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)	10 mg/mL	Bocci G, Oprea TI, Benet LZ
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
Disease progression	1457.35	15.90	942	41038	121816	63325226
Malignant neoplasm progression	1185.04	15.90	714	41266	81407	63365635
Thrombocytopenia	1001.40	15.90	815	41165	150342	63296700
Neutropenia	725.57	15.90	725	41255	174280	63272762
Thrombotic microangiopathy	584.83	15.90	231	41749	10330	63436712
Neoplasm progression	525.10	15.90	317	41663	36111	63410931
Anaemia	386.25	15.90	693	41287	292737	63154305
Metastases to liver	362.09	15.90	214	41766	23425	63423617
Myelosuppression	353.71	15.90	211	41769	23492	63423550
Haematotoxicity	299.70	15.90	139	41841	9237	63437805
Off label use	287.40	15.90	1036	40944	673426	62773616
Pancytopenia	229.34	15.90	301	41679	96632	63350410
Metastases to lung	220.65	15.90	125	41855	12625	63434417
Metastases to bone	213.84	15.90	147	41833	20872	63426170
Leukopenia	204.87	15.90	254	41726	77036	63370006
Platelet count decreased	204.29	15.90	313	41667	115809	63331233
Diffuse large B-cell lymphoma recurrent	199.03	15.90	70	41910	2250	63444792
Metastases to lymph nodes	194.57	15.90	99	41881	8059	63438983
Febrile neutropenia	187.22	15.90	304	41676	118145	63328897
Ascites	183.47	15.90	177	41803	40551	63406491
Pleural effusion	177.82	15.90	261	41719	92949	63354093
Neutrophil count decreased	170.14	15.90	198	41782	56208	63390834
Death	165.29	15.90	583	41397	373798	63073244
Pyrexia	163.71	15.90	679	41301	469799	62977243
Joint swelling	162.09	15.90	15	41965	327651	63119391
Arthralgia	160.28	15.90	89	41891	569621	62877421
Rheumatoid arthritis	153.08	15.90	3	41977	253816	63193226
Biliary tract infection	143.21	15.90	41	41939	661	63446381
Metastases to peritoneum	141.92	15.90	61	41919	3381	63443661
Recall phenomenon	141.78	15.90	40	41940	610	63446432
Bone marrow failure	138.94	15.90	131	41849	29159	63417883
Acute myeloid leukaemia	135.72	15.90	103	41877	17044	63429998
Cholangitis	131.20	15.90	67	41913	5494	63441548
Second primary malignancy	129.64	15.90	75	41905	7878	63439164
Neuropathy peripheral	124.79	15.90	249	41731	113418	63333624
Contraindicated product administered	122.34	15.90	5	41975	217643	63229399
Neurotoxicity	121.28	15.90	96	41884	16894	63430148
Therapy partial responder	114.23	15.90	77	41903	10581	63436461
Posterior reversible encephalopathy syndrome	111.11	15.90	92	41888	17253	63429789
Capillary leak syndrome	110.91	15.90	45	41935	2155	63444887
Maternal exposure during pregnancy	108.95	15.90	10	41970	220052	63226990
Haemolytic uraemic syndrome	108.62	15.90	46	41934	2457	63444585
Cytopenia	108.32	15.90	77	41903	11524	63435518
Cytokine release syndrome	106.75	15.90	83	41897	14231	63432811
Product dose omission issue	102.84	15.90	16	41964	234297	63212745
Systemic lupus erythematosus	102.08	15.90	10	41970	208908	63238134
Hypertransaminasaemia	101.58	15.90	60	41920	6549	63440493
Sepsis	98.40	15.90	272	41708	152851	63294191
Fall	96.84	15.90	71	41909	392263	63054779
Mucosal inflammation	96.13	15.90	136	41844	46792	63400250
Swelling	92.99	15.90	33	41947	275345	63171697
Abdominal discomfort	91.68	15.90	49	41931	320836	63126206
Palmar-plantar erythrodysaesthesia syndrome	85.25	15.90	90	41890	22925	63424117
Headache	84.91	15.90	183	41797	633058	62813984
Hepatic failure	83.09	15.90	110	41870	35546	63411496
Arthropathy	82.99	15.90	26	41954	234766	63212276
Wound	81.92	15.90	7	41973	163256	63283786
Lymphoma	80.89	15.90	66	41914	12121	63434921
Weight increased	80.27	15.90	36	41944	260756	63186286
Blood lactate dehydrogenase increased	79.64	15.90	87	41893	23029	63424013
Therapeutic product effect decreased	78.65	15.90	16	41964	193171	63253871
Pulmonary embolism	78.65	15.90	211	41769	116473	63330569
Nasopharyngitis	78.40	15.90	35	41945	254222	63192820
Abdominal pain	77.46	15.90	391	41589	293065	63153977
Drug hypersensitivity	76.91	15.90	56	41924	310631	63136411
Musculoskeletal stiffness	75.76	15.90	15	41965	184603	63262439
Diffuse large B-cell lymphoma refractory	75.47	15.90	29	41951	1201	63445841
Metastases to central nervous system	74.68	15.90	65	41915	13040	63434002
Sinusitis	73.41	15.90	29	41951	226624	63220418
Pain	73.00	15.90	249	41731	740379	62706663
Vomiting	72.36	15.90	623	41357	558994	62888048
Tumour lysis syndrome	68.93	15.90	53	41927	8937	63438105
Alopecia	68.87	15.90	73	41907	337463	63109579
Polyneuropathy	68.69	15.90	65	41915	14524	63432518
PIK3CA-activated mutation	68.68	15.90	26	41954	1033	63446009
Neutropenic sepsis	67.59	15.90	68	41912	16370	63430672
Myositis	67.51	15.90	53	41927	9213	63437829
General physical health deterioration	66.83	15.90	287	41693	201115	63245927
Peripheral swelling	65.72	15.90	48	41932	265894	63181148
Myelodysplastic syndrome	64.70	15.90	67	41913	16687	63430355
Cholangitis infective	64.15	15.90	19	41961	347	63446695
Disease recurrence	63.05	15.90	85	41895	27945	63419097
Asthma	62.56	15.90	6	41974	127555	63319487
Lower respiratory tract infection	58.09	15.90	9	41971	132298	63314744
Pericarditis	57.66	15.90	9	41971	131570	63315472
Hepatotoxicity	56.97	15.90	94	41886	36947	63410095
Pericardial effusion	55.56	15.90	83	41897	29975	63417067
Breast cancer metastatic	55.54	15.90	53	41927	11965	63435077
Breast cancer recurrent	55.42	15.90	35	41945	4306	63442736
Ovarian cancer recurrent	55.41	15.90	22	41958	995	63446047
Metastases to pleura	55.35	15.90	25	41955	1560	63445482
Exposure during pregnancy	55.34	15.90	17	41963	155530	63291512
Metastasis	54.38	15.90	37	41943	5160	63441882
Microangiopathic haemolytic anaemia	54.21	15.90	19	41961	604	63446438
Drug resistance	53.81	15.90	71	41909	22862	63424180
Dehydration	52.91	15.90	241	41739	173113	63273929
Pneumonitis	52.32	15.90	88	41892	35134	63411908
Hepatic enzyme increased	50.64	15.90	36	41944	202292	63244750
Arthritis	50.63	15.90	8	41972	115913	63331129
Acquired gene mutation	49.19	15.90	20	41960	963	63446079
Metastases to skin	48.04	15.90	23	41957	1640	63445402
Product use issue	48.03	15.90	45	41935	220475	63226567
Haemoglobin decreased	47.97	15.90	207	41773	145278	63301764
Bile duct stenosis	47.67	15.90	21	41959	1235	63445807
Contusion	47.26	15.90	20	41960	150024	63297018
Hypoalbuminaemia	47.01	15.90	48	41932	11757	63435285
Thrombotic thrombocytopenic purpura	46.66	15.90	30	41950	3806	63443236
Small intestinal obstruction	46.51	15.90	59	41921	18278	63428764
Memory impairment	45.97	15.90	7	41973	104251	63342791
Overdose	45.85	15.90	10	41970	115068	63331974
White blood cell count decreased	45.16	15.90	197	41783	138907	63308135
Injection site pain	44.72	15.90	15	41965	129785	63317257
Peripheral ischaemia	44.67	15.90	32	41948	4846	63442196
Embolism	44.62	15.90	39	41941	7867	63439175
Proteinuria	44.50	15.90	59	41921	19086	63427956
Injection site erythema	43.30	15.90	3	41977	83171	63363871
Psoriatic arthropathy	43.08	15.90	5	41975	91515	63355527
Cholestasis	43.00	15.90	73	41907	29361	63417681
Discomfort	42.91	15.90	29	41951	167345	63279697
Neutropenic infection	42.84	15.90	20	41960	1347	63445695
Sleep disorder	42.30	15.90	3	41977	81563	63365479
Pancreatic carcinoma metastatic	42.17	15.90	23	41957	2155	63444887
Urinary tract obstruction	41.88	15.90	23	41957	2185	63444857
Interstitial lung disease	40.72	15.90	111	41869	61797	63385245
BRCA2 gene mutation	40.46	15.90	10	41970	88	63446954
Bronchitis	40.40	15.90	16	41964	124919	63322123
Atypical haemolytic uraemic syndrome	40.40	15.90	16	41964	719	63446323
Insomnia	40.12	15.90	50	41930	215202	63231840
Pancreatic fistula	39.93	15.90	7	41973	6	63447036
Cerebral ischaemia	39.61	15.90	34	41946	6694	63440348
Migraine	39.16	15.90	10	41970	103336	63343706
Capillary permeability increased	39.02	15.90	8	41972	26	63447016
Muscle spasms	38.78	15.90	28	41952	156122	63290920
Erythema	38.69	15.90	223	41757	175528	63271514
Dry gangrene	38.50	15.90	15	41965	645	63446397
Mobility decreased	38.39	15.90	16	41964	121143	63325899
Metastases to meninges	38.36	15.90	23	41957	2579	63444463
Urticaria	38.30	15.90	32	41948	165770	63281272
Somnolence	38.27	15.90	37	41943	178648	63268394
Product use in unapproved indication	37.98	15.90	225	41755	178855	63268187
Loss of personal independence in daily activities	37.67	15.90	9	41971	97281	63349761
Hormone receptor positive breast cancer	37.62	15.90	14	41966	530	63446512
EGFR gene mutation	37.55	15.90	12	41968	285	63446757
Jaundice	36.86	15.90	68	41912	29183	63417859
Pseudocellulitis	36.57	15.90	7	41973	14	63447028
Metastases to chest wall	36.45	15.90	14	41966	579	63446463
Blood cholesterol increased	35.82	15.90	9	41971	94023	63353019
Asthenia	35.66	15.90	399	41581	383205	63063837
Folliculitis	35.30	15.90	3	41977	70314	63376728
Hyperbilirubinaemia	34.55	15.90	40	41940	11274	63435768
Anxiety	34.17	15.90	57	41923	217484	63229558
Gait disturbance	33.66	15.90	43	41937	183135	63263907
Peripheral sensory neuropathy	32.81	15.90	32	41948	7419	63439623
Laryngospasm	32.74	15.90	22	41958	3006	63444036
Carcinoembryonic antigen increased	32.42	15.90	18	41962	1747	63445295
Muscle injury	32.22	15.90	3	41977	65342	63381700
Cardiac cirrhosis	32.16	15.90	9	41971	133	63446909
Thrombophlebitis migrans	32.16	15.90	9	41971	133	63446909
Myelitis transverse	32.12	15.90	16	41964	1244	63445798
Injury	32.10	15.90	5	41975	73242	63373800
Toxic erythema of chemotherapy	31.97	15.90	9	41971	136	63446906
Colitis	31.90	15.90	87	41893	48441	63398601
Drug interaction	31.59	15.90	65	41915	229066	63217976
Feeling abnormal	31.46	15.90	31	41949	148361	63298681
Deep vein thrombosis	31.35	15.90	124	41856	83676	63363366
Wheezing	31.30	15.90	12	41968	95583	63351459
Blister	31.30	15.90	24	41956	129790	63317252
Hypokalaemia	30.67	15.90	143	41837	103661	63343381
Subacute cutaneous lupus erythematosus	30.50	15.90	20	41960	2623	63444419
Suicidal ideation	30.43	15.90	3	41977	62418	63384624
Depression	30.38	15.90	52	41928	196440	63250602
Epistaxis	29.99	15.90	111	41869	72614	63374428
Treatment failure	29.58	15.90	54	41926	198989	63248053
Suicide attempt	29.51	15.90	3	41977	60915	63386127
Granulocyte count decreased	29.42	15.90	15	41965	1225	63445817
Device occlusion	29.35	15.90	30	41950	7357	63439685
Tumour associated fever	28.12	15.90	10	41970	332	63446710
Osteoarthritis	28.01	15.90	14	41966	95329	63351713
Adverse drug reaction	27.82	15.90	9	41971	79705	63367337
Acute erythroid leukaemia	27.61	15.90	7	41973	69	63446973
Condition aggravated	27.42	15.90	155	41825	402062	63044980
Carbohydrate antigen 125 increased	27.00	15.90	19	41961	2797	63444245
Decreased appetite	26.98	15.90	269	41711	250783	63196259
Paraneoplastic pemphigus	26.91	15.90	7	41973	77	63446965
Performance status decreased	26.71	15.90	21	41959	3657	63443385
Carbohydrate antigen 19-9 increased	26.69	15.90	9	41971	254	63446788
Gastrointestinal toxicity	26.42	15.90	29	41951	7712	63439330
Impaired healing	25.96	15.90	18	41962	102524	63344518
Metastatic neoplasm	25.88	15.90	22	41958	4273	63442769
Injection site reaction	25.63	15.90	4	41976	58520	63388522
Metastases to bone marrow	25.19	15.90	10	41970	452	63446590
Skin mass	25.15	15.90	25	41955	5930	63441112
Infusion related reaction	25.11	15.90	81	41899	245440	63201602
Influenza	25.08	15.90	21	41959	108701	63338341
Hepatic cytolysis	24.91	15.90	40	41940	15367	63431675
Hyperpyrexia	24.80	15.90	20	41960	3612	63443430
Dizziness	24.52	15.90	175	41805	429750	63017292
Nausea	24.50	15.90	738	41242	853733	62593309
Blood disorder	24.22	15.90	26	41954	6745	63440297
Generalised oedema	24.13	15.90	40	41940	15778	63431264
Pain in extremity	24.09	15.90	125	41855	331361	63115681
Catabolic state	23.77	15.90	6	41974	58	63446984
Haemoglobinaemia	23.59	15.90	6	41974	60	63446982
Intestinal perforation	23.50	15.90	34	41946	11929	63435113
Pneumocystis jirovecii pneumonia	23.46	15.90	41	41939	16873	63430169
Oedema peripheral	23.31	15.90	209	41771	189302	63257740
Extremity necrosis	23.11	15.90	14	41966	1599	63445443
Portal vein occlusion	23.05	15.90	4	41976	3	63447039
Rash	22.84	15.90	249	41731	560622	62886420
Hospitalisation	22.81	15.90	14	41966	85067	63361975
Cardiotoxicity	22.75	15.90	28	41952	8410	63438632
Mediastinum neoplasm	22.67	15.90	6	41974	71	63446971
Neoplasm	22.48	15.90	26	41954	7319	63439723
Systemic infection	22.39	15.90	21	41959	4639	63442403
Gait inability	22.35	15.90	4	41976	52955	63394087
Bacillus infection	22.24	15.90	11	41969	842	63446200
Skin toxicity	22.18	15.90	21	41959	4693	63442349
Neutrophil count abnormal	22.06	15.90	17	41963	2875	63444167
Wrong technique in product usage process	21.82	15.90	7	41973	62333	63384709
Hepatic lesion	21.77	15.90	21	41959	4804	63442238
Pulmonary toxicity	21.76	15.90	29	41951	9426	63437616
Leukaemic lymphoma	21.74	15.90	6	41974	84	63446958
Metastases to diaphragm	21.63	15.90	5	41975	32	63447010
Lymphangitis	21.60	15.90	11	41969	896	63446146
Injection site swelling	21.42	15.90	3	41977	47569	63399473
Gastrointestinal perforation	21.28	15.90	18	41962	3473	63443569
Adverse event	21.27	15.90	9	41971	67550	63379492
Gastric neoplasm	21.22	15.90	8	41972	314	63446728
IIIrd nerve paralysis	21.22	15.90	10	41970	688	63446354
Vaginal cellulitis	21.17	15.90	6	41974	93	63446949
Splenic marginal zone lymphoma	21.11	15.90	5	41975	36	63447006
Stress	21.06	15.90	9	41971	67158	63379884
Peritoneal disorder	21.03	15.90	9	41971	493	63446549
Hypocalcaemia	20.99	15.90	57	41923	31656	63415386
Immune-mediated hepatic disorder	20.81	15.90	9	41971	506	63446536
Drug ineffective	20.68	15.90	530	41450	1044235	62402807
Blood pressure fluctuation	20.67	15.90	3	41977	46314	63400728
Metastases to adrenals	20.35	15.90	10	41970	755	63446287
Metastases to bladder	20.20	15.90	7	41973	215	63446827
Hypercalcaemia of malignancy	20.14	15.90	7	41973	217	63446825
Gastrointestinal disorder	20.03	15.90	35	41945	131204	63315838
Cognitive disorder	20.02	15.90	6	41974	55809	63391233
Metastases to stomach	19.90	15.90	7	41973	225	63446817
Myocardial infarction	19.89	15.90	22	41958	99871	63347171
Tumour marker abnormal	19.80	15.90	8	41972	379	63446663
Biliary obstruction	19.76	15.90	16	41964	2905	63444137
Adenosquamous cell lung cancer stage IV	19.75	15.90	4	41976	12	63447030
Metastases to abdominal wall	19.65	15.90	6	41974	122	63446920
Hypomagnesaemia	19.36	15.90	52	41928	28685	63418357
Vena cava thrombosis	19.23	15.90	14	41966	2173	63444869
Ureteric fistula	19.07	15.90	4	41976	15	63447027
Neoplasm recurrence	19.02	15.90	15	41965	2623	63444419
Paresis cranial nerve	18.97	15.90	3	41977	0	63447042
Pseudosepsis	18.97	15.90	3	41977	0	63447042
Paraneoplastic dermatomyositis	18.86	15.90	4	41976	16	63447026
Retinopathy	18.85	15.90	16	41964	3103	63443939
Acute kidney injury	18.83	15.90	261	41719	263154	63183888
Stress cardiomyopathy	18.77	15.90	27	41953	9423	63437619
Febrile infection	18.50	15.90	12	41968	1545	63445497
Pancreatic carcinoma	18.49	15.90	24	41956	7604	63439438
Lymphoedema	18.42	15.90	30	41950	11662	63435380
Bone marrow infiltration	18.37	15.90	9	41971	675	63446367
Tumour thrombosis	18.30	15.90	4	41976	19	63447023
Intestinal metastasis	18.30	15.90	6	41974	155	63446887
Metastases to spine	18.28	15.90	16	41964	3233	63443809
Bronchostenosis	18.17	15.90	8	41972	470	63446572
Blast cells present	18.14	15.90	8	41972	472	63446570
Metastases to spleen	18.12	15.90	6	41974	160	63446882
Medication error	18.07	15.90	6	41974	52278	63394764
Heart rate decreased	18.06	15.90	4	41976	45556	63401486
Joint stiffness	18.03	15.90	3	41977	41866	63405176
Chills	17.69	15.90	132	41848	113246	63333796
Jaundice cholestatic	17.68	15.90	23	41957	7301	63439741
Disseminated intravascular coagulation	17.68	15.90	39	41941	19012	63428030
Febrile bone marrow aplasia	17.68	15.90	23	41957	7302	63439740
Postictal state	17.43	15.90	10	41970	1033	63446009
Cholangitis acute	17.40	15.90	8	41972	520	63446522
Obstruction gastric	17.40	15.90	10	41970	1037	63446005
Hepatic function abnormal	17.28	15.90	59	41921	37083	63409959
Renal salt-wasting syndrome	17.25	15.90	7	41973	335	63446707
Fluid retention	17.17	15.90	9	41971	59677	63387365
Red blood cell sedimentation rate increased	17.15	15.90	4	41976	43978	63403064
Blood pressure increased	16.88	15.90	53	41927	162009	63285033
Pulmonary alveolar haemorrhage	16.83	15.90	18	41962	4650	63442392
Purtscher retinopathy	16.80	15.90	5	41975	93	63446949
Post thrombotic syndrome	16.73	15.90	8	41972	569	63446473
Hyperphosphataemia	16.68	15.90	13	41967	2235	63444807
Urinary tract infection enterococcal	16.56	15.90	14	41966	2699	63444343
Left ventricular dysfunction	16.55	15.90	29	41951	11959	63435083
Ischaemia	16.50	15.90	18	41962	4754	63442288
Oroticaciduria	16.43	15.90	3	41977	4	63447038
Localised oedema	16.40	15.90	19	41961	5359	63441683
Malaise	16.38	15.90	186	41794	415768	63031274
Hydronephrosis	16.31	15.90	27	41953	10635	63436407
Sedation	16.23	15.90	3	41977	38806	63408236
Renal vein thrombosis	16.16	15.90	7	41973	395	63446647
Ovarian cancer metastatic	16.07	15.90	9	41971	888	63446154
Nasal congestion	16.00	15.90	12	41968	65648	63381394
Malignant ascites	15.99	15.90	9	41971	897	63446145
Rhinorrhoea	15.96	15.90	12	41968	65565	63381477

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
Disease progression	1228.38	17.28	973	36284	107104	34812570
Thrombocytopenia	640.26	17.28	808	36449	155439	34764235
Thrombotic microangiopathy	417.93	17.28	211	37046	10419	34909255
Malignant neoplasm progression	386.24	17.28	472	36785	87574	34832100
Neutropenia	362.79	17.28	620	36637	156158	34763516
Myelosuppression	308.64	17.28	214	37043	19051	34900623
Neoplasm progression	307.36	17.28	230	37027	23070	34896604
Anaemia	280.07	17.28	704	36553	232631	34687043
Off label use	273.66	17.28	1021	36236	418503	34501171
Pancytopenia	251.51	17.28	400	36857	94757	34824917
Febrile neutropenia	197.33	17.28	444	36813	136405	34783269
Cholangitis	191.72	17.28	118	37139	8571	34911103
Diffuse large B-cell lymphoma recurrent	191.13	17.28	85	37172	3143	34916531
Pyrexia	182.05	17.28	768	36489	332245	34587429
Leukopenia	171.10	17.28	268	36989	62588	34857086
Haematotoxicity	155.10	17.28	101	37156	8093	34911581
Cytokine release syndrome	136.31	17.28	144	37113	22733	34896941
Therapy partial responder	135.88	17.28	99	37158	9517	34910157
Haemolytic uraemic syndrome	125.17	17.28	57	37200	2229	34917445
Neuropathy peripheral	117.38	17.28	268	36989	82995	34836679
General physical health deterioration	117.30	17.28	351	36906	127918	34791756
Neutrophil count decreased	102.11	17.28	190	37067	50914	34868760
Pneumonitis	101.33	17.28	151	37106	33727	34885947
Diffuse large B-cell lymphoma refractory	100.34	17.28	41	37216	1225	34918449
Neutropenic sepsis	99.08	17.28	96	37161	13671	34906003
Product dose omission issue	97.63	17.28	8	37249	119703	34799971
Platelet count decreased	91.46	17.28	308	36949	119409	34800265
Bacteraemia	89.90	17.28	108	37149	19609	34900065
Biliary tract infection	83.53	17.28	30	37227	625	34919049
Interstitial lung disease	83.11	17.28	202	37055	65080	34854594
Pseudocellulitis	79.76	17.28	17	37240	37	34919637
Liver abscess	78.61	17.28	50	37207	3845	34915829
Neurotoxicity	74.60	17.28	94	37163	17916	34901758
Arthralgia	72.40	17.28	46	37211	169995	34749679
Capillary leak syndrome	72.05	17.28	39	37218	2219	34917455
Sepsis	70.37	17.28	357	36900	166204	34753470
Drug interaction	68.68	17.28	84	37173	225862	34693812
Bone marrow failure	67.69	17.28	116	37141	29137	34890537
Product use in unapproved indication	67.65	17.28	276	36981	117223	34802451
Pancreatic carcinoma metastatic	65.02	17.28	40	37217	2900	34916774
Metastases to liver	62.54	17.28	75	37182	13588	34906086
Overdose	60.06	17.28	12	37245	91047	34828627
Pulmonary embolism	57.44	17.28	218	37039	89528	34830146
Pancreatic enzyme abnormality	57.33	17.28	14	37243	67	34919607
Hypertransaminasaemia	55.94	17.28	47	37210	5559	34914115
Pleural effusion	54.61	17.28	201	37056	81345	34838329
Headache	54.44	17.28	81	37176	200554	34719120
Fall	54.00	17.28	83	37174	202802	34716872
Seizure	52.50	17.28	23	37234	104834	34814840
Nasopharyngitis	51.07	17.28	7	37250	69961	34849713
Disease recurrence	50.74	17.28	86	37171	21404	34898270
Peripheral ischaemia	49.30	17.28	44	37213	5643	34914031
Metastases to lung	49.09	17.28	55	37202	9265	34910409
Drug hypersensitivity	48.36	17.28	13	37244	80516	34839158
Biliary obstruction	47.49	17.28	32	37225	2713	34916961
Myositis	46.84	17.28	61	37196	12009	34907665
Pulmonary toxicity	46.37	17.28	44	37213	6103	34913571
Immune-mediated hepatitis	46.11	17.28	29	37228	2186	34917488
Feeling abnormal	44.59	17.28	7	37250	63228	34856446
Cytopenia	44.32	17.28	61	37196	12662	34907012
Asthenia	43.34	17.28	425	36832	244826	34674848
Hyperpyrexia	42.35	17.28	30	37227	2758	34916916
Atypical haemolytic uraemic syndrome	41.87	17.28	15	37242	310	34919364
Insomnia	41.65	17.28	30	37227	103877	34815797
Blood lactate dehydrogenase increased	41.60	17.28	82	37175	22908	34896766
Pancreatic carcinoma	40.96	17.28	49	37208	8852	34910822
Metastases to central nervous system	40.80	17.28	47	37210	8158	34911516
Anxiety	40.79	17.28	28	37229	99400	34820274
Depression	40.29	17.28	27	37230	97071	34822603
Enterocolitis infectious	39.89	17.28	24	37233	1671	34918003
Myalgia	39.71	17.28	20	37237	84090	34835584
Chills	39.40	17.28	181	37076	80862	34838812
Lymphoma	39.18	17.28	57	37200	12450	34907224
Vomiting	38.46	17.28	418	36839	247203	34672471
Ascites	37.42	17.28	122	37135	46449	34873225
Weight increased	37.10	17.28	27	37230	93006	34826668
Recall phenomenon	36.92	17.28	16	37241	555	34919119
Muscle spasms	36.67	17.28	17	37240	74984	34844690
Deep vein thrombosis	36.49	17.28	152	37105	65096	34854578
Decreased appetite	35.79	17.28	301	36956	166091	34753583
Mucosal inflammation	35.48	17.28	106	37151	38516	34881158
Unmasking of previously unidentified disease	35.48	17.28	18	37239	896	34918778
Urosepsis	35.35	17.28	55	37202	12744	34906930
Joint swelling	35.33	17.28	10	37247	59880	34859794
Right ventricular ejection fraction decreased	35.15	17.28	9	37248	54	34919620
Bicytopenia	34.71	17.28	25	37232	2359	34917315
Blood pressure increased	34.57	17.28	26	37231	88076	34831598
Lymphadenopathy	33.99	17.28	86	37171	28377	34891297
Nausea	33.93	17.28	529	36728	339379	34580295
White blood cell count decreased	33.73	17.28	195	37062	95250	34824424
Hospitalisation	32.66	17.28	10	37247	56892	34862782
Skin toxicity	31.88	17.28	32	37225	4752	34914922
Chronic myelomonocytic leukaemia	31.73	17.28	15	37242	639	34919035
Biliary sepsis	30.83	17.28	15	37242	682	34918992
Vena cava thrombosis	30.58	17.28	18	37239	1204	34918470
Coronary artery disease	30.54	17.28	7	37250	48298	34871376
Electrocardiogram QT prolonged	30.11	17.28	4	37253	40948	34878726
Device occlusion	30.07	17.28	36	37221	6509	34913165
Toxicity to various agents	30.06	17.28	111	37146	200251	34719423
Bradycardia	29.92	17.28	22	37235	75396	34844278
Microangiopathic haemolytic anaemia	29.79	17.28	16	37241	896	34918778
Agitation	29.66	17.28	12	37245	57387	34862287
Hepatocellular injury	29.59	17.28	70	37187	22141	34897533
Pancreatic carcinoma recurrent	29.36	17.28	8	37249	63	34919611
Tremor	29.16	17.28	27	37230	82560	34837114
Histiocytic necrotising lymphadenitis	28.49	17.28	6	37251	12	34919662
Embolism	27.97	17.28	38	37219	7791	34911883
Discontinued product administered	27.29	17.28	6	37251	16	34919658
Extremity necrosis	27.17	17.28	20	37237	1952	34917722
Ill-defined disorder	26.86	17.28	51	37206	13858	34905816
Dermatitis acneiform	26.74	17.28	33	37224	6156	34913518
Cardiac failure congestive	26.26	17.28	30	37227	83240	34836434
Injection site pain	26	17.28	5	37252	39000	34880674
Memory impairment	25.98	17.28	7	37250	43311	34876363
Cardiac disorder	25.81	17.28	7	37250	43119	34876555
Abdominal pain	25.71	17.28	277	36980	163341	34756333
Myocardial infarction	25.54	17.28	57	37200	121028	34798646
Somnolence	25.38	17.28	50	37207	111066	34808608
Adenoviral hepatitis	24.94	17.28	12	37245	532	34919142
Inappropriate schedule of product administration	24.93	17.28	18	37239	62278	34857396
Acute myeloid leukaemia	24.80	17.28	58	37199	18212	34901462
Metastases to chest wall	24.60	17.28	9	37248	198	34919476
Adenovirus reactivation	23.83	17.28	9	37248	217	34919457
Metabolic disorder	23.80	17.28	26	37231	4257	34915417
Second primary malignancy	23.34	17.28	35	37222	7851	34911823
Erythropenia	23.19	17.28	9	37248	234	34919440
Tumour lysis syndrome	22.98	17.28	54	37203	17005	34902669
Chest discomfort	22.83	17.28	15	37242	54515	34865159
Cardiotoxicity	22.62	17.28	29	37228	5619	34914055
Renal-limited thrombotic microangiopathy	22.54	17.28	7	37250	91	34919583
Angioedema	22.49	17.28	6	37251	37368	34882306
PIK3CA-activated mutation	22.26	17.28	7	37250	95	34919579
Metastases to peritoneum	21.65	17.28	17	37240	1827	34917847
Peritoneal lesion	21.62	17.28	7	37250	105	34919569
Jaundice cholestatic	21.42	17.28	26	37231	4768	34914906
Palpitations	21.25	17.28	8	37249	39978	34879696
Sleep disorder	21.25	17.28	4	37253	31684	34887990
Wrong technique in product usage process	21.24	17.28	6	37251	35980	34883694
Rhabdomyolysis	21.01	17.28	25	37232	68138	34851536
Thyroglobulin increased	21.01	17.28	5	37252	21	34919653
Wheezing	20.83	17.28	9	37248	41393	34878281
Colitis	20.36	17.28	87	37170	37663	34882011
Pain in extremity	20.35	17.28	68	37189	126445	34793229
Influenza	20.33	17.28	14	37243	49652	34870022
Resorption bone increased	20.33	17.28	8	37249	216	34919458
Granulocyte-colony stimulating factor level increased	20.14	17.28	4	37253	5	34919669
Incorrect dose administered	20.08	17.28	9	37248	40506	34879168
Vascular purpura	20.03	17.28	16	37241	1762	34917912
Contusion	19.79	17.28	7	37250	36357	34883317
Peripheral swelling	19.66	17.28	32	37225	76509	34843165
Metastases to muscle	19.64	17.28	8	37249	237	34919437
Malaise	19.56	17.28	117	37140	185708	34733966
Abdominal discomfort	19.47	17.28	21	37236	59814	34859860
Duodenal stenosis	19.45	17.28	8	37249	243	34919431
Diffuse large B-cell lymphoma	19.42	17.28	31	37226	7339	34912335
Pneumonia adenoviral	19.38	17.28	9	37248	368	34919306
Gastrointestinal obstruction	19.32	17.28	12	37245	885	34918789
Blood creatine phosphokinase increased	19.24	17.28	12	37245	44845	34874829
Condition aggravated	19.20	17.28	123	37134	192073	34727601
Hallucination	19.18	17.28	16	37241	51482	34868192
Cystoid macular oedema	19.13	17.28	11	37246	704	34918970
Vascular pseudoaneurysm ruptured	19.11	17.28	6	37251	81	34919593
Ilium fracture	18.92	17.28	7	37250	159	34919515
Vision blurred	18.76	17.28	13	37244	45950	34873724
Balance disorder	18.68	17.28	10	37247	40644	34879030
Pruritus	18.54	17.28	83	37174	141898	34777776
Hypophagia	18.46	17.28	62	37195	23960	34895714
Cardio-respiratory arrest	18.43	17.28	19	37238	55254	34864420
Peripheral artery occlusion	18.43	17.28	15	37242	1697	34917977
Toxic erythema of chemotherapy	18.35	17.28	6	37251	93	34919581
Chronic coronary syndrome	18.33	17.28	7	37250	174	34919500
Molluscum contagiosum	18.29	17.28	8	37249	284	34919390
Transitional cell carcinoma recurrent	17.85	17.28	4	37253	12	34919662
Testicular disorder	17.85	17.28	11	37246	800	34918874
Tumour necrosis	17.60	17.28	13	37244	1275	34918399
Portal vein stenosis	17.54	17.28	3	37254	0	34919674
Retroperitoneal neoplasm metastatic	17.54	17.28	3	37254	0	34919674
Dizziness	17.44	17.28	149	37108	218372	34701302
Tumour fistulisation	17.38	17.28	4	37253	14	34919660
Disseminated intravascular coagulation	17.38	17.28	57	37200	21759	34897915
Haemoglobin decreased	17.37	17.28	201	37056	120571	34799103
Gastroenteritis radiation	17.35	17.28	8	37249	322	34919352
Fistula of small intestine	17.28	17.28	9	37248	473	34919201

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
Disease progression	1964.74	15.29	1450	65335	182912	79494691
Thrombocytopenia	1583.88	15.29	1492	65293	263767	79413836
Thrombotic microangiopathy	1101.63	15.29	467	66318	19702	79657901
Malignant neoplasm progression	1081.07	15.29	901	65884	135089	79542514
Neutropenia	935.83	15.29	1176	65609	286534	79391069
Anaemia	624.14	15.29	1236	65549	443779	79233824
Myelosuppression	616.36	15.29	397	66388	39899	79637704
Neoplasm progression	571.97	15.29	417	66368	51265	79626338
Pancytopenia	449.96	15.29	621	66164	165124	79512479
Haematotoxicity	376.49	15.29	206	66579	15313	79662290
Febrile neutropenia	347.50	15.29	662	66123	230337	79447266
Off label use	332.80	15.29	1568	65217	905647	78771956
Leukopenia	331.79	15.29	447	66338	116066	79561537
Pyrexia	331.32	15.29	1280	65505	677429	79000174
Cholangitis	308.27	15.29	169	66616	12607	79664996
Metastases to liver	282.98	15.29	215	66570	28099	79649504
Diffuse large B-cell lymphoma recurrent	282.50	15.29	113	66672	4094	79673509
Platelet count decreased	263.64	15.29	534	66251	194130	79483473
Neuropathy peripheral	255.61	15.29	439	66346	140866	79536737
Cytokine release syndrome	253.66	15.29	223	66562	35775	79641828
Arthralgia	248.10	15.29	85	66700	571718	79105885
Therapy partial responder	247.77	15.29	164	66621	17233	79660370
Neutrophil count decreased	242.66	15.29	344	66441	93615	79583988
Haemolytic uraemic syndrome	219.70	15.29	96	66689	4353	79673250
Biliary tract infection	218.06	15.29	70	66715	1318	79676285
Metastases to lung	199.53	15.29	146	66639	18017	79659586
General physical health deterioration	183.84	15.29	577	66208	274661	79402942
Bone marrow failure	181.55	15.29	219	66566	50888	79626715
Joint swelling	177.36	15.29	18	66767	288628	79388975
Capillary leak syndrome	169.17	15.29	77	66708	3848	79673755
Recall phenomenon	169.07	15.29	55	66730	1082	79676521
Metastases to lymph nodes	160.24	15.29	103	66682	10294	79667309
Rheumatoid arthritis	159.62	15.29	3	66782	208467	79469136
Ascites	157.01	15.29	250	66535	75312	79602291
Hypertransaminasaemia	156.82	15.29	107	66678	11817	79665786
Neurotoxicity	152.46	15.29	161	66624	32357	79645246
Pleural effusion	151.56	15.29	359	66426	144903	79532700
Pneumonitis	151.45	15.29	219	66566	60641	79616962
Sepsis	148.06	15.29	529	66256	268899	79408704
Headache	146.01	15.29	201	66584	653571	79024032
Acute myeloid leukaemia	143.17	15.29	152	66633	30733	79646870
Product dose omission issue	143.17	15.29	19	66766	247518	79430085
Diffuse large B-cell lymphoma refractory	141.37	15.29	51	66734	1384	79676219
Neutropenic sepsis	139.51	15.29	141	66644	26923	79650680
Fall	133.64	15.29	127	66658	487502	79190101
Metastases to bone	132.80	15.29	131	66654	24296	79653307
Interstitial lung disease	127.01	15.29	287	66498	112313	79565290
Nasopharyngitis	126.10	15.29	29	66756	253852	79423751
Pulmonary embolism	124.88	15.29	371	66414	171283	79506320
Myositis	121.69	15.29	112	66673	19056	79658547
Second primary malignancy	119.73	15.29	98	66687	14252	79663351
Metastases to peritoneum	117.10	15.29	62	66723	4310	79673293
Pseudocellulitis	112.53	15.29	23	66762	53	79677550
Drug hypersensitivity	112.27	15.29	55	66730	298861	79378742
Musculoskeletal stiffness	109.86	15.29	10	66775	174998	79502605
Weight increased	107.30	15.29	49	66736	277337	79400266
Disease recurrence	105.77	15.29	156	66629	43953	79633650
Mucosal inflammation	105.30	15.29	210	66575	75370	79602233
Overdose	104.46	15.29	15	66770	184191	79493412
Blood lactate dehydrogenase increased	103.39	15.29	145	66640	39025	79638578
Product use in unapproved indication	101.48	15.29	447	66338	249912	79427691
Cytopenia	101.06	15.29	104	66681	20279	79657324
Contraindicated product administered	93.72	15.29	11	66774	157527	79520076
Peripheral ischaemia	92.67	15.29	71	66714	9386	79668217
Asthma	92.63	15.29	5	66780	135090	79542513
Peripheral swelling	91.94	15.29	56	66729	269561	79408042
Bacteraemia	91.87	15.29	125	66660	32699	79644904
Liver abscess	88.44	15.29	58	66727	5996	79671607
Abdominal discomfort	88.42	15.29	50	66735	250677	79426926
Tumour lysis syndrome	87.31	15.29	104	66681	23835	79653768
Maternal exposure during pregnancy	82.55	15.29	9	66776	136529	79541074
Insomnia	82.09	15.29	52	66733	245118	79432485
Metastases to central nervous system	81.99	15.29	84	66701	16291	79661312
Atypical haemolytic uraemic syndrome	80.85	15.29	31	66754	1001	79676602
Arthropathy	80.73	15.29	24	66761	177087	79500516
Pain	80.17	15.29	311	66474	703491	78974112
Swelling	79.65	15.29	41	66744	216670	79460933
Microangiopathic haemolytic anaemia	78.82	15.29	34	66751	1493	79676110
Therapeutic product effect decreased	76.91	15.29	21	66764	163842	79513761
Systemic lupus erythematosus	75.81	15.29	7	66778	121142	79556461
Muscle spasms	75.52	15.29	26	66759	174704	79502899
Feeling abnormal	75.48	15.29	20	66765	159179	79518424
Sinusitis	74.85	15.29	35	66750	195466	79482137
Wound	74.65	15.29	6	66779	116173	79561430
Drug interaction	74.46	15.29	147	66638	415036	79262567
Embolism	74.17	15.29	74	66711	13908	79663695
Contusion	73.82	15.29	17	66768	148759	79528844
Pancreatic carcinoma metastatic	72.64	15.29	43	66742	3710	79673893
Anxiety	72.43	15.29	61	66724	248451	79429152
Pulmonary toxicity	71.57	15.29	70	66715	12844	79664759
Posterior reversible encephalopathy syndrome	68.92	15.29	97	66688	26184	79651419
White blood cell count decreased	67.94	15.29	325	66460	187963	79489640
Hyperpyrexia	66.96	15.29	49	66736	6043	79671560
Vomiting	66.16	15.29	849	65936	664979	79012624
Skin toxicity	65.65	15.29	55	66730	8259	79669344
Injection site pain	64.09	15.29	15	66770	129823	79547780
Asthenia	62.98	15.29	680	66105	511009	79166594
Memory impairment	61.27	15.29	10	66775	111724	79565879
Immune-mediated hepatitis	60.78	15.29	38	66747	3618	79673985
Cardiotoxicity	59.86	15.29	62	66723	12177	79665426
Abdominal pain	59.72	15.29	542	66243	389027	79288576
Psoriasis	59.34	15.29	4	66781	89583	79588020
Biliary obstruction	59.23	15.29	41	66744	4633	79672970
Bile duct stenosis	58.02	15.29	30	66755	1986	79675617
Exposure during pregnancy	57.86	15.29	8	66777	101124	79576479
Colitis	57.63	15.29	163	66622	73144	79604459
Deep vein thrombosis	57.62	15.29	227	66558	120692	79556911
Suicide attempt	57.06	15.29	3	66782	82929	79594674
Depression	56.35	15.29	59	66726	216731	79460872
Extremity necrosis	55.45	15.29	34	66751	3127	79674476
Cholangitis infective	55.42	15.29	21	66764	656	79676947
Device occlusion	54.27	15.29	58	66727	11808	79665795
Drug resistance	53.71	15.29	113	66672	42100	79635503
Pancreatic enzyme abnormality	53.48	15.29	14	66771	122	79677481
Sleep disorder	53.47	15.29	5	66780	85672	79591931
Injection site erythema	53.27	15.29	3	66782	78194	79599409
Chills	52.40	15.29	269	66516	159965	79517638
Suicidal ideation	51.78	15.29	3	66782	76337	79601266
Pericarditis	51.53	15.29	12	66773	104224	79573379
Mobility decreased	51.38	15.29	19	66766	122156	79555447
Wheezing	51.03	15.29	17	66768	116647	79560956
Arthritis	49.79	15.29	17	66768	114863	79562740
Palmar-plantar erythrodysaesthesia syndrome	49.70	15.29	95	66690	33039	79644564
Toxic erythema of chemotherapy	48.99	15.29	15	66770	240	79677363
Pericardial effusion	48.94	15.29	115	66670	46122	79631481
Pain in extremity	48.88	15.29	150	66635	364388	79313215
Decreased appetite	48.73	15.29	469	66316	341949	79335654
Haemoglobin decreased	47.67	15.29	334	66451	221785	79455818
Hepatotoxicity	47.22	15.29	121	66664	51231	79626372
Product use issue	47.18	15.29	64	66721	209758	79467845
Hepatic failure	47.04	15.29	135	66650	61077	79616526
Somnolence	46.89	15.29	80	66705	238901	79438702
Loss of personal independence in daily activities	46.55	15.29	14	66771	102566	79575037
Nasal congestion	46.38	15.29	5	66780	76547	79601056
Blood pressure increased	45.99	15.29	66	66719	211294	79466309
Discomfort	45.78	15.29	24	66761	125593	79552010
Hepatic enzyme increased	44.92	15.29	52	66733	182558	79495045
Subacute cutaneous lupus erythematosus	44.57	15.29	31	66754	3530	79674073
Urticaria	44.20	15.29	54	66731	185147	79492456
Biliary sepsis	43.50	15.29	23	66762	1594	79676009
Bronchitis	43.30	15.29	28	66757	130616	79546987
Dizziness	43.30	15.29	261	66524	526180	79151423
Osteoarthritis	43.26	15.29	10	66775	87299	79590304
Cerebral ischaemia	43.08	15.29	50	66735	11145	79666458
Pancreatic carcinoma	43.08	15.29	55	66730	13522	79664081
Gait disturbance	42.06	15.29	68	66717	207438	79470165
Stress	41.74	15.29	8	66777	79604	79597999
Peripheral sensory neuropathy	41.68	15.29	53	66732	12980	79664623
Blood cholesterol increased	40.67	15.29	10	66775	83710	79593893
Injury	40.18	15.29	8	66777	77488	79600115
Metastasis	39.45	15.29	38	66747	6842	79670761
Myalgia	39.38	15.29	59	66726	185582	79492021
Malaise	38.64	15.29	246	66539	489623	79187980
Lower respiratory tract infection	38.51	15.29	31	66754	129189	79548414
Hypercalcaemia of malignancy	38.19	15.29	14	66771	398	79677205
Blister	37.73	15.29	27	66758	119449	79558154
Erythropenia	37.58	15.29	14	66771	417	79677186
Renal-limited thrombotic microangiopathy	37.35	15.29	11	66774	153	79677450
Urosepsis	37.34	15.29	74	66711	26421	79651182
Pancreatic fistula	37.33	15.29	10	66775	96	79677507
EGFR gene mutation	36.57	15.29	14	66771	450	79677153
PIK3CA-activated mutation	36.38	15.29	15	66770	588	79677015
Dehydration	36.30	15.29	342	66443	247845	79429758
Influenza	36.30	15.29	33	66752	129573	79548030
Right ventricular ejection fraction decreased	36.24	15.29	9	66776	62	79677541
Migraine	36.13	15.29	14	66771	87479	79590124
Myelodysplastic syndrome	36.11	15.29	79	66706	30222	79647381
Capillary permeability increased	36.04	15.29	8	66777	31	79677572
Metastases to pleura	35.95	15.29	20	66765	1534	79676069
Hospitalisation	35.85	15.29	17	66768	94219	79583384
Hypoalbuminaemia	35.62	15.29	64	66721	21233	79656370
Seizure	35.42	15.29	65	66720	188769	79488834
Dry gangrene	35.20	15.29	17	66768	972	79676631
Lymphoma	35.18	15.29	57	66728	17403	79660200
Lymphadenopathy	34.85	15.29	111	66674	53136	79624467
Injection site reaction	34.71	15.29	3	66782	54782	79622821
Hepatocellular injury	33.73	15.29	102	66683	47491	79630112
Rhinorrhoea	33.41	15.29	11	66774	76063	79601540
Jaundice cholestatic	33.14	15.29	44	66741	11240	79666363
BRCA2 gene mutation	33.00	15.29	9	66776	93	79677510
Dermatitis acneiform	32.53	15.29	41	66744	9952	79667651
Gastrointestinal toxicity	32.52	15.29	37	66748	8072	79669531
Disseminated intravascular coagulation	32.48	15.29	84	66701	35758	79641845
Small intestinal obstruction	32.38	15.29	71	66714	27201	79650402
Retroperitoneal neoplasm metastatic	31.98	15.29	7	66778	25	79677578
Performance status decreased	31.77	15.29	32	66753	6081	79671522
Pancreatic carcinoma recurrent	31.72	15.29	10	66775	177	79677426
Myocardial infarction	31.41	15.29	67	66718	184062	79493541
Nephropathy toxic	31.18	15.29	59	66726	20360	79657243
Chronic myelomonocytic leukaemia	31.17	15.29	15	66770	851	79676752
Polyneuropathy	31.12	15.29	65	66720	24086	79653517
Bicytopenia	31.03	15.29	28	66757	4642	79672961
Hypophagia	31.00	15.29	96	66689	45271	79632332
Cholestasis	30.86	15.29	105	66680	52004	79625599
Breast cancer metastatic	30.75	15.29	37	66748	8565	79669038
Jaundice	30.28	15.29	106	66679	53243	79624360
Inappropriate schedule of product administration	29.78	15.29	41	66744	133587	79544016
Tremor	29.76	15.29	61	66724	170022	79507581
Alopecia	29.71	15.29	97	66688	231258	79446345
Blood bilirubin increased	29.66	15.29	122	66663	66110	79611493
Carbohydrate antigen 19-9 increased	29.53	15.29	12	66773	453	79677150
Tumour necrosis	29.51	15.29	19	66766	1903	79675700
Heart rate decreased	29.45	15.29	11	66774	70305	79607298
Type 2 diabetes mellitus	29.40	15.29	6	66779	57116	79620487
Immune effector cell-associated neurotoxicity syndrome	29.28	15.29	30	66755	5818	79671785
Pneumocystis jirovecii pneumonia	29.26	15.29	76	66709	32432	79645171
Aggression	29.22	15.29	4	66781	50954	79626649
Fluid retention	29.11	15.29	11	66774	69798	79607805
Disturbance in attention	29.10	15.29	4	66781	50797	79626806
Condition aggravated	29.02	15.29	274	66511	500850	79176753
Gait inability	28.69	15.29	7	66778	58910	79618693
Urinary tract obstruction	28.62	15.29	27	66758	4738	79672865
Wrong technique in product usage process	28.61	15.29	13	66772	73862	79603741
Angioedema	28.49	15.29	14	66771	76021	79601582
Nausea	28.46	15.29	1023	65762	956173	78721430
Breast cancer recurrent	28.40	15.29	22	66763	2955	79674648
Illness	28.27	15.29	3	66782	46508	79631095
Folliculitis	28.12	15.29	6	66779	55374	79622229
Oedema peripheral	28.09	15.29	329	66456	251959	79425644
Palpitations	28.06	15.29	39	66746	126571	79551032
Heart rate increased	27.96	15.29	36	66749	120688	79556915
Infusion related reaction	27.89	15.29	99	66686	230138	79447465
Balance disorder	27.88	15.29	25	66760	98832	79578771
Bradycardia	27.86	15.29	44	66741	135513	79542090
Coma	27.74	15.29	26	66759	100623	79576980
Diffuse large B-cell lymphoma	27.73	15.29	42	66743	12107	79665496
Renal salt-wasting syndrome	27.59	15.29	13	66772	703	79676900
Impaired healing	27.43	15.29	20	66765	87635	79589968
Postictal state	27.35	15.29	18	66767	1871	79675732
Systemic infection	27.07	15.29	37	66748	9715	79667888
Myelitis transverse	26.86	15.29	18	66767	1929	79675674
Cystoid macular oedema	26.58	15.29	18	66767	1962	79675641
Electrocardiogram QT prolonged	26.53	15.29	22	66763	90364	79587239
Muscle necrosis	26.39	15.29	16	66769	1442	79676161
Dry mouth	26.37	15.29	21	66764	87998	79589605
Injection site swelling	26.33	15.29	4	66781	47128	79630475
Coronary artery disease	26.18	15.29	11	66774	65463	79612140
Hyperbilirubinaemia	25.96	15.29	61	66724	24457	79653146
Unmasking of previously unidentified disease	25.96	15.29	18	66767	2039	79675564
Obstruction gastric	25.96	15.29	17	66768	1753	79675850
Cardiac cirrhosis	25.91	15.29	9	66776	218	79677385
Metastases to spleen	25.77	15.29	12	66773	632	79676971
Post thrombotic syndrome	25.61	15.29	12	66773	641	79676962
Cardio-respiratory arrest	25.50	15.29	32	66753	108478	79569125
Paraneoplastic pemphigus	25.05	15.29	8	66777	148	79677455
Carcinoembryonic antigen increased	24.81	15.29	18	66767	2191	79675412
Enterocolitis infectious	24.79	15.29	20	66765	2849	79674754
Stress cardiomyopathy	24.64	15.29	38	66747	11128	79666475
Testicular disorder	24.58	15.29	9	66776	255	79677348
Cognitive disorder	24.54	15.29	14	66771	69912	79607691
Aortic thrombosis	24.18	15.29	16	66769	1679	79675924
Malignant ascites	23.97	15.29	14	66771	1178	79676425
Chest discomfort	23.73	15.29	50	66735	137994	79539609
Road traffic accident	23.73	15.29	4	66781	43660	79633943
Metastatic neoplasm	23.69	15.29	25	66760	5017	79672586
Gastrointestinal obstruction	23.53	15.29	16	66769	1756	79675847
Ovarian cancer recurrent	23.29	15.29	10	66775	434	79677169
Metastases to abdominal wall	23.22	15.29	8	66777	189	79677414
Chronic coronary syndrome	23.10	15.29	7	66778	108	79677495
Hepatic infection	23.01	15.29	13	66772	1027	79676576
Ischaemia	22.97	15.29	31	66754	8044	79669559
Swollen tongue	22.91	15.29	4	66781	42566	79635037
Portal vein stenosis	22.82	15.29	5	66780	18	79677585
Laryngospasm	22.77	15.29	22	66763	3975	79673628
Metastases to meninges	22.77	15.29	21	66764	3580	79674023
Hallucination	22.64	15.29	23	66762	85722	79591881
Gastric perforation	22.59	15.29	22	66763	4015	79673588
Intestinal perforation	22.57	15.29	47	66738	17379	79660224
Splenic infarction	22.46	15.29	21	66764	3643	79673960
Acquired gene mutation	22.39	15.29	17	66768	2216	79675387
Histiocytic necrotising lymphadenitis	22.36	15.29	6	66779	58	79677545
Thrombophlebitis	22.24	15.29	27	66758	6308	79671295
Gastrooesophageal reflux disease	22.22	15.29	33	66752	104213	79573390
Treatment noncompliance	22.19	15.29	8	66777	52260	79625343
Tumour associated fever	22.00	15.29	12	66773	885	79676718
Respiratory failure	21.97	15.29	240	66545	180671	79496932
Sedation	21.93	15.29	8	66777	51887	79625716
Lymphangitis	21.82	15.29	14	66771	1394	79676209
Hypoaesthesia	21.79	15.29	77	66708	179275	79498328
Acute kidney injury	21.73	15.29	579	66206	518825	79158778
Scleroderma-like reaction	21.69	15.29	7	66778	134	79677469
Adenoviral hepatitis	21.63	15.29	12	66773	915	79676688
Metastases to skin	21.44	15.29	15	66770	1724	79675879
Red blood cell sedimentation rate increased	21.33	15.29	6	66779	45936	79631667
Metastases to chest wall	21.33	15.29	10	66775	535	79677068
Gastrointestinal perforation	21.29	15.29	26	66759	6111	79671492
Adenovirus reactivation	21.20	15.29	9	66776	380	79677223
Neutropenic infection	21.14	15.29	17	66768	2410	79675193
Granulocyte-colony stimulating factor level increased	21.10	15.29	4	66781	5	79677598
Pruritus	21.06	15.29	220	66565	394428	79283175
Granulocyte count decreased	20.91	15.29	15	66770	1793	79675810
Delirium	20.90	15.29	24	66761	84603	79593000
Generalised oedema	20.90	15.29	55	66730	23654	79653949
Incorrect dose administered	20.87	15.29	20	66765	76610	79600993
Flank pain	20.61	15.29	49	66736	19795	79657808
Thrombotic thrombocytopenic purpura	20.50	15.29	26	66759	6350	79671253
Pleural mass	20.47	15.29	6	66779	82	79677521
Livedo reticularis	20.45	15.29	21	66764	4082	79673521
Vascular pseudoaneurysm ruptured	20.29	15.29	7	66778	166	79677437
Ilium fracture	20.28	15.29	8	66777	279	79677324
Metastases to bladder	20.28	15.29	8	66777	279	79677324
Leukaemic lymphoma	20.27	15.29	6	66779	85	79677518
Metastases to the mediastinum	20.25	15.29	10	66775	600	79677003
Thrombocytosis	20.21	15.29	30	66755	8496	79669107
Discontinued product administered	20.02	15.29	6	66779	89	79677514
Back pain	19.94	15.29	161	66624	304019	79373584
Mediastinum neoplasm	19.89	15.29	6	66779	91	79677512
Septic shock	19.85	15.29	173	66612	122628	79554975
Vaginal cellulitis	19.77	15.29	6	66779	93	79677510
Catabolic state	19.71	15.29	6	66779	94	79677509
Unevaluable event	19.69	15.29	11	66774	55574	79622029
Drug dependence	19.54	15.29	5	66780	40764	79636839
Blood creatine phosphokinase increased	19.50	15.29	16	66769	66074	79611529
Hypersensitivity	19.47	15.29	134	66651	262105	79415498
Vascular purpura	19.46	15.29	18	66767	3080	79674523
Hiccups	19.20	15.29	32	66753	9999	79667604
Bacillus infection	19.19	15.29	12	66773	1143	79676460
Febrile bone marrow aplasia	19.12	15.29	37	66748	12983	79664620
Head injury	19.07	15.29	4	66781	37365	79640238
Epistaxis	19.03	15.29	159	66626	111356	79566247
Amnesia	18.94	15.29	15	66770	63042	79614561
Burning sensation	18.84	15.29	13	66772	58619	79618984
Pneumonia adenoviral	18.83	15.29	9	66776	503	79677100
Adenosquamous cell lung cancer stage IV	18.81	15.29	4	66781	12	79677591
Transitional cell carcinoma recurrent	18.81	15.29	4	66781	12	79677591
Proteinuria	18.81	15.29	65	66720	32437	79645166
Platelet count increased	18.77	15.29	51	66734	22355	79655248
Metastases to diaphragm	18.76	15.29	5	66780	47	79677556
Drug level increased	18.75	15.29	5	66780	39646	79637957
Product quality issue	18.68	15.29	3	66782	33937	79643666
Medication error	18.60	15.29	18	66767	68624	79608979
Gastric neoplasm	18.51	15.29	8	66777	353	79677250
Erythema	18.50	15.29	276	66509	223014	79454589
Pneumothorax	18.49	15.29	59	66726	28264	79649339
Transaminases increased	18.40	15.29	89	66696	51654	79625949
Hormone receptor positive breast cancer	18.38	15.29	8	66777	359	79677244
Febrile infection	18.28	15.29	18	66767	3328	79674275
Pseudosepsis	18.26	15.29	3	66782	0	79677603
Neoplasm recurrence	18.23	15.29	20	66765	4194	79673409
Dacryostenosis acquired	18.18	15.29	9	66776	543	79677060
Respiratory arrest	18.17	15.29	13	66772	57537	79620066
Blood alkaline phosphatase increased	18.16	15.29	103	66682	63561	79614042
Cardiac disorder	18.10	15.29	17	66768	65740	79611863
Haematuria	18.10	15.29	109	66676	68727	79608876
Influenza like illness	18.08	15.29	20	66765	71687	79605916
Pain in jaw	18.06	15.29	8	66777	46143	79631460
Intestinal metastasis	17.99	15.29	8	66777	378	79677225
Loss of consciousness	17.90	15.29	76	66709	167867	79509736
Renal vein thrombosis	17.89	15.29	9	66776	562	79677041
Renal failure	17.67	15.29	251	66534	200717	79476886
Infusion site thrombosis	17.62	15.29	7	66778	249	79677354
Speech disorder	17.59	15.29	12	66773	54433	79623170
Ureteric fistula	17.54	15.29	4	66781	18	79677585
Lymphadenopathy mediastinal	17.53	15.29	20	66765	4376	79673227
BRAF gene mutation	17.51	15.29	5	66780	62	79677541
Gastrointestinal disorder	17.28	15.29	49	66736	122156	79555447
Duodenal obstruction	17.26	15.29	8	66777	417	79677186
Splenic marginal zone lymphoma	17.22	15.29	5	66780	66	79677537
Ovarian cancer metastatic	17.18	15.29	9	66776	612	79676991
Q fever	17.18	15.29	7	66778	266	79677337
Emotional distress	17.17	15.29	6	66779	39963	79637640
Dyskinesia	17.15	15.29	8	66777	44765	79632838
Basal cell carcinoma	17.14	15.29	5	66780	37370	79640233
Acute erythroid leukaemia	16.98	15.29	7	66778	274	79677329
Hydronephrosis	16.95	15.29	42	66743	17412	79660191
Ureteric compression	16.94	15.29	7	66778	276	79677327
Thrombophlebitis migrans	16.87	15.29	8	66777	439	79677164
Oropharyngeal pain	16.86	15.29	42	66743	109311	79568292
Subdural haematoma	16.81	15.29	3	66782	31431	79646172
Therapeutic product effect incomplete	16.77	15.29	187	66598	141458	79536145
Metastases to stomach	16.73	15.29	7	66778	285	79677318
Tumour thrombosis	16.66	15.29	6	66779	162	79677441
Blood disorder	16.66	15.29	27	66758	8246	79669357
Herpes zoster	16.60	15.29	33	66752	93050	79584553
Dyspepsia	16.56	15.29	42	66743	108645	79568958
Necrosis	16.48	15.29	29	66756	9464	79668139
Peripheral artery occlusion	16.34	15.29	15	66770	2542	79675061
Bone trimming	16.31	15.29	4	66781	26	79677577
Haemoptysis	16.24	15.29	91	66694	55908	79621695
Thyroglobulin increased	16.22	15.29	5	66780	82	79677521
Embolism arterial	16.21	15.29	12	66773	1506	79676097
Molluscum contagiosum	16.19	15.29	8	66777	481	79677122
Musculoskeletal pain	16.02	15.29	39	66746	102315	79575288
Peritoneal disorder	15.76	15.29	9	66776	726	79676877
Oroticaciduria	15.72	15.29	3	66782	4	79677599
Tumour fistulisation	15.69	15.29	4	66781	31	79677572
Heart rate irregular	15.68	15.29	4	66781	32675	79644928
Recurrent cancer	15.68	15.29	15	66770	2678	79674925
Haemobilia	15.61	15.29	8	66777	520	79677083
Lymphoedema	15.52	15.29	33	66752	12380	79665223
Pancreatic abscess	15.48	15.29	5	66780	96	79677507
Chronic obstructive pulmonary disease	15.48	15.29	30	66755	85389	79592214
Incorrect route of product administration	15.42	15.29	5	66780	34924	79642679
Platelet toxicity	15.32	15.29	3	66782	5	79677598
Metastases to muscle	15.32	15.29	7	66778	353	79677250

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
Thymidylate synthase	Enzyme	P04818	TYSY_HUMAN		WOMBAT-PK
Deoxycytidine kinase	Kinase	P27707	DCK_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
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	0409-0181	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	0409-0182	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	0409-0183	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	0409-0185	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	0409-0186	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	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	16729-092	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	16729-117	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 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	16729-391	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	16729-419	INJECTION, SOLUTION	100 mg	INTRAVENOUS	NDA	26 sections
GEMCITABINE	HUMAN PRESCRIPTION DRUG LABEL	1	16729-423	INJECTION, SOLUTION	100 mg	INTRAVENOUS	NDA	26 sections