All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

azacitidine 🐶 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	25	320-67-2

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: 5-azacytidine azacitidine azacytidine ladakamycin ledakamycin vidaza U-18496

A pyrimidine analogue that inhibits DNA methyltransferase, impairing DNA methylation. It is also an antimetabolite of cytidine, incorporated primarily into RNA. Azacytidine has been used as an antineoplastic agent. Molecular weight: 244.21 Formula: C8H12N4O5 CLOGP: -2.20 LIPINSKI: 0 HAC: 9 HDO: 4 TPSA: 140.97 ALOGS: -1.30 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)	3	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	89 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	62 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	177.10 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution)	0.47 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	35 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	0.36 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
Jan. 21, 2011	PMDA	Nippon Shinyaku Co., Ltd.
Aug. 2, 2019	EMA	Celgene Europe BV
May 19, 2004	FDA	CELGENE

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
Acute myeloid leukaemia	1467.62	21.62	414	14532	16558	56260563
Febrile neutropenia	1450.69	21.62	655	14291	104890	56172231
Thrombocytopenia	405.57	21.62	315	14631	135909	56141212
Death	394.02	21.62	467	14479	340959	55936162
Myelodysplastic syndrome	389.49	21.62	151	14795	16255	56260866
Sepsis	330.96	21.62	283	14663	139557	56137564
Pneumonia	330.35	21.62	468	14478	406630	55870491
Pancytopenia	309.97	21.62	226	14720	88489	56188632
Neutropenia	283.72	21.62	274	14672	157893	56119228
Acute myeloid leukaemia recurrent	275.71	21.62	67	14879	1461	56275660
Septic shock	196.58	21.62	148	14798	60687	56216434
Platelet count decreased	169.49	21.62	173	14773	106210	56170911
Blast cell count increased	160.95	21.62	34	14912	382	56276739
Myelodysplastic syndrome transformation	154.46	21.62	33	14913	393	56276728
Neutrophil count decreased	145.11	21.62	114	14832	49708	56227413
Bronchopulmonary aspergillosis	140.82	21.62	60	14886	8204	56268917
Myelosuppression	135.82	21.62	74	14872	17381	56259740
Cytopenia	131.26	21.62	60	14886	9695	56267426
Pyrexia	130.94	21.62	320	14626	418453	55858668
Anaemia	122.98	21.62	239	14707	267272	56009849
Pneumonitis	118.19	21.62	84	14862	31480	56245641
Transformation to acute myeloid leukaemia	117.84	21.62	24	14922	222	56276899
Pain	109.12	21.62	22	14924	663162	55613959
White blood cell count decreased	78.87	21.62	129	14817	125861	56151260
Differentiation syndrome	78.81	21.62	23	14923	1026	56276095
Respiratory failure	75.93	21.62	109	14837	94953	56182168
Multiple organ dysfunction syndrome	75.29	21.62	81	14865	52689	56224432
Pneumonia fungal	75.08	21.62	33	14913	4860	56272261
Arthralgia	73.83	21.62	21	14925	501648	55775473
Acute febrile neutrophilic dermatosis	71.47	21.62	27	14919	2698	56274423
Neutropenic sepsis	60.51	21.62	42	14904	15143	56261978
Headache	56.38	21.62	40	14906	559004	55718117
Aspergillus infection	56.26	21.62	31	14915	7434	56269687
Bone marrow failure	54.27	21.62	51	14895	28235	56248886
Refractory anaemia with an excess of blasts	53.32	21.62	14	14932	420	56276701
Leukaemia	53.24	21.62	24	14922	3751	56273370
Myelofibrosis	52.94	21.62	18	14928	1326	56275795
Infection	52.94	21.62	144	14802	200062	56077059
Joint swelling	51.00	21.62	8	14938	289792	55987329
Abdominal discomfort	50.30	21.62	7	14939	277267	55999854
Swelling	48.71	21.62	4	14942	239767	56037354
Cerebral haemorrhage	48.15	21.62	48	14898	28558	56248563
Tumour lysis syndrome	46.61	21.62	28	14918	7895	56269226
Soft tissue infection	46.08	21.62	18	14928	1969	56275152
Acute myeloid leukaemia refractory	45.81	21.62	9	14937	68	56277053
Therapy non-responder	45.55	21.62	68	14878	61287	56215834
Organising pneumonia	45.35	21.62	24	14922	5311	56271810
Acute graft versus host disease	44.86	21.62	22	14924	4153	56272968
Allogenic stem cell transplantation	44.43	21.62	8	14938	35	56277086
Cardiac failure	43.35	21.62	78	14868	82015	56195106
Product dose omission issue	42.76	21.62	3	14943	204750	56072371
Peripheral swelling	42.39	21.62	6	14940	234720	56042401
Pneumonia adenoviral	41.46	21.62	9	14937	116	56277005
Nasopharyngitis	41.45	21.62	5	14941	220954	56056167
Drug hypersensitivity	41.37	21.62	11	14935	275194	56001927
Graft versus host disease in skin	40.70	21.62	18	14928	2689	56274432
Escherichia sepsis	40.37	21.62	21	14925	4488	56272633
Graft versus host disease in gastrointestinal tract	39.28	21.62	18	14928	2921	56274200
Periorbital cellulitis	39.13	21.62	12	14934	635	56276486
Maternal exposure during pregnancy	38.94	21.62	3	14943	189550	56087571
Disease progression	38.78	21.62	86	14860	105087	56172034
Alopecia	38.34	21.62	15	14931	293443	55983678
Hypertension	38.19	21.62	9	14937	244269	56032852
Graft versus host disease	37.41	21.62	23	14923	6758	56270363
Subdural haematoma	37.35	21.62	30	14916	13469	56263652
Toxic neuropathy	36.02	21.62	10	14936	372	56276749
Bacteraemia	35.51	21.62	31	14915	15600	56261521
Hypersensitivity	35.36	21.62	12	14934	256396	56020725
Weight increased	34.86	21.62	9	14937	229694	56047427
Leukopenia	33.19	21.62	64	14882	70876	56206245
Cellulitis	33.10	21.62	66	14880	74883	56202238
Graft versus host disease in liver	32.99	21.62	10	14936	509	56276612
Fatigue	32.97	21.62	104	14842	788448	55488673
Adenoviral hepatitis	32.23	21.62	9	14937	342	56276779
Condition aggravated	31.74	21.62	27	14919	344871	55932250
Chloroma	31.31	21.62	8	14938	215	56276906
Liver abscess	31.20	21.62	15	14931	2711	56274410
Stenotrophomonas infection	30.56	21.62	13	14933	1768	56275353
Pleural effusion	30.49	21.62	69	14877	85411	56191710
Infusion related reaction	30.18	21.62	9	14937	208922	56068199
Haemoglobin decreased	30.09	21.62	91	14855	134046	56143075
Pulmonary sepsis	29.98	21.62	12	14934	1399	56275722
Iron overload	28.76	21.62	10	14936	788	56276333
Full blood count decreased	28.40	21.62	33	14913	23316	56253805
Bone marrow necrosis	28.11	21.62	6	14940	71	56277050
Subarachnoid haemorrhage	26.78	21.62	23	14923	11324	56265797
Blastic plasmacytoid dendritic cell neoplasia	26.74	21.62	5	14941	28	56277093
Anxiety	26.69	21.62	9	14937	193163	56083958
Renal tubular disorder	26.31	21.62	13	14933	2493	56274628
Dizziness	26.26	21.62	37	14909	376103	55901018
Staphylococcal sepsis	26.21	21.62	19	14927	7330	56269791
Pseudomonal skin infection	26.17	21.62	4	14942	4	56277117
Exposure during pregnancy	25.77	21.62	3	14943	136339	56140782
Acute leukaemia	25.61	21.62	10	14936	1092	56276029
Minimal residual disease	25.27	21.62	6	14940	118	56277003
Portal vein cavernous transformation	25.27	21.62	6	14940	118	56277003
Renal tubular acidosis	25.26	21.62	11	14935	1584	56275537
Drug intolerance	25.25	21.62	20	14926	264798	56012323
Abdominal pain upper	25.17	21.62	8	14938	178305	56098816
Intestinal ulcer	24.92	21.62	10	14936	1174	56275947
Dyspnoea	24.82	21.62	78	14868	592499	55684622
Constipation	24.23	21.62	112	14834	201831	56075290
Leukaemia recurrent	23.81	21.62	10	14936	1318	56275803
Pseudomonal bacteraemia	23.72	21.62	10	14936	1330	56275791
Chronic myelomonocytic leukaemia	23.65	21.62	7	14939	328	56276793
Rash	23.49	21.62	61	14885	492986	55784135
Cytomegalovirus infection reactivation	23.41	21.62	13	14933	3163	56273958
Therapeutic product effect decreased	23.22	21.62	8	14938	169444	56107677
COVID-19 pneumonia	23.19	21.62	21	14925	11081	56266040
Leukocytosis	23.08	21.62	30	14916	23761	56253360
Disseminated intravascular coagulation	22.97	21.62	26	14920	17859	56259262
Pseudomonas infection	22.93	21.62	20	14926	10051	56267070
Acute erythroid leukaemia	22.65	21.62	5	14941	70	56277051
Discomfort	22.58	21.62	5	14941	141756	56135365
Haemorrhage intracranial	22.57	21.62	22	14924	12733	56264388
Hypoaesthesia	22.52	21.62	5	14941	141486	56135635
Bone marrow transplant	22.50	21.62	8	14938	673	56276448
Bicytopenia	22.20	21.62	11	14935	2122	56274999
Enterococcal infection	22.10	21.62	17	14929	7167	56269954
Pain in extremity	22.03	21.62	28	14918	297403	55979718
Gait disturbance	21.88	21.62	8	14938	163313	56113808
Cholestatic liver injury	21.64	21.62	11	14935	2241	56274880

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
Acute myeloid leukaemia	1837.58	18.14	640	22795	18032	31655877
Febrile neutropenia	1706.45	18.14	1077	22358	120772	31553137
Myelodysplastic syndrome	645.79	18.14	305	23130	18946	31654963
Pneumonia	529.47	18.14	909	22526	334403	31339506
Sepsis	440.14	18.14	550	22885	151379	31522530
Death	315.60	18.14	767	22668	359802	31314107
Neutrophil count decreased	289.89	18.14	254	23181	46140	31627769
Platelet count decreased	287.91	18.14	380	23055	110055	31563854
Neutropenia	259.10	18.14	410	23025	139954	31533955
Blast cell count increased	238.51	18.14	68	23367	959	31672950
Acute myeloid leukaemia recurrent	229.94	18.14	77	23358	1897	31672012
Pancytopenia	228.17	18.14	301	23134	87015	31586894
Septic shock	220.88	18.14	258	23177	65900	31608009
Thrombocytopenia	212.69	18.14	379	23056	142368	31531541
Tumour lysis syndrome	200.82	18.14	131	23304	15254	31658655
Myelodysplastic syndrome transformation	191.21	18.14	47	23388	356	31673553
Chronic myelomonocytic leukaemia	190.47	18.14	52	23383	619	31673290
Transformation to acute myeloid leukaemia	181.36	18.14	51	23384	682	31673227
White blood cell count decreased	177.31	18.14	267	23168	87131	31586778
Anaemia	170.60	18.14	440	22995	213082	31460827
Pneumonia fungal	166.28	18.14	85	23350	6244	31667665
Infection	147.55	18.14	237	23198	81694	31592215
Cytopenia	139.39	18.14	92	23343	10918	31662991
Pyrexia	123.10	18.14	496	22939	303344	31370565
Acute febrile neutrophilic dermatosis	116.16	18.14	41	23394	1187	31672722
Myelosuppression	101.77	18.14	86	23349	14834	31659075
Drug interaction	84.06	18.14	25	23410	208518	31465391
Bacteraemia	76.46	18.14	79	23356	17555	31656354
Bronchopulmonary aspergillosis	73.88	18.14	69	23366	13565	31660344
Neutropenic sepsis	67.75	18.14	63	23372	12316	31661593
Organising pneumonia	67.20	18.14	45	23390	5465	31668444
Headache	62.26	18.14	29	23406	183623	31490286
Blood product transfusion dependent	61.60	18.14	19	23416	356	31673553
Graft versus host disease in gastrointestinal tract	56.37	18.14	34	23401	3445	31670464
Product dose omission issue	54.29	18.14	7	23428	105579	31568330
Completed suicide	52.43	18.14	4	23431	91510	31582399
Disseminated intravascular coagulation	52.23	18.14	70	23365	20467	31653442
Toxicity to various agents	51.02	18.14	36	23399	181451	31492458
Febrile bone marrow aplasia	50.98	18.14	44	23391	7802	31666107
Pyoderma gangrenosum	50.46	18.14	23	23412	1309	31672600
Myelofibrosis	45.02	18.14	23	23412	1685	31672224
Acute leukaemia	44.96	18.14	20	23415	1075	31672834
Pneumonitis	44.91	18.14	81	23354	30571	31643338
Cerebral haemorrhage	44.67	18.14	84	23351	32728	31641181
Therapy non-responder	44.10	18.14	85	23350	33726	31640183
Injection site reaction	43.10	18.14	48	23387	11603	31662306
Anxiety	42.34	18.14	8	23427	91025	31582884
Blood pressure increased	41.61	18.14	5	23430	79628	31594281
Cardiac failure	39.98	18.14	147	23288	85806	31588103
Soft tissue infection	39.08	18.14	22	23413	1959	31671950
Arthralgia	38.78	18.14	33	23402	151391	31522518
Minimal residual disease	37.68	18.14	13	23422	351	31673558
Tremor	37.10	18.14	6	23429	76414	31597495
Graft versus host disease	36.87	18.14	42	23393	10405	31663504
Necrotising fasciitis	36.68	18.14	26	23409	3460	31670449
General physical health deterioration	36.30	18.14	173	23262	113262	31560647
Overdose	36.20	18.14	9	23426	84655	31589254
Cellulitis	35.08	18.14	96	23339	47922	31625987
Myositis	34.82	18.14	42	23393	11052	31662857
Somnolence	34.75	18.14	15	23420	99430	31574479
Drug hypersensitivity	34.58	18.14	6	23429	72593	31601316
Muscle spasms	33.99	18.14	5	23430	68313	31605596
Graft versus host disease in skin	33.69	18.14	25	23410	3572	31670337
Pain	33.53	18.14	54	23381	186705	31487204
Leukaemia	33.34	18.14	26	23409	3999	31669910
Enteritis infectious	33.10	18.14	17	23418	1259	31672650
Pain in extremity	32.69	18.14	23	23412	116180	31557729
Haemoglobin abnormal	32.58	18.14	24	23411	3391	31670518
Bone marrow failure	32.43	18.14	67	23368	27941	31645968
Leukaemia recurrent	32.17	18.14	18	23417	1584	31672325
Weight increased	31.48	18.14	11	23424	82936	31590973
Neutropenic colitis	30.48	18.14	21	23414	2671	31671238
Condition aggravated	29.83	18.14	47	23388	163962	31509947
Dyspnoea	29.09	18.14	143	23292	343336	31330573
Aeromonas infection	28.88	18.14	10	23425	273	31673636
Refractory anaemia with an excess of blasts	28.43	18.14	11	23424	414	31673495
Dizziness	28.42	18.14	66	23369	199081	31474828
Peripheral swelling	27.52	18.14	8	23427	67857	31606052
Meningeal neoplasm	27.50	18.14	7	23428	62	31673847
Aspergillus infection	27.34	18.14	38	23397	11490	31662419
Anal abscess	26.98	18.14	27	23408	5773	31668136
Leukocytosis	26.90	18.14	54	23381	22060	31651849
Urticaria	26.85	18.14	5	23430	57512	31616397
Myalgia	26.44	18.14	12	23423	77246	31596663
Pulmonary sepsis	25.91	18.14	17	23418	1995	31671914
Hypoaesthesia	25.88	18.14	5	23430	56017	31617892
Depression	25.50	18.14	18	23417	90797	31583112
Hyperhidrosis	25.46	18.14	9	23426	67384	31606525
Iron overload	25.39	18.14	14	23421	1197	31672712
Seizure	25.20	18.14	22	23413	99746	31574163
Insomnia	25.08	18.14	20	23415	94816	31579093
Epstein-Barr virus infection reactivation	24.19	18.14	12	23423	826	31673083
Paraesthesia	23.89	18.14	6	23429	56065	31617844
Chest discomfort	23.68	18.14	4	23431	49365	31624544
International normalised ratio increased	23.22	18.14	3	23432	45220	31628689
Febrile infection	23.14	18.14	16	23419	2046	31671863
Disease progression	22.70	18.14	129	23306	90335	31583574
Chloroma	22.65	18.14	10	23425	528	31673381
Juvenile chronic myelomonocytic leukaemia	22.61	18.14	4	23431	3	31673906
Angiodysplasia	22.45	18.14	10	23425	539	31673370
Escherichia sepsis	22.39	18.14	21	23414	4146	31669763
Malaise	22.34	18.14	58	23377	168453	31505456
Neutrophilic panniculitis	22.28	18.14	5	23430	24	31673885
Gait disturbance	22.23	18.14	15	23420	77480	31596429
Haemoglobin decreased	22.21	18.14	151	23284	112524	31561385
Acute graft versus host disease	22.16	18.14	25	23410	6128	31667781
Pneumonia bacterial	21.58	18.14	32	23403	10264	31663645
Central nervous system leukaemia	21.56	18.14	8	23427	268	31673641
Subdural haematoma	21.51	18.14	45	23390	18926	31654983
Constipation	21.45	18.14	161	23274	123830	31550079
Epistaxis	21.00	18.14	87	23348	53620	31620289
Agitation	20.86	18.14	7	23428	54162	31619747
Full blood count decreased	20.85	18.14	41	23394	16499	31657410
Drug ineffective	20.74	18.14	190	23245	395383	31278526
Weight decreased	20.48	18.14	56	23379	159896	31514013
Clostridium difficile colitis	20.39	18.14	37	23398	14019	31659890
Foetal exposure during pregnancy	20.31	18.14	3	23432	40873	31633036
Hypertension	20.30	18.14	40	23395	128060	31545849
Platelet disorder	20.22	18.14	13	23422	1474	31672435
Rhabdomyolysis	20.06	18.14	11	23424	63570	31610339
Klebsiella sepsis	19.90	18.14	14	23421	1841	31672068
Catheter site infection	19.85	18.14	15	23420	2202	31671707
Escherichia bacteraemia	19.84	18.14	17	23418	2984	31670925
Muscular weakness	19.68	18.14	12	23423	65436	31608473
Multiple organ dysfunction syndrome	19.64	18.14	101	23334	68102	31605807
Staphylococcal bacteraemia	19.60	18.14	26	23409	7522	31666387
Enterococcal infection	19.55	18.14	28	23407	8703	31665206
Pseudomembranous colitis	19.33	18.14	16	23419	2679	31671230
Asthma	19.27	18.14	4	23431	42607	31631302
Neutropenic infection	19.05	18.14	12	23423	1313	31672596
Pseudomonal sepsis	18.91	18.14	17	23418	3179	31670730
Infusion related reaction	18.88	18.14	6	23429	48049	31625860
Allogenic stem cell transplantation	18.84	18.14	5	23430	53	31673856
Vision blurred	18.82	18.14	4	23431	41911	31631998
Injection site vasculitis	18.63	18.14	3	23432	0	31673909
Pericardial effusion	18.58	18.14	47	23388	22376	31651533
Thrombocytosis	18.56	18.14	18	23417	3705	31670204
Memory impairment	18.48	18.14	3	23432	38127	31635782
Musculoskeletal stiffness	18.44	18.14	4	23431	41321	31632588
Fungal infection	18.26	18.14	36	23399	14515	31659394
Pruritus	18.22	18.14	41	23394	125126	31548783

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
Febrile neutropenia	2898.73	18.46	1559	32138	202759	70691988
Acute myeloid leukaemia	2640.32	18.46	854	32843	30086	70864661
Pneumonia	816.66	18.46	1192	32505	595040	70299707
Myelodysplastic syndrome	769.44	18.46	344	33353	29441	70865306
Sepsis	729.79	18.46	728	32969	243817	70650930
Death	615.88	18.46	963	32734	509098	70385649
Thrombocytopenia	520.74	18.46	603	33094	238507	70656240
Neutropenia	480.49	18.46	600	33097	256556	70638191
Acute myeloid leukaemia recurrent	474.15	18.46	134	33563	2920	70891827
Platelet count decreased	422.45	18.46	470	33227	177752	70716995
Neutrophil count decreased	411.97	18.46	331	33366	83225	70811522
Pancytopenia	411.63	18.46	429	33268	150678	70744069
Septic shock	399.56	18.46	369	33328	111889	70782858
Blast cell count increased	331.94	18.46	85	33612	1252	70893495
Anaemia	307.05	18.46	624	33073	402799	70491948
Transformation to acute myeloid leukaemia	258.63	18.46	65	33632	884	70893863
Cytopenia	251.13	18.46	135	33562	17188	70877559
Tumour lysis syndrome	245.73	18.46	143	33554	21217	70873530
White blood cell count decreased	237.53	18.46	345	33352	169796	70724951
Myelosuppression	228.77	18.46	155	33542	29990	70864757
Pneumonia fungal	222.32	18.46	104	33593	9849	70884898
Pyrexia	221.71	18.46	711	32986	606241	70288506
Myelodysplastic syndrome transformation	203.72	18.46	50	33647	613	70894134
Bronchopulmonary aspergillosis	191.11	18.46	121	33576	20881	70873866
Acute febrile neutrophilic dermatosis	160.14	18.46	61	33636	3458	70891289
Pneumonitis	150.08	18.46	156	33541	54441	70840306
Pain	140.09	18.46	62	33635	628754	70265993
Infection	136.58	18.46	306	33391	210479	70684268
Chronic myelomonocytic leukaemia	133.34	18.46	38	33659	853	70893894
Headache	131.19	18.46	56	33641	580349	70314398
Arthralgia	128.22	18.46	40	33657	503350	70391397
Rheumatoid arthritis	124.41	18.46	3	33694	291802	70602945
Blood product transfusion dependent	121.39	18.46	30	33667	379	70894368
Therapy non-responder	120.53	18.46	165	33532	76750	70817997
Bacteraemia	105.31	18.46	97	33600	29212	70865535
Organising pneumonia	104.35	18.46	63	33634	9987	70884760
Neutropenic sepsis	100.72	18.46	88	33609	24742	70870005
Completed suicide	94.32	18.46	3	33694	227132	70667615
Differentiation syndrome	84.76	18.46	34	33663	2213	70892534
Cerebral haemorrhage	82.02	18.46	114	33583	53750	70840997
Drug hypersensitivity	80.26	18.46	14	33683	262445	70632302
Graft versus host disease	79.21	18.46	62	33635	14961	70879786
Multiple organ dysfunction syndrome	78.69	18.46	165	33532	108350	70786397
Drug interaction	78.10	18.46	42	33655	381399	70513348
Respiratory failure	76.56	18.46	214	33483	168521	70726226
Joint swelling	76.35	18.46	14	33683	253197	70641550
Cardiac failure	76.21	18.46	193	33504	143348	70751399
Product dose omission issue	74.98	18.46	8	33689	217460	70677287
Aspergillus infection	73.82	18.46	64	33633	17804	70876943
Febrile bone marrow aplasia	73.18	18.46	54	33643	11937	70882810
Acute leukaemia	72.93	18.46	28	33669	1621	70893126
Soft tissue infection	72.78	18.46	35	33662	3522	70891225
Peripheral swelling	71.49	18.46	13	33684	236550	70658197
Myelofibrosis	71.00	18.46	31	33666	2496	70892251
Bone marrow failure	70.58	18.46	101	33596	48909	70845838
Toxicity to various agents	69.97	18.46	48	33649	382124	70512623
Weight increased	69.71	18.46	15	33682	242316	70652431
Refractory anaemia with an excess of blasts	69.14	18.46	23	33674	875	70893872
Cardiovascular disorder	67.44	18.46	59	33638	16611	70878136
Cellulitis	66.63	18.46	146	33551	98782	70795965
Abdominal discomfort	66.61	18.46	11	33686	214647	70680100
Disseminated intravascular coagulation	66.59	18.46	81	33616	33517	70861230
Escherichia sepsis	64.98	18.46	42	33655	7501	70887246
Anxiety	64.68	18.46	13	33684	220317	70674430
Leukaemia	64.49	18.46	37	33660	5338	70889409
Dyspnoea	62.34	18.46	175	33522	769885	70124862
Allogenic stem cell transplantation	60.54	18.46	12	33685	48	70894699
Pain in extremity	60.31	18.46	41	33656	328041	70566706
Graft versus host disease in gastrointestinal tract	55.94	18.46	35	33662	5909	70888838
Swelling	55.60	18.46	11	33686	188528	70706219
Subdural haematoma	55.42	18.46	69	33628	29229	70865518
Hypersensitivity	55.35	18.46	20	33677	229792	70664955
Condition aggravated	54.68	18.46	74	33623	427561	70467186
Nasopharyngitis	54.10	18.46	19	33678	222187	70672560
Blood pressure increased	53.53	18.46	12	33685	188505	70706242
Infusion related reaction	53.30	18.46	14	33683	197520	70697227
Graft versus host disease in liver	52.57	18.46	22	33675	1596	70893151
Chloroma	52.52	18.46	18	33679	751	70893996
Fatigue	51.88	18.46	209	33488	824110	70070637
Pulmonary sepsis	51.37	18.46	27	33670	3280	70891467
General physical health deterioration	51.23	18.46	235	33462	235796	70658951
Dizziness	51.02	18.46	89	33608	464052	70430695
Necrotising fasciitis	50.66	18.46	32	33665	5494	70889253
Tremor	50.50	18.46	7	33690	155617	70739130
Malaise	50.37	18.46	80	33617	432852	70461895
Constipation	50.18	18.46	245	33452	252193	70642554
Iron overload	48.80	18.46	21	33676	1632	70893115
Paraesthesia	48.54	18.46	6	33691	145531	70749216
Hypoaesthesia	47.41	18.46	8	33689	153731	70741016
Pericardial effusion	47.29	18.46	77	33620	41699	70853048
Leukaemia recurrent	46.97	18.46	24	33673	2751	70891996
Full blood count decreased	46.32	18.46	57	33640	23861	70870886
Drug intolerance	45.92	18.46	25	33672	225662	70669085
Overdose	45.85	18.46	12	33685	169733	70725014
Somnolence	45.17	18.46	23	33674	215583	70679164
Acute graft versus host disease	45.16	18.46	37	33660	9525	70885222
Hypertension	44.50	18.46	45	33652	295988	70598759
Maternal exposure during pregnancy	43.12	18.46	3	33694	115342	70779405
Gait disturbance	43.08	18.46	17	33680	185089	70709658
Pruritus	42.94	18.46	61	33636	345499	70549248
Pyoderma gangrenosum	42.89	18.46	25	33672	3714	70891033
Acute myeloid leukaemia refractory	41.73	18.46	10	33687	110	70894637
Staphylococcal sepsis	41.68	18.46	41	33656	13386	70881361
Insomnia	41.65	18.46	26	33671	217780	70676967
Epistaxis	41.53	18.46	125	33572	102502	70792245
Minimal residual disease	41.50	18.46	13	33684	407	70894340
Muscle spasms	41.40	18.46	11	33686	154035	70740712
Klebsiella sepsis	40.83	18.46	22	33675	2809	70891938
Neutropenic colitis	40.46	18.46	27	33670	5087	70889660
Graft versus host disease in skin	40.44	18.46	28	33669	5602	70889145
Asthma	40.23	18.46	5	33692	120788	70773959
Haemoglobin decreased	39.95	18.46	198	33499	204961	70689786
Chest discomfort	39.41	18.46	6	33691	124375	70770372
Escherichia bacteraemia	39.39	18.46	28	33669	5841	70888906
Disease progression	39.32	18.46	163	33534	156509	70738238
Enterococcal infection	38.85	18.46	41	33656	14541	70880206
Enteritis infectious	38.56	18.46	22	33675	3140	70891607
Periorbital cellulitis	36.39	18.46	14	33683	815	70893932
Alopecia	36.18	18.46	25	33672	198465	70696282
Pneumonia bacterial	36.07	18.46	42	33655	16599	70878148
Myositis	36.01	18.46	43	33654	17446	70877301
Mobility decreased	34.95	18.46	4	33693	102995	70791752
Stenotrophomonas infection	34.78	18.46	21	33676	3328	70891419
Acute graft versus host disease in skin	34.51	18.46	28	33669	7109	70887638
Abdominal pain upper	34.48	18.46	25	33672	193577	70701170
Leukocytosis	34.35	18.46	65	33632	39603	70855144
Anal abscess	32.64	18.46	29	33668	8329	70886418
Pleural effusion	32.37	18.46	137	33560	132727	70762020
Therapeutic product effect decreased	31.87	18.46	14	33683	143004	70751743
Pseudomonal bacteraemia	31.65	18.46	18	33679	2554	70892193
Discomfort	31.39	18.46	6	33691	105430	70789317
Epstein-Barr virus infection reactivation	31.27	18.46	15	33682	1501	70893246
Sinusitis	31.25	18.46	21	33676	169174	70725573
Exposure during pregnancy	30.80	18.46	3	33694	87714	70807033
Myalgia	30.79	18.46	21	33676	167871	70726876
Aeromonas infection	30.59	18.46	10	33687	360	70894387
Feeling abnormal	30.07	18.46	15	33682	142304	70752443
Haemorrhage intracranial	29.86	18.46	47	33650	24730	70870017
Renal tubular disorder	29.61	18.46	24	33673	6086	70888661
Palpitations	29.58	18.46	8	33689	110745	70784002
Clostridium difficile colitis	29.55	18.46	51	33646	28945	70865802
Pseudomonal sepsis	29.51	18.46	23	33674	5514	70889233
Cytomegalovirus infection reactivation	29.45	18.46	25	33672	6756	70887991
Liver abscess	29.28	18.46	23	33674	5576	70889171
Rash	29.22	18.46	134	33563	510428	70384319
Depression	29.03	18.46	31	33666	198943	70695804
Platelet disorder	28.87	18.46	17	33680	2574	70892173
Wheezing	28.81	18.46	5	33692	94165	70800582
Neutrophilic panniculitis	28.73	18.46	7	33690	83	70894664
Haemoglobin abnormal	28.71	18.46	24	33673	6353	70888394
Memory impairment	28.16	18.46	5	33692	92636	70802111
Systemic candida	28.10	18.46	23	33674	5911	70888836
Aplasia	28.00	18.46	25	33672	7226	70887521
Hyperhidrosis	27.60	18.46	14	33683	131572	70763175
Juvenile chronic myelomonocytic leukaemia	27.45	18.46	5	33692	11	70894736
Blister	27.34	18.46	7	33690	100519	70794228
Intentional product misuse	27.23	18.46	3	33694	79592	70815155
Geotrichum infection	27.06	18.46	12	33685	1003	70893744
Vision blurred	27.04	18.46	6	33691	94978	70799769
Colitis	27.01	18.46	79	33618	63735	70831012
Agitation	26.38	18.46	6	33691	93369	70801378
Anorectal infection	26.20	18.46	9	33688	378	70894369
Febrile infection	26.02	18.46	17	33680	3092	70891655
Muscular weakness	25.77	18.46	17	33680	138319	70756428
Blastic plasmacytoid dendritic cell neoplasia	25.51	18.46	7	33690	136	70894611
Toxic neuropathy	25.41	18.46	11	33686	867	70893880
Angiodysplasia	25.37	18.46	11	33686	871	70893876
Loss of personal independence in daily activities	24.92	18.46	5	33692	84905	70809842
Acute erythroid leukaemia	24.91	18.46	8	33689	272	70894475
Transplant	24.67	18.46	11	33686	931	70893816
Pneumonia adenoviral	24.46	18.46	9	33688	463	70894284
Injection site reaction	24.33	18.46	65	33632	49787	70844960
Gingival bleeding	24.32	18.46	33	33664	15199	70879548
Chest pain	24.23	18.46	52	33645	251208	70643539
COVID-19 pneumonia	24.19	18.46	40	33657	21929	70872818
Weight decreased	23.95	18.46	72	33625	310416	70584331
Leukaemic infiltration extramedullary	23.85	18.46	7	33690	175	70894572
Flushing	23.78	18.46	5	33692	82167	70812580
Leukopenia	23.75	18.46	107	33590	106453	70788294
Gastrooesophageal reflux disease	23.44	18.46	7	33690	90832	70803915
Dry mouth	23.25	18.46	3	33694	70454	70824293
Balance disorder	23.16	18.46	7	33690	90121	70804626
Fungal infection	22.65	18.46	53	33644	37414	70857333
Cough	22.64	18.46	79	33618	325298	70569449
Impaired healing	22.63	18.46	4	33693	74370	70820377
Cystitis haemorrhagic	22.60	18.46	24	33673	8569	70886178
Staphylococcal bacteraemia	22.41	18.46	27	33670	11055	70883692
Atypical pneumonia	22.18	18.46	20	33677	5855	70888892
Mucormycosis	22.18	18.46	23	33674	7991	70886756
Central nervous system leukaemia	22.13	18.46	8	33689	391	70894356
Diverticulitis	21.99	18.46	56	33641	41678	70853069
Neutropenic infection	21.91	18.46	13	33684	1996	70892751
Interstitial lung disease	21.76	18.46	103	33594	104582	70790165
Phlebitis	21.75	18.46	23	33674	8171	70886576
Portal vein cavernous transformation	21.52	18.46	6	33691	124	70894623
Acinetobacter bacteraemia	21.49	18.46	7	33690	249	70894498
Fungal sepsis	21.17	18.46	12	33685	1691	70893056
Transfusion reaction	21.11	18.46	12	33685	1701	70893046
Thrombocytosis	20.93	18.46	22	33675	7762	70886985
Anal infection	20.91	18.46	6	33691	138	70894609
Pseudomonal skin infection	20.83	18.46	4	33693	13	70894734
Refractoriness to platelet transfusion	20.67	18.46	6	33691	144	70894603
Injection site vasculitis	20.60	18.46	4	33693	14	70894733
Blood lactate dehydrogenase increased	20.48	18.46	49	33648	35078	70859669
Drug ineffective	20.47	18.46	319	33378	939433	69955314
Wrong technique in product usage process	20.25	18.46	4	33693	68694	70826053
Tumour associated fever	20.18	18.46	9	33688	762	70893985
Isocitrate dehydrogenase gene mutation	19.96	18.46	3	33694	0	70894747
Pneumonia respiratory syncytial viral	19.95	18.46	11	33686	1470	70893277
Heart rate decreased	19.62	18.46	3	33694	62012	70832735
Seizure	19.61	18.46	34	33663	177928	70716819
Subarachnoid haemorrhage	19.48	18.46	34	33663	19470	70875277
Adenoviral hepatitis	19.39	18.46	9	33688	836	70893911
Neutrophilic dermatosis	19.37	18.46	8	33689	561	70894186
Anal fissure	19.28	18.46	19	33678	6214	70888533
Visual impairment	19.28	18.46	7	33690	80243	70814504
Nasal congestion	18.99	18.46	4	33693	65668	70829079
Sleep disorder	18.74	18.46	5	33692	69867	70824880
Bradycardia	18.63	18.46	19	33678	124596	70770151
Acute graft versus host disease in intestine	18.51	18.46	15	33682	3801	70890946

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01BC07	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:35610	antineoplastic agents
MeSH PA	D000963	Antimetabolites
MeSH PA	D000964	Antimetabolites, Antineoplastic
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D009676	Noxae

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

Disease	Relation	SNOMED_ID	DOID
Acute myeloid leukemia, disease	indication	91861009
Myelodysplastic syndrome	indication	109995007
Chronic myelomonocytic leukemia	indication	127225006
Hepatic failure	contraindication	59927004
Kidney disease	contraindication	90708001	DOID:557
Pregnancy, function	contraindication	289908002
Thrombocytopenic disorder	contraindication	302215000	DOID:1588
Neutropenic disorder	contraindication	303011007	DOID:1227
Breastfeeding (mother)	contraindication	413712001
Advanced Malignant Neoplasm of Liver	contraindication

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.32	acidic
pKa2	12.92	acidic
pKa3	13.79	acidic
pKa4	4.43	Basic
pKa5	2.98	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
200MG	ONUREG	CELGENE CORP	N214120	Sept. 1, 2020	RX	TABLET	ORAL	8846628	June 3, 2030	CONTINUED TREATMENT OF ADULTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR CR WITH INCOMPLETE BLOOD COUNT RECOVERY FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMPLETE INTENSIVE CURATIVE THERAPY
300MG	ONUREG	CELGENE CORP	N214120	Sept. 1, 2020	RX	TABLET	ORAL	8846628	June 3, 2030	CONTINUED TREATMENT OF ADULTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR CR WITH INCOMPLETE BLOOD COUNT RECOVERY FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMPLETE INTENSIVE CURATIVE THERAPY

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
200MG	ONUREG	CELGENE CORP	N214120	Sept. 1, 2020	RX	TABLET	ORAL	Sept. 1, 2023	NEW PRODUCT
300MG	ONUREG	CELGENE CORP	N214120	Sept. 1, 2020	RX	TABLET	ORAL	Sept. 1, 2023	NEW PRODUCT
100MG/VIAL	VIDAZA	BRISTOL-MYERS	N050794	May 19, 2004	RX	POWDER	INTRAVENOUS, SUBCUTANEOUS	May 20, 2025	TREATMENT OF PEDIATRIC PATIENTS AGED ONE MONTH AND OLDER WITH NEWLY DIAGNOSED JUVENILE MYELOMONOCYTIC LEUKEMIA (JMML)
200MG	ONUREG	CELGENE CORP	N214120	Sept. 1, 2020	RX	TABLET	ORAL	Sept. 1, 2027	INDICATED FOR CONTINUED TREATMENT OF ADULT PATIENTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR COMPLETE REMISSION WITH INCOMPLETE BLOOD COUNT RECOVERY (CRI) FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMPLETE INTENSIVE CURATIVE THERAPY
300MG	ONUREG	CELGENE CORP	N214120	Sept. 1, 2020	RX	TABLET	ORAL	Sept. 1, 2027	INDICATED FOR CONTINUED TREATMENT OF ADULT PATIENTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR COMPLETE REMISSION WITH INCOMPLETE BLOOD COUNT RECOVERY (CRI) FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMPLETE INTENSIVE CURATIVE THERAPY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
DNA (cytosine-5)-methyltransferase 1	Enzyme	P26358	DNMT1_HUMAN	INHIBITOR	IC50	6.52		CHEMBL	CHEMBL
DNA (cytosine-5)-methyltransferase 3A	Enzyme	Q9Y6K1	DNM3A_HUMAN	INHIBITOR				CHEMBL	CHEMBL

External reference:

ID	Source
4021468	VUID
N0000148852	NUI
D03021	KEGG_DRUG
1251	RXNORM
C0004475	UMLSCUI
CHEBI:2038	CHEBI
5AE	PDB_CHEM_ID
CHEMBL1489	ChEMBL_ID
D001374	MESH_DESCRIPTOR_UI
DB00928	DRUGBANK_ID
6796	IUPHAR_LIGAND_ID
4520	INN_ID
M801H13NRU	UNII
9444	PUBCHEM_CID
008661	NDDF
412328000	SNOMEDCT_US
412329008	SNOMEDCT_US
88551000	SNOMEDCT_US
4021468	VANDF
18639	MMSL
205981	MMSL
53994	MMSL
d05293	MMSL

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Azacitidine	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9606	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	24 sections
Azacitidine	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9606	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	24 sections
Azacitidine	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3253	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	SUBCUTANEOUS	NDA AUTHORIZED GENERIC	28 sections
Azacitidine	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3253	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	SUBCUTANEOUS	NDA AUTHORIZED GENERIC	28 sections
Azacitidine	HUMAN PRESCRIPTION DRUG LABEL	1	0781-9253	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	SUBCUTANEOUS	NDA AUTHORIZED GENERIC	28 sections
Azacitidine	HUMAN PRESCRIPTION DRUG LABEL	1	0781-9253	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	SUBCUTANEOUS	NDA AUTHORIZED GENERIC	28 sections
Azacitidine	HUMAN PRESCRIPTION DRUG LABEL	1	16714-578	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	25 sections
Azacitidine	HUMAN PRESCRIPTION DRUG LABEL	1	16714-927	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	SUBCUTANEOUS	ANDA	24 sections
Azacitidine	HUMAN PRESCRIPTION DRUG LABEL	1	16729-306	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	25 sections
Azacitidine	HUMAN PRESCRIPTION DRUG LABEL	1	16729-306	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	25 sections
Azacitidine	HUMAN PRESCRIPTION DRUG LABEL	1	43598-143	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	SUBCUTANEOUS	ANDA	24 sections
Azacitidine	HUMAN PRESCRIPTION DRUG LABEL	1	43598-305	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	SUBCUTANEOUS	ANDA	24 sections
Azacitidine	HUMAN PRESCRIPTION DRUG LABEL	1	43598-465	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	SUBCUTANEOUS	ANDA	24 sections
AZACITIDINE AZACITIDINE	HUMAN PRESCRIPTION DRUG LABEL	1	43598-678	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	24 sections
Azacitidine	HUMAN PRESCRIPTION DRUG LABEL	1	43817-906	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	SUBCUTANEOUS	ANDA	28 sections
Azacitidine	HUMAN PRESCRIPTION DRUG LABEL	1	51991-797	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	SUBCUTANEOUS	ANDA	28 sections
VIDAZA	HUMAN PRESCRIPTION DRUG LABEL	1	59572-102	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	NDA	27 sections
VIDAZA	HUMAN PRESCRIPTION DRUG LABEL	1	59572-102	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	NDA	27 sections
VIDAZA	HUMAN PRESCRIPTION DRUG LABEL	1	59572-102	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	NDA	27 sections
ONUREG	HUMAN PRESCRIPTION DRUG LABEL	1	59572-730	TABLET, FILM COATED	200 mg	ORAL	NDA	31 sections
ONUREG	HUMAN PRESCRIPTION DRUG LABEL	1	59572-730	TABLET, FILM COATED	200 mg	ORAL	NDA	31 sections
ONUREG	HUMAN PRESCRIPTION DRUG LABEL	1	59572-740	TABLET, FILM COATED	300 mg	ORAL	NDA	31 sections
ONUREG	HUMAN PRESCRIPTION DRUG LABEL	1	59572-740	TABLET, FILM COATED	300 mg	ORAL	NDA	31 sections
Azacitidine	HUMAN PRESCRIPTION DRUG LABEL	1	63323-771	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	25 sections
AZACITIDINE	HUMAN PRESCRIPTION DRUG LABEL	1	64679-096	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	23 sections
Azacitidine	HUMAN PRESCRIPTION DRUG LABEL	1	67457-254	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	27 sections
Azacitidine	HUMAN PRESCRIPTION DRUG LABEL	1	68001-313	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	NDA	17 sections
Azacitidine	HUMAN PRESCRIPTION DRUG LABEL	1	68001-313	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	NDA	17 sections
Azacitidine	HUMAN PRESCRIPTION DRUG LABEL	1	68001-504	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	SUBCUTANEOUS	ANDA	26 sections
Azacitidine	HUMAN PRESCRIPTION DRUG LABEL	1	68001-527	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	24 sections