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

Stem definition	Drug id	CAS RN
antineoplastic, alkylating agents, (beta-chloroethyl)amine derivatives	302	16506-27-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: bendamustine bendamustine hydrochloride treanda bendamustine HCl	A nitrogen mustard compound that functions as an ALKYLATING ANTINEOPLASTIC AGENT and is used in the treatment of CHRONIC LYMPHOCYTIC LEUKEMIA and NON-HODGKIN'S LYMPHOMA. Molecular weight: 358.26 Formula: C16H21Cl2N3O2 CLOGP: 3.24 LIPINSKI: 0 HAC: 5 HDO: 1 TPSA: 58.36 ALOGS: -3.76 ROTB: 9 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

bendamustine
bendamustine hydrochloride
treanda
bendamustine HCl

A nitrogen mustard compound that functions as an ALKYLATING ANTINEOPLASTIC AGENT and is used in the treatment of CHRONIC LYMPHOCYTIC LEUKEMIA and NON-HODGKIN'S LYMPHOMA.

Molecular weight: 358.26
Formula: C16H21Cl2N3O2
CLOGP: 3.24
LIPINSKI: 0
HAC: 5
HDO: 1
TPSA: 58.36
ALOGS: -3.76
ROTB: 9

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
EoM (Fraction excreted unchanged in urine)	1 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	6.26 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution)	0.22 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	4.49 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.05 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	0.41 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
March 20, 2008	FDA	CEPHALON
Sept. 27, 2010	PMDA	SymBio Pharmaceuticals Limited

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	816.58	21.27	498	19591	122260	63346673
Progressive multifocal leukoencephalopathy	486.57	21.27	175	19914	12796	63456137
Neutropenia	471.39	21.27	411	19678	174594	63294339
Pancytopenia	407.48	21.27	296	19793	96637	63372296
Febrile neutropenia	382.18	21.27	309	19780	118140	63350793
Lymphoma	345.73	21.27	134	19955	12053	63456880
Neutrophil count decreased	338.90	21.27	215	19874	56191	63412742
Cytomegalovirus infection	325.01	21.27	150	19939	20802	63448131
Blood lactate dehydrogenase increased	310.94	21.27	150	19939	22966	63445967
Diffuse large B-cell lymphoma recurrent	282.16	21.27	77	20012	2243	63466690
Pyrexia	281.48	21.27	519	19570	469959	62998974
Myelosuppression	268.91	21.27	137	19952	23566	63445367
Lymphocyte count decreased	250.96	21.27	142	19947	30115	63438818
Off label use	243.77	21.27	606	19483	673856	62795077
Thrombocytopenia	239.44	21.27	266	19823	150891	63318042
Platelet count decreased	238.80	21.27	235	19854	115887	63353046
Cytopenia	214.71	21.27	94	19995	11507	63457426
Diffuse large B-cell lymphoma	166.48	21.27	67	20022	6645	63462288
Hypogammaglobulinaemia	165.73	21.27	68	20021	7087	63461846
Malignant neoplasm progression	150.01	21.27	156	19933	81965	63386968
Tumour lysis syndrome	141.32	21.27	65	20024	8925	63460008
White blood cell count decreased	125.14	21.27	185	19904	138919	63330014
Lymphopenia	117.80	21.27	73	20016	18254	63450679
B-cell lymphoma recurrent	117.08	21.27	27	20062	386	63468547
Arthralgia	116.94	21.27	20	20069	569690	62899243
Therapy partial responder	110.45	21.27	58	20031	10600	63458333
Cytomegalovirus infection reactivation	106.77	21.27	42	20047	3921	63465012
COVID-19	105.41	21.27	153	19936	112950	63355983
Pain	104.89	21.27	52	20037	740576	62728357
Sepsis	94.75	21.27	172	19917	152951	63315982
Cytomegalovirus chorioretinitis	89.63	21.27	30	20059	1763	63467170
JC virus infection	85.68	21.27	30	20059	2021	63466912
Abdominal discomfort	84.84	21.27	4	20085	320881	63148052
CD4 lymphocytes decreased	83.93	21.27	27	20062	1400	63467533
Diffuse large B-cell lymphoma refractory	83.65	21.27	26	20063	1204	63467729
Anaemia	83.24	21.27	242	19847	293188	63175745
Cytokine release syndrome	81.95	21.27	53	20036	14261	63454672
Bone marrow failure	76.88	21.27	68	20021	29222	63439711
Vasogenic cerebral oedema	74.03	21.27	22	20067	874	63468059
Headache	72.23	21.27	57	20032	633184	62835749
Pneumocystis jirovecii pneumonia	71.64	21.27	52	20037	16862	63452071
Agranulocytosis	67.25	21.27	59	20030	25075	63443858
Myelodysplastic syndrome	65.32	21.27	49	20040	16705	63452228
Autoimmune haemolytic anaemia	65.29	21.27	31	20058	4570	63464363
Pneumonia	64.23	21.27	300	19789	456467	63012466
Haematotoxicity	61.90	21.27	38	20051	9338	63459595
Rash maculo-papular	58.90	21.27	61	20028	31835	63437098
Condition aggravated	58.66	21.27	27	20062	402190	63066743
Hepatitis B	58.15	21.27	27	20062	3785	63465148
Cytomegalovirus test positive	57.59	21.27	25	20064	2993	63465940
Maternal exposure during pregnancy	57.31	21.27	3	20086	220059	63248874
Erythropoiesis abnormal	55.60	21.27	14	20075	295	63468638
Peripheral swelling	55.17	21.27	9	20080	265933	63203000
Gastrointestinal fungal infection	53.87	21.27	14	20075	336	63468597
Varicella zoster virus infection	53.70	21.27	23	20066	2666	63466267
Product use in unapproved indication	52.91	21.27	150	19939	178930	63290003
Prescribed underdose	51.65	21.27	55	20034	29634	63439299
Drug hypersensitivity	51.64	21.27	17	20072	310670	63158263
Leukopenia	50.53	21.27	89	20000	77201	63391732
Fatigue	49.82	21.27	132	19957	887896	62581037
Swelling	49.54	21.27	13	20076	275365	63193568
Nasopharyngitis	47.68	21.27	11	20078	254246	63214687
Herpes zoster	47.63	21.27	90	19999	82372	63386561
Sinus polyp	47.19	21.27	13	20076	392	63468541
B-cell lymphoma refractory	47.01	21.27	10	20079	96	63468837
Extravasation	46.41	21.27	20	20069	2352	63466581
Product dose omission issue	46.27	21.27	9	20080	234304	63234629
Dizziness	44.90	21.27	42	20047	429883	63039050
Mantle cell lymphoma recurrent	44.76	21.27	11	20078	209	63468724
Bronchopulmonary aspergillosis	44.63	21.27	30	20059	8605	63460328
Toxic skin eruption	44.35	21.27	35	20054	12850	63456083
Atrial fibrillation	43.93	21.27	107	19982	116529	63352404
Musculoskeletal stiffness	43.77	21.27	4	20085	184614	63284319
Chronic lymphocytic leukaemia recurrent	43.63	21.27	11	20078	233	63468700
Venoocclusive liver disease	43.61	21.27	24	20065	4811	63464122
Cerebral toxoplasmosis	43.53	21.27	15	20074	963	63467970
Hypercalcaemia	43.25	21.27	49	20040	28273	63440660
Chills	42.68	21.27	104	19985	113274	63355659
Lymphoma transformation	42.55	21.27	10	20079	156	63468777
Cerebral aspergillosis	42.12	21.27	12	20077	410	63468523
Enterococcal sepsis	41.64	21.27	16	20073	1402	63467531
Plasma cell leukaemia	41.41	21.27	15	20074	1115	63467818
COVID-19 pneumonia	41.35	21.27	35	20054	14174	63454759
Neoplasm progression	40.97	21.27	54	20035	36374	63432559
Pemphigus	40.94	21.27	5	20084	183721	63285212
Nasal abscess	40.74	21.27	10	20079	189	63468744
Haemolytic anaemia	40.33	21.27	30	20059	10095	63458838
Wound	40.18	21.27	3	20086	163260	63305673
Cytomegalovirus viraemia	40.13	21.27	24	20065	5625	63463308
Hypertensive cardiomyopathy	40.02	21.27	10	20079	204	63468729
Anxiety	39.63	21.27	10	20079	217531	63251402
Neurological symptom	39.61	21.27	24	20065	5759	63463174
Insomnia	39.01	21.27	10	20079	215242	63253691
Lymphadenopathy	38.68	21.27	54	20035	38404	63430529
Non-small cell lung cancer	38.48	21.27	20	20069	3575	63465358
Gait disturbance	38.42	21.27	6	20083	183172	63285761
Acute myeloid leukaemia	37.58	21.27	36	20053	17111	63451822
Fear of injection	37.29	21.27	25	20064	7139	63461794
Drug interaction	37.25	21.27	13	20076	229118	63239815
Abdominal pain upper	36.63	21.27	10	20079	206434	63262499
Discomfort	36.22	21.27	5	20084	167369	63301564
Mucosal inflammation	35.92	21.27	58	20031	46870	63422063
Feeling abnormal	35.75	21.27	3	20086	148389	63320544
Campylobacter infection	34.70	21.27	13	20076	1063	63467870
Encephalitis cytomegalovirus	34.57	21.27	11	20078	550	63468383
Febrile bone marrow aplasia	34.43	21.27	24	20065	7301	63461632
Neuropathy peripheral	34.31	21.27	96	19993	113571	63355362
Mucosal erosion	33.72	21.27	14	20075	1502	63467431
Pneumonia fungal	33.21	21.27	21	20068	5434	63463499
Humoral immune defect	33.17	21.27	9	20080	256	63468677
Exposure during pregnancy	32.83	21.27	5	20084	155542	63313391
Infusion site irritation	32.80	21.27	12	20077	918	63468015
Second primary malignancy	32.65	21.27	24	20065	7929	63461004
Obliterative bronchiolitis	32.46	21.27	15	20074	2080	63466853
Pneumonitis	31.82	21.27	47	20042	35175	63433758
Therapy responder	30.87	21.27	9	20080	334	63468599
Plasma cell myeloma refractory	30.47	21.27	9	20080	350	63468583
Weight increased	30.22	21.27	23	20066	260769	63208164
Adenocarcinoma of colon	29.91	21.27	15	20074	2489	63466444
Splenic marginal zone lymphoma recurrent	29.81	21.27	5	20084	10	63468923
Cytomegalovirus enterocolitis	28.59	21.27	10	20079	671	63468262
Enterococcal infection	28.49	21.27	22	20067	7826	63461107
Platelet count abnormal	28.43	21.27	16	20073	3348	63465585
Neutropenic infection	28.31	21.27	12	20077	1355	63467578
Neutrophil count abnormal	27.87	21.27	15	20074	2877	63466056
Fungal oesophagitis	27.73	21.27	10	20079	734	63468199
Cytomegalovirus colitis	27.72	21.27	14	20075	2358	63466575
Oral fungal infection	26.94	21.27	15	20074	3076	63465857
Muscle spasms	26.89	21.27	8	20081	156142	63312791
Pseudomembranous colitis	26.84	21.27	15	20074	3097	63465836
Hepatitis B reactivation	26.73	21.27	15	20074	3122	63465811
VIth nerve paresis	26.47	21.27	6	20083	79	63468854
Leukaemic lymphoma	26.13	21.27	6	20083	84	63468849
Schistocytosis	25.57	21.27	5	20084	30	63468903
Fall	25.31	21.27	54	20035	392280	63076653
Ototoxicity	25.07	21.27	11	20078	1351	63467582
Blood pressure increased	24.98	21.27	10	20079	162052	63306881
Aplasia	24.94	21.27	16	20073	4243	63464690
Splenic marginal zone lymphoma	24.79	21.27	5	20084	36	63468897
Alopecia	24.78	21.27	43	20046	337493	63131440
Alopecia scarring	24.67	21.27	6	20083	109	63468824
Hepatic enzyme increased	24.53	21.27	17	20072	202311	63266622
Hypoglossal nerve paresis	24.47	21.27	6	20083	113	63468820
Death	24.44	21.27	202	19887	374179	63094754
Aplasia pure red cell	24.18	21.27	16	20073	4471	63464462
Listeria sepsis	24.14	21.27	9	20080	726	63468207
Cryoglobulinaemia	23.98	21.27	8	20081	465	63468468
Hypertension	23.95	21.27	32	20057	279271	63189662
Overdose	23.60	21.27	4	20085	115074	63353859
Cardiac failure	22.80	21.27	71	20018	89071	63379862
Eastern Cooperative Oncology Group performance status worsened	22.67	21.27	10	20079	1244	63467689
Blood disorder	22.46	21.27	18	20071	6753	63462180
Urinary tract infection bacterial	22.26	21.27	16	20073	5106	63463827
Bacterial infection	22.06	21.27	29	20060	19470	63449463
Drug intolerance	22.04	21.27	40	20049	308621	63160312
Hypoaesthesia	21.98	21.27	13	20076	168380	63300553
Disease recurrence	21.93	21.27	35	20054	27995	63440938
Polyneuropathy	21.86	21.27	25	20064	14564	63454369
Infusion site phlebitis	21.33	21.27	5	20084	77	63468856

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	878.93	17.43	735	29598	107342	34819256
Febrile neutropenia	418.04	17.43	552	29781	136297	34790301
Progressive multifocal leukoencephalopathy	360.79	17.43	174	30159	9590	34917008
Off label use	327.15	17.43	946	29387	418578	34508020
Cytomegalovirus infection	316.97	17.43	226	30107	25909	34900689
Pyrexia	300.77	17.43	793	29540	332220	34594378
Neutrophil count decreased	273.88	17.43	276	30057	50828	34875770
Lymphocyte count decreased	259.13	17.43	189	30144	22433	34904165
Neutropenia	239.42	17.43	461	29872	156317	34770281
Myelosuppression	229.85	17.43	165	30168	19100	34907498
Hypogammaglobulinaemia	212.89	17.43	113	30220	7627	34918971
Lymphoma	211.39	17.43	133	30200	12374	34914224
Cytopenia	204.33	17.43	131	30202	12592	34914006
Tumour lysis syndrome	196.41	17.43	143	30190	16916	34909682
Diffuse large B-cell lymphoma recurrent	191.06	17.43	80	30253	3148	34923450
Blood lactate dehydrogenase increased	180.99	17.43	154	30179	22836	34903762
Malignant neoplasm progression	178.03	17.43	293	30040	87753	34838845
COVID-19	166.17	17.43	265	30068	77285	34849313
Myelodysplastic syndrome	158.04	17.43	132	30201	19076	34907522
Pancytopenia	157.59	17.43	290	30043	94867	34831731
Cytomegalovirus chorioretinitis	147.96	17.43	69	30264	3520	34923078
End stage renal disease	144.15	17.43	92	30241	8769	34917829
Thrombocytopenia	125.03	17.43	357	29976	155890	34770708
Product use in unapproved indication	122.06	17.43	296	30037	117203	34809395
Neoplasm progression	115.88	17.43	121	30212	23179	34903419
Neutropenic sepsis	114.04	17.43	95	30238	13672	34912926
Infusion related reaction	107.68	17.43	177	30156	52880	34873718
Therapy partial responder	107.01	17.43	79	30254	9537	34917061
Cytomegalovirus infection reactivation	105.94	17.43	62	30271	5056	34921542
B-cell lymphoma recurrent	98.85	17.43	34	30299	770	34925828
Lymphadenopathy	94.54	17.43	120	30213	28343	34898255
Prescribed underdose	94.07	17.43	71	30262	8862	34917736
Hepatitis B reactivation	93.61	17.43	52	30281	3839	34922759
Drug interaction	92.88	17.43	40	30293	225906	34700692
White blood cell count decreased	91.20	17.43	233	30100	95212	34831386
Diffuse large B-cell lymphoma	89.86	17.43	64	30269	7306	34919292
Platelet count decreased	87.48	17.43	265	30068	119452	34807146
Pneumocystis jirovecii pneumonia	86.82	17.43	96	30237	19614	34906984
Lymphoma transformation	86.74	17.43	24	30309	253	34926345
Extravasation	86.25	17.43	39	30294	1851	34924747
Cytokine release syndrome	84.91	17.43	102	30231	22775	34903823
Pneumonia	84.41	17.43	570	29763	362057	34564541
Product dose omission issue	83.87	17.43	5	30328	119706	34806892
Second primary malignancy	83.75	17.43	63	30270	7823	34918775
Autoimmune haemolytic anaemia	81.47	17.43	50	30283	4446	34922152
Acute myeloid leukaemia	77.06	17.43	87	30246	18183	34908415
Septic shock	75.59	17.43	182	30151	71652	34854946
COVID-19 pneumonia	75.34	17.43	83	30250	16884	34909714
Arthralgia	74.94	17.43	27	30306	170014	34756584
Chronic lymphocytic leukaemia recurrent	73.25	17.43	23	30310	387	34926211
Toxicity to various agents	71.07	17.43	43	30290	200319	34726279
Bone marrow failure	68.16	17.43	104	30229	29149	34897449
Infection	68.01	17.43	203	30130	90712	34835886
Cytomegalovirus test positive	67.33	17.43	42	30291	3844	34922754
Headache	67.14	17.43	46	30287	200589	34726009
Chills	59.70	17.43	180	30153	80863	34845735
Pneumonia cytomegaloviral	57.99	17.43	35	30298	3019	34923579
Basal cell carcinoma	57.69	17.43	78	30255	19580	34907018
Lymphopenia	57.63	17.43	71	30262	16264	34910334
Dizziness	57.46	17.43	63	30270	218458	34708140
Cytomegalovirus enterocolitis	56.69	17.43	24	30309	970	34925628
Squamous cell carcinoma	55.97	17.43	59	30274	11416	34915182
CD4 lymphocytes decreased	55.27	17.43	28	30305	1713	34924885
Sepsis	54.06	17.43	286	30047	166275	34760323
Overdose	52.78	17.43	8	30325	91051	34835547
Fall	52.78	17.43	59	30274	202826	34723772
Haematotoxicity	52.72	17.43	49	30284	8145	34918453
Endocarditis noninfective	52.58	17.43	14	30319	126	34926472
Drug ineffective for unapproved indication	52.01	17.43	82	30251	23633	34902965
Pain	51.64	17.43	61	30272	204614	34721984
Bacteraemia	50.07	17.43	73	30260	19644	34906954
Hepatitis B	48.94	17.43	41	30292	5942	34920656
Hypertension	48.73	17.43	29	30304	136414	34790184
Cytomegalovirus viraemia	46.97	17.43	44	30289	7386	34919212
Rash	46.81	17.43	342	29991	222410	34704188
Infusion site extravasation	46.78	17.43	35	30298	4309	34922289
Somnolence	46.66	17.43	19	30314	111097	34815501
Anaemia	46.63	17.43	354	29979	232981	34693617
Insomnia	46.59	17.43	16	30317	103891	34822707
Rash maculo-papular	46.08	17.43	86	30247	28365	34898233
Mantle cell lymphoma recurrent	45.45	17.43	19	30314	744	34925854
Rhabdomyolysis	44.42	17.43	4	30329	68159	34858439
Seizure	43.91	17.43	18	30315	104839	34821759
Pain in extremity	43.63	17.43	28	30305	126485	34800113
Human polyomavirus infection	42.55	17.43	18	30315	726	34925872
Cerebrovascular accident	41.75	17.43	11	30322	84800	34841798
Paraneoplastic pemphigus	40.82	17.43	10	30323	62	34926536
Anxiety	40.14	17.43	18	30315	99410	34827188
Neoplasm	39.71	17.43	35	30298	5432	34921166
Condition aggravated	38.84	17.43	67	30266	192129	34734469
Depression	38.54	17.43	18	30315	97080	34829518
Squamous cell carcinoma of skin	37.90	17.43	47	30286	10834	34915764
Infusion site phlebitis	37.58	17.43	9	30324	50	34926548
Serum sickness	35.62	17.43	22	30311	1978	34924620
Neuropathy peripheral	34.91	17.43	154	30179	83109	34843489
Inappropriate schedule of product administration	34.90	17.43	6	30327	62290	34864308
Blood bilirubin decreased	34.87	17.43	13	30320	374	34926224
Hepatitis E	34.77	17.43	22	30311	2064	34924534
Phlebitis	34.75	17.43	28	30305	3842	34922756
Chronic lymphocytic leukaemia	34.61	17.43	29	30304	4203	34922395
Aplasia	34.58	17.43	30	30303	4558	34922040
Muscle spasms	34.57	17.43	11	30322	74990	34851608
Hospitalisation	32.96	17.43	5	30328	56897	34869701
Pneumonia pseudomonal	32.33	17.43	27	30306	3895	34922703
Peripheral T-cell lymphoma unspecified	32.31	17.43	13	30320	461	34926137
Fungal infection	32.07	17.43	53	30280	15882	34910716
Dermatitis exfoliative generalised	31.56	17.43	26	30307	3681	34922917
Atypical pneumonia	31.51	17.43	25	30308	3355	34923243
Cytomegalovirus syndrome	31.47	17.43	9	30324	108	34926490
Fatigue	31.38	17.43	191	30142	370462	34556136
Disease recurrence	31.17	17.43	62	30271	21428	34905170
Polyneuropathy	30.59	17.43	50	30283	14846	34911752
Enterococcal infection	30.51	17.43	39	30294	9267	34917331
Weight increased	30.18	17.43	22	30311	93011	34833587
Primary amyloidosis	30.00	17.43	9	30324	129	34926469
Campylobacter infection	29.66	17.43	15	30318	914	34925684
Nausea	29.36	17.43	174	30159	339734	34586864
Cell-mediated cytotoxicity	29.21	17.43	7	30326	39	34926559
Peripheral swelling	29.14	17.43	15	30318	76526	34850072
Hypoglycaemia	29.04	17.43	6	30327	54634	34871964
Aplasia pure red cell	28.97	17.43	31	30302	6101	34920497
Metastases to muscle	28.72	17.43	10	30323	235	34926363
Neoplasm recurrence	28.50	17.43	20	30313	2229	34924369
Bradycardia	28.39	17.43	15	30318	75403	34851195
Metastases to retroperitoneum	28.29	17.43	10	30323	246	34926352
B-cell lymphoma	27.89	17.43	26	30307	4337	34922261
Gait disturbance	27.79	17.43	20	30313	85120	34841478
Leukopenia	27.67	17.43	118	30215	62738	34863860
Musculoskeletal stiffness	27.27	17.43	4	30329	46676	34879922
Agitation	27.21	17.43	8	30325	57391	34869207
Humoral immune defect	26.98	17.43	9	30324	185	34926413
Dermatitis exfoliative	26.94	17.43	31	30302	6608	34919990
Secondary immunodeficiency	26.85	17.43	11	30322	409	34926189
Urethral obstruction	26.54	17.43	9	30324	195	34926403
Coma	26.48	17.43	4	30329	45674	34880924
Blood stem cell harvest failure	26.28	17.43	6	30327	26	34926572
Feeling abnormal	26.22	17.43	11	30322	63224	34863374
Type IV hypersensitivity reaction	26.11	17.43	16	30317	1418	34925180
Neuroendocrine carcinoma of the skin	25.93	17.43	13	30320	778	34925820
Haemophagocytic lymphohistiocytosis	25.90	17.43	43	30290	12930	34913668
Oedema peripheral	25.83	17.43	40	30293	119772	34806826
Cytomegalovirus hepatitis	25.81	17.43	11	30322	452	34926146
Candida pneumonia	25.77	17.43	11	30322	454	34926144
Procalcitonin increased	25.58	17.43	17	30316	1734	34924864
International normalised ratio increased	25.56	17.43	5	30328	47322	34879276
Cardiac failure congestive	25.35	17.43	21	30312	83249	34843349
Injection site phlebitis	25.10	17.43	6	30327	33	34926565
Cytomegalovirus gastritis	24.78	17.43	9	30324	240	34926358
Cytomegalovirus colitis	24.70	17.43	20	30313	2764	34923834
Toxic skin eruption	24.45	17.43	39	30294	11346	34915252
Therapy non-responder	24.27	17.43	82	30251	39064	34887534
JC virus infection	24.24	17.43	18	30315	2190	34924408
Metastases to bone marrow	24.23	17.43	11	30322	527	34926071
Ototoxicity	24.18	17.43	17	30316	1900	34924698
Abdominal neoplasm	23.93	17.43	10	30323	391	34926207
Retinitis	23.91	17.43	10	30323	392	34926206
Infusion site irritation	23.88	17.43	9	30324	267	34926331
Haemolysis	23.56	17.43	32	30301	8062	34918536
Aggression	23.56	17.43	3	30330	38961	34887637
Blood pressure increased	23.55	17.43	25	30308	88077	34838521
Immune effector cell-associated neurotoxicity syndrome	23.49	17.43	22	30311	3691	34922907
Sphingomonas paucimobilis infection	23.39	17.43	6	30327	46	34926552
Drug resistance	23.38	17.43	62	30271	25865	34900733
Herpes zoster	23.07	17.43	74	30259	34325	34892273
Pneumocystis jirovecii infection	23.04	17.43	16	30317	1754	34924844
Blood pressure decreased	22.89	17.43	97	30236	51418	34875180
Stevens-Johnson syndrome	22.63	17.43	50	30283	18589	34908009
Hyponatraemia	22.62	17.43	23	30310	82668	34843930
Vision blurred	22.54	17.43	6	30327	45957	34880641
Metastases to spleen	22.43	17.43	10	30323	459	34926139
Suicidal ideation	22.38	17.43	4	30329	40384	34886214
Skin toxicity	22.27	17.43	24	30309	4760	34921838
Nephrogenic diabetes insipidus	22.19	17.43	14	30319	1307	34925291
Abdominal lymphadenopathy	22.16	17.43	12	30321	842	34925756
Pneumonitis	21.92	17.43	72	30261	33806	34892792
Pneumonia bacterial	21.92	17.43	38	30295	11834	34914764
Blood creatine phosphokinase increased	21.72	17.43	6	30327	44851	34881747
Adenocarcinoma	21.72	17.43	16	30317	1924	34924674
Gastrointestinal haemorrhage	21.60	17.43	27	30306	88450	34838148
Chest pain	21.43	17.43	49	30284	126713	34799885
Malaise	21.28	17.43	86	30247	185739	34740859
Haemolytic anaemia	21.28	17.43	35	30298	10444	34916154
Infusion site induration	21.27	17.43	8	30325	236	34926362
Myalgia	21.24	17.43	25	30308	84085	34842513
Splenomegaly	21.18	17.43	43	30290	15074	34911524
Ilium fracture	20.33	17.43	7	30326	159	34926439
Follicular lymphoma	20.21	17.43	7	30326	162	34926436
Fat tissue increased	20.12	17.43	9	30324	416	34926182
Blood glucose increased	20.09	17.43	17	30316	66701	34859897
Abdominal distension	20.07	17.43	13	30320	58479	34868119
Encephalitis cytomegalovirus	19.80	17.43	10	30323	608	34925990
Marginal zone lymphoma recurrent	19.76	17.43	5	30328	36	34926562
Pneumonia escherichia	19.63	17.43	9	30324	441	34926157
Pseudomonas infection	19.51	17.43	37	30296	12345	34914253
Product use issue	19.39	17.43	107	30226	63109	34863489
Cardio-respiratory arrest	19.36	17.43	12	30321	55261	34871337
Mantle cell lymphoma	19.27	17.43	13	30320	1359	34925239
Pneumonia mycoplasmal	19.17	17.43	10	30323	650	34925948
Guillain-Barre syndrome	19.15	17.43	25	30308	6062	34920536
Muscular weakness	19.13	17.43	21	30312	72876	34853722
Infusion site reaction	19.12	17.43	11	30322	868	34925730
Myositis	18.93	17.43	36	30297	12034	34914564
Myocardial infarction	18.74	17.43	49	30284	121036	34805562
Rheumatoid arthritis	18.73	17.43	5	30328	38233	34888365
Balance disorder	18.66	17.43	6	30327	40648	34885950
JC polyomavirus test positive	18.66	17.43	10	30323	687	34925911
Constipation	18.60	17.43	59	30274	136923	34789675
Epistaxis	18.59	17.43	14	30319	58237	34868361
Acquired C1 inhibitor deficiency	18.43	17.43	4	30329	13	34926585
Resorption bone increased	18.28	17.43	7	30326	217	34926381
Mucosal inflammation	18.16	17.43	74	30259	38548	34888050
Hyperuricaemia	17.89	17.43	28	30305	8015	34918583
Haematochezia	17.89	17.43	9	30324	46525	34880073
Diffuse large B-cell lymphoma refractory	17.79	17.43	12	30321	1254	34925344
Vomiting	17.70	17.43	134	30199	247487	34679111
Hydronephrosis	17.66	17.43	32	30301	10314	34916284
Intentional product use issue	17.52	17.43	100	30233	59716	34866882
Gastroenteritis sapovirus	17.44	17.43	6	30327	136	34926462

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	1119.80	16.45	861	41265	183501	79518761
Progressive multifocal leukoencephalopathy	723.53	16.45	305	41821	20295	79681967
Febrile neutropenia	673.59	16.45	714	41412	230285	79471977
Cytomegalovirus infection	555.39	16.45	321	41805	42323	79659939
Neutropenia	500.22	16.45	684	41442	287026	79415236
Off label use	491.81	16.45	1307	40819	905908	78796354
Myelosuppression	486.95	16.45	289	41837	40007	79662255
Pyrexia	473.47	16.45	1078	41048	677631	79024631
Neutrophil count decreased	446.46	16.45	381	41745	93578	79608684
Cytopenia	389.71	16.45	198	41928	20185	79682077
Diffuse large B-cell lymphoma recurrent	373.07	16.45	123	42003	4084	79698178
Hypogammaglobulinaemia	367.32	16.45	165	41961	12786	79689476
Blood lactate dehydrogenase increased	347.54	16.45	231	41895	38939	79663323
Pancytopenia	344.90	16.45	431	41695	165314	79536948
Lymphocyte count decreased	317.25	16.45	235	41891	47054	79655208
Malignant neoplasm progression	312.66	16.45	372	41754	135618	79566644
COVID-19	304.28	16.45	395	41731	157279	79544983
Thrombocytopenia	298.45	16.45	516	41610	264743	79437519
Tumour lysis syndrome	271.74	16.45	165	41961	23774	79678488
Lymphoma	242.08	16.45	137	41989	17323	79684939
Platelet count decreased	224.39	16.45	383	41743	194281	79507981
Cytomegalovirus chorioretinitis	222.14	16.45	90	42036	5400	79696862
Myelodysplastic syndrome	215.43	16.45	156	41970	30145	79672117
Cytomegalovirus infection reactivation	209.45	16.45	99	42027	8617	79693645
Diffuse large B-cell lymphoma	206.26	16.45	109	42017	12040	79690222
Therapy partial responder	197.66	16.45	120	42006	17277	79684985
Product use in unapproved indication	191.63	16.45	414	41712	249945	79452317
Arthralgia	190.33	16.45	36	42090	571767	79130495
Pneumonia	187.51	16.45	766	41360	659480	79042782
Cytokine release syndrome	183.17	16.45	152	41974	35846	79666416
Pain	163.83	16.45	84	42042	703718	78998544
B-cell lymphoma recurrent	155.57	16.45	45	42081	955	79701307
End stage renal disease	153.68	16.45	90	42036	12130	79690132
Lymphopenia	149.20	16.45	126	42000	30431	79671831
Pneumocystis jirovecii pneumonia	146.43	16.45	128	41998	32380	79669882
Sepsis	146.18	16.45	390	41736	269038	79433224
Autoimmune haemolytic anaemia	144.56	16.45	76	42050	8304	79693958
Prescribed underdose	142.66	16.45	121	42005	29393	79672869
White blood cell count decreased	140.11	16.45	308	41818	187980	79514282
Headache	137.84	16.45	88	42038	653684	79048578
COVID-19 pneumonia	136.84	16.45	117	42009	28732	79673530
Cytomegalovirus test positive	132.09	16.45	64	42062	5883	79696379
CD4 lymphocytes decreased	123.38	16.45	48	42078	2586	79699676
Acute myeloid leukaemia	118.26	16.45	111	42015	30774	79671488
Lymphadenopathy	114.57	16.45	141	41985	53106	79649156
Second primary malignancy	113.81	16.45	79	42047	14271	79687991
Neoplasm progression	111.43	16.45	137	41989	51545	79650717
Hepatitis B reactivation	109.94	16.45	57	42069	6051	79696211
Anaemia	108.73	16.45	494	41632	444521	79257741
Bone marrow failure	104.62	16.45	132	41994	50975	79651287
Septic shock	104.18	16.45	212	41914	122589	79579673
Drug interaction	98.75	16.45	48	42078	415135	79287127
Dizziness	97.65	16.45	81	42045	526360	79175902
Chronic lymphocytic leukaemia recurrent	91.28	16.45	27	42099	621	79701641
Rash maculo-papular	90.53	16.45	129	41997	55949	79646313
Rheumatoid arthritis	89.80	16.45	5	42121	208465	79493797
Lymphoma transformation	89.47	16.45	23	42103	307	79701955
Product dose omission issue	87.92	16.45	13	42113	247524	79454738
JC virus infection	86.90	16.45	42	42084	3839	79698423
Haematotoxicity	86.23	16.45	69	42057	15450	79686812
Neuropathy peripheral	83.12	16.45	211	41915	141094	79561168
Peripheral swelling	81.40	16.45	21	42105	269596	79432666
Cytomegalovirus enterocolitis	80.50	16.45	31	42095	1624	79700638
Condition aggravated	77.99	16.45	90	42036	501034	79201228
Neutropenic sepsis	77.33	16.45	83	42043	26981	79675281
Arthropathy	77.05	16.45	4	42122	177107	79525155
Chills	76.92	16.45	222	41904	160012	79542250
Cytomegalovirus viraemia	73.36	16.45	58	42068	12763	79689499
Fall	73.29	16.45	90	42036	487539	79214723
Insomnia	72.30	16.45	20	42106	245150	79457112
Swelling	69.11	16.45	15	42111	216696	79485566
Drug ineffective for unapproved indication	68.60	16.45	108	42018	51130	79651132
Infusion related reaction	68.01	16.45	271	41855	229966	79472296
Hypertension	67.63	16.45	46	42080	330946	79371316
Anxiety	66.63	16.45	24	42102	248488	79453774
Agranulocytosis	66.02	16.45	99	42027	44931	79657331
Drug hypersensitivity	65.95	16.45	38	42088	298878	79403384
Musculoskeletal stiffness	64.96	16.45	8	42118	175000	79527262
Overdose	64.65	16.45	10	42116	184196	79518066
Abdominal discomfort	64.25	16.45	26	42100	250701	79451561
Aplasia	64.24	16.45	44	42082	7776	79694486
Pain in extremity	63.99	16.45	59	42067	364479	79337783
Erythropoiesis abnormal	63.51	16.45	19	42107	455	79701807
Campylobacter infection	63.41	16.45	27	42099	1836	79700426
Leukopenia	63.39	16.45	169	41957	116344	79585918
Enterococcal infection	63.26	16.45	58	42068	15602	79686660
Fatigue	63.25	16.45	265	41861	929462	78772800
Varicella zoster virus infection	61.95	16.45	35	42091	4406	79697856
Toxic skin eruption	61.30	16.45	67	42059	22226	79680036
Pneumonia cytomegaloviral	60.90	16.45	36	42090	4933	79697329
Therapeutic product effect decreased	59.59	16.45	8	42118	163855	79538407
Mantle cell lymphoma recurrent	58.94	16.45	19	42107	586	79701676
Asthma	58.91	16.45	3	42123	135092	79567170
Bronchopulmonary aspergillosis	57.85	16.45	65	42061	22229	79680033
Diffuse large B-cell lymphoma refractory	56.25	16.45	23	42103	1412	79700850
Basal cell carcinoma	55.98	16.45	83	42043	37292	79664970
Muscle spasms	55.90	16.45	12	42114	174718	79527544
Squamous cell carcinoma	55.71	16.45	54	42072	15568	79686694
Vasogenic cerebral oedema	55.37	16.45	23	42103	1470	79700792
Feeling abnormal	55.05	16.45	9	42117	159190	79543072
Cerebral aspergillosis	54.49	16.45	24	42102	1772	79700490
Infection	54.22	16.45	262	41864	241450	79460812
Encephalitis cytomegalovirus	54.01	16.45	21	42105	1129	79701133
Neoplasm	53.80	16.45	42	42084	9074	79693188
Bacteraemia	53.69	16.45	76	42050	32748	79669514
Hepatitis B	52.69	16.45	40	42086	8292	79693970
Endocarditis noninfective	52.52	16.45	14	42112	217	79702045
Gait disturbance	52.38	16.45	22	42104	207484	79494778
Weight increased	52.18	16.45	42	42084	277344	79424918
Human polyomavirus infection	51.25	16.45	20	42106	1086	79701176
Cytomegalovirus colitis	49.85	16.45	31	42095	4654	79697608
Nasopharyngitis	49.58	16.45	37	42089	253844	79448418
Atrial fibrillation	48.40	16.45	220	41906	197666	79504596
Somnolence	47.74	16.45	34	42092	238947	79463315
Toxicity to various agents	46.95	16.45	95	42031	421445	79280817
Febrile bone marrow aplasia	46.42	16.45	45	42081	12975	79689287
Malaise	46.02	16.45	121	42005	489748	79212514
Pneumonia pseudomonal	45.60	16.45	32	42094	5879	79696383
Procalcitonin increased	45.51	16.45	25	42101	2981	79699281
Blood pressure increased	45.01	16.45	28	42098	211332	79490930
Neuroendocrine carcinoma of the skin	44.61	16.45	19	42107	1293	79700969
Contusion	44.09	16.45	12	42114	148764	79553498
Wound	43.87	16.45	5	42121	116174	79586088
Humoral immune defect	43.74	16.45	14	42112	422	79701840
Herpes zoster	43.70	16.45	128	41998	92955	79609307
Squamous cell carcinoma of skin	43.58	16.45	45	42081	13988	79688274
Pneumonitis	43.43	16.45	98	42028	60762	79641500
Gastrooesophageal reflux disease	43.37	16.45	3	42123	104243	79598019
Inappropriate schedule of product administration	43.10	16.45	9	42117	133619	79568643
Hepatitis E	42.92	16.45	24	42102	2962	79699300
Paraneoplastic pemphigus	42.92	16.45	11	42115	145	79702117
Hepatic enzyme increased	42.01	16.45	22	42104	182588	79519674
Aplasia pure red cell	41.85	16.45	34	42092	7776	79694486
Gastrointestinal fungal infection	41.26	16.45	14	42112	508	79701754
Serum sickness	40.89	16.45	25	42101	3641	79698621
Pericarditis	40.61	16.45	4	42122	104232	79598030
Blood stem cell harvest failure	40.59	16.45	10	42116	111	79702151
Depression	40.54	16.45	33	42093	216757	79485505
Oral fungal infection	40.41	16.45	25	42101	3718	79698544
Rhabdomyolysis	40.06	16.45	4	42122	103127	79599135
Dermatitis exfoliative	39.69	16.45	38	42088	10791	79691471
Chronic lymphocytic leukaemia	39.07	16.45	27	42099	4839	79697423
Plasma cell leukaemia	39.00	16.45	19	42107	1767	79700495
Pleural effusion	38.92	16.45	166	41960	145096	79557166
Arthritis	38.60	16.45	7	42119	114873	79587389
Drug intolerance	38.31	16.45	50	42076	264069	79438193
Balance disorder	37.97	16.45	4	42122	98853	79603409
Guillain-Barre syndrome	37.77	16.45	34	42092	8931	79693331
Alopecia	37.62	16.45	40	42086	231315	79470947
Follicular lymphoma	37.11	16.45	12	42114	374	79701888
Drug resistance	37.09	16.45	74	42052	42139	79660123
Sinus polyp	36.99	16.45	13	42113	525	79701737
Nausea	36.94	16.45	326	41800	956870	78745392
Immune effector cell-associated neurotoxicity syndrome	36.82	16.45	28	42098	5820	79696442
Exposure during pregnancy	36.61	16.45	5	42121	101127	79601135
Intentional overdose	36.61	16.45	6	42120	105954	79596308
Pneumonia bacterial	36.52	16.45	48	42078	19283	79682979
Chest pain	36.46	16.45	58	42068	282246	79420016
Haemolytic anaemia	36.41	16.45	46	42080	17774	79684488
Intentional product misuse	36.17	16.45	4	42122	95161	79607101
Abdominal pain upper	36.05	16.45	39	42087	223780	79478482
Nasal abscess	35.96	16.45	10	42116	183	79702079
Mobility decreased	35.93	16.45	10	42116	122165	79580097
Dermatitis exfoliative generalised	35.62	16.45	30	42096	7211	79695051
Hydronephrosis	35.57	16.45	45	42081	17409	79684853
Extravasation	35.38	16.45	23	42103	3727	79698535
Pseudomonas infection	35.07	16.45	49	42077	20854	79681408
Seizure	34.99	16.45	29	42097	188805	79513457
Osteoarthritis	34.95	16.45	3	42123	87306	79614956
Hypoglycaemia	34.55	16.45	6	42120	101588	79600674
Hypercalcaemia	34.53	16.45	68	42058	38362	79663900
Neurological symptom	34.44	16.45	32	42094	8751	79693511
Plasmacytoma	34.35	16.45	24	42102	4379	79697883
Injection site pain	34.00	16.45	13	42113	129825	79572437
Discomfort	33.87	16.45	12	42114	125605	79576657
Peripheral T-cell lymphoma unspecified	33.83	16.45	13	42113	677	79701585
Atypical pneumonia	33.69	16.45	28	42098	6608	79695654
Pemphigus	33.61	16.45	6	42120	99576	79602686
Primary amyloidosis	33.38	16.45	9	42117	146	79702116
Neoplasm recurrence	32.94	16.45	23	42103	4191	79698071
Cytomegalovirus hepatitis	32.22	16.45	13	42113	771	79701491
Cell-mediated cytotoxicity	32.09	16.45	7	42119	43	79702219
Haemophagocytic lymphohistiocytosis	31.99	16.45	48	42078	21789	79680473
JC polyomavirus test positive	31.88	16.45	16	42110	1586	79700676
Wheezing	31.70	16.45	11	42115	116653	79585609
Abdominal lymphadenopathy	31.58	16.45	15	42111	1319	79700943
Dyspnoea	31.25	16.45	296	41830	856729	78845533
Stress	31.15	16.45	3	42123	79609	79622653
Hospitalisation	31.11	16.45	6	42120	94230	79608032
B-cell lymphoma	31.09	16.45	26	42100	6189	79696073
Splenomegaly	30.95	16.45	46	42080	20708	79681554
Neutropenic infection	30.84	16.45	18	42108	2409	79699853
Ototoxicity	30.69	16.45	20	42106	3254	79699008
Pneumonia escherichia	30.49	16.45	13	42113	887	79701375
Blood disorder	30.26	16.45	29	42097	8244	79694018
Injury	30.12	16.45	3	42123	77493	79624769
Venoocclusive liver disease	29.99	16.45	34	42092	11737	79690525
Metastases to muscle	29.82	16.45	10	42116	350	79701912
Splenic marginal zone lymphoma	29.64	16.45	7	42119	64	79702198
Fungal infection	29.53	16.45	67	42059	41681	79660581
Disease recurrence	29.23	16.45	69	42057	44040	79658222
Enterococcal sepsis	28.91	16.45	18	42108	2708	79699554
Vision blurred	28.75	16.45	10	42116	105888	79596374
Metastases to retroperitoneum	28.69	16.45	10	42116	394	79701868
Cerebral toxoplasmosis	28.65	16.45	17	42109	2345	79699917
Back pain	28.63	16.45	75	42051	304105	79398157
Coma	28.21	16.45	9	42117	100640	79601622
Urethral obstruction	28.12	16.45	9	42117	271	79701991
Hypoaesthesia	28.06	16.45	32	42094	179320	79522942
Mantle cell lymphoma	28.00	16.45	14	42112	1377	79700885
Pneumonia fungal	27.92	16.45	32	42094	11178	79691084
Agitation	27.80	16.45	9	42117	99706	79602556
Haemolysis	27.66	16.45	34	42092	12778	79689484
Blood immunoglobulin G decreased	27.57	16.45	19	42107	3390	79698872
Cytomegalovirus syndrome	27.48	16.45	9	42117	292	79701970
Colitis	27.24	16.45	93	42033	73214	79629048
Nasal congestion	27.20	16.45	4	42122	76548	79625714
Obliterative bronchiolitis	27.17	16.45	18	42108	3010	79699252
Sleep disorder	27.15	16.45	6	42120	85671	79616591
Suicidal ideation	27.10	16.45	4	42122	76336	79625926
Leukaemia cutis	26.57	16.45	8	42118	196	79702066
Aspergillus infection	26.49	16.45	41	42085	19120	79683142
Memory impairment	26.38	16.45	13	42113	111721	79590541
Helicobacter infection	26.31	16.45	3	42123	69701	79632561
Cerebrovascular accident	26.20	16.45	26	42100	155266	79546996
Fungal oesophagitis	26.15	16.45	12	42114	976	79701286
Bradycardia	26.13	16.45	20	42106	135537	79566725
Medication error	25.80	16.45	3	42123	68639	79633623
Polyneuropathy	25.77	16.45	46	42080	24105	79678157
Loss of personal independence in daily activities	25.67	16.45	11	42115	102569	79599693
Oedema peripheral	25.45	16.45	60	42066	252228	79450034
Adenocarcinoma	25.34	16.45	19	42107	3867	79698395
Blister	25.18	16.45	16	42110	119460	79582802
Psoriasis	25.12	16.45	8	42118	89579	79612683
Coronavirus infection	25.03	16.45	25	42101	7472	79694790
Metastases to bone marrow	24.99	16.45	11	42115	811	79701451
International normalised ratio increased	24.79	16.45	7	42119	84714	79617548
Duodenal ulcer perforation	24.62	16.45	3	42123	66208	79636054
Metastases to meninges	24.36	16.45	18	42108	3583	79698679
Metastases to spleen	24.15	16.45	10	42116	634	79701628
Musculoskeletal pain	24.03	16.45	12	42114	102342	79599920
Therapy responder	23.89	16.45	9	42117	444	79701818
Plasma cell myeloma refractory	23.74	16.45	10	42116	662	79701600
Cytomegalovirus gastritis	23.66	16.45	9	42117	456	79701806
Candida pneumonia	23.61	16.45	10	42116	671	79701591
Mucosal inflammation	23.11	16.45	90	42036	75490	79626772
Pneumocystis jirovecii infection	23.10	16.45	16	42110	2878	79699384
Leukaemic lymphoma	23.01	16.45	6	42120	85	79702177
Skin toxicity	22.87	16.45	25	42101	8289	79693973
Impaired healing	22.58	16.45	9	42117	87646	79614616
Haematochezia	22.58	16.45	9	42117	87636	79614626
Campylobacter gastroenteritis	22.47	16.45	12	42114	1353	79700909
Neutrophil count abnormal	22.46	16.45	17	42109	3509	79698753
Nephrogenic diabetes insipidus	22.40	16.45	14	42112	2120	79700142
Candida infection	22.37	16.45	57	42069	38157	79664105
Gastrointestinal disorder	22.34	16.45	19	42107	122186	79580076
Cardio-respiratory arrest	22.23	16.45	15	42111	108495	79593767
Alopecia scarring	22.16	16.45	6	42120	99	79702163
Heart rate decreased	22.13	16.45	5	42121	70311	79631951
Blood glucose increased	22.11	16.45	17	42109	114958	79587304
Marginal zone lymphoma recurrent	22.11	16.45	5	42121	37	79702225
Acute kidney injury	22.03	16.45	391	41735	519013	79183249
Sphingomonas paucimobilis infection	21.88	16.45	6	42120	104	79702158
Tumour flare	21.72	16.45	11	42115	1112	79701150
Hyponatraemia	21.59	16.45	38	42088	177810	79524452
Radiation injury	21.56	16.45	10	42116	833	79701429
Myalgia	21.35	16.45	41	42085	185600	79516662
Mucosal erosion	21.34	16.45	14	42112	2304	79699958
Hypoglossal nerve paresis	21.12	16.45	6	42120	119	79702143
Chronic lymphocytic leukaemia refractory	21.08	16.45	6	42120	120	79702142
Acute febrile neutrophilic dermatosis	21.05	16.45	17	42109	3855	79698407
Blood pressure decreased	20.97	16.45	106	42020	99360	79602902
Klebsiella infection	20.84	16.45	33	42093	15687	79686575
Schistocytosis	20.77	16.45	5	42121	50	79702212
Blood pressure fluctuation	20.69	16.45	5	42121	67140	79635122
Infusion site extravasation	20.50	16.45	26	42100	10082	79692180
Stevens-Johnson syndrome	20.46	16.45	56	42070	39110	79663152
Adverse drug reaction	20.34	16.45	5	42121	66387	79635875
VIth nerve paresis	20.24	16.45	6	42120	139	79702123
B-cell small lymphocytic lymphoma recurrent	20.18	16.45	4	42122	14	79702248
Cytomegalovirus gastroenteritis	20.13	16.45	8	42118	456	79701806
Ureteric compression	20.08	16.45	7	42119	276	79701986
Fluid retention	19.99	16.45	6	42120	69803	79632459
Immunosuppression	19.99	16.45	29	42097	12774	79689488
Ilium fracture	19.98	16.45	7	42119	280	79701982
Mixed dementia	19.88	16.45	7	42119	284	79701978
Visual impairment	19.88	16.45	12	42114	92119	79610143
Myositis	19.80	16.45	36	42090	19132	79683130
B-cell lymphoma refractory	19.77	16.45	6	42120	151	79702111
Acquired C1 inhibitor deficiency	19.76	16.45	4	42122	16	79702246
Infusion site phlebitis	19.73	16.45	6	42120	152	79702110
Platelet count abnormal	19.62	16.45	18	42108	4844	79697418
Gastroenteritis sapovirus	19.55	16.45	6	42120	157	79702105
Cytokine storm	19.51	16.45	10	42116	1036	79701226
Post-acute COVID-19 syndrome	19.32	16.45	8	42118	507	79701755
Secondary immunodeficiency	19.30	16.45	15	42111	3219	79699043
Nocardiosis	19.07	16.45	19	42107	5660	79696602
Cardiomyopathy	19.05	16.45	45	42081	28729	79673533
Amnesia	18.84	16.45	5	42121	63052	79639210
General physical health deterioration	18.71	16.45	225	41901	275013	79427249
Cryoglobulinaemia	18.60	16.45	9	42117	824	79701438
Venoocclusive disease	18.59	16.45	17	42109	4556	79697706
Heart rate increased	18.38	16.45	22	42104	120702	79581560
Urticaria papular	18.37	16.45	6	42120	193	79702069
Neutrophil Pelger-Huet anomaly present	18.30	16.45	7	42119	360	79701902
Dry mouth	18.26	16.45	12	42114	88007	79614255
Type IV hypersensitivity reaction	18.23	16.45	16	42110	4065	79698197
Chest discomfort	18.15	16.45	28	42098	138016	79564246
Pseudomembranous colitis	18.09	16.45	18	42108	5356	79696906
Fear of injection	18.05	16.45	21	42105	7453	79694809
Treatment noncompliance	17.96	16.45	3	42123	52265	79649997
Varicella zoster oesophagitis	17.88	16.45	4	42122	28	79702234
Rectal haemorrhage	17.83	16.45	9	42117	76291	79625971
Coagulation factor V level decreased	17.76	16.45	8	42118	623	79701639
B-cell aplasia	17.75	16.45	6	42120	215	79702047
Loss of consciousness	17.69	16.45	39	42087	167904	79534358
Adenocarcinoma of colon	17.62	16.45	18	42108	5523	79696739
Lymphoplasmacytoid lymphoma/immunocytoma refractory	17.56	16.45	3	42123	3	79702259
Hyperthermia	17.53	16.45	33	42093	18004	79684258
Metabolic acidosis	17.46	16.45	11	42115	82518	79619744
Oral disorder	17.44	16.45	24	42102	10071	79692191
Rosai-Dorfman syndrome	17.41	16.45	4	42122	32	79702230
Fat tissue increased	17.39	16.45	9	42117	951	79701311
Epistaxis	17.32	16.45	20	42106	111495	79590767
Varicella zoster gastritis	17.31	16.45	4	42122	33	79702229
Non-small cell lung cancer	17.28	16.45	19	42107	6341	79695921
Abdominal distension	16.98	16.45	23	42103	119627	79582635
Borrelia infection	16.87	16.45	6	42120	251	79702011
Wrong technique in product usage process	16.83	16.45	9	42117	73866	79628396
Multiple organ dysfunction syndrome	16.81	16.45	115	42011	120131	79582131
Renal failure	16.73	16.45	171	41955	200797	79501465
Hepatitis B e antigen positive	16.71	16.45	4	42122	39	79702223
Blood creatine phosphokinase increased	16.67	16.45	7	42119	66083	79636179
Cystitis viral	16.67	16.45	8	42118	720	79701542
Chronic lymphocytic leukaemia transformation	16.67	16.45	6	42120	260	79702002
Bacterial infection	16.62	16.45	45	42081	31235	79671027
Hepatitis viral	16.57	16.45	9	42117	1049	79701213
Vomiting	16.50	16.45	250	41876	665578	79036684

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01AA09	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS ALKYLATING AGENTS Nitrogen mustard analogues
FDA MoA	N0000000236	Alkylating Activity
FDA EPC	N0000175558	Alkylating Drug
MeSH PA	D000477	Alkylating Agents
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D018906	Antineoplastic Agents, Alkylating
MeSH PA	D009676	Noxae

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

Disease	Relation	SNOMED_ID	DOID
Chronic lymphoid leukemia, disease	indication	92814006
Follicular non-Hodgkin's lymphoma	indication	308121000
Treatment prior to tumor-specific T-cell infusion therapy	indication
Indolent B-Cell Lymphoma	indication
Diffuse large B-cell lymphoma refractory	indication
Mantle cell lymphoma	off-label use	443487006
Fluid volume disorder	contraindication	1860003
Hyperkalemia	contraindication	14140009
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Acute infectious disease	contraindication	63171007
Kidney disease	contraindication	90708001	DOID:557
Disease of liver	contraindication	235856003	DOID:409
Anemia	contraindication	271737000	DOID:2355
Pregnancy, function	contraindication	289908002
Thrombocytopenic disorder	contraindication	302215000	DOID:1588
Neutropenic disorder	contraindication	303011007	DOID:1227
Bone marrow depression	contraindication	307762000
Breastfeeding (mother)	contraindication	413712001
Smokes tobacco daily	contraindication	449868002
Chemotherapy-Induced Hyperuricemia	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	4.61	acidic
pKa2	6.18	Basic
pKa3	2.83	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
100MG/VIAL	TREANDA	CEPHALON	N022249	March 20, 2008	RX	POWDER	IV (INFUSION)	8791270	Jan. 12, 2026	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
180MG/2ML (90MG/ML)	TREANDA	CEPHALON	N022249	Sept. 13, 2013	DISCN	SOLUTION	IV (INFUSION)	8791270	Jan. 12, 2026	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
25MG/VIAL	TREANDA	CEPHALON	N022249	May 1, 2009	RX	POWDER	IV (INFUSION)	8791270	Jan. 12, 2026	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
45MG/0.5ML (90MG/ML)	TREANDA	CEPHALON	N022249	Sept. 13, 2013	DISCN	SOLUTION	IV (INFUSION)	8791270	Jan. 12, 2026	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	8791270	Jan. 12, 2026	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	8791270	Jan. 12, 2026	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	8791270	Jan. 12, 2026	FOR USE IN TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR NON-HODGKINS LYMPHOMA
100MG/VIAL	TREANDA	CEPHALON	N022249	March 20, 2008	RX	POWDER	IV (INFUSION)	8445524	March 26, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
100MG/VIAL	TREANDA	CEPHALON	N022249	March 20, 2008	RX	POWDER	IV (INFUSION)	8669279	March 26, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
100MG/VIAL	TREANDA	CEPHALON	N022249	March 20, 2008	RX	POWDER	IV (INFUSION)	8883836	March 26, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
100MG/VIAL	TREANDA	CEPHALON	N022249	March 20, 2008	RX	POWDER	IV (INFUSION)	9533955	March 26, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
100MG/VIAL	TREANDA	CEPHALON	N022249	March 20, 2008	RX	POWDER	IV (INFUSION)	9533955	March 26, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
25MG/VIAL	TREANDA	CEPHALON	N022249	May 1, 2009	RX	POWDER	IV (INFUSION)	8445524	March 26, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
25MG/VIAL	TREANDA	CEPHALON	N022249	May 1, 2009	RX	POWDER	IV (INFUSION)	8669279	March 26, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
25MG/VIAL	TREANDA	CEPHALON	N022249	May 1, 2009	RX	POWDER	IV (INFUSION)	8883836	March 26, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
25MG/VIAL	TREANDA	CEPHALON	N022249	May 1, 2009	RX	POWDER	IV (INFUSION)	9533955	March 26, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
25MG/VIAL	TREANDA	CEPHALON	N022249	May 1, 2009	RX	POWDER	IV (INFUSION)	9533955	March 26, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
180MG/2ML (90MG/ML)	TREANDA	CEPHALON	N022249	Sept. 13, 2013	DISCN	SOLUTION	IV (INFUSION)	8344006	Sept. 23, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
45MG/0.5ML (90MG/ML)	TREANDA	CEPHALON	N022249	Sept. 13, 2013	DISCN	SOLUTION	IV (INFUSION)	8344006	Sept. 23, 2029	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	11103483	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	11103483	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	9572796	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	9572796	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	9572797	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	9572797	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	11103483	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	11103483	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9572796	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9572796	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9572797	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9572797	Jan. 28, 2031	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	8609707	Aug. 11, 2031	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BELRAPZO	EAGLE PHARMS	N205580	May 15, 2018	RX	SOLUTION	IV (INFUSION)	8609707	Aug. 11, 2031	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	8609707	Aug. 11, 2031	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	10052385	March 15, 2033	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	10052385	March 15, 2033	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9000021	March 15, 2033	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9034908	March 15, 2033	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9144568	March 15, 2033	FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-HODGKINS LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9572887	March 15, 2033	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9572887	March 15, 2033	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9579384	March 15, 2033	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9579384	March 15, 2033	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9597397	March 15, 2033	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9597397	March 15, 2033	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9597398	March 15, 2033	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9597399	March 15, 2033	FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
100MG/4ML (25MG/ML)	BENDEKA	EAGLE PHARMS	N208194	Dec. 7, 2015	RX	SOLUTION	IV (INFUSION)	9597399	March 15, 2033	FOR THE TREATMENT OF PATIENTS WITH INDOLENT B-CELL NON-HODGKIN LYMPHOMA

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
100MG/VIAL	BENDAMUSTINE HYDROCHLORIDE	ACCORD HLTHCARE	A205574	Dec. 7, 2022	RX	POWDER	IV (INFUSION)	June 5, 2023	PATENT CHALLENGE
25MG/VIAL	BENDAMUSTINE HYDROCHLORIDE	ACCORD HLTHCARE	A205574	Dec. 7, 2022	RX	POWDER	IV (INFUSION)	June 5, 2023	PATENT CHALLENGE

Bioactivity Summary:

Target	Class	Pharos	UniProt	Type	Activity value (-log[M])	Bioact source
Histone deacetylase 5	Enzyme	Q9UQL6	HDAC5_HUMAN	IC50	8	CHEMBL
Histone deacetylase 2	Enzyme	Q92769	HDAC2_HUMAN	IC50	8.05	CHEMBL
Histone deacetylase 1	Enzyme	Q13547	HDAC1_HUMAN	IC50	7.77	CHEMBL
Histone deacetylase 3	Enzyme	O15379	HDAC3_HUMAN	IC50	7.60	CHEMBL
Histone deacetylase 6	Enzyme	Q9UBN7	HDAC6_HUMAN	IC50	8.22	CHEMBL
Histone deacetylase 8	Enzyme	Q9BY41	HDAC8_HUMAN	IC50	6.97	CHEMBL
Histone deacetylase 4	Enzyme	P56524	HDAC4_HUMAN	IC50	8	CHEMBL
Histone deacetylase 10	Enzyme	Q969S8	HDA10_HUMAN	IC50	7.14	CHEMBL

External reference:

ID	Source
4027339	VUID
N0000179513	NUI
D07085	KEGG_DRUG
3543-75-7	SECONDARY_CAS_RN
1114693	RXNORM
C0525079	UMLSCUI
CHEBI:135515	CHEBI
CHEMBL487253	ChEMBL_ID
DB06769	DRUGBANK_ID
CHEMBL1201734	ChEMBL_ID
D000069461	MESH_DESCRIPTOR_UI
65628	PUBCHEM_CID
7478	IUPHAR_LIGAND_ID
5228	INN_ID
9266D9P3PQ	UNII
132929	MMSL
241056	MMSL
25220	MMSL
275320	MMSL
d07121	MMSL
427812009	SNOMEDCT_US
428012008	SNOMEDCT_US
430082006	SNOMEDCT_US
4027339	VANDF
006925	NDDF
006926	NDDF

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
BENDAMUSTINE HYDROCHLORIDE	HUMAN PRESCRIPTION DRUG LABEL	1	10019-079	INJECTION	100 mg	INTRAVENOUS	NDA	26 sections
bendamustine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	16729-250	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	25 mg	INTRAVENOUS	ANDA	26 sections
bendamustine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	16729-251	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	26 sections
BELRAPZO	HUMAN PRESCRIPTION DRUG LABEL	1	42367-521	INJECTION	100 mg	INTRAVENOUS	NDA	29 sections
BELRAPZO	HUMAN PRESCRIPTION DRUG LABEL	1	42367-521	INJECTION	100 mg	INTRAVENOUS	NDA	29 sections
BENDAMUSTINE HYDROCHLORIDE	Human Prescription Drug Label	1	55150-391	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	25 mg	INTRAVENOUS	ANDA	27 sections
BENDAMUSTINE HYDROCHLORIDE	Human Prescription Drug Label	1	55150-392	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	27 sections
Bendamustine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	60505-6095	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	25 mg	INTRAVENOUS	ANDA	24 sections
Bendamustine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	60505-6096	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	24 sections
Bendamustine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	60505-6228	INJECTION, SOLUTION	25 mg	INTRAVENOUS	NDA	24 sections
Bendeka	HUMAN PRESCRIPTION DRUG LABEL	1	63459-348	INJECTION, SOLUTION	25 mg	INTRAVENOUS	NDA	32 sections
Bendeka	HUMAN PRESCRIPTION DRUG LABEL	1	63459-348	INJECTION, SOLUTION	25 mg	INTRAVENOUS	NDA	32 sections
TREANDA	HUMAN PRESCRIPTION DRUG LABEL	1	63459-390	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	25 mg	INTRAVENOUS	NDA	27 sections
TREANDA	HUMAN PRESCRIPTION DRUG LABEL	1	63459-390	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	25 mg	INTRAVENOUS	NDA	27 sections
TREANDA	HUMAN PRESCRIPTION DRUG LABEL	1	63459-391	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	NDA	27 sections
TREANDA	HUMAN PRESCRIPTION DRUG LABEL	1	63459-391	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	NDA	27 sections
TREANDA	HUMAN PRESCRIPTION DRUG LABEL	1	63459-395	INJECTION, SOLUTION, CONCENTRATE	45 mg	INTRAVENOUS	NDA	27 sections
TREANDA	HUMAN PRESCRIPTION DRUG LABEL	1	63459-395	INJECTION, SOLUTION, CONCENTRATE	45 mg	INTRAVENOUS	NDA	27 sections
TREANDA	HUMAN PRESCRIPTION DRUG LABEL	1	63459-396	INJECTION, SOLUTION, CONCENTRATE	180 mg	INTRAVENOUS	NDA	27 sections
TREANDA	HUMAN PRESCRIPTION DRUG LABEL	1	63459-396	INJECTION, SOLUTION, CONCENTRATE	180 mg	INTRAVENOUS	NDA	27 sections
bendamustine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	68001-571	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	25 mg	INTRAVENOUS	ANDA	26 sections
bendamustine hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	68001-572	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	26 sections
VIVIMUSTA	Human Prescription Drug Label	1	71225-120	INJECTION	25 mg	INTRAVENOUS	NDA	25 sections
Bendamustine	HUMAN PRESCRIPTION DRUG LABEL	1	71288-102	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	25 mg	INTRAVENOUS	ANDA	28 sections
Bendamustine	HUMAN PRESCRIPTION DRUG LABEL	1	71288-103	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	100 mg	INTRAVENOUS	ANDA	28 sections