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

Stem definition	Drug id	CAS RN
proteasome inhibitors	391	179324-69-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: LDP-341 PS-341 bortezomib velcade radiciol	A pyrazine and boronic acid derivative that functions as a reversible PROTEASOME INHIBITOR. It is used as an ANTINEOPLASTIC AGENT in the treatment of MULTIPLE MYELOMA and MANTLE CELL LYMPHOMA. Molecular weight: 384.24 Formula: C19H25BN4O4 CLOGP: 0.80 LIPINSKI: 0 HAC: 8 HDO: 4 TPSA: 124.44 ALOGS: -3.86 ROTB: 9 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

LDP-341
PS-341
bortezomib
velcade
radiciol

A pyrazine and boronic acid derivative that functions as a reversible PROTEASOME INHIBITOR. It is used as an ANTINEOPLASTIC AGENT in the treatment of MULTIPLE MYELOMA and MANTLE CELL LYMPHOMA.

Molecular weight: 384.24
Formula: C19H25BN4O4
CLOGP: 0.80
LIPINSKI: 0
HAC: 8
HDO: 4
TPSA: 124.44
ALOGS: -3.86
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
S (Water solubility)	3.30 mg/mL	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.08 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution)	10 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	19 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.17 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	18 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company
Nov. 14, 2019	EMA	FRESENIUS KABI DEUTSCHLAND GMBH
Aug. 22, 2019	PMDA	Janssen Pharmaceutical K.K.
May 13, 2003	FDA	MILLENNIUM PHARMS

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
Plasma cell myeloma	6090.51	13.42	2199	61534	44447	56183887
Neuropathy peripheral	2397.94	13.42	1474	62259	101419	56126915
Thrombocytopenia	594.84	13.42	751	62982	135473	56092861
Plasma cell myeloma recurrent	572.45	13.42	185	63548	2589	56225745
Platelet count decreased	419.46	13.42	558	63175	105825	56122509
Rheumatoid arthritis	407.32	13.42	5	63728	382599	55845735
Diarrhoea	388.15	13.42	1585	62148	636922	55591412
Disease progression	377.27	13.42	527	63206	104646	56123688
Plasmacytoma	337.96	13.42	121	63612	2345	56225989
Polyneuropathy	297.58	13.42	185	63548	12865	56215469
Constipation	265.52	13.42	656	63077	201287	56027047
Pneumonia	264.16	13.42	1033	62700	406065	55822269
Neutropenia	263.29	13.42	564	63169	157603	56070731
Plasma cell leukaemia	236.36	13.42	77	63656	1106	56227228
White blood cell count decreased	219.69	13.42	458	63275	125532	56102802
Pancytopenia	192.89	13.42	354	63379	88361	56139973
Contraindicated product administered	191.39	13.42	4	63729	186282	56042052
Maternal exposure during pregnancy	183.99	13.42	7	63726	189546	56038788
Arthralgia	173.26	13.42	188	63545	501481	55726853
Drug hypersensitivity	168.82	13.42	51	63682	275154	55953180
Full blood count decreased	158.27	13.42	162	63571	23187	56205147
Headache	153.75	13.42	248	63485	558796	55669538
Sepsis	151.57	13.42	423	63310	139417	56088917
Glossodynia	150.12	13.42	5	63728	152453	56075881
Tumour lysis syndrome	145.36	13.42	98	63635	7825	56220509
Exposure during pregnancy	139.72	13.42	3	63730	136339	56091995
Pain	138.86	13.42	345	63388	662839	55565495
Anaemia	128.56	13.42	621	63112	266890	55961444
Posterior reversible encephalopathy syndrome	125.34	13.42	120	63613	15840	56212494
Amyloidosis	123.88	13.42	47	63686	1078	56227256
Drug ineffective	123.20	13.42	580	63153	918409	55309925
Therapeutic product effect decreased	120.29	13.42	23	63710	169429	56058905
Unevaluable event	120.02	13.42	203	63530	47484	56180850
Febrile neutropenia	118.00	13.42	323	63410	105222	56123112
Laboratory test abnormal	116.82	13.42	142	63591	24553	56203781
Cardiac amyloidosis	115.88	13.42	41	63692	766	56227568
Peripheral sensory neuropathy	115.70	13.42	81	63652	6875	56221459
Swelling	113.89	13.42	65	63668	239706	55988628
Deep vein thrombosis	112.67	13.42	261	63472	76716	56151618
Alopecia	111.40	13.42	101	63632	293357	55934977
Arthropathy	110.87	13.42	44	63689	200231	56028103
Dehydration	108.99	13.42	411	63322	158414	56069920
Neutrophil count decreased	103.44	13.42	195	63538	49627	56178707
Chalazion	103.27	13.42	31	63702	334	56228000
Wound	102.50	13.42	17	63716	138787	56089547
Abdominal discomfort	102.20	13.42	98	63635	277176	55951158
Primary amyloidosis	101.24	13.42	22	63711	50	56228284
Discomfort	101.11	13.42	19	63714	141742	56086592
Pericarditis	99.29	13.42	6	63727	108917	56119417
Plasma cell myeloma refractory	98.46	13.42	21	63712	42	56228292
Condition aggravated	98.39	13.42	149	63584	344749	55883585
Off label use	97.08	13.42	1008	62725	555172	55673162
Septic shock	96.51	13.42	213	63520	60622	56167712
Musculoskeletal stiffness	93.61	13.42	30	63703	155977	56072357
Joint swelling	90.81	13.42	117	63616	289683	55938651
Treatment failure	90.16	13.42	40	63693	170352	56057982
Renal failure	89.49	13.42	302	63431	110198	56118136
Cytopenia	89.49	13.42	80	63653	9675	56218659
Product use in unapproved indication	88.91	13.42	355	63378	140467	56087867
Hordeolum	82.66	13.42	46	63687	2600	56225734
Light chain analysis increased	81.54	13.42	35	63698	1114	56227220
Herpes zoster	80.59	13.42	228	63505	75661	56152673
Therapy partial responder	71.72	13.42	64	63669	7721	56220613
Overdose	71.69	13.42	16	63717	105814	56122520
Hyperviscosity syndrome	68.56	13.42	19	63714	150	56228184
Myelodysplastic syndrome	67.50	13.42	88	63645	16318	56212016
Drug interaction	67.42	13.42	83	63650	209672	56018662
Hypersensitivity	67.21	13.42	117	63616	256291	55972043
Mobility decreased	66.98	13.42	15	63718	98976	56129358
Monoclonal immunoglobulin present	66.27	13.42	27	63706	752	56227582
Thrombosis	65.50	13.42	181	63552	59246	56169088
Orthostatic hypotension	65.28	13.42	127	63606	33072	56195262
Atrial fibrillation	65.11	13.42	270	63463	108627	56119707
Helicobacter infection	63.96	13.42	5	63728	73263	56155071
Injection site pain	62.72	13.42	27	63706	117091	56111243
Protein total increased	61.95	13.42	38	63695	2577	56225757
Hepatic enzyme increased	61.44	13.42	62	63671	171322	56057012
Haemoglobin decreased	60.43	13.42	306	63427	133831	56094503
Stem cell transplant	59.12	13.42	32	63701	1712	56226622
Blister	55.35	13.42	27	63706	108860	56119474
Autonomic neuropathy	54.60	13.42	26	63707	1059	56227275
Cytomegalovirus infection reactivation	52.86	13.42	37	63696	3139	56225195
Coombs indirect test positive	52.82	13.42	12	63721	36	56228298
Pathological fracture	52.77	13.42	55	63678	8034	56220300
Fibromyalgia	52.21	13.42	4	63729	59599	56168735
Hepatitis B reactivation	51.82	13.42	33	63700	2391	56225943
Haematotoxicity	51.14	13.42	55	63678	8328	56220006
Folliculitis	50.18	13.42	3	63730	54976	56173358
Ageusia	48.47	13.42	65	63668	12386	56215948
Hypocalcaemia	48.22	13.42	103	63630	28657	56199677
Wrong technique in product usage process	48.00	13.42	5	63728	58163	56170171
Irritable bowel syndrome	47.07	13.42	10	63723	68448	56159886
Cytomegalovirus infection	47.02	13.42	81	63652	19215	56209119
Malignant neoplasm progression	45.98	13.42	185	63548	73402	56154932
Ileus paralytic	45.78	13.42	38	63695	4157	56224177
Suicide attempt	45.17	13.42	6	63727	57830	56170504
Hypercalcaemia	44.92	13.42	93	63640	25318	56203016
Bone marrow failure	44.79	13.42	99	63634	28187	56200147
Pneumonia fungal	44.63	13.42	40	63693	4853	56223481
Peripheral sensorimotor neuropathy	44.21	13.42	24	63709	1291	56227043
Bone pain	44.03	13.42	141	63592	50044	56178290
Migraine	43.39	13.42	22	63711	86775	56141559
Pyrexia	43.02	13.42	689	63044	418084	55810250
Endocarditis bacterial	40.99	13.42	18	63715	606	56227728
Morganella infection	40.23	13.42	18	63715	634	56227700
Syncope	40.04	13.42	234	63499	107965	56120369
Mesenteric abscess	39.90	13.42	11	63722	85	56228249
Cardiac failure	39.59	13.42	191	63542	81902	56146432
Inappropriate antidiuretic hormone secretion	39.25	13.42	62	63671	13694	56214640
Electrolyte imbalance	39.18	13.42	72	63661	17961	56210373
Blood pressure increased	39.14	13.42	65	63668	145111	56083223
Oedema peripheral	38.47	13.42	328	63405	170926	56057408
Plasmablastic lymphoma	38.32	13.42	14	63719	288	56228046
Peripheral motor neuropathy	37.97	13.42	23	63710	1525	56226809
Osteolysis	37.90	13.42	28	63705	2585	56225749
Large intestinal ulcer perforation	37.51	13.42	10	63723	67	56228267
Anxiety	37.50	13.42	104	63629	193068	56035266
Therapy non-responder	37.33	13.42	153	63580	61202	56167132
Body dysmorphic disorder	37.19	13.42	14	63719	314	56228020
Blood cholesterol increased	36.87	13.42	18	63715	72561	56155773
Pleural effusion	36.38	13.42	192	63541	85288	56143046
Osteoarthritis	36.34	13.42	23	63710	80273	56148061
Disturbance in social behaviour	36.25	13.42	29	63704	3012	56225322
Colitis	36.25	13.42	117	63616	41694	56186640
Blood potassium decreased	36.08	13.42	111	63622	38561	56189773
Asthenia	35.82	13.42	566	63167	342407	55885927
Hypertension	35.54	13.42	149	63584	244129	55984205
Depression	34.94	13.42	97	63636	180020	56048314
Arthritis	34.77	13.42	37	63696	99815	56128519
Nasal abscess	34.70	13.42	11	63722	144	56228190
Osteonecrosis of jaw	34.20	13.42	99	63634	33259	56195075
Death	33.99	13.42	559	63174	340867	55887467
Impaired healing	33.95	13.42	29	63704	86812	56141522
Taste disorder	33.73	13.42	48	63685	9667	56218667
Crossmatch incompatible	33.64	13.42	8	63725	31	56228303
Drug intolerance	32.93	13.42	171	63562	264647	55963687
Hip arthroplasty	32.70	13.42	3	63730	38620	56189714
Drug abuse	32.52	13.42	18	63715	67592	56160742
Gastrointestinal fungal infection	32.44	13.42	12	63721	256	56228078
Inappropriate schedule of product administration	32.41	13.42	28	63705	83359	56144975
Fatigue	32.18	13.42	1141	62592	787411	55440923
Blood pressure fluctuation	31.97	13.42	4	63729	40356	56187978
Mantle cell lymphoma	31.73	13.42	15	63718	601	56227733
Hypoaesthesia	31.24	13.42	270	63463	141221	56087113
Hypokalaemia	30.99	13.42	198	63535	94239	56134095
Loss of personal independence in daily activities	30.81	13.42	28	63705	81341	56146993
Cerebellar haemangioma	30.77	13.42	9	63724	88	56228246
Renal amyloidosis	30.67	13.42	10	63723	144	56228190
Acute lymphocytic leukaemia	30.24	13.42	25	63708	2719	56225615
Hypersensitivity myocarditis	30.22	13.42	8	63725	52	56228282
Cardiac failure congestive	30.08	13.42	186	63547	87534	56140800
Joint stiffness	29.34	13.42	3	63730	35422	56192912
Target skin lesion	29.33	13.42	9	63724	105	56228229
Acute kidney injury	29.28	13.42	408	63325	240355	55987979
Blood stem cell harvest failure	29.23	13.42	8	63725	60	56228274
Large intestine perforation	29.06	13.42	40	63693	7811	56220523
Acute myeloid leukaemia	28.69	13.42	61	63672	16911	56211423
Injury	28.69	13.42	16	63717	59835	56168499
Clostridium bacteraemia	28.45	13.42	10	63723	183	56228151
Suicidal ideation	28.31	13.42	15	63718	57727	56170607
Neurotoxicity	28.14	13.42	58	63675	15737	56212597
Guillain-Barre syndrome	28.00	13.42	27	63706	3593	56224741
Blood pressure systolic increased	28.00	13.42	6	63727	40830	56187504
Ill-defined disorder	27.90	13.42	22	63711	68521	56159813
Renal impairment	27.58	13.42	171	63562	80542	56147792
Refractory cytopenia with multilineage dysplasia	27.02	13.42	9	63724	139	56228195
Spinal cord compression	26.99	13.42	27	63706	3757	56224577
Bone lesion	26.94	13.42	32	63701	5398	56222936
Blood lactate dehydrogenase increased	26.88	13.42	67	63666	20608	56207726
Meningitis listeria	26.75	13.42	13	63720	554	56227780
Sinus polyp	26.45	13.42	11	63722	323	56228011
Pseudomonal sepsis	26.38	13.42	21	63712	2165	56226169
Adenoviral haemorrhagic cystitis	26.12	13.42	9	63724	155	56228179
Bronchiolitis	26.09	13.42	22	63711	2460	56225874
Hyperproteinaemia	26.02	13.42	8	63725	94	56228240
Wheezing	25.90	13.42	28	63705	74998	56153336
Toxic skin eruption	25.66	13.42	47	63686	11692	56216642
Heart rate increased	25.63	13.42	34	63699	83239	56145095
Anaphylactic reaction	25.21	13.42	18	63715	58977	56169357
Liver injury	25.16	13.42	8	63725	41840	56186494
Stress	25.14	13.42	18	63715	58892	56169442
Ileus	24.76	13.42	51	63682	13831	56214503
Oncologic complication	24.68	13.42	9	63724	184	56228150
Pregnancy	24.47	13.42	4	63729	33029	56195305
Nasal congestion	24.35	13.42	17	63716	56353	56171981
Graft versus host disease	24.28	13.42	34	63699	6747	56221587
Transplant	24.27	13.42	13	63720	681	56227653
Hypophosphataemia	23.99	13.42	41	63692	9661	56218673
Malaise	23.89	13.42	284	63449	367576	55860758
COVID-19	23.78	13.42	156	63577	74902	56153432
Sinusitis	23.76	13.42	129	63604	197452	56030882
Joint ankylosis	23.43	13.42	14	63719	905	56227429
Flushing	23.28	13.42	27	63706	70073	56158261
Compression fracture	22.90	13.42	31	63702	5958	56222376
Contusion	22.84	13.42	72	63661	128358	56099976
Sleep disorder	22.53	13.42	26	63707	67637	56160697
Pneumonia pneumococcal	22.38	13.42	18	63715	1884	56226450
Salmonella sepsis	22.31	13.42	9	63724	244	56228090
Intraductal proliferative breast lesion	22.31	13.42	21	63712	2712	56225622
Gait disturbance	22.28	13.42	102	63631	163219	56065115
N-terminal prohormone brain natriuretic peptide decreased	22.27	13.42	5	63728	14	56228320
Thrombotic microangiopathy	22.27	13.42	39	63694	9372	56218962
Palpitations	22.18	13.42	50	63683	99622	56128712
Failure to thrive	22.13	13.42	32	63701	6538	56221796
Neuralgia	22.09	13.42	68	63665	23627	56204707
Injection site swelling	21.84	13.42	11	63722	43567	56184767
Type 2 diabetes mellitus	21.79	13.42	13	63720	46849	56181485
Hypothyroidism	21.76	13.42	8	63725	38188	56190146
Bacteraemia	21.75	13.42	52	63681	15579	56212755
Peritonitis viral	21.58	13.42	6	63727	48	56228286
Varicella zoster virus infection	21.37	13.42	20	63713	2564	56225770
Product quality issue	21.08	13.42	5	63728	31731	56196603
Weight increased	20.99	13.42	163	63570	229540	55998794
Enterococcal sepsis	20.99	13.42	15	63718	1315	56227019
Mucosal inflammation	20.92	13.42	100	63633	42710	56185624
Blepharitis	20.81	13.42	19	63714	2361	56225973
Myalgia	20.78	13.42	78	63655	131947	56096387
Infusion related reaction	20.65	13.42	145	63588	208786	56019548
Rash	20.65	13.42	716	63017	492331	55736003
Urosepsis	20.51	13.42	53	63680	16663	56211671
Acute respiratory distress syndrome	20.51	13.42	63	63670	21863	56206471
Human chorionic gonadotropin increased	20.43	13.42	15	63718	1371	56226963
Sedation	20.36	13.42	7	63726	34847	56193487
Hypotension	20.23	13.42	397	63336	250111	55978223
Hypoalbuminaemia	20.17	13.42	40	63693	10559	56217775
Serotonin syndrome	20.09	13.42	3	63730	26487	56201847
Toxicity to various agents	19.89	13.42	361	63372	224203	56004131
Cardiotoxicity	19.81	13.42	33	63700	7617	56220717
Osteoporosis	19.60	13.42	18	63715	52034	56176300
Pulmonary embolism	19.40	13.42	196	63537	106928	56121406
Blood creatine phosphokinase increased	19.38	13.42	4	63729	27948	56200386
5q minus syndrome	19.30	13.42	8	63725	233	56228101
Rhinovirus infection	19.27	13.42	23	63710	3899	56224435
Adverse drug reaction	19.21	13.42	133	63600	64999	56163335
Spinal fracture	19.06	13.42	51	63682	16373	56211961
Tooth disorder	19.06	13.42	68	63665	25485	56202849
Mucosal erosion	18.90	13.42	14	63719	1297	56227037
Injection site bruising	18.89	13.42	10	63723	38511	56189823
VIth nerve paresis	18.89	13.42	6	63727	79	56228255
Seasonal allergy	18.73	13.42	52	63681	17056	56211278
Back pain	18.53	13.42	374	63359	236796	55991538
Pulmonary oedema	18.51	13.42	110	63623	51033	56177301
Acute myopia	18.49	13.42	6	63727	85	56228249
Plasma cells decreased	18.44	13.42	5	63728	36	56228298
Pain in extremity	18.39	13.42	232	63501	297199	55931135
Somnolence	18.39	13.42	109	63624	163304	56065030
Disease recurrence	18.23	13.42	64	63669	23796	56204538
Asthma	18.16	13.42	66	63667	112704	56115630
Full blood count increased	18.10	13.42	12	63721	931	56227403
Light chain analysis	17.87	13.42	4	63729	11	56228323
Clostridium difficile colitis	17.68	13.42	54	63679	18684	56209650
Fungal oesophagitis	17.60	13.42	10	63723	588	56227746
Sleep apnoea syndrome	17.52	13.42	4	63729	26057	56202277
Cough	17.51	13.42	199	63534	259762	55968572
Monoclonal immunoglobulin increased	17.48	13.42	6	63727	102	56228232
Paraesthesia	17.42	13.42	225	63508	130289	56098045
Lymphopenia	17.40	13.42	50	63683	16724	56211610
Foot deformity	17.39	13.42	3	63730	23822	56204512
Diarrhoea haemorrhagic	17.33	13.42	32	63701	8011	56220323
Underdose	17.32	13.42	3	63730	23754	56204580
Meningitis cryptococcal	17.27	13.42	13	63720	1234	56227100
Respiratory failure	17.25	13.42	174	63559	94888	56133446
Drug reaction with eosinophilia and systemic symptoms	17.20	13.42	74	63659	30230	56198104
Pneumonia influenzal	17.20	13.42	14	63719	1490	56226844
Hyperintensity in brain deep nuclei	17.14	13.42	4	63729	14	56228320
Therapy interrupted	17.09	13.42	4	63729	25621	56202713
Hypogammaglobulinaemia	17.01	13.42	28	63705	6398	56221936
Nocardiosis	16.92	13.42	15	63718	1793	56226541
Hypoglossal nerve paresis	16.91	13.42	6	63727	113	56228221
Inflammation	16.75	13.42	33	63700	69038	56159296
Infection reactivation	16.70	13.42	12	63721	1061	56227273
Clostridium difficile infection	16.68	13.42	68	63665	27130	56201204
Osteonecrosis	16.65	13.42	61	63672	23154	56205180
Incorrect dose administered	16.64	13.42	21	63712	52526	56175808
Myeloma cast nephropathy	16.62	13.42	6	63727	119	56228215
Pseudomyopia	16.56	13.42	5	63728	55	56228279
Spinal compression fracture	16.49	13.42	42	63691	13092	56215242
Duodenal stenosis	16.35	13.42	9	63724	498	56227836
Cardiac failure acute	16.30	13.42	33	63700	8840	56219494
Superficial spreading melanoma stage unspecified	16.17	13.42	6	63727	129	56228205
Human herpesvirus 8 infection	16.16	13.42	7	63726	228	56228106
Lower respiratory tract infection	16.07	13.42	71	63662	114723	56113611
Autoimmune retinopathy	15.83	13.42	4	63729	21	56228313
Coma	15.80	13.42	27	63706	59628	56168706
Injection site haemorrhage	15.76	13.42	3	63730	22198	56206136
Chronic graft versus host disease in skin	15.76	13.42	10	63723	720	56227614
Sensory level abnormal	15.76	13.42	6	63727	139	56228195
Hyperamylasaemia	15.72	13.42	8	63725	377	56227957
Dysarthria	15.71	13.42	13	63720	39537	56188797
Infection in an immunocompromised host	15.66	13.42	9	63724	541	56227793
Staphylococcal bacteraemia	15.59	13.42	24	63709	5185	56223149
Aggression	15.57	13.42	3	63730	22003	56206331
Performance status decreased	15.53	13.42	19	63714	3304	56225030
Drug withdrawal syndrome	15.44	13.42	5	63728	25852	56202482
Rhabdomyolysis	15.38	13.42	14	63719	40644	56187690
Myelosuppression	15.26	13.42	49	63684	17406	56210928
Joint injury	15.25	13.42	5	63728	25649	56202685
Clavicle fracture	15.20	13.42	18	63715	3027	56225307
Blood immunoglobulin A increased	15.02	13.42	8	63725	414	56227920
Pulmonary alveolar haemorrhage	14.70	13.42	21	63712	4243	56224091
Cryptococcosis	14.70	13.42	11	63722	1035	56227299
Rash pruritic	14.69	13.42	106	63627	52488	56175846
Respiratory tract infection	14.64	13.42	80	63653	35991	56192343
JC virus CSF test positive	14.61	13.42	4	63729	30	56228304
Paraproteinaemia	14.53	13.42	6	63727	173	56228161
Urticaria	14.48	13.42	100	63633	144576	56083758
Haemorrhoidal haemorrhage	14.33	13.42	20	63713	3956	56224378
Hepatitis B	14.23	13.42	19	63714	3605	56224729
Nasopharyngitis	14.16	13.42	171	63562	220788	56007546
Atelectasis	14.07	13.42	51	63682	19257	56209077
Blood magnesium decreased	13.91	13.42	37	63696	11837	56216497
Skin exfoliation	13.76	13.42	80	63653	36820	56191514
Decreased appetite	13.72	13.42	335	63398	218896	56009438
Pneumonia cytomegaloviral	13.69	13.42	14	63719	2000	56226334
Therapy cessation	13.49	13.42	7	63726	27257	56201077
Precursor B-lymphoblastic lymphoma	13.47	13.42	3	63730	8	56228326

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
Plasma cell myeloma	6273.25	13.01	2924	72306	53607	31568507
Neuropathy peripheral	2435.35	13.01	1752	73478	73897	31548217
Plasma cell myeloma recurrent	582.21	13.01	250	74980	3674	31618440
Polyneuropathy	518.91	13.01	345	74885	12677	31609437
Thrombocytopenia	447.22	13.01	1021	74209	141726	31480388
Platelet count decreased	390.99	13.01	830	74400	109605	31512509
Plasmacytoma	330.19	13.01	161	75069	3216	31618898
Disease progression	306.27	13.01	668	74562	89796	31532318
Drug interaction	275.85	13.01	77	75153	208466	31413648
Pneumonia	272.86	13.01	1535	73695	333777	31288337
Unevaluable event	223.35	13.01	317	74913	30258	31591856
Completed suicide	201.66	13.01	3	75227	91511	31530603
Drug abuse	192.84	13.01	3	75227	87755	31534359
Plasma cell leukaemia	179.60	13.01	72	75158	879	31621235
Tumour lysis syndrome	165.02	13.01	193	75037	15192	31606922
Orthostatic hypotension	161.46	13.01	240	74990	23879	31598235
Herpes zoster	138.65	13.01	262	74968	31731	31590383
Plasma cell myeloma refractory	133.79	13.01	36	75194	101	31622013
White blood cell count decreased	128.96	13.01	478	74752	86920	31535194
Amyloidosis	123.70	13.01	73	75157	2163	31619951
Diarrhoea	123.05	13.01	1326	73904	351083	31271031
Overdose	121.98	13.01	26	75204	84638	31537476
Constipation	120.92	13.01	598	74632	123393	31498721
Peripheral sensory neuropathy	118.36	13.01	107	75123	6208	31615906
Autonomic neuropathy	111.26	13.01	50	75180	823	31621291
Fatigue	109.48	13.01	1245	73985	333961	31288153
Product use issue	104.25	13.01	334	74896	56425	31565689
Deep vein thrombosis	104.02	13.01	349	74881	60387	31561727
Primary amyloidosis	96.06	13.01	29	75201	137	31621977
Neutropenia	93.25	13.01	611	74619	139753	31482361
Headache	91.89	13.01	186	75044	183466	31438648
Hypercalcaemia	91.80	13.01	138	75092	13862	31608252
Rhabdomyolysis	90.60	13.01	20	75210	63561	31558553
Light chain analysis increased	86.54	13.01	47	75183	1183	31620931
Pancytopenia	84.94	13.01	421	74809	86895	31535219
Psoriasis	84.62	13.01	7	75223	46712	31575402
Rash	83.42	13.01	786	74444	200700	31421414
Ileus paralytic	82.94	13.01	82	75148	5326	31616788
Osteonecrosis of jaw	79.20	13.01	144	75086	16927	31605187
Full blood count decreased	78.62	13.01	141	75089	16399	31605715
Thrombosis	74.25	13.01	256	74974	44895	31577219
Therapy partial responder	73.16	13.01	84	75146	6478	31615636
Product use in unapproved indication	72.82	13.01	443	74787	98728	31523386
Myelodysplastic syndrome	71.71	13.01	148	75082	19103	31603011
Off label use	70.69	13.01	1186	74044	346088	31276026
Cystitis haemorrhagic	69.86	13.01	74	75156	5215	31616899
Blood creatine phosphokinase increased	69.04	13.01	9	75221	41965	31580149
Arthralgia	67.77	13.01	163	75067	151261	31470853
Cytopenia	67.21	13.01	105	75125	10905	31611209
Inappropriate schedule of product administration	66.58	13.01	19	75211	50804	31571310
Hypertension	62.94	13.01	131	75099	127969	31494145
Depression	62.56	13.01	74	75156	90741	31531373
B precursor type acute leukaemia	61.01	13.01	23	75207	235	31621879
Condition aggravated	59.03	13.01	196	75034	163813	31458301
Abdominal pain	56.32	13.01	169	75061	145783	31476331
Chalazion	55.64	13.01	18	75212	111	31622003
Adverse drug reaction	54.39	13.01	157	75073	25044	31597070
Spinal compression fracture	52.65	13.01	71	75159	6451	31615663
Blood pressure increased	52.62	13.01	67	75163	79566	31542548
Aggression	52.57	13.01	12	75218	37279	31584835
Seizure	52.46	13.01	98	75132	99670	31522444
Neuralgia	52.40	13.01	98	75132	11768	31610346
Anxiety	51.88	13.01	85	75145	90948	31531166
Drug hypersensitivity	51.24	13.01	58	75172	72541	31549573
Infection	50.92	13.01	351	74879	81580	31540534
Hypoaesthesia	50.84	13.01	265	74965	55757	31566357
Cardiac amyloidosis	50.61	13.01	31	75199	984	31621130
Pyrexia	50.59	13.01	1006	74224	302834	31319280
Protein total increased	49.13	13.01	41	75189	2134	31619980
Suicidal ideation	48.82	13.01	13	75217	36393	31585721
Atrial fibrillation	47.52	13.01	445	74785	113338	31508776
Sepsis	45.18	13.01	555	74675	151374	31470740
Spinal cord compression	44.91	13.01	50	75180	3727	31618387
Wrong technique in product usage process	44.53	13.01	12	75218	33331	31588783
Laboratory test abnormal	44.31	13.01	121	75109	18693	31603421
Asthma	44.11	13.01	23	75207	42588	31579526
Hypoglycaemia	43.83	13.01	34	75196	50912	31571202
Compression fracture	43.22	13.01	43	75187	2814	31619300
Stem cell transplant	42.97	13.01	37	75193	2011	31620103
Therapy non-responder	40.97	13.01	174	75056	33637	31588477
BK virus infection	40.42	13.01	55	75175	5040	31617074
Peripheral sensorimotor neuropathy	40.25	13.01	31	75199	1437	31620677
Haematochezia	40.20	13.01	23	75207	40441	31581673
Bradycardia	40.17	13.01	64	75166	69263	31552851
Ageusia	39.88	13.01	76	75154	9255	31612859
Paraesthesia	39.54	13.01	248	74982	55823	31566291
Stress	39.48	13.01	6	75224	24935	31597179
Hyperviscosity syndrome	39.21	13.01	16	75214	205	31621909
Septic shock	38.50	13.01	279	74951	65879	31556235
Metapneumovirus infection	38.30	13.01	22	75208	619	31621495
Guillain-Barre syndrome	36.80	13.01	54	75176	5306	31616808
Rash pruritic	36.13	13.01	132	75098	23806	31598308
Monoclonal immunoglobulin present	35.39	13.01	24	75206	910	31621204
Pathological fracture	35.35	13.01	46	75184	4036	31618078
Neutrophil count decreased	35.11	13.01	209	75021	46185	31575929
Hypogammaglobulinaemia	34.74	13.01	59	75171	6568	31615546
Agitation	34.31	13.01	47	75183	54122	31567992
Oroantral fistula	33.20	13.01	14	75216	196	31621918
Intentional product misuse	33.06	13.01	25	75205	37926	31584188
Hallucination	32.82	13.01	37	75193	46373	31575741
Bone pain	32.03	13.01	110	75120	19241	31602873
Flushing	31.57	13.01	16	75214	30112	31592002
Bone disorder	31.56	13.01	53	75177	5846	31616268
Asthenia	31.45	13.01	726	74504	224029	31398085
Hyperkalaemia	31.41	13.01	66	75164	64285	31557829
Malaise	31.23	13.01	253	74977	168258	31453856
Progressive multifocal leukoencephalopathy	31.03	13.01	68	75162	9145	31612969
Squamous cell carcinoma of skin	30.82	13.01	72	75158	10102	31612012
Angioedema	30.78	13.01	21	75209	33597	31588517
Contraindicated product administered	30.74	13.01	5	75225	19767	31602347
Hiccups	30.66	13.01	68	75162	9219	31612895
H1N1 influenza	30.65	13.01	22	75208	915	31621199
Electrocardiogram QT prolonged	30.63	13.01	27	75203	37960	31584154
Colitis ulcerative	30.40	13.01	4	75226	18525	31603589
Erythema	30.33	13.01	94	75136	80311	31541803
Dehydration	30.30	13.01	423	74807	118688	31503426
Adenocarcinoma of colon	30.04	13.01	38	75192	3242	31618872
Hordeolum	29.45	13.01	21	75209	864	31621250
Renal failure	29.39	13.01	433	74797	122897	31499217
Drug-induced liver injury	28.58	13.01	11	75219	24352	31597762
Osteonecrosis	28.52	13.01	85	75145	13799	31608315
Ileus	28.48	13.01	90	75140	15079	31607035
Parainfluenzae virus infection	28.40	13.01	32	75198	2417	31619697
Pulmonary embolism	28.13	13.01	307	74923	81339	31540775
Incorrect dose administered	28.12	13.01	26	75204	35726	31586388
Somnolence	27.97	13.01	131	75099	99314	31522800
Myocardial infarction	27.66	13.01	157	75073	113297	31508817
Peripheral motor neuropathy	27.65	13.01	27	75203	1727	31620387
Bacterial infection	27.17	13.01	83	75147	13656	31608458
Bone marrow failure	27.15	13.01	135	75095	27873	31594241
Hyperhidrosis	26.70	13.01	77	75153	67316	31554798
Lactic acidosis	26.60	13.01	22	75208	31915	31590199
Metabolic acidosis	26.44	13.01	33	75197	39544	31582570
Osteolysis	26.42	13.01	30	75200	2285	31619829
Injection site pain	26.29	13.01	26	75204	34608	31587506
Blood stem cell harvest failure	26.18	13.01	7	75223	19	31622095
Respirovirus test positive	26.03	13.01	9	75221	70	31622044
Gastrointestinal amyloidosis	25.92	13.01	7	75223	20	31622094
Renal amyloidosis	25.92	13.01	9	75221	71	31622043
Visceral leishmaniasis	25.65	13.01	16	75214	525	31621589
Drug level increased	25.60	13.01	8	75222	20178	31601936
Bacteraemia	25.57	13.01	96	75134	17538	31604576
Blood pressure fluctuation	25.48	13.01	11	75219	22725	31599389
Mobility decreased	25.36	13.01	17	75213	27452	31594662
Tooth deposit	25.28	13.01	9	75221	77	31622037
Anaphylactic reaction	25.06	13.01	20	75210	29533	31592581
VIth nerve paralysis	25.00	13.01	18	75212	752	31621362
Diverticular perforation	24.82	13.01	34	75196	3135	31618979
Meningitis pneumococcal	24.10	13.01	11	75219	188	31621926
Performance status decreased	23.69	13.01	37	75193	3841	31618273
Acute lymphocytic leukaemia	23.61	13.01	35	75195	3471	31618643
Pallor	23.36	13.01	12	75218	22412	31599702
Bone lesion	23.33	13.01	31	75199	2776	31619338
Musculoskeletal stiffness	23.14	13.01	39	75191	41286	31580828
Abnormal behaviour	23.02	13.01	14	75216	23814	31598300
Wheezing	23.01	13.01	31	75199	35955	31586159
Phrenic nerve paralysis	22.89	13.01	9	75221	104	31622010
Autologous haematopoietic stem cell transplant	22.79	13.01	6	75224	15	31622099
Spinal fracture	22.25	13.01	50	75180	6838	31615276
Dysarthria	22.12	13.01	26	75204	31991	31590123
Hepatitis B reactivation	22.10	13.01	34	75196	3484	31618630
Demyelinating polyneuropathy	21.99	13.01	20	75210	1169	31620945
Cytomegalovirus infection	21.80	13.01	116	75114	24591	31597523
Palmar-plantar erythrodysaesthesia syndrome	21.78	13.01	5	75225	15478	31606636
Tachycardia	21.65	13.01	100	75130	76107	31546007
Chronic inflammatory demyelinating polyradiculoneuropathy	21.62	13.01	16	75214	698	31621416
JC virus infection	21.35	13.01	25	75205	1969	31620145
Product prescribing error	21.23	13.01	10	75220	19632	31602482
Anaphylactic shock	21.07	13.01	4	75226	14141	31607973
Coronary artery disease	21.06	13.01	49	75181	46038	31576076
Myalgia	21.00	13.01	103	75127	77155	31544959
Haemoglobin decreased	20.67	13.01	379	74851	112296	31509818
Disturbance in attention	20.58	13.01	14	75216	22436	31599678
Brief psychotic disorder with marked stressors	20.40	13.01	10	75220	202	31621912
Accidental overdose	20.37	13.01	9	75221	18341	31603773
Blood immunoglobulin M increased	20.09	13.01	10	75220	209	31621905
Ascites	20.06	13.01	42	75188	40971	31581143
Gastric ulcer	20.05	13.01	5	75225	14629	31607485
Cerebrovascular accident	19.90	13.01	109	75121	79375	31542739
Respiratory depression	19.80	13.01	5	75225	14505	31607609
Neurogenic bladder	19.79	13.01	22	75208	1637	31620477
Conjunctival irritation	19.71	13.01	8	75222	101	31622013
Acute febrile neutrophilic dermatosis	19.54	13.01	19	75211	1209	31620905
Acute myeloid leukaemia	19.53	13.01	92	75138	18580	31603534
Loss of personal independence in daily activities	19.51	13.01	23	75207	28265	31593849
Emotional distress	19.48	13.01	5	75225	14351	31607763
Rectal adenocarcinoma	19.47	13.01	16	75214	815	31621299
Blood pressure systolic increased	19.43	13.01	11	75219	19459	31602655
Febrile neutropenia	19.35	13.01	401	74829	121448	31500666
Synovitis	19.34	13.01	3	75227	12280	31609834
Basal cell carcinoma	19.33	13.01	90	75140	18089	31604025
Depressed level of consciousness	19.33	13.01	39	75191	38562	31583552
Monoclonal gammopathy	19.33	13.01	11	75219	304	31621810
Blood immunoglobulin A increased	19.23	13.01	11	75219	307	31621807
Infusion related reaction	19.06	13.01	186	75044	47869	31574245
Polyomavirus-associated nephropathy	19.01	13.01	32	75198	3536	31618578
End stage renal disease	18.94	13.01	52	75178	8057	31614057
Rib fracture	18.90	13.01	72	75158	13244	31608870
Hallucination, visual	18.75	13.01	7	75223	15787	31606327
Cardiac arrest	18.72	13.01	129	75101	88933	31533181
Respiratory arrest	18.49	13.01	21	75209	26236	31595878
Jaundice	18.46	13.01	27	75203	30260	31591854
Enterococcal infection	18.45	13.01	54	75176	8677	31613437
Blood immunoglobulin G increased	18.40	13.01	16	75214	881	31621233
Clostridium difficile colitis	18.33	13.01	74	75156	13982	31608132
Haematuria	18.28	13.01	53	75177	46261	31575853
Neuromyotonia	18.28	13.01	6	75224	39	31622075
Anaemia	18.20	13.01	648	74582	212874	31409240
Blood calcium increased	18.11	13.01	30	75200	3272	31618842
Obstructive airways disorder	17.99	13.01	4	75226	12660	31609454
Dyskinesia	17.92	13.01	14	75216	20896	31601218
Sopor	17.78	13.01	3	75227	11549	31610565
Heart rate increased	17.76	13.01	45	75185	41065	31581049
Accidental exposure to product	17.66	13.01	3	75227	11492	31610622
Depressed mood	17.44	13.01	10	75220	17565	31604549
Medication error	17.39	13.01	17	75213	22755	31599359
Vomiting	17.37	13.01	402	74828	223571	31398543
Alanine aminotransferase increased	17.28	13.01	105	75125	74551	31547563
Respiratory tract infection	17.27	13.01	85	75145	17476	31604638
Melaena	17.21	13.01	32	75198	32622	31589492
Gastrooesophageal reflux disease	17.15	13.01	34	75196	33837	31588277
Hyperlipidaemia	17.08	13.01	5	75225	13155	31608959
Coma	17.05	13.01	46	75184	41104	31581010
Nephrolithiasis	17.03	13.01	24	75206	27315	31594799
Blepharitis	16.86	13.01	17	75213	1130	31620984
Type 2 diabetes mellitus	16.81	13.01	7	75223	14777	31607337
Cytomegalovirus infection reactivation	16.79	13.01	32	75198	3897	31618217
Pleuritic pain	16.65	13.01	28	75202	3092	31619022
Aphasia	16.27	13.01	14	75216	19917	31602197
Diabetic ketoacidosis	16.24	13.01	10	75220	16895	31605219
Product quality issue	16.22	13.01	9	75221	16102	31606012
Extrapyramidal disorder	16.18	13.01	4	75226	11774	31610340
Laryngeal cancer metastatic	16.12	13.01	6	75224	59	31622055
Haemorrhagic fever	16.01	13.01	5	75225	27	31622087
Pain	15.97	13.01	330	74900	186429	31435685
Hypersensitivity	15.92	13.01	73	75157	55670	31566444
Injury	15.90	13.01	14	75216	19695	31602419
Full blood count increased	15.86	13.01	14	75216	787	31621327
Autonomic nervous system imbalance	15.72	13.01	24	75206	2443	31619671
Fat tissue increased	15.71	13.01	10	75220	340	31621774
Spinal column injury	15.64	13.01	12	75218	553	31621561
Cholestasis	15.63	13.01	22	75208	25053	31597061
Blood lactate dehydrogenase increased	15.62	13.01	92	75138	20247	31601867
Hypocalcaemic seizure	15.57	13.01	5	75225	30	31622084
Genital erythema	15.50	13.01	8	75222	181	31621933
Escherichia sepsis	15.47	13.01	32	75198	4135	31617979
Glycosylated haemoglobin increased	15.36	13.01	3	75227	10397	31611717
Eosinophilic pneumonia chronic	15.33	13.01	9	75221	264	31621850
Bacterial parotitis	15.30	13.01	5	75225	32	31622082
Neutropenic sepsis	15.22	13.01	64	75166	12315	31609799
Oesophageal adenocarcinoma	15.21	13.01	14	75216	831	31621283
Chest discomfort	15.10	13.01	63	75167	49306	31572808
Hepatic steatosis	15.06	13.01	10	75220	16229	31605885
Dystonia	15.00	13.01	3	75227	10222	31611892
Haematotoxicity	14.95	13.01	44	75186	7093	31615021
Light chain analysis decreased	14.92	13.01	5	75225	35	31622079
Inflammation	14.90	13.01	23	75207	25218	31596896
HCoV-OC43 infection	14.79	13.01	5	75225	36	31622078
Adenovirus infection	14.79	13.01	34	75196	4720	31617394
Morganella infection	14.68	13.01	11	75219	489	31621625
Refractory cytopenia with multilineage dysplasia	14.62	13.01	7	75223	134	31621980
Plasmablastic lymphoma	14.54	13.01	9	75221	291	31621823
Peripheral swelling	14.50	13.01	234	74996	67631	31554483
Ventricular fibrillation	14.48	13.01	14	75216	18834	31603280
Bacterial sepsis	14.44	13.01	34	75196	4794	31617320
Blood culture positive	14.43	13.01	33	75197	4565	31617549
Body height decreased	14.29	13.01	28	75202	3479	31618635
Drug ineffective	14.25	13.01	781	74449	394792	31227322
Blood triglycerides increased	14.21	13.01	7	75223	13390	31608724
Hepatitis	14.11	13.01	19	75211	22047	31600067
Cellulitis orbital	14.06	13.01	9	75221	309	31621805
Bladder sphincter atony	13.99	13.01	4	75226	15	31622099
Refractory anaemia with an excess of blasts	13.95	13.01	10	75220	415	31621699
Agranulocytosis	13.89	13.01	18	75212	21229	31600885
Pregnancy of partner	13.88	13.01	9	75221	316	31621798
Mantle cell lymphoma	13.86	13.01	19	75211	1753	31620361
Colitis	13.84	13.01	132	75098	33755	31588359
VIth nerve paresis	13.82	13.01	5	75225	45	31622069
Therapy interrupted	13.80	13.01	4	75226	10592	31611522
Hepatotoxicity	13.79	13.01	15	75215	19111	31603003
Serratia sepsis	13.78	13.01	4	75226	16	31622098
Chest pain	13.77	13.01	195	75035	116762	31505352
International normalised ratio increased	13.65	13.01	58	75172	45165	31576949
Blood glucose increased	13.57	13.01	87	75143	60996	31561118
Hepatitis B	13.43	13.01	37	75193	5744	31616370
Speech disorder	13.40	13.01	23	75207	24178	31597936
Pleural effusion	13.37	13.01	251	74979	74669	31547445
Muscle spasms	13.29	13.01	232	74998	68086	31554028
Iron deficiency anaemia	13.21	13.01	3	75227	9356	31612758
Dyspnoea	13.14	13.01	674	74556	342805	31279309
Blastic plasmacytoid dendritic cell neoplasia	13.12	13.01	6	75224	103	31622011
Restlessness	13.12	13.01	22	75208	23339	31598775
Hypercapnic coma	13.11	13.01	7	75223	170	31621944
Acute myocardial infarction	13.10	13.01	69	75161	50754	31571360
Myositis	13.03	13.01	5	75225	11089	31611025

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
Plasma cell myeloma	11018.79	11.89	4178	107343	69023	70747900
Neuropathy peripheral	3283.77	11.89	2194	109327	124702	70692221
Plasma cell myeloma recurrent	1162.49	11.89	382	111139	3964	70812959
Thrombocytopenia	1070.93	11.89	1580	109941	237530	70579393
Polyneuropathy	761.53	11.89	454	111067	20961	70795962
Platelet count decreased	746.04	11.89	1142	110379	177080	70639843
Disease progression	658.42	11.89	1006	110515	155666	70661257
Plasmacytoma	615.73	11.89	234	111287	3820	70813103
Pneumonia	615.34	11.89	2193	109328	594039	70222884
Rheumatoid arthritis	441.65	11.89	3	111518	291802	70525121
Plasma cell leukaemia	388.40	11.89	136	111385	1735	70815188
Completed suicide	331.34	11.89	5	111516	227130	70589793
Neutropenia	327.09	11.89	1017	110504	256139	70560784
Unevaluable event	326.48	11.89	406	111115	51657	70765266
Tumour lysis syndrome	293.71	11.89	254	111267	21106	70795817
Arthralgia	272.51	11.89	235	111286	503155	70313768
Headache	269.51	11.89	310	111211	580095	70236828
Diarrhoea	263.23	11.89	2114	109407	781227	70035696
Amyloidosis	262.24	11.89	114	111407	2665	70814258
Pancytopenia	246.59	11.89	654	110867	150453	70666470
Drug interaction	244.17	11.89	149	111372	381292	70435631
Plasma cell myeloma refractory	241.85	11.89	58	111463	153	70816770
Peripheral sensory neuropathy	241.26	11.89	179	111342	11931	70804992
White blood cell count decreased	238.80	11.89	697	110824	169444	70647479
Drug hypersensitivity	235.60	11.89	61	111460	262398	70554525
Off label use	228.39	11.89	1966	109555	741094	70075829
Product use in unapproved indication	226.22	11.89	779	110742	206699	70610224
Sepsis	215.39	11.89	857	110664	243688	70573235
Orthostatic hypotension	213.72	11.89	330	111191	51413	70765510
Primary amyloidosis	205.66	11.89	51	111470	162	70816761
Constipation	194.37	11.89	849	110672	251589	70565334
Deep vein thrombosis	191.73	11.89	491	111030	110551	70706372
Synovitis	187.72	11.89	3	111518	129225	70687698
Herpes zoster	176.14	11.89	404	111117	84831	70732092
Contraindicated product administered	174.42	11.89	9	111512	134603	70682320
Pain	163.01	11.89	480	111041	628336	70188587
Drug abuse	162.75	11.89	20	111501	147236	70669687
Septic shock	160.38	11.89	463	111058	111795	70705128
Myelodysplastic syndrome	158.11	11.89	214	111307	29571	70787352
Overdose	157.02	11.89	37	111484	169708	70647215
Autonomic neuropathy	156.66	11.89	69	111452	1666	70815257
Cytopenia	155.96	11.89	163	111358	17160	70799763
Maternal exposure during pregnancy	155.04	11.89	6	111515	115339	70701584
Febrile neutropenia	149.49	11.89	677	110844	203641	70613282
Cardiac amyloidosis	146.24	11.89	64	111457	1521	70815402
Systemic lupus erythematosus	145.40	11.89	3	111518	101899	70715024
Alopecia	142.27	11.89	67	111454	198423	70618500
Arthropathy	140.19	11.89	32	111489	150025	70666898
Light chain analysis increased	137.37	11.89	60	111461	1419	70815504
Chalazion	136.93	11.89	44	111477	422	70816501
Ileus paralytic	136.53	11.89	112	111409	8649	70808274
Psoriasis	136.25	11.89	4	111517	98429	70718494
Joint swelling	134.56	11.89	120	111401	253091	70563832
Atrial fibrillation	129.76	11.89	604	110917	183744	70633179
Neutrophil count decreased	128.50	11.89	354	111167	83202	70733721
Therapy partial responder	128.04	11.89	126	111395	12348	70804575
Anaemia	127.83	11.89	1076	110445	402347	70414576
Condition aggravated	126.09	11.89	306	111215	427329	70389594
Dehydration	125.53	11.89	693	110828	225449	70591474
Therapeutic product effect decreased	121.26	11.89	37	111484	142981	70673942
Exposure during pregnancy	119.84	11.89	4	111517	87713	70729210
Musculoskeletal stiffness	118.65	11.89	42	111479	147718	70669205
Hypersensitivity	118.43	11.89	112	111409	229700	70587223
Glossodynia	117.96	11.89	4	111517	86483	70730440
Full blood count decreased	116.68	11.89	165	111356	23753	70793170
Pyrexia	111.16	11.89	1448	110073	605504	70211419
Hypercalcaemia	110.59	11.89	196	111325	34189	70782734
Anxiety	110.49	11.89	110	111411	220220	70596703
Swelling	109.27	11.89	82	111439	188457	70628466
Blood pressure increased	105.44	11.89	85	111436	188432	70628491
Renal failure	101.30	11.89	574	110947	188496	70628427
Abdominal discomfort	101.09	11.89	113	111408	214545	70602378
Suicide attempt	100.86	11.89	6	111515	79504	70737419
Product use issue	99.53	11.89	551	110970	179386	70637537
Posterior reversible encephalopathy syndrome	97.06	11.89	153	111368	24249	70792674
Wound	96.41	11.89	19	111502	98713	70718210
Malignant neoplasm progression	93.94	11.89	410	111111	121329	70695594
Discomfort	93.57	11.89	25	111496	105411	70711512
Mobility decreased	90.32	11.89	25	111496	102974	70713949
Injection site pain	88.50	11.89	37	111484	117582	70699341
Stem cell transplant	85.20	11.89	59	111462	3526	70813397
Peripheral sensorimotor neuropathy	84.66	11.89	53	111468	2669	70814254
Depression	82.93	11.89	115	111406	198859	70618064
Weight increased	82.41	11.89	160	111361	242171	70574752
Cytomegalovirus infection	80.49	11.89	187	111334	39571	70777352
Thrombosis	80.16	11.89	281	111240	75124	70741799
Hyperviscosity syndrome	79.06	11.89	28	111493	370	70816553
Rhabdomyolysis	78.97	11.89	26	111495	95734	70721189
Malaise	78.42	11.89	382	111139	432550	70384373
Hepatitis B reactivation	78.33	11.89	66	111455	5289	70811634
Hypertension	75.71	11.89	227	111294	295806	70521117
Pathological fracture	75.43	11.89	84	111437	9499	70807424
Osteonecrosis of jaw	74.56	11.89	185	111336	40817	70776106
Bone marrow failure	72.71	11.89	205	111316	48805	70768118
Wrong technique in product usage process	71.93	11.89	11	111510	68687	70748236
Monoclonal immunoglobulin present	71.90	11.89	33	111488	880	70816043
Peripheral motor neuropathy	70.82	11.89	50	111471	3082	70813841
Blood pressure fluctuation	70.39	11.89	6	111515	59006	70757917
Cystitis haemorrhagic	68.80	11.89	76	111445	8517	70808406
Inappropriate schedule of product administration	68.68	11.89	42	111479	107513	70709410
Cytomegalovirus infection reactivation	68.67	11.89	68	111453	6713	70810210
Stress	68.66	11.89	12	111509	67954	70748969
Spinal cord compression	68.64	11.89	64	111457	5864	70811059
Pleural effusion	68.26	11.89	399	111122	132465	70684458
Helicobacter infection	68.23	11.89	5	111516	55651	70761272
B precursor type acute leukaemia	66.84	11.89	26	111495	453	70816470
Blood stem cell harvest failure	65.63	11.89	18	111503	93	70816830
Haemoglobin decreased	64.68	11.89	547	110974	204612	70612311
Treatment failure	64.48	11.89	79	111442	144063	70672860
Duodenal ulcer perforation	64.39	11.89	4	111517	51108	70765815
Blood cholesterol increased	63.98	11.89	12	111509	64592	70752331
Cardiac failure	63.03	11.89	414	111107	143127	70673796
Protein total increased	62.95	11.89	49	111472	3508	70813415
Arthritis	62.93	11.89	38	111483	97942	70718981
Colitis	62.88	11.89	232	111289	63582	70753341
Pulmonary embolism	62.74	11.89	440	111081	155427	70661496
Fibromyalgia	62.63	11.89	3	111518	47871	70769052
Nasopharyngitis	61.50	11.89	164	111357	222042	70594881
Blood creatine phosphokinase increased	61.49	11.89	11	111510	61252	70755671
Guillain-Barre syndrome	60.76	11.89	69	111452	7971	70808952
Hordeolum	60.16	11.89	42	111479	2543	70814380
Therapy non-responder	59.27	11.89	259	111262	76656	70740267
Blister	59.14	11.89	43	111478	100483	70716440
Osteolysis	59.09	11.89	47	111474	3472	70813451
Coombs indirect test positive	58.83	11.89	15	111506	55	70816868
Ileus	58.10	11.89	122	111399	24115	70792808
Hepatic enzyme increased	57.49	11.89	99	111422	156891	70660032
Migraine	57.17	11.89	21	111500	72217	70744706
Flushing	56.92	11.89	29	111492	82143	70734780
Hypogammaglobulinaemia	56.87	11.89	80	111441	11458	70805465
Blood lactate dehydrogenase increased	56.14	11.89	151	111370	34976	70781947
Haematotoxicity	56.13	11.89	87	111434	13587	70803336
Irritable bowel syndrome	55.93	11.89	7	111514	50843	70766080
Acute myeloid leukaemia	55.62	11.89	139	111382	30801	70786122
Morganella infection	54.45	11.89	29	111492	1073	70815850
Wheezing	51.95	11.89	43	111478	94127	70722796
Injury	51.58	11.89	19	111502	65226	70751697
Plasmablastic lymphoma	51.48	11.89	23	111498	575	70816348
Acute lymphocytic leukaemia	51.38	11.89	53	111468	5492	70811431
Asthma	51.13	11.89	69	111452	120724	70696199
Bacteraemia	49.90	11.89	129	111392	29180	70787743
Suicidal ideation	49.05	11.89	24	111497	69572	70747351
Pericarditis	48.83	11.89	37	111484	84668	70732255
Red blood cell sedimentation rate increased	48.75	11.89	3	111518	38639	70778284
Metapneumovirus infection	48.29	11.89	30	111491	1490	70815433
Gastrooesophageal reflux disease	48.25	11.89	43	111478	90796	70726127
Anaphylactic reaction	48.25	11.89	29	111492	74945	70741978
Sedation	47.75	11.89	8	111513	46723	70770200
Compression fracture	47.70	11.89	53	111468	5978	70810945
Renal amyloidosis	47.43	11.89	15	111506	136	70816787
Osteoarthritis	47.27	11.89	29	111492	74118	70742805
Pruritus	47.01	11.89	334	111187	345226	70471697
Bone pain	46.94	11.89	181	111340	50641	70766282
Ill-defined disorder	46.67	11.89	14	111507	54727	70762196
Hypocalcaemia	46.66	11.89	166	111355	44693	70772230
Blood pressure systolic increased	46.41	11.89	16	111505	57243	70759680
Squamous cell carcinoma of skin	45.51	11.89	76	111445	12636	70804287
Loss of personal independence in daily activities	45.33	11.89	40	111481	84870	70732053
Somnolence	45.17	11.89	180	111341	215426	70601497
Myalgia	44.14	11.89	127	111394	167765	70649158
Erythema	43.47	11.89	164	111357	199399	70617524
Pneumonia fungal	43.22	11.89	65	111456	9888	70807035
Heart rate increased	42.57	11.89	63	111458	106085	70710838
Sleep disorder	42.26	11.89	29	111492	69843	70747080
Syncope	42.16	11.89	422	111099	165287	70651636
Aggression	42.01	11.89	12	111509	48434	70768489
Folliculitis	41.96	11.89	8	111513	42562	70774361
Neuralgia	41.79	11.89	119	111402	28484	70788439
Drug intolerance	41.44	11.89	198	111323	225489	70591434
Nasal congestion	41.43	11.89	26	111495	65646	70751277
Asthenia	41.35	11.89	976	110545	456690	70360233
Inflammation	40.87	11.89	38	111483	78627	70738296
Contusion	40.55	11.89	88	111433	127948	70688975
BK virus infection	40.28	11.89	56	111465	7933	70808990
Crossmatch incompatible	39.81	11.89	10	111511	34	70816889
Large intestine perforation	39.60	11.89	73	111448	13122	70803801
Spinal compression fracture	39.29	11.89	80	111441	15473	70801450
Performance status decreased	38.86	11.89	46	111475	5555	70811368
Refractory cytopenia with multilineage dysplasia	38.79	11.89	15	111506	257	70816666
Drug ineffective	38.57	11.89	1155	110366	938597	69878326
Thrombotic microangiopathy	38.39	11.89	86	111435	17762	70799161
Hyperhidrosis	38.01	11.89	95	111426	131491	70685432
Respiratory failure	37.89	11.89	419	111102	168316	70648607
Sopor	37.78	11.89	3	111518	31264	70785659
Mantle cell lymphoma	37.62	11.89	27	111494	1708	70815215
Urticaria	37.48	11.89	131	111390	162918	70654005
Colitis ulcerative	36.51	11.89	5	111516	33918	70783005
Progressive multifocal leukoencephalopathy	36.31	11.89	88	111433	19126	70797797
Diverticular perforation	36.21	11.89	44	111477	5460	70811463
Abdominal pain upper	36.04	11.89	169	111352	193433	70623490
Palpitations	36.01	11.89	75	111446	110678	70706245
Osteoporosis	35.80	11.89	16	111505	48891	70768032
Inappropriate antidiuretic hormone secretion	35.14	11.89	98	111423	23178	70793745
Cough	34.89	11.89	335	111186	325042	70491881
JC virus infection	34.83	11.89	35	111486	3516	70813407
Drug withdrawal syndrome	34.79	11.89	5	111516	32710	70784213
Respiratory tract infection	34.37	11.89	145	111376	42253	70774670
Sinusitis	34.33	11.89	143	111378	169052	70647871
Infection	34.32	11.89	493	111028	210292	70606631
Large intestinal ulcer perforation	34.26	11.89	10	111511	67	70816856
Neurotoxicity	34.18	11.89	114	111407	29712	70787211
Impaired healing	34.05	11.89	40	111481	74334	70742589
Abdominal pain	33.49	11.89	360	111161	341767	70475156
Bacterial sepsis	33.29	11.89	50	111471	7597	70809326
Hypophosphataemia	33.27	11.89	77	111444	16249	70800674
Lactic acidosis	33.09	11.89	32	111489	64992	70751931
Type 2 diabetes mellitus	32.93	11.89	14	111507	44066	70772857
Demyelinating polyneuropathy	32.69	11.89	24	111497	1573	70815350
End stage renal disease	32.67	11.89	61	111460	11072	70805851
Lymphopenia	32.63	11.89	106	111415	27253	70789670
Underdose	32.42	11.89	4	111517	29379	70787544
Rash	32.29	11.89	1040	110481	509522	70307401
Mesenteric abscess	32.02	11.89	11	111510	132	70816791
VIth nerve paresis	31.94	11.89	11	111510	133	70816790
Prescribed overdose	31.78	11.89	3	111518	27178	70789745
Pneumonia pneumococcal	31.51	11.89	33	111488	3481	70813442
Obesity	31.18	11.89	3	111518	26768	70790155
Seizure	31.01	11.89	159	111362	177803	70639120
Nasal abscess	30.95	11.89	11	111510	147	70816776
Pain in extremity	30.60	11.89	349	111172	327733	70489190
Hypoglycaemia	30.59	11.89	64	111457	94300	70722623
Nocardiosis	30.54	11.89	39	111482	5090	70811833
Hip arthroplasty	30.50	11.89	4	111517	28036	70788887
Injection site swelling	30.23	11.89	15	111506	43142	70773781
Blepharitis	30.14	11.89	29	111492	2764	70814159
Endocarditis bacterial	30.10	11.89	22	111499	1432	70815491
Toxicity to various agents	30.03	11.89	800	110721	381372	70435551
Clostridium difficile colitis	29.89	11.89	107	111414	28889	70788034
Blood immunoglobulin A increased	29.89	11.89	16	111505	598	70816325
Heart rate decreased	29.87	11.89	32	111489	61983	70754940
Hepatitis B	29.70	11.89	49	111472	8065	70808858
Product quality issue	29.58	11.89	6	111515	30555	70786368
Visceral leishmaniasis	29.32	11.89	19	111502	1016	70815907
Ageusia	29.09	11.89	69	111452	14793	70802130
Dysarthria	29.08	11.89	33	111488	62280	70754643
Hypothyroidism	29.02	11.89	18	111503	45737	70771186
Meningitis listeria	28.83	11.89	18	111503	902	70816021
Hypoalbuminaemia	28.37	11.89	80	111441	19042	70797881
Chronic inflammatory demyelinating polyradiculoneuropathy	28.35	11.89	19	111502	1076	70815847
Incorrect dose administered	28.34	11.89	38	111483	66681	70750242
Rib fracture	28.25	11.89	96	111425	25260	70791663
Mucosal inflammation	28.13	11.89	193	111328	67657	70749266
Drug-induced liver injury	28.11	11.89	28	111493	56085	70760838
H1N1 influenza	28.05	11.89	26	111495	2364	70814559
Oedema peripheral	27.96	11.89	509	111012	227582	70589341
Osteonecrosis	27.87	11.89	105	111416	29055	70787868
Cerebellar haemangioma	27.85	11.89	9	111512	88	70816835
Liver injury	27.65	11.89	15	111506	41020	70775903
Oroantral fistula	27.25	11.89	13	111508	379	70816544
Feeling abnormal	27.21	11.89	123	111398	142196	70674727
Dry mouth	27.11	11.89	43	111478	70414	70746509
Taste disorder	26.93	11.89	57	111464	11328	70805595
Enterococcal infection	26.72	11.89	66	111455	14516	70802407
Body dysmorphic disorder	26.71	11.89	12	111509	304	70816619
Multiple sclerosis	26.58	11.89	4	111517	25281	70791642
Failure to thrive	26.52	11.89	55	111466	10774	70806149
Hyperproteinaemia	26.43	11.89	10	111511	161	70816762
Pneumonia cytomegaloviral	26.09	11.89	34	111487	4527	70812396
Rectal adenocarcinoma	26.09	11.89	20	111501	1400	70815523
Blood immunoglobulin G increased	26.01	11.89	23	111498	1967	70814956
Autonomic nervous system imbalance	25.84	11.89	33	111488	4306	70812617
Hiccups	25.82	11.89	49	111472	9003	70807920
Iron deficiency anaemia	25.80	11.89	3	111518	23069	70793854
Meningitis pneumococcal	25.66	11.89	13	111508	433	70816490
Musculoskeletal pain	25.47	11.89	66	111455	90261	70726662
Joint range of motion decreased	25.42	11.89	5	111516	26021	70790902
Depressed level of consciousness	25.34	11.89	63	111458	87368	70729555
Angioedema	25.30	11.89	41	111480	66569	70750354
Drug reaction with eosinophilia and systemic symptoms	25.24	11.89	167	111354	57846	70759077
Diabetic ketoacidosis	25.20	11.89	9	111512	31503	70785420
Oropharyngeal pain	25.19	11.89	73	111448	96237	70720686
Fungal oesophagitis	25.15	11.89	16	111505	829	70816094
Lip swelling	25.14	11.89	11	111510	34043	70782880
Myelosuppression	25.14	11.89	104	111417	30041	70786882
Gait disturbance	25.09	11.89	179	111342	184927	70631996
Target skin lesion	25.07	11.89	9	111512	124	70816799
Respirovirus test positive	25.00	11.89	9	111512	125	70816798
Oral surgery	25.00	11.89	17	111504	986	70815937
Accidental overdose	24.91	11.89	12	111509	35109	70781814
Dyskinesia	24.90	11.89	17	111504	41057	70775866
VIth nerve paralysis	24.79	11.89	20	111501	1508	70815415
Chest discomfort	24.68	11.89	106	111415	124275	70692648
Adenocarcinoma of colon	24.54	11.89	36	111485	5356	70811567
Blastic plasmacytoid dendritic cell neoplasia	24.43	11.89	9	111512	134	70816789
Gastrointestinal fungal infection	24.36	11.89	12	111509	376	70816547
COVID-19 pneumonia	24.32	11.89	83	111438	21886	70795037
Swollen tongue	24.30	11.89	14	111507	37032	70779891
Refractory anaemia with an excess of blasts	24.26	11.89	16	111505	882	70816041
Depressed mood	24.17	11.89	20	111501	43800	70773123
Clostridium bacteraemia	23.80	11.89	11	111510	298	70816625
Respiratory depression	23.77	11.89	5	111516	24826	70792097
Dyspepsia	23.68	11.89	67	111454	89010	70727913
Throat irritation	23.65	11.89	13	111508	35291	70781632
Bradycardia	23.64	11.89	108	111413	124507	70692416
Death	23.50	11.89	1003	110518	509058	70307865
Bacterial infection	23.36	11.89	93	111428	26399	70790524
Nephrolithiasis	23.26	11.89	24	111497	47299	70769624
Parainfluenzae virus infection	23.24	11.89	34	111487	5046	70811877
Escherichia sepsis	22.97	11.89	42	111479	7501	70809422
Acute febrile neutrophilic dermatosis	22.94	11.89	28	111493	3491	70813432
Electrocardiogram QT prolonged	22.81	11.89	62	111459	83455	70733468
Hypersensitivity myocarditis	22.71	11.89	8	111513	104	70816819
Electrolyte imbalance	22.66	11.89	93	111428	26768	70790155
Basal cell carcinoma	22.63	11.89	109	111412	33589	70783334
Medication error	22.60	11.89	34	111487	56878	70760045
Pneumonia influenzal	22.49	11.89	24	111497	2586	70814337
Pseudomonal sepsis	22.41	11.89	35	111486	5502	70811421
Hot flush	22.34	11.89	27	111494	49557	70767366
Coma	22.32	11.89	72	111449	91772	70725151
Pallor	22.23	11.89	19	111502	40955	70775968
Blood potassium decreased	22.15	11.89	128	111393	42293	70774630
Pseudomyopia	21.99	11.89	7	111514	65	70816858
Therapy interrupted	21.77	11.89	6	111515	24796	70792127
Neutropenic sepsis	21.77	11.89	87	111434	24743	70792180
Hypoaesthesia	21.70	11.89	351	111170	153388	70663535
Superficial spreading melanoma stage unspecified	21.50	11.89	10	111511	275	70816648
Blood culture positive	21.50	11.89	42	111479	7884	70809039
Toxic skin eruption	21.30	11.89	75	111446	20087	70796836
Disturbance in social behaviour	21.24	11.89	29	111492	4038	70812885
Acute respiratory distress syndrome	21.23	11.89	124	111397	41130	70775793
Conjunctival irritation	21.19	11.89	8	111513	128	70816795
Neurogenic bladder	21.15	11.89	28	111493	3785	70813138
Pulmonary oedema	21.13	11.89	210	111311	82068	70734855
Meningitis cryptococcal	20.92	11.89	26	111495	3302	70813621
Memory impairment	20.90	11.89	75	111446	92566	70724357
Crying	20.85	11.89	4	111517	21195	70795728
Hallucination, visual	20.84	11.89	10	111511	29327	70787596
Accidental exposure to product	20.81	11.89	9	111512	28042	70788881
Mantle cell lymphoma recurrent	20.80	11.89	12	111509	520	70816403
Frequent bowel movements	20.79	11.89	4	111517	21149	70795774
Lung infiltration	20.78	11.89	78	111443	21546	70795377
Pulmonary arterial hypertension	20.73	11.89	13	111508	32842	70784081
Bursitis	20.69	11.89	8	111513	26665	70790258
Laboratory test abnormal	20.68	11.89	88	111433	25735	70791188
N-terminal prohormone brain natriuretic peptide decreased	20.63	11.89	5	111516	14	70816909
Device dislocation	20.61	11.89	5	111516	22502	70794421
Leukaemia	20.41	11.89	33	111488	5342	70811581
Irritability	20.41	11.89	18	111503	38207	70778716
Bronchopulmonary aspergillosis	20.38	11.89	76	111445	20926	70795997
Extrapyramidal disorder	20.23	11.89	4	111517	20746	70796177
Acne	20.22	11.89	7	111514	24982	70791941
Injection site bruising	20.20	11.89	18	111503	38014	70778909
Bone lesion	20.16	11.89	33	111488	5397	70811526
Surgery	20.15	11.89	11	111510	29978	70786945
Dyspnoea	20.10	11.89	998	110523	769062	70047861
Chromaturia	20.08	11.89	6	111515	23522	70793401
Amnesia	19.90	11.89	32	111489	52123	70764800
Light chain analysis abnormal	19.88	11.89	8	111513	153	70816770
Refractory cancer	19.78	11.89	9	111512	235	70816688
Bronchiolitis	19.62	11.89	27	111494	3787	70813136
Visual impairment	19.44	11.89	63	111458	80187	70736736
Fatigue	19.36	11.89	1525	109996	822794	69994129
Sinus polyp	19.36	11.89	11	111510	463	70816460
Hyperthyroidism	19.33	11.89	4	111517	20087	70796836
General physical condition abnormal	19.29	11.89	34	111487	5902	70811021
Transplant	18.93	11.89	14	111507	928	70815995
Torsade de pointes	18.74	11.89	3	111518	18113	70798810
Peritonitis viral	18.72	11.89	6	111515	57	70816866
Rhinovirus infection	18.65	11.89	36	111485	6697	70810226
Graft versus host disease	18.64	11.89	59	111462	14964	70801959
Polyomavirus-associated nephropathy	18.57	11.89	31	111490	5152	70811771
Tooth deposit	18.57	11.89	9	111512	272	70816651
Adenovirus infection	18.50	11.89	39	111482	7729	70809194
Brief psychotic disorder with marked stressors	18.36	11.89	9	111512	279	70816644
COVID-19	18.26	11.89	250	111271	105507	70711416
Intentional product misuse	18.25	11.89	64	111457	79531	70737392
Varicella	18.14	11.89	22	111499	2725	70814198
Foot deformity	18.12	11.89	5	111516	20650	70796273
Malignant melanoma in situ	18.09	11.89	19	111502	2010	70814913
Sleep apnoea syndrome	17.96	11.89	15	111506	32698	70784225
Cardiac failure congestive	17.91	11.89	306	111215	135151	70681772
Oncologic complication	17.90	11.89	9	111512	295	70816628
Intraductal proliferative breast lesion	17.89	11.89	20	111501	2271	70814652
Neck pain	17.82	11.89	50	111471	66607	70750316
Product prescribing error	17.77	11.89	21	111500	38931	70777992
Faeces discoloured	17.77	11.89	10	111511	26799	70790124
Glycosylated haemoglobin increased	17.72	11.89	3	111518	17388	70799535
Poor quality sleep	17.72	11.89	5	111516	20344	70796579
Blood immunoglobulin M increased	17.64	11.89	11	111510	550	70816373
Atrial flutter	17.64	11.89	71	111450	20256	70796667
Tachycardia	17.50	11.89	162	111359	158384	70658539
Plasma cells present	17.45	11.89	4	111517	8	70816915
Phrenic nerve paralysis	17.33	11.89	9	111512	316	70816607
Haematochezia	17.27	11.89	58	111463	73023	70743900
Hypokalaemia	17.22	11.89	296	111225	130892	70686031
Nodule	17.21	11.89	5	111516	19964	70796959
Body temperature decreased	17.20	11.89	12	111509	28660	70788263
Paraesthesia	17.20	11.89	323	111198	145214	70671709
Gastrointestinal amyloidosis	17.03	11.89	6	111515	78	70816845
Gastric ulcer	16.93	11.89	15	111506	31775	70785148
Therapeutic response decreased	16.90	11.89	153	111368	58300	70758623
Genital erythema	16.84	11.89	8	111513	231	70816692
Enteric neuropathy	16.83	11.89	4	111517	10	70816913
Light chain analysis	16.83	11.89	4	111517	10	70816913
Plasma cells decreased	16.82	11.89	5	111516	36	70816887
Rash pruritic	16.77	11.89	162	111359	62829	70754094
Small intestinal obstruction	16.73	11.89	80	111441	24575	70792348
Disturbance in attention	16.67	11.89	26	111495	42868	70774055
Cerebral aspergillosis	16.66	11.89	17	111504	1739	70815184
Myocardial infarction	16.61	11.89	181	111340	171464	70645459
Stomatitis	16.58	11.89	126	111395	128385	70688538
Tendonitis	16.56	11.89	7	111514	22115	70794808
Fear	16.55	11.89	6	111515	20805	70796118
Renal impairment	16.51	11.89	318	111203	143619	70673304
Procedural pain	16.49	11.89	4	111517	18005	70798918
Injection site exfoliation	16.41	11.89	7	111514	156	70816767
Respiratory arrest	16.31	11.89	38	111483	53895	70763028
Blood immunoglobulin A decreased	16.25	11.89	11	111510	633	70816290
Enterococcal sepsis	16.11	11.89	20	111501	2537	70814386
Staphylococcal bacteraemia	16.08	11.89	46	111475	11036	70805887
Aphasia	16.07	11.89	27	111494	43222	70773701
Pulmonary alveolar haemorrhage	15.99	11.89	44	111477	10325	70806598
Thrombotic thrombocytopenic purpura	15.87	11.89	32	111489	6145	70810778
Clostridium difficile infection	15.84	11.89	110	111411	38706	70778217
Adenoviral haemorrhagic cystitis	15.82	11.89	10	111511	512	70816411
Multiple organ dysfunction syndrome	15.77	11.89	249	111272	108266	70708657
Febrile bone marrow aplasia	15.71	11.89	48	111473	11943	70804980
Liver function test increased	15.71	11.89	18	111503	33829	70783094
Hyperlipidaemia	15.68	11.89	9	111512	23854	70793069
Paraproteinaemia	15.64	11.89	9	111512	388	70816535
Pneumonia parainfluenzae viral	15.48	11.89	8	111513	278	70816645
Hyperkalaemia	15.47	11.89	101	111420	106490	70710433
Neuromyotonia	15.40	11.89	6	111515	105	70816818
Venous thrombosis	15.39	11.89	33	111488	6616	70810307
Laryngeal cancer metastatic	15.37	11.89	5	111516	50	70816873
Engraftment syndrome	15.32	11.89	14	111507	1250	70815673
Pneumonia respiratory syncytial viral	15.27	11.89	15	111506	1466	70815457
Blood creatinine increased	15.09	11.89	312	111209	142689	70674234
Nightmare	15.07	11.89	8	111513	22148	70794775
Immunosuppression	15.06	11.89	46	111475	11446	70805477
Panic attack	15.03	11.89	8	111513	22111	70794812
Feeling hot	14.95	11.89	34	111487	48636	70768287
Empyema	14.94	11.89	24	111497	3863	70813060
Escherichia infection	14.94	11.89	58	111463	16273	70800650
Ejection fraction decreased	14.89	11.89	91	111430	30671	70786252
Organising pneumonia	14.86	11.89	42	111479	10008	70806915
Parkinsonism	14.85	11.89	3	111518	15322	70801601
Hypercholesterolaemia	14.79	11.89	5	111516	18112	70798811
Hypocalcaemic seizure	14.79	11.89	5	111516	57	70816866
Hypoglossal nerve paresis	14.71	11.89	6	111515	119	70816804
Eosinophil count increased	14.71	11.89	3	111518	15219	70801704
Infection in an immunocompromised host	14.70	11.89	13	111508	1112	70815811
Bone erosion	14.64	11.89	3	111518	15170	70801753
Movement disorder	14.61	11.89	10	111511	24119	70792804
Leukopenia	14.55	11.89	242	111279	106318	70710605
Lung disorder	14.43	11.89	170	111351	69314	70747609
Disability	14.38	11.89	3	111518	14980	70801943
Pneumonia bacterial	14.34	11.89	58	111463	16583	70800340
Light chain disease	14.34	11.89	7	111514	215	70816708
Periodontitis	14.34	11.89	25	111496	4303	70812620
Serratia sepsis	14.31	11.89	6	111515	128	70816795
Drug level increased	14.27	11.89	22	111499	36447	70780476
Erysipelas	14.22	11.89	41	111480	9883	70807040
Capillary leak syndrome	14.17	11.89	22	111499	3440	70813483
Mouth ulceration	14.15	11.89	20	111501	34329	70782594
Monoclonal gammopathy	14.14	11.89	11	111510	787	70816136
Infection reactivation	14.06	11.89	18	111503	2355	70814568
Transitional cell carcinoma	14.03	11.89	18	111503	2359	70814564
Eosinophilic pneumonia chronic	13.96	11.89	9	111512	477	70816446
Oesophageal adenocarcinoma	13.84	11.89	11	111510	812	70816111
Hyperamylasaemia	13.71	11.89	12	111509	1012	70815911
Blood triglycerides increased	13.52	11.89	7	111514	19657	70797266
Scrotal pain	13.44	11.89	9	111512	509	70816414
Cardiomegaly	13.43	11.89	75	111446	24470	70792453
Cytomegalovirus enterocolitis	13.43	11.89	14	111507	1469	70815454
Delayed engraftment	13.39	11.89	7	111514	249	70816674
Venoocclusive liver disease	13.30	11.89	42	111479	10636	70806287
Gastrointestinal disorder	13.30	11.89	104	111417	105323	70711600
Cardiotoxicity	13.30	11.89	43	111478	11027	70805896
Haemorrhagic fever	13.20	11.89	4	111517	31	70816892
Squamous cell carcinoma of lung	13.15	11.89	17	111504	2245	70814678
Bence Jones proteinuria	13.08	11.89	3	111518	6	70816917
Decreased appetite	13.04	11.89	595	110926	304185	70512738
Cholelithiasis	13.03	11.89	35	111486	47305	70769618
Atelectasis	12.98	11.89	84	111437	28878	70788045
Osteopenia	12.96	11.89	5	111516	16692	70800231
Clostridium colitis	12.95	11.89	18	111503	2548	70814375
Delusion	12.92	11.89	7	111514	19158	70797765
Malignant neoplasm of unknown primary site	12.84	11.89	10	111511	716	70816207
Pneumocystis jirovecii infection	12.80	11.89	18	111503	2576	70814347
Follicle centre lymphoma, follicular grade I, II, III recurrent	12.77	11.89	3	111518	7	70816916
Protein total decreased	12.75	11.89	35	111486	8201	70808722
Ulcer	12.73	11.89	13	111508	25741	70791182
Cytomegalovirus hepatitis	12.70	11.89	10	111511	728	70816195
Psychotic disorder	12.70	11.89	25	111496	37676	70779247
Paranoid personality disorder	12.67	11.89	4	111517	36	70816887
Bacterial parotitis	12.67	11.89	4	111517	36	70816887
Sciatica	12.67	11.89	12	111509	24615	70792308
Squamous cell carcinoma	12.66	11.89	51	111470	14553	70802370
Minimal residual disease	12.62	11.89	8	111513	412	70816511
Insomnia	12.59	11.89	254	111267	217552	70599371
Heart rate irregular	12.57	11.89	17	111504	29726	70787197
Therapy cessation	12.53	11.89	21	111500	33655	70783268
Impaired work ability	12.51	11.89	5	111516	16335	70800588
Prinzmetal angina	12.46	11.89	14	111507	1598	70815325
Hepatitis	12.27	11.89	39	111482	49941	70766982
Anger	12.25	11.89	5	111516	16127	70800796
Electrodesiccation	12.23	11.89	3	111518	9	70816914
Pulmonary sepsis	12.14	11.89	20	111501	3287	70813636
Encephalitis viral	12.13	11.89	17	111504	2425	70814498
Spinal fracture	12.11	11.89	54	111467	16113	70800810
Vertigo	12.05	11.89	54	111467	62589	70754334
Glomerular filtration rate decreased	12.04	11.89	9	111512	20747	70796176
Obstructive airways disorder	12.00	11.89	14	111507	26099	70790824
Oxygen saturation decreased	11.98	11.89	121	111400	116308	70700615
Cardio-respiratory arrest	11.93	11.89	101	111420	100576	70716347

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01XG01	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Proteasome inhibitors
FDA MoA	N0000175075	Proteasome Inhibitors
MeSH PA	D000970	Antineoplastic Agents
FDA EPC	N0000175604	Proteasome Inhibitor
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:35820	antiprotozoal drugs
CHEBI has role	CHEBI:37670	protease inhibitors
CHEBI has role	CHEBI:52726	proteasome inhibitors

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

Disease	Relation	SNOMED_ID	DOID
Systemic AL amyloidosis	indication	23132008
Multiple myeloma	indication	109989006	DOID:9538
Mantle cell lymphoma	indication	443487006
Orthostatic hypotension	contraindication	28651003
Dehydration	contraindication	34095006
Low blood pressure	contraindication	45007003
Chronic heart failure	contraindication	48447003
Disorder of cardiovascular system	contraindication	49601007	DOID:1287
Interstitial pneumonia	contraindication	64667001
Adult respiratory distress syndrome	contraindication	67782005	DOID:11394
Pulmonary hypertension	contraindication	70995007	DOID:6432
Diabetes mellitus	contraindication	73211009	DOID:9351
Intestinal obstruction	contraindication	81060008	DOID:8437
Prolonged QT interval	contraindication	111975006
Pneumonia	contraindication	233604007	DOID:552
Disease of liver	contraindication	235856003	DOID:409
Syncope	contraindication	271594007
Pregnancy, function	contraindication	289908002
Thrombocytopenic disorder	contraindication	302215000	DOID:1588
Peripheral nerve disease	contraindication	302226006
Neutropenic disorder	contraindication	303011007	DOID:1227
Breastfeeding (mother)	contraindication	413712001
Posterior reversible encephalopathy syndrome	contraindication	450886002
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	9.39	acidic
pKa2	12.09	acidic
pKa3	13.65	acidic
pKa4	2.9	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
3.5MG/VIAL	VELCADE	TAKEDA PHARMS USA	N021602	May 13, 2003	RX	INJECTABLE	INTRAVENOUS, SUBCUTANEOUS	April 8, 2022	PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Proteasome subunit beta type-5	Enzyme	P28074	PSB5_HUMAN	INHIBITOR	Ki	9.26	CHEMBL	CHEMBL
Proteasome subunit beta type-8	Enzyme	P28062	PSB8_HUMAN	INHIBITOR	IC50	8.09	CHEMBL	CHEMBL
Proteasome subunit alpha type-1	Enzyme	P25786	PSA1_HUMAN	INHIBITOR	Ki	9.21	WOMBAT-PK	CHEMBL
Proteasome subunit beta type-1	Enzyme	P20618	PSB1_HUMAN	INHIBITOR	IC50	7.28	CHEMBL	CHEMBL
Proteasome subunit beta type-2	Enzyme	P49721	PSB2_HUMAN	INHIBITOR	IC50	6.23	CHEMBL	CHEMBL
Prothrombin	Enzyme	P00734	THRB_HUMAN		Ki	4.89	CHEMBL
Carbonic anhydrase 5A, mitochondrial	Enzyme	P35218	CAH5A_HUMAN		Ki	5.16	CHEMBL
Carbonic anhydrase 5B, mitochondrial	Enzyme	Q9Y2D0	CAH5B_HUMAN		Ki	5.17	CHEMBL
Carbonic anhydrase 7	Enzyme	P43166	CAH7_HUMAN		Ki	5.16	CHEMBL
Cytochrome P450 2C19	Enzyme	P33261	CP2CJ_HUMAN		Ki	4.75	WOMBAT-PK
26S proteasome non-ATPase regulatory subunit 1	Cytosolic other	Q99460	PSMD1_HUMAN		Ki	7.75	WOMBAT-PK
Histone deacetylase 2	Enzyme	Q92769	HDAC2_HUMAN		IC50	6.10	CHEMBL
Histone deacetylase 1	Enzyme	Q13547	HDAC1_HUMAN		IC50	6.21	CHEMBL
Histone deacetylase 3	Enzyme	O15379	HDAC3_HUMAN		IC50	5.93	CHEMBL
Histone deacetylase 6	Enzyme	Q9UBN7	HDAC6_HUMAN		IC50	4.16	CHEMBL
Neutrophil elastase	Enzyme	P08246	ELNE_HUMAN		Ki	5.64	CHEMBL
Carbonic anhydrase 3	Enzyme	P07451	CAH3_HUMAN		Ki	5.34	CHEMBL
Carbonic anhydrase 6	Enzyme	P23280	CAH6_HUMAN		Ki	5.36	CHEMBL
Histone deacetylase 8	Enzyme	Q9BY41	HDAC8_HUMAN		IC50	7.14	CHEMBL
Cathepsin G	Enzyme	P08311	CATG_HUMAN		Ki	6.20	CHEMBL
Carbonic anhydrase 14	Enzyme	Q9ULX7	CAH14_HUMAN		Ki	5.48	CHEMBL
Chymase	Enzyme	P23946	CMA1_HUMAN		IC50	5.92	CHEMBL
Chymotrypsinogen B	Enzyme	P17538	CTRB1_HUMAN		Ki	6.49	CHEMBL
Lysosomal protective protein	Enzyme	P10619	PPGB_HUMAN		IC50	5.04	CHEMBL
Carbonic anhydrase 13	Enzyme	Q8N1Q1	CAH13_HUMAN		Ki	5.07	CHEMBL
PH and SEC7 domain-containing protein 1	Unclassified	A5PKW4	PSD1_HUMAN		Ki	7.75	WOMBAT-PK
Nuclear factor NF-kappa-B complex	Transcription factor	P19838 Q00653 Q04206	NFKB1_HUMAN NFKB2_HUMAN TF65_HUMAN		IC50	8.01	CHEMBL
Proteasome subunit beta type-9	Enzyme	P28065	PSB9_HUMAN		IC50	8.52	CHEMBL
Proteasome subunit beta type-10	Enzyme	P40306	PSB10_HUMAN		IC50	6.03	CHEMBL
Carbonic anhydrase 2	Enzyme	P00918	CAH2_HUMAN		Ki	5.94	CHEMBL
Carbonic anhydrase 1	Enzyme	P00915	CAH1_HUMAN		Ki	5.89	CHEMBL
Carbonic anhydrase 4	Enzyme	P22748	CAH4_HUMAN		Ki	5.19	CHEMBL
Carbonic anhydrase 9	Enzyme	Q16790	CAH9_HUMAN		Ki	5.47	CHEMBL
Carbonic anhydrase 12	Enzyme	O43570	CAH12_HUMAN		Ki	5.23	CHEMBL
Carbonic anhydrase 15	Enzyme		CAH15_MOUSE		Ki	5.57	CHEMBL
Beta-carbonic anhydrase 1	Enzyme		MTCA1_MYCTU		Ki	5.14	CHEMBL
Alpha-chymotrypsin	Enzyme		CTRA_BOVIN		Ki	5.62	CHEMBL
Proteasome subunit beta	Enzyme		Q8IJT1_PLAF7		IC50	7.51	IUPHAR
Proteasome subunit beta type-8	Enzyme		PSB8_MOUSE		IC50	7.78	CHEMBL
ATP-dependent Clp protease proteolytic subunit	Enzyme		CLPP_STAA8		IC50	5.28	CHEMBL

External reference:

ID	Source
4021393	VUID
N0000148811	NUI
D03150	KEGG_DRUG
356733	RXNORM
4021393	VANDF
C1176309	UMLSCUI
CHEBI:52717	CHEBI
BO2	PDB_CHEM_ID
CHEMBL325041	ChEMBL_ID
DB00188	DRUGBANK_ID
D000069286	MESH_DESCRIPTOR_UI
387447	PUBCHEM_CID
6391	IUPHAR_LIGAND_ID
8331	INN_ID
69G8BD63PP	UNII
17263	MMSL
233935	MMSL
46756	MMSL
d04871	MMSL
009985	NDDF
398907002	SNOMEDCT_US
407097007	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
bortezomib	HUMAN PRESCRIPTION DRUG LABEL	1	0143-9098	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	INTRAVENOUS	ANDA	31 sections
Bortezomib	HUMAN PRESCRIPTION DRUG LABEL	1	0409-1700	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	INTRAVENOUS	ANDA	33 sections
BORTEZOMIB	HUMAN PRESCRIPTION DRUG LABEL	1	0409-1703	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	2.50 mg	INTRAVENOUS	NDA	33 sections
BORTEZOMIB	HUMAN PRESCRIPTION DRUG LABEL	1	0409-1704	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1 mg	INTRAVENOUS	NDA	33 sections
bortezomib	HUMAN PRESCRIPTION DRUG LABEL	1	0781-3258	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	INTRAVENOUS	ANDA	27 sections
BORTEZOMIB	HUMAN PRESCRIPTION DRUG LABEL	1	10019-991	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	INTRAVENOUS	ANDA	28 sections
BORTEZOMIB	HUMAN PRESCRIPTION DRUG LABEL	1	25021-244	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	INTRAVENOUS	ANDA	31 sections
Bortezomib	HUMAN PRESCRIPTION DRUG LABEL	1	43598-426	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	INTRAVENOUS	ANDA	30 sections
Bortezomib	HUMAN PRESCRIPTION DRUG LABEL	1	43598-865	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	INTRAVENOUS	NDA	26 sections
Bortezomib	HUMAN PRESCRIPTION DRUG LABEL	1	50742-484	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	INTRAVENOUS	ANDA	31 sections
Bortezomib	HUMAN PRESCRIPTION DRUG LABEL	1	51817-586	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	INTRAVENOUS	ANDA	32 sections
BORTEZOMIB	Human Prescription Drug Label	1	55150-337	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	INTRAVENOUS	ANDA	28 sections
BORTEZOMIB	HUMAN PRESCRIPTION DRUG LABEL	1	60505-6050	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	INTRAVENOUS	ANDA	28 sections
VELCADE	HUMAN PRESCRIPTION DRUG LABEL	1	63020-049	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	INTRAVENOUS	NDA	31 sections
VELCADE	HUMAN PRESCRIPTION DRUG LABEL	1	63020-049	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	INTRAVENOUS	NDA	31 sections
VELCADE	HUMAN PRESCRIPTION DRUG LABEL	1	63020-049	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	INTRAVENOUS	NDA	31 sections
Bortezomib	HUMAN PRESCRIPTION DRUG LABEL	1	63323-721	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1 mg	INTRAVENOUS	NDA	31 sections
Bortezomib	HUMAN PRESCRIPTION DRUG LABEL	1	63323-721	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1 mg	INTRAVENOUS	NDA	31 sections
Bortezomib	HUMAN PRESCRIPTION DRUG LABEL	1	63323-821	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	INTRAVENOUS	ANDA	30 sections
Bortezomib	HUMAN PRESCRIPTION DRUG LABEL	1	67184-0530	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	INTRAVENOUS	ANDA	31 sections
Bortezomib	HUMAN PRESCRIPTION DRUG LABEL	1	68001-534	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	INTRAVENOUS	ANDA	31 sections
Bortezomib	HUMAN PRESCRIPTION DRUG LABEL	1	68001-540	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	INTRAVENOUS	ANDA	31 sections
Bortezomib	HUMAN PRESCRIPTION DRUG LABEL	1	68001-541	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	INTRAVENOUS	ANDA	26 sections
Bortezomib	HUMAN PRESCRIPTION DRUG LABEL	1	70511-161	INJECTION	1 mg	INTRAVENOUS	NDA	31 sections
Bortezomib	HUMAN PRESCRIPTION DRUG LABEL	1	70511-162	INJECTION	2.50 mg	INTRAVENOUS	NDA	31 sections
BORTEZOMIB	HUMAN PRESCRIPTION DRUG LABEL	1	70710-1411	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1 mg	INTRAVENOUS	ANDA	26 sections
BORTEZOMIB	HUMAN PRESCRIPTION DRUG LABEL	1	70771-1708	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	1 mg	INTRAVENOUS	ANDA	2 sections
Bortezomib	HUMAN PRESCRIPTION DRUG LABEL	1	70860-225	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	INTRAVENOUS	ANDA	31 sections
Bortezomib	HUMAN PRESCRIPTION DRUG LABEL	1	71288-118	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	INTRAVENOUS	ANDA	28 sections
Bortezomib	Human Prescription Drug Label	1	72205-183	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	3.50 mg	INTRAVENOUS	ANDA	26 sections