	474	52667	187183	64258408
Haemolytic uraemic syndrome	207.26	15.01	89	53052	3932	64441659
Neuropathy peripheral	190.77	15.01	345	52796	117180	64328411
Neutrophil count decreased	177.16	15.01	265	52876	76931	64368660
Biliary tract infection	175.39	15.01	54	53087	897	64444694
Arthralgia	174.82	15.01	73	53068	442187	64003404
Recall phenomenon	168.23	15.01	53	53088	953	64444638
Metastases to lung	167.90	15.01	122	53019	15142	64430449
Capillary leak syndrome	163.46	15.01	71	53070	3226	64442365
General physical health deterioration	161.41	15.01	450	52691	203975	64241616
Bone marrow failure	160.87	15.01	198	52943	47754	64397837
Therapy partial responder	160.67	15.01	102	53039	10146	64435445
Pleural effusion	150.34	15.01	326	52815	126233	64319358
Ascites	139.61	15.01	211	52930	61790	64383801
Acute myeloid leukaemia	137.91	15.01	140	53001	27323	64418268
Metastases to lymph nodes	137.25	15.01	87	53054	8630	64436961
Pneumonitis	131.73	15.01	184	52957	50181	64395410
Interstitial lung disease	125.59	15.01	260	52881	97472	64348119
Neurotoxicity	123.78	15.01	132	53009	27272	64418319
Joint swelling	120.82	15.01	17	53124	215365	64230226
Diffuse large B-cell lymphoma refractory	119.15	15.01	42	53099	1082	64444509
Pulmonary embolism	117.22	15.01	324	52817	146032	64299559
Fall	115.73	15.01	104	53037	416722	64028869
Product dose omission issue	114.99	15.01	13	53128	194734	64250857
Second primary malignancy	114.33	15.01	89	53052	12248	64433343
Neutropenic sepsis	112.07	15.01	116	53025	23156	64422435
Pseudocellulitis	111.49	15.01	22	53119	40	64445551
Myositis	109.87	15.01	98	53043	16279	64429312
Cytokine release syndrome	109.75	15.01	109	53032	20720	64424871
Headache	106.70	15.01	170	52971	529297	63916294
Sepsis	100.75	15.01	416	52725	229925	64215666
Metastases to bone	100.46	15.01	103	53038	20332	64425259
Product use in unapproved indication	97.85	15.01	344	52797	176274	64269317
Nasopharyngitis	93.89	15.01	23	53118	196050	64249541
Overdose	90.88	15.01	12	53129	159554	64286037
Mucosal inflammation	90.55	15.01	175	52966	62409	64383182
Hypertransaminasaemia	89.53	15.01	62	53079	7129	64438462
Drug interaction	89.39	15.01	100	53041	361983	64083608
Musculoskeletal stiffness	88.04	15.01	3	53138	123203	64322388
Drug hypersensitivity	83.49	15.01	46	53095	237769	64207822
Weight increased	79.76	15.01	38	53103	213310	64232281
Vomiting	79.25	15.01	746	52395	550371	63895220
Abdominal pain	76.39	15.01	479	52662	311896	64133695
Liver abscess	71.62	15.01	48	53093	5232	64440359
Tumour lysis syndrome	71.26	15.01	84	53057	19356	64426235
Cytopenia	70.70	15.01	75	53066	15396	64430195
Atypical haemolytic uraemic syndrome	70.09	15.01	25	53116	667	64444924
Pancreatic carcinoma metastatic	68.32	15.01	40	53101	3438	64442153
Embolism	68.13	15.01	66	53075	12169	64433422
Posterior reversible encephalopathy syndrome	67.83	15.01	89	53052	22857	64422734
Bacteraemia	65.45	15.01	95	53046	26816	64418775
Pulmonary toxicity	65.04	15.01	55	53086	8506	64437085
Metastases to peritoneum	64.99	15.01	39	53102	3508	64442083
Metastases to central nervous system	64.56	15.01	68	53073	13844	64431747
Contraindicated product administered	64.12	15.01	7	53134	107822	64337769
Injection site pain	61.95	15.01	9	53132	111399	64334192
Peripheral swelling	61.85	15.01	49	53092	209104	64236487
Disease recurrence	60.87	15.01	100	53041	31410	64414181
Insomnia	60.21	15.01	45	53096	197791	64247800
Deep vein thrombosis	60.04	15.01	207	52934	104975	64340616
Peripheral ischaemia	59.93	15.01	52	53089	8326	64437265
Asthma	59.74	15.01	5	53136	95220	64350371
Asthenia	59.22	15.01	575	52566	427469	64018122
Bile duct stenosis	58.96	15.01	29	53112	1755	64443836
Chills	58.43	15.01	246	52895	137018	64308573
Drug ineffective	58.17	15.01	430	52711	839817	63605774
Feeling abnormal	57.78	15.01	19	53122	133583	64312008
Muscle spasms	56.02	15.01	23	53118	141000	64304591
Immune-mediated hepatitis	55.25	15.01	31	53110	2458	64443133
Maternal exposure during pregnancy	55.08	15.01	7	53134	95877	64349714
Biliary obstruction	54.51	15.01	36	53105	3828	64441763
White blood cell count decreased	53.86	15.01	265	52876	157572	64288019
Abdominal discomfort	52.30	15.01	44	53097	182278	64263313
Pericardial effusion	52.22	15.01	106	53035	39148	64406443
Sinusitis	51.51	15.01	28	53113	145900	64299691
Pain	50.88	15.01	259	52882	553252	63892339
Toxic erythema of chemotherapy	50.64	15.01	15	53126	217	64445374
Swelling	50.63	15.01	35	53106	160183	64285408
Device occlusion	50.60	15.01	51	53090	9862	64435729
Hyperpyrexia	50.04	15.01	38	53103	5039	64440552
Subacute cutaneous lupus erythematosus	49.64	15.01	31	53110	2994	64442597
Contusion	49.64	15.01	16	53125	113949	64331642
Pancreatic carcinoma	48.67	15.01	51	53090	10322	64435269
Palmar-plantar erythrodysaesthesia syndrome	47.18	15.01	85	53056	28734	64416857
Anxiety	46.70	15.01	59	53082	202590	64243001
Injection site erythema	46.46	15.01	3	53138	70797	64374794
Haemoglobin decreased	46.28	15.01	297	52844	194766	64250825
Microangiopathic haemolytic anaemia	44.59	15.01	22	53119	1340	64444251
Nausea	44.49	15.01	900	52241	784900	63660691
Arthropathy	44.49	15.01	22	53119	120945	64324646
Psoriasis	44.34	15.01	4	53137	71699	64373892
Hepatotoxicity	44.06	15.01	100	53041	39862	64405729
Therapeutic product effect decreased	43.92	15.01	20	53121	115331	64330260
Exposure during pregnancy	43.83	15.01	6	53135	77669	64367922
Systemic lupus erythematosus	43.78	15.01	6	53135	77606	64367985
Suicidal ideation	43.13	15.01	3	53138	66539	64379052
Wound	42.93	15.01	6	53135	76471	64369120
Decreased appetite	42.90	15.01	386	52755	280903	64164688
Extremity necrosis	42.32	15.01	27	53114	2707	64442884
Memory impairment	41.09	15.01	10	53131	85672	64359919
Depression	40.55	15.01	55	53086	183236	64262355
Dehydration	39.71	15.01	310	52831	216453	64229138
Colitis	39.33	15.01	122	53019	58552	64387039
Right ventricular ejection fraction decreased	39	15.01	9	53132	44	64445547
Erythropenia	38.99	15.01	14	53127	381	64445210
Hepatic failure	38.83	15.01	117	53024	55277	64390314
Cardiotoxicity	38.66	15.01	45	53096	10229	64435362
Somnolence	38.46	15.01	68	53073	203577	64242014
Hepatocellular injury	38.00	15.01	102	53039	45133	64400458
Skin toxicity	37.48	15.01	36	53105	6566	64439025
Bronchitis	36.74	15.01	22	53119	108721	64336870
Capillary permeability increased	36.17	15.01	8	53133	31	64445560
Gait disturbance	35.76	15.01	54	53087	172101	64273490
Mobility decreased	35.74	15.01	13	53128	85827	64359764
BRCA2 gene mutation	35.66	15.01	9	53132	68	64445523
Small intestinal obstruction	35.41	15.01	67	53074	23506	64422085
Oedema peripheral	35.38	15.01	295	52846	210022	64235569
Dermatitis acneiform	35.20	15.01	39	53102	8404	64437187
Biliary sepsis	35.04	15.01	19	53122	1409	64444182
Pancreatic fistula	34.78	15.01	9	53132	76	64445515
Blood lactate dehydrogenase increased	34.51	15.01	81	53060	32997	64412594
Metastases to pleura	34.34	15.01	18	53123	1246	64444345
Product use issue	34.09	15.01	45	53096	151670	64293921
Inappropriate schedule of product administration	33.60	15.01	17	53124	92269	64353322
Renal salt-wasting syndrome	33.23	15.01	13	53128	451	64445140
Cerebral ischaemia	33.17	15.01	41	53100	9921	64435670
Sleep disorder	32.78	15.01	5	53136	59704	64385887
Hypoalbuminaemia	32.67	15.01	55	53086	17619	64427972
Dizziness	32.64	15.01	214	52927	429949	64015642
Cholestasis	32.61	15.01	96	53045	44776	64400815
Drug resistance	32.40	15.01	82	53059	35020	64410571
Carbohydrate antigen 19-9 increased	32.10	15.01	12	53129	367	64445224
Hepatic enzyme increased	31.87	15.01	36	53105	129907	64315684
PIK3CA-activated mutation	31.67	15.01	13	53128	512	64445079
Pain in extremity	30.59	15.01	137	53004	302948	64142643
Condition aggravated	30.46	15.01	181	52960	372245	64073346
Influenza	30.18	15.01	26	53115	106505	64339086
Angioedema	30.06	15.01	7	53134	61814	64383777
Electrocardiogram QT prolonged	29.89	15.01	14	53127	79434	64366157
Arthritis	29.68	15.01	16	53125	83798	64361793
Blood pressure increased	29.62	15.01	61	53080	172491	64273100
Chronic coronary syndrome	29.42	15.01	7	53134	40	64445551
Tumour necrosis	29.28	15.01	18	53123	1691	64443900
Osteoarthritis	29.20	15.01	8	53133	63328	64382263
Immune effector cell-associated neurotoxicity syndrome	29.12	15.01	21	53120	2574	64443017
Metastases to spleen	28.74	15.01	12	53129	494	64445097
Cystoid macular oedema	28.66	15.01	18	53123	1756	64443835
Seizure	28.64	15.01	59	53082	166833	64278758
Urosepsis	28.60	15.01	59	53082	22035	64423556
Performance status decreased	28.12	15.01	28	53113	5336	64440255
Flank pain	28.11	15.01	49	53092	16140	64429451
Nephropathy toxic	27.83	15.01	51	53090	17463	64428128
Injection site reaction	27.81	15.01	3	53138	46661	64398930
Wheezing	27.65	15.01	16	53125	80563	64365028
Tremor	27.53	15.01	50	53091	148180	64297411
Myalgia	27.28	15.01	56	53085	158561	64287030
Stress	27.25	15.01	8	53133	60526	64385065
Hospitalisation	27.16	15.01	14	53127	75193	64370398
Myelodysplastic syndrome	27.12	15.01	66	53075	27513	64418078
Balance disorder	26.95	15.01	18	53123	83908	64361683
Breast cancer recurrent	26.94	15.01	20	53121	2563	64443028
Loss of personal independence in daily activities	26.90	15.01	13	53128	72441	64373150
Obstruction gastric	26.75	15.01	16	53125	1430	64444161
Post thrombotic syndrome	26.65	15.01	12	53129	594	64444997
Myocardial infarction	26.49	15.01	61	53080	165760	64279831
Gastrointestinal toxicity	26.47	15.01	27	53114	5295	64440296
Jaundice	26.38	15.01	94	53047	48418	64397173
Cardiac cirrhosis	26.33	15.01	9	53132	211	64445380
Disseminated intravascular coagulation	26.23	15.01	72	53069	32276	64413315
Jaundice cholestatic	26.20	15.01	34	53107	8636	64436955
Aortic thrombosis	26.07	15.01	16	53125	1498	64444093
Injury	25.95	15.01	7	53134	55985	64389606
Ovarian cancer recurrent	25.78	15.01	10	53131	339	64445252
Hepatic infection	25.63	15.01	13	53128	840	64444751
EGFR gene mutation	25.37	15.01	10	53131	354	64445237
Urticaria	25.34	15.01	52	53089	147265	64298326
Carcinoembryonic antigen increased	25.34	15.01	17	53124	1856	64443735
Aggression	25.09	15.01	4	53137	46228	64399363
Urinary tract obstruction	24.90	15.01	23	53118	3994	64441597
Thrombocytosis	24.71	15.01	30	53111	7126	64438465
Metastases to skin	24.13	15.01	15	53126	1437	64444154
Muscle necrosis	23.85	15.01	14	53127	1209	64444382
Injection site swelling	23.79	15.01	3	53138	41350	64404241
Pericarditis	23.54	15.01	11	53130	62505	64383086
Gastric perforation	23.46	15.01	21	53120	3502	64442089
Rhinorrhoea	23.45	15.01	10	53131	59959	64385632
Enterocolitis infectious	23.31	15.01	18	53123	2446	64443145
Polyneuropathy	23.29	15.01	51	53090	19843	64425748
Malignant ascites	23.23	15.01	13	53128	1025	64444566
Peripheral sensory neuropathy	23.18	15.01	37	53104	11341	64434250
Cholangitis infective	23.13	15.01	10	53131	449	64445142
Portal vein stenosis	22.90	15.01	5	53136	18	64445573
Hypercalcaemia of malignancy	22.77	15.01	9	53132	321	64445270
Histiocytic necrotising lymphadenitis	22.65	15.01	6	53135	56	64445535
Livedo reticularis	22.59	15.01	21	53120	3676	64441915
Cardio-respiratory arrest	22.28	15.01	29	53112	98364	64347227
Hydronephrosis	22.28	15.01	41	53100	14084	64431507
Malaise	22.21	15.01	214	52927	396033	64049558
Coronary artery disease	22.20	15.01	11	53130	60422	64385169
Wrong technique in product usage process	22.15	15.01	13	53128	64961	64380630
Metastases to bladder	22.10	15.01	8	53133	223	64445368
Bradycardia	21.83	15.01	40	53101	118179	64327412
Metastases to the mediastinum	21.68	15.01	10	53131	524	64445067
Fluid retention	21.67	15.01	11	53130	59595	64385996
Sedation	21.59	15.01	4	53137	41458	64404133
Metastasis	21.52	15.01	25	53116	5670	64439921
Palpitations	21.47	15.01	33	53108	104455	64341136
Disturbance in attention	21.31	15.01	4	53137	41070	64404521
Pleural mass	21.28	15.01	6	53135	72	64445519
Granulocyte-colony stimulating factor level increased	21.17	15.01	4	53137	5	64445586
Metastatic neoplasm	21.12	15.01	22	53119	4420	64441171
Intestinal metastasis	21.03	15.01	8	53133	257	64445334
Splenic infarction	20.88	15.01	19	53122	3238	64442353
Vascular pseudoaneurysm ruptured	20.85	15.01	7	53134	155	64445436
Gastrointestinal perforation	20.81	15.01	24	53117	5400	64440191
Coma	20.70	15.01	25	53116	87590	64358001
Pneumothorax	20.62	15.01	55	53086	24243	64421348
Thrombotic thrombocytopenic purpura	20.52	15.01	25	53116	5959	64439632
Pancreatic enzyme abnormality	20.50	15.01	6	53135	83	64445508
Leukaemic lymphoma	20.37	15.01	6	53135	85	64445506
Mediastinum neoplasm	20.18	15.01	6	53135	88	64445503
Haemoptysis	20.14	15.01	87	53054	48961	64396630
Stress cardiomyopathy	20.10	15.01	31	53110	9226	64436365
Gastric neoplasm	20.01	15.01	8	53133	294	64445297
Renal vein thrombosis	19.94	15.01	9	53132	448	64445143
Lymphadenopathy mediastinal	19.89	15.01	20	53121	3856	64441735
Catabolic state	19.81	15.01	6	53135	94	64445497
Infusion site thrombosis	19.65	15.01	7	53134	186	64445405
Hormone receptor positive breast cancer	19.61	15.01	8	53133	310	64445281
Heart rate increased	19.49	15.01	32	53109	98643	64346948
Migraine	19.38	15.01	14	53127	62663	64382928
Lymphadenopathy	19.32	15.01	83	53058	46603	64398988
Q fever	19.21	15.01	7	53134	199	64445392
Discomfort	19.19	15.01	23	53118	80855	64364736
Pneumocystis jirovecii pneumonia	19.02	15.01	58	53083	27576	64418015
Metastases to diaphragm	18.94	15.01	5	53136	46	64445545
Respiratory arrest	18.93	15.01	10	53131	52975	64392616
Transitional cell carcinoma recurrent	18.87	15.01	4	53137	12	64445579
Epistaxis	18.86	15.01	142	52999	97989	64347602
BRAF gene mutation	18.84	15.01	5	53136	47	64445544
Heart rate decreased	18.80	15.01	11	53130	55056	64390535
Erythema	18.74	15.01	236	52905	186834	64258757
Platelet count increased	18.65	15.01	45	53096	18651	64426940
Scleroderma-like reaction	18.64	15.01	6	53135	116	64445475
Haemolysis	18.63	15.01	33	53108	11006	64434585
Vascular purpura	18.55	15.01	16	53125	2540	64443051
Discontinued product administered	18.47	15.01	5	53136	51	64445540
Lower respiratory tract infection	18.39	15.01	31	53110	94583	64351008
Type 2 diabetes mellitus	18.33	15.01	3	53138	34017	64411574
Pseudosepsis	18.31	15.01	3	53138	0	64445591
Retroperitoneal neoplasm metastatic	18.31	15.01	3	53138	0	64445591
Impaired healing	18.06	15.01	14	53127	60459	64385132
Duodenal obstruction	18.06	15.01	8	53133	381	64445210
Ureteric fistula	17.99	15.01	4	53137	16	64445575
Lymphangitis	17.98	15.01	12	53129	1299	64444292
Hypophagia	17.65	15.01	72	53069	39515	64406076
Generalised oedema	17.49	15.01	47	53094	20806	64424785
Transaminases increased	17.48	15.01	78	53063	44516	64401075
Cognitive disorder	17.43	15.01	12	53129	55075	64390516
Unevaluable event	17.35	15.01	10	53131	50479	64395112
Lung opacity	17.33	15.01	17	53124	3182	64442409
Herpes zoster	17.26	15.01	24	53117	79163	64366428
Cardiomyopathy	17.24	15.01	53	53088	25303	64420288
Back pain	17.19	15.01	128	53013	250043	64195548
Skin mass	17.15	15.01	25	53116	7081	64438510
Delirium	17.15	15.01	19	53122	69175	64376416
Hypoaesthesia	17.14	15.01	58	53083	139050	64306541
Blood cholesterol increased	17.09	15.01	10	53131	50056	64395535
Hallucination	16.95	15.01	21	53120	72767	64372824
Peritoneal disorder	16.95	15.01	9	53132	640	64444951
Swollen tongue	16.91	15.01	4	53137	34950	64410641
Fistula of small intestine	16.87	15.01	9	53132	646	64444945
Loss of consciousness	16.86	15.01	64	53077	148301	64297290
Thrombophlebitis	16.81	15.01	22	53119	5632	64439959
Molluscum contagiosum	16.81	15.01	8	53133	450	64445141
Gait inability	16.67	15.01	7	53134	42361	64403230
Intestinal perforation	16.52	15.01	38	53103	15275	64430316
Blood bilirubin increased	16.41	15.01	92	53049	57461	64388130
Bone trimming	16.37	15.01	4	53137	26	64445565
Pancreatic abscess	16.35	15.01	5	53136	81	64445510
Laryngospasm	16.27	15.01	17	53124	3428	64442163
Blister	16.23	15.01	26	53115	80941	64364650
Biliary dilatation	16.06	15.01	14	53127	2254	64443337
Disseminated cryptococcosis	16.05	15.01	12	53129	1555	64444036
Chest discomfort	16.00	15.01	46	53095	116060	64329531
Road traffic accident	15.94	15.01	3	53138	30742	64414849
Triple negative breast cancer	15.92	15.01	5	53136	89	64445502
Treatment noncompliance	15.84	15.01	8	53133	43474	64402117
Oroticaciduria	15.77	15.01	3	53138	4	64445587
Blood creatine phosphokinase increased	15.73	15.01	15	53126	58543	64387048
Head injury	15.42	15.01	4	53137	32838	64412753
Platelet toxicity	15.37	15.01	3	53138	5	64445586
Gravitational oedema	15.35	15.01	12	53129	1660	64443931
Tumour thrombosis	15.28	15.01	5	53136	102	64445489
Influenza like illness	15.23	15.01	17	53124	61685	64383906
Therapy cessation	15.17	15.01	4	53137	32485	64413106
Neoplasm recurrence	15.12	15.01	17	53124	3722	64441869
Paraneoplastic pemphigus	15.05	15.01	5	53136	107	64445484
Toxicity to various agents	15.03	15.01	210	52931	363303	64082288
Stoma site dermatitis	15.02	15.01	3	53138	6	64445585

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01BC05	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS ANTIMETABOLITES Pyrimidine analogues
FDA MoA	N0000000233	Nucleic Acid Synthesis Inhibitors
FDA EPC	N0000175595	Nucleoside Metabolic Inhibitor
CHEBI has role	CHEBI:35221	antimetabolite
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:35705	immunosuppressive agents
CHEBI has role	CHEBI:36044	antiviral drugs
CHEBI has role	CHEBI:74213	EC 1.17.4.1 inhibitor
CHEBI has role	CHEBI:132992	radiosensitizing agents
CHEBI has role	CHEBI:149553	anticoronaviral drug
CHEBI has role	CHEBI:35703	Xenobiotic
CHEBI has role	CHEBI:47868	photosensitising agent
CHEBI has role	CHEBI:50266	Prodrugs
CHEBI has role	CHEBI:59517	DNA synthesis inhibitors
CHEBI has role	CHEBI:78298	environmental contaminants

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Non-small cell lung cancer	indication	254637007	DOID:3908
Malignant tumor of ovary	indication	363443007	DOID:2394
Adenocarcinoma of pancreas	indication	700423003	DOID:4074
Metastatic Breast Carcinoma	indication
Ewing's sarcoma	off-label use	76909002	DOID:3369
Small cell carcinoma of lung	off-label use	254632001	DOID:5409
Malignant tumor of head and/or neck	off-label use	255056009
Malignant tumor of testis	off-label use	363449006	DOID:2998
Malignant tumor of urinary bladder	off-label use	399326009	DOID:11054
Biliary Tract Malignancy	off-label use
Refractory Osteosarcoma	off-label use
Infectious disease	contraindication	40733004
Interstitial pneumonia	contraindication	64667001
Leukopenia	contraindication	84828003	DOID:615
Kidney disease	contraindication	90708001	DOID:557
Hemolytic uremic syndrome	contraindication	111407006	DOID:12554
Disease of liver	contraindication	235856003	DOID:409
Anemia	contraindication	271737000	DOID:2355
Pregnancy, function	contraindication	289908002
Thrombocytopenic disorder	contraindication	302215000	DOID:1588
Bone marrow depression	contraindication	307762000
Breastfeeding (mother)	contraindication	413712001

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	10.69	acidic
pKa2	12.86	acidic
pKa3	3.97	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Bioact source	MoA source
Ribonucleoside-diphosphate reductase large subunit	Enzyme	P23921	RIR1_HUMAN	INHIBITOR	WOMBAT-PK	CHEMBL
Ribonucleoside-diphosphate reductase subunit M2	Enzyme	P31350	RIR2_HUMAN	INHIBITOR	WOMBAT-PK	CHEMBL
DNA polymerase (alpha/delta/epsilon)	Enzyme	P09884 P28340 Q07864	DPOLA_HUMAN DPOD1_HUMAN DPOE1_HUMAN	INHIBITOR	CHEMBL	CHEMBL
Deoxycytidine kinase	Kinase	P27707	DCK_HUMAN		WOMBAT-PK
Thymidylate synthase	Enzyme	P04818	TYSY_HUMAN		WOMBAT-PK
UMP-CMP kinase	Kinase	P30085	KCY_HUMAN		WOMBAT-PK

External reference:

ID	Source
4024031	VUID
N0000022036	NUI
D01155	KEGG_DRUG
122111-03-9	SECONDARY_CAS_RN
4020975	VANDF
4024031	VANDF
C0045093	UMLSCUI
CHEBI:175901	CHEBI
GEO	PDB_CHEM_ID
CHEMBL888	ChEMBL_ID
DB00441	DRUGBANK_ID
CHEMBL1637	ChEMBL_ID
C056507	MESH_SUPPLEMENTAL_RECORD_UI
60750	PUBCHEM_CID
4793	IUPHAR_LIGAND_ID
6515	INN_ID
B76N6SBZ8R	UNII
12574	RXNORM
130312	MMSL
35333	MMSL
4777	MMSL
d04010	MMSL
005472	NDDF
005473	NDDF
108811008	SNOMEDCT_US
386920008	SNOMEDCT_US
412187004	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Gemcitabine	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9394	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	200 mg	INTRAVENOUS	ANDA	24 sections
Gemcitabine	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9395	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	24 sections
Gemcitabine	HUMAN PRESCRIPTION DRUG LABEL	1	0409-0181	INJECTION, SOLUTION	38 mg	INTRAVENOUS	NDA	27 sections
Gemcitabine	HUMAN PRESCRIPTION DRUG LABEL	1	0409-0181	INJECTION, SOLUTION	38 mg	INTRAVENOUS	NDA	27 sections
Gemcitabine	HUMAN PRESCRIPTION DRUG LABEL	1	0409-0182	INJECTION, SOLUTION	38 mg	INTRAVENOUS	NDA	27 sections
Gemcitabine	HUMAN PRESCRIPTION DRUG LABEL	1	0409-0182	INJECTION, SOLUTION	38 mg	INTRAVENOUS	NDA	27 sections
Gemcitabine	HUMAN PRESCRIPTION DRUG LABEL	1	0409-0183	INJECTION, SOLUTION	38 mg	INTRAVENOUS	NDA	27 sections
Gemcitabine	HUMAN PRESCRIPTION DRUG LABEL	1	0409-0183	INJECTION, SOLUTION	38 mg	INTRAVENOUS	NDA	27 sections
Gemcitabine	HUMAN PRESCRIPTION DRUG LABEL	1	0409-0185	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	38 mg	INTRAVENOUS	ANDA	27 sections
Gemcitabine	HUMAN PRESCRIPTION DRUG LABEL	1	0409-0186	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	38 mg	INTRAVENOUS	ANDA	27 sections
GEMCITABINE	HUMAN PRESCRIPTION DRUG LABEL	1	0409-0187	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	38 mg	INTRAVENOUS	ANDA	27 sections
GEMCITABINE	HUMAN PRESCRIPTION DRUG LABEL	1	16714-909	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	200 mg	INTRAVENOUS	ANDA	25 sections
GEMCITABINE	HUMAN PRESCRIPTION DRUG LABEL	1	16714-930	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	25 sections
GEMCITABINE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	16729-092	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	200 mg	INTRAVENOUS	ANDA	23 sections
GEMCITABINE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	16729-117	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	23 sections
GEMCITABINE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	16729-118	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	2 g	INTRAVENOUS	ANDA	23 sections
GEMCITABINE	HUMAN PRESCRIPTION DRUG LABEL	1	16729-391	INJECTION, SOLUTION	100 mg	INTRAVENOUS	NDA	26 sections
GEMCITABINE	HUMAN PRESCRIPTION DRUG LABEL	1	16729-419	INJECTION, SOLUTION	100 mg	INTRAVENOUS	NDA	26 sections
GEMCITABINE	HUMAN PRESCRIPTION DRUG LABEL	1	16729-423	INJECTION, SOLUTION	100 mg	INTRAVENOUS	NDA	26 sections
GEMCITABINE	HUMAN PRESCRIPTION DRUG LABEL	1	16729-426	INJECTION, SOLUTION	100 mg	INTRAVENOUS	NDA	26 sections
gemcitabine	HUMAN PRESCRIPTION DRUG LABEL	1	25021-234	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	200 mg	INTRAVENOUS	ANDA	25 sections
gemcitabine	HUMAN PRESCRIPTION DRUG LABEL	1	25021-235	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	25 sections
gemcitabine	HUMAN PRESCRIPTION DRUG LABEL	1	55111-686	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	200 mg	INTRAVENOUS	ANDA	26 sections
gemcitabine	HUMAN PRESCRIPTION DRUG LABEL	1	55111-687	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1 g	INTRAVENOUS	ANDA	26 sections
gemcitabine	HUMAN PRESCRIPTION DRUG LABEL	1	55390-391	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	40 mg	INTRAVENOUS	ANDA	25 sections
INFUGEM	HUMAN PRESCRIPTION DRUG LABEL	1	62756-008	INJECTION, SOLUTION	10 mg	INTRAVENOUS	NDA	27 sections
INFUGEM	HUMAN PRESCRIPTION DRUG LABEL	1	62756-073	INJECTION, SOLUTION	10 mg	INTRAVENOUS	NDA	27 sections
INFUGEM	HUMAN PRESCRIPTION DRUG LABEL	1	62756-102	INJECTION, SOLUTION	10 mg	INTRAVENOUS	NDA	27 sections
INFUGEM	HUMAN PRESCRIPTION DRUG LABEL	1	62756-219	INJECTION, SOLUTION	10 mg	INTRAVENOUS	NDA	27 sections
INFUGEM	HUMAN PRESCRIPTION DRUG LABEL	1	62756-321	INJECTION, SOLUTION	10 mg	INTRAVENOUS	NDA	27 sections