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

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

Stem definition	Drug id	CAS RN
antacids, aluminium derivatives	3128	201530-41-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: ICL670A ICL-670A ICL 670A deferasirox exjade	A triazole and benzoate derivative that acts as a selective iron chelator. It is used in the management of chronic IRON OVERLOAD due to blood transfusion or non-transfusion dependent THALASSEMIA. Molecular weight: 373.37 Formula: C21H15N3O4 CLOGP: 3.95 LIPINSKI: 0 HAC: 7 HDO: 3 TPSA: 108.47 ALOGS: -4.04 ROTB: 4 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)	2	Hosey CM, Chan R, Benet LZ
BA (Bioavailability)	70 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.20 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	0.84 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.00 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	4.05 hours	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.04 mg/mL	Bocci G, Oprea TI, Benet LZ

Approvals:

Date	Agency	Company	Orphan
Sept. 26, 2019	EMA	Mylan S.A.S
Nov. 2, 2005	FDA	NOVARTIS

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
Sickle cell anaemia with crisis	2565.81	17.52	552	20369	5451	63462650
Serum ferritin increased	1242.01	17.52	308	20613	5874	63462227
Death	399.89	17.52	550	20371	373831	63094270
Blood iron increased	305.24	17.52	76	20845	1466	63466635
Haemoglobin decreased	272.31	17.52	285	20636	145200	63322901
Blood creatinine increased	260.11	17.52	222	20699	87622	63380479
Diarrhoea	164.59	17.52	562	20359	714804	62753297
Sickle cell anaemia	159.81	17.52	37	20884	516	63467585
Drug ineffective	137.82	17.52	88	20833	1044677	62423424
Iron overload	137.45	17.52	36	20885	855	63467246
Blood bilirubin increased	122.48	17.52	100	20821	37040	63431061
Blood urea increased	113.11	17.52	83	20838	26296	63441805
Abdominal pain	109.88	17.52	275	20646	293181	63174920
Sickle cell disease	102.43	17.52	18	20903	50	63468051
Aspartate aminotransferase increased	102.25	17.52	137	20784	90140	63377961
Off label use	98.38	17.52	50	20871	674412	62793689
Pyrexia	96.79	17.52	357	20564	470121	62997980
Alanine aminotransferase increased	96.08	17.52	143	20778	103627	63364474
Myelodysplastic syndrome transformation	88.84	17.52	22	20899	414	63467687
Proteinuria	88.36	17.52	63	20858	19082	63449019
Renal disorder	84.75	17.52	77	20844	32897	63435204
Acute myeloid leukaemia	80.46	17.52	57	20864	17090	63451011
Platelet count decreased	80.11	17.52	140	20781	115982	63352119
Glycosuria	79.78	17.52	25	20896	1141	63466960
Neoplasm malignant	77.27	17.52	70	20851	29791	63438310
Haemochromatosis	75.53	17.52	20	20901	496	63467605
Chromaturia	72.55	17.52	53	20868	16664	63451437
Abdominal pain upper	71.48	17.52	188	20733	206256	63261845
Haematocrit decreased	71.47	17.52	76	20845	39264	63428837
Renal impairment	69.53	17.52	113	20808	88242	63379859
Liver disorder	69.38	17.52	87	20834	53600	63414501
Serum ferritin decreased	69.36	17.52	26	20895	2044	63466057
Myelodysplastic syndrome	67.96	17.52	51	20870	16703	63451398
Haemosiderosis	65.62	17.52	15	20906	197	63467904
Infusion related reaction	65.02	17.52	4	20917	245517	63222584
Hyperammonaemia	63.22	17.52	32	20889	5200	63462901
Splenomegaly	61.59	17.52	41	20880	11116	63456985
Leukaemia	60.58	17.52	29	20892	4179	63463922
Hospitalisation	59.20	17.52	103	20818	84978	63383123
Renal failure	57.95	17.52	123	20798	117529	63350572
Fanconi syndrome acquired	57.71	17.52	19	20902	1017	63467084
Drug hypersensitivity	56.86	17.52	16	20905	310671	63157430
Arthropathy	56.15	17.52	6	20915	234786	63233315
Renal tubular disorder	56.14	17.52	24	20897	2658	63465443
Paroxysmal nocturnal haemoglobinuria	54.19	17.52	13	20908	213	63467888
Cardiac iron overload	53.60	17.52	8	20913	3	63468098
Systemic lupus erythematosus	53.56	17.52	4	20917	208914	63259187
Malaise	53.31	17.52	274	20647	415680	63052421
Blood alkaline phosphatase increased	52.93	17.52	68	20853	42899	63425202
Hepatomegaly	52.29	17.52	38	20883	11851	63456250
Renal tubular acidosis	52.17	17.52	20	20901	1672	63466429
Blood lactate dehydrogenase increased	51.74	17.52	50	20871	23066	63445035
Therapy cessation	50.36	17.52	56	20865	30401	63437700
Toxicity to various agents	48.57	17.52	11	20910	247239	63220862
Joint swelling	46.56	17.52	25	20896	327641	63140460
Sepsis	45.56	17.52	132	20789	152991	63315110
Haemolysis	45.09	17.52	28	20893	6740	63461361
Vomiting	44.63	17.52	326	20595	559291	62908810
Acute leukaemia	44.49	17.52	16	20905	1118	63466983
Glossodynia	41.68	17.52	5	20916	178871	63289230
Acute chest syndrome	41.53	17.52	14	20907	807	63467294
Metabolic acidosis	41.51	17.52	62	20859	45007	63423094
Pneumonia	39.82	17.52	272	20649	456495	63011606
Pancytopenia	38.42	17.52	93	20828	96840	63371261
Hypophosphataemia	38.14	17.52	31	20890	11395	63456706
Musculoskeletal stiffness	36.67	17.52	8	20913	184610	63283491
Anaemia	36.62	17.52	192	20729	293238	63174863
Jaundice	35.56	17.52	46	20875	29205	63438896
Reticulocyte count increased	35.50	17.52	13	20908	957	63467144
Product dose omission issue	35.43	17.52	162	20759	234151	63233950
Product use in unapproved indication	35.09	17.52	8	20913	179072	63289029
Treatment failure	35.02	17.52	11	20910	199032	63269069
Liver function test abnormal	34.37	17.52	59	20862	48122	63419979
Fungal endocarditis	33.58	17.52	9	20912	234	63467867
Hepatic failure	32.76	17.52	49	20872	35607	63432494
Sinusitis	32.61	17.52	17	20904	226636	63241465
Hepatic siderosis	31.15	17.52	5	20916	6	63468095
Red blood cell count decreased	30.62	17.52	51	20870	40594	63427507
Nausea	30.39	17.52	421	20500	854050	62614051
Liver iron concentration increased	30.32	17.52	5	20916	8	63468093
Product use issue	29.62	17.52	18	20903	220502	63247599
Serum ferritin abnormal	28.98	17.52	8	20913	233	63467868
Therapy interrupted	28.96	17.52	44	20877	32411	63435690
Infective aneurysm	28.95	17.52	9	20912	400	63467701
White blood cell count increased	28.94	17.52	55	20866	48506	63419595
Faeces discoloured	28.83	17.52	33	20888	18476	63449625
Intentional product use issue	28.76	17.52	4	20917	127888	63340213
Discomfort	28.13	17.52	10	20911	167364	63300737
Thrombocytopenia	27.85	17.52	111	20810	151046	63317055
Arthralgia	27.55	17.52	96	20825	569614	62898487
Yersinia infection	27.26	17.52	5	20916	19	63468082
Hepatic function abnormal	27.17	17.52	46	20875	37096	63431005
White blood cell count decreased	26.31	17.52	103	20818	139001	63329100
Blood product transfusion dependent	25.87	17.52	7	20914	189	63467912
Alopecia	25.61	17.52	45	20876	337491	63130610
Wound	25.38	17.52	11	20910	163252	63304849
Injection site pain	25.02	17.52	6	20915	129794	63338307
Eye infection bacterial	25.00	17.52	7	20914	215	63467886
Anxiety	24.96	17.52	21	20900	217520	63250581
Ocular icterus	24.04	17.52	15	20906	3641	63464460
Thalassaemia beta	23.68	17.52	4	20917	8	63468093
Hypersplenism	23.30	17.52	7	20914	277	63467824
Ammonia increased	23.05	17.52	16	20905	4640	63463461
Beta 2 microglobulin urine increased	23.03	17.52	5	20916	51	63468050
Stomatitis	22.12	17.52	9	20912	138716	63329385
Gamma-glutamyltransferase increased	22.10	17.52	40	20881	33991	63434110
Lower respiratory tract infection	22.06	17.52	8	20913	132299	63335802
Retinopathy sickle cell	21.71	17.52	5	20916	68	63468033
Depression	21.30	17.52	20	20901	196472	63271629
Impaired healing	21.28	17.52	4	20917	102538	63365563
Hepatic pain	21.26	17.52	13	20908	3043	63465058
Blood pressure increased	20.70	17.52	14	20907	162048	63306053
Bone marrow transplant	20.15	17.52	8	20913	734	63467367
Aplastic anaemia	20.11	17.52	20	20901	9549	63458552
Investigation	19.93	17.52	10	20911	1595	63466506
Reticulocyte count decreased	19.85	17.52	7	20914	462	63467639
Drug interaction	19.78	17.52	28	20893	229103	63238998
Loss of personal independence in daily activities	19.75	17.52	4	20917	97286	63370815
Swelling	19.73	17.52	38	20883	275340	63192761
Transformation to acute myeloid leukaemia	19.51	17.52	6	20915	257	63467844
Osteoarthritis	19.19	17.52	4	20917	95339	63372762
Eye colour change	18.87	17.52	6	20915	287	63467814
Myelofibrosis	18.34	17.52	9	20912	1368	63466733
Nasopharyngitis	18.29	17.52	35	20886	254222	63213879
Blister	18.27	17.52	10	20911	129804	63338297
Fanconi syndrome	18.25	17.52	9	20912	1383	63466718
Basophil count increased	18.19	17.52	8	20913	949	63467152
Transaminases increased	18.04	17.52	35	20886	31332	63436769
Hypersensitivity	17.98	17.52	44	20877	292641	63175460
Hypouricaemia	17.97	17.52	5	20916	150	63467951
Hypertension	17.95	17.52	41	20880	279262	63188839
Injection site erythema	17.79	17.52	3	20918	83171	63384930

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
Sickle cell anaemia with crisis	985.14	16.31	266	20850	3787	34932028
Serum ferritin increased	910.04	16.31	274	20842	5872	34929943
Death	393.84	16.31	787	20329	397262	34538553
Blood creatinine increased	304.74	16.31	329	20787	94647	34841168
Haemoglobin decreased	230.52	16.31	322	20794	120450	34815365
Blood iron increased	209.70	16.31	57	21059	829	34934986
Myelodysplastic syndrome	151.51	16.31	111	21005	19097	34916718
Blood urea increased	141.27	16.31	129	20987	30235	34905580
Neoplasm malignant	139.13	16.31	107	21009	19798	34916017
Platelet count decreased	125.75	16.31	244	20872	119473	34816342
Diarrhoea	122.93	16.31	512	20604	389400	34546415
Myelodysplastic syndrome transformation	122.77	16.31	32	21084	392	34935423
Serum ferritin abnormal	114.07	16.31	27	21089	215	34935600
Acute myeloid leukaemia	107.96	16.31	89	21027	18181	34917634
Off label use	102.20	16.31	64	21052	419460	34516355
Iron overload	101.64	16.31	36	21080	1297	34934518
Acute leukaemia	98.46	16.31	34	21082	1135	34934680
Blood bilirubin increased	92.76	16.31	115	21001	38181	34897634
Myelofibrosis	91.39	16.31	35	21081	1576	34934239
Blast cell count increased	85.58	16.31	30	21086	1048	34934767
Renal disorder	84.46	16.31	90	21026	25390	34910425
Pyrexia	77.75	16.31	401	20715	332612	34603203
Aspartate aminotransferase increased	77.03	16.31	143	20973	67640	34868175
White blood cell count decreased	75.07	16.31	173	20943	95272	34840543
Toxicity to various agents	68.98	16.31	18	21098	200344	34735471
Alanine aminotransferase increased	66.32	16.31	149	20967	80666	34855149
Sickle cell anaemia	65.24	16.31	17	21099	208	34935607
Splenomegaly	64.04	16.31	61	21055	15056	34920759
Drug ineffective	63.57	16.31	112	21004	456639	34479176
Red blood cell count decreased	63.53	16.31	83	21033	29007	34906808
Haematocrit decreased	62.85	16.31	87	21029	32129	34903686
Drug interaction	58.33	16.31	32	21084	225914	34709901
Haemochromatosis	52.42	16.31	21	21095	1067	34934748
Abdominal pain	50.47	16.31	214	20902	163404	34772411
Abdominal pain upper	50.14	16.31	124	20992	71366	34864449
Creatinine renal clearance decreased	50.00	16.31	29	21087	3352	34932463
White blood cell count increased	49.47	16.31	89	21027	41062	34894753
Renal failure	48.48	16.31	181	20935	130376	34805439
Renal impairment	47.43	16.31	145	20971	94368	34841447
Neutrophil count decreased	47.35	16.31	99	21017	51005	34884810
Leukaemia	46.55	16.31	31	21085	4572	34931243
Serum ferritin decreased	45.33	16.31	17	21099	722	34935093
Jaundice	44.94	16.31	74	21042	31808	34904007
Blood lactate dehydrogenase increased	44.70	16.31	62	21054	22928	34912887
Completed suicide	44.59	16.31	4	21112	98164	34837651
Acute chest syndrome	43.47	16.31	17	21099	810	34935005
Haemosiderosis	42.48	16.31	13	21103	293	34935522
Liver disorder	39.19	16.31	71	21045	32926	34902889
Pneumonia	38.38	16.31	360	20756	362267	34573548
Fanconi syndrome acquired	37.44	16.31	20	21096	1971	34933844
Liver function test abnormal	37.08	16.31	67	21049	31007	34904808
Nephrolithiasis	36.96	16.31	66	21050	30267	34905548
Overdose	35.77	16.31	6	21110	91053	34844762
Blood alkaline phosphatase increased	34.41	16.31	65	21051	31110	34904705
Glycosuria	33.78	16.31	16	21100	1221	34934594
Gastrointestinal pain	33.77	16.31	23	21093	3519	34932296
Sickle cell disease	33.03	16.31	9	21107	132	34935683
Hypotension	31.93	16.31	53	21063	221596	34714219
Cholelithiasis	31.04	16.31	50	21066	21098	34914717
Vomiting	30.34	16.31	254	20862	247367	34688448
Chromaturia	29.49	16.31	40	21076	14480	34921335
Deafness	29.14	16.31	35	21081	11230	34924585
Malaise	29.13	16.31	202	20914	185623	34750192
Hepatic enzyme increased	28.66	16.31	69	21047	39011	34896804
Disease progression	28.48	16.31	135	20981	107942	34827873
Drug hypersensitivity	28.12	16.31	7	21109	80522	34855293
Rhabdomyolysis	27.88	16.31	4	21112	68159	34867656
Haemolysis	27.53	16.31	29	21087	8065	34927750
Proteinuria	27.25	16.31	44	21072	18598	34917217
Blood pressure increased	26.55	16.31	10	21106	88092	34847723
Abdominal discomfort	26.51	16.31	88	21028	59747	34876068
Retinal dystrophy	26.25	16.31	5	21111	11	34935804
Moyamoya disease	26.25	16.31	5	21111	11	34935804
Fanconi syndrome	26.09	16.31	15	21101	1705	34934110
Infection	25.75	16.31	116	21000	90799	34845016
Anxiety	25.72	16.31	14	21102	99414	34836401
Intentional product use issue	25.69	16.31	3	21113	59813	34876002
Decreased immune responsiveness	23.88	16.31	14	21102	1650	34934165
Hyperhidrosis	23.81	16.31	8	21108	75684	34860131
Blood product transfusion dependent	23.74	16.31	9	21107	394	34935421
Bone marrow transplant	23.73	16.31	12	21104	1056	34934759
Therapy cessation	23.38	16.31	39	21077	16934	34918881
Product use in unapproved indication	23.26	16.31	22	21094	117477	34818338
Hypertension	23.20	16.31	29	21087	136414	34799401
Hypoacusis	23.18	16.31	38	21078	16263	34919552
Sepsis	23.17	16.31	176	20940	166385	34769430
Anaemia	21.83	16.31	226	20890	233109	34702706
Myocardial infarction	21.36	16.31	25	21091	121060	34814755
Hepatic failure	21.19	16.31	57	21059	34474	34901341
Aplasia pure red cell	20.91	16.31	22	21094	6110	34929705
Urine output decreased	20.89	16.31	28	21088	10021	34925794
Tremor	20.82	16.31	12	21104	82575	34853240
Depression	20.64	16.31	17	21099	97081	34838734
Pulmonary embolism	19.98	16.31	15	21101	89731	34846084
COVID-19	19.94	16.31	11	21105	77539	34858276
Blood calcium decreased	19.30	16.31	27	21089	10057	34925758
Cardiac iron overload	19.24	16.31	3	21113	0	34935815
Alloimmunisation	19.24	16.31	3	21113	0	34935815
Hepatic siderosis	19.09	16.31	6	21110	148	34935667
Bradycardia	18.95	16.31	11	21105	75407	34860408
Concomitant disease progression	18.60	16.31	14	21102	2504	34933311
Neutrophilic panniculitis	17.74	16.31	4	21112	25	34935790
Reticulocyte count increased	17.48	16.31	8	21108	564	34935251
Extramedullary haemopoiesis	17.45	16.31	5	21111	89	34935726
Transaminases increased	17.19	16.31	45	21071	26778	34909037
Neuropathy peripheral	17.18	16.31	15	21101	83248	34852567
Hospitalisation	17.15	16.31	74	21042	56828	34878987
Hallucination	16.98	16.31	5	21111	51493	34884322
Rash	16.85	16.31	207	20909	222545	34713270
Transfusion reaction	16.69	16.31	9	21107	903	34934912
Complications of bone marrow transplant	16.46	16.31	6	21110	235	34935580
Transfusion	16.45	16.31	23	21093	8562	34927253
Pancytopenia	16.41	16.31	106	21010	95051	34840764
Musculoskeletal stiffness	16.40	16.31	4	21112	46676	34889139
Renal function test abnormal	16.36	16.31	13	21103	2517	34933298
Asthma	16.33	16.31	3	21113	42653	34893162

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
Sickle cell anaemia with crisis	2285.92	15.92	531	26416	7391	79710050
Serum ferritin increased	1336.60	15.92	361	26586	9486	79707955
Death	963.34	15.92	1062	25885	565452	79151989
Blood creatinine increased	423.33	15.92	378	26569	154679	79562762
Haemoglobin decreased	321.32	15.92	385	26562	221734	79495707
Blood iron increased	279.51	15.92	72	26875	1558	79715883
Blood urea increased	184.87	15.92	144	26803	48646	79668795
Diarrhoea	179.84	15.92	677	26270	879812	78837629
Platelet count decreased	167.98	15.92	263	26684	194401	79523040
Sickle cell anaemia	167.59	15.92	40	26907	624	79716817
Myelodysplastic syndrome	159.22	15.92	109	26838	30192	79687249
Iron overload	139.27	15.92	43	26904	1821	79715620
Aspartate aminotransferase increased	134.66	15.92	198	26749	138443	79578998
Blood bilirubin increased	128.42	15.92	134	26813	66098	79651343
Alanine aminotransferase increased	121.64	15.92	206	26741	162364	79555077
Drug ineffective	119.70	15.92	114	26833	1080799	78636642
Pyrexia	114.16	15.92	492	26455	678217	79039224
Acute myeloid leukaemia	112.31	15.92	89	26858	30796	79686645
Abdominal pain	110.32	15.92	335	26612	389234	79328207
Renal impairment	101.31	15.92	187	26760	157596	79559845
Serum ferritin abnormal	99.12	15.92	24	26923	399	79717042
Glycosuria	96.92	15.92	34	26913	2154	79715287
Myelodysplastic syndrome transformation	96.85	15.92	26	26921	663	79716778
Renal disorder	94.07	15.92	92	26855	42013	79675428
Neoplasm malignant	93.43	15.92	81	26866	31729	79685712
Off label use	92.00	15.92	103	26844	907112	78810329
White blood cell count decreased	89.60	15.92	197	26750	188091	79529350
Toxicity to various agents	89.60	15.92	17	26930	421523	79295918
Myelofibrosis	88.82	15.92	33	26914	2467	79714974
Fanconi syndrome acquired	86.41	15.92	33	26914	2661	79714780
Hospitalisation	84.89	15.92	130	26817	94106	79623335
Renal tubular acidosis	77.03	15.92	33	26914	3581	79713860
Hyperammonaemia	75.64	15.92	47	26900	11046	79706395
Haemochromatosis	75.56	15.92	25	26922	1325	79716116
Therapy cessation	74.58	15.92	77	26870	37485	79679956
Blast cell count increased	74.49	15.92	25	26922	1385	79716056
Abdominal pain upper	70.41	15.92	200	26747	223619	79493822
Haemosiderosis	69.91	15.92	19	26928	508	79716933
Splenomegaly	67.40	15.92	56	26891	20698	79696743
Completed suicide	67.03	15.92	4	26943	245763	79471678
Haematocrit decreased	64.48	15.92	91	26856	61221	79656220
Product dose omission issue	63.59	15.92	206	26741	247331	79470110
Proteinuria	63.40	15.92	66	26881	32436	79685005
Red blood cell count decreased	62.92	15.92	87	26860	57426	79660015
Blood lactate dehydrogenase increased	59.88	15.92	70	26877	39100	79678341
Infusion related reaction	59.18	15.92	5	26942	230232	79487209
Renal failure	58.78	15.92	175	26772	200793	79516648
Leukaemia	58.71	15.92	32	26915	5893	79711548
Serum ferritin decreased	58.32	15.92	24	26923	2356	79715085
Drug hypersensitivity	57.54	15.92	15	26932	298901	79418540
Chromaturia	57.02	15.92	56	26891	25690	79691751
Liver disorder	54.39	15.92	92	26855	72325	79645116
Blood alkaline phosphatase increased	53.38	15.92	85	26862	63579	79653862
Jaundice	51.44	15.92	76	26871	53273	79664168
Neutrophil count decreased	51.24	15.92	104	26843	93855	79623586
Liver function test abnormal	51.22	15.92	84	26863	64391	79653050
Haemolysis	51.08	15.92	39	26908	12773	79704668
Vomiting	48.93	15.92	388	26559	665440	79052001
Renal tubular disorder	48.10	15.92	29	26918	6457	79710984
Drug interaction	47.82	15.92	42	26905	415141	79302300
Anaemia	46.01	15.92	282	26665	444733	79272708
Paroxysmal nocturnal haemoglobinuria	45.92	15.92	12	26935	275	79717166
White blood cell count increased	44.79	15.92	86	26861	74547	79642894
Metabolic acidosis	44.58	15.92	91	26856	82438	79635003
Acute leukaemia	44.32	15.92	18	26929	1708	79715733
Anxiety	43.23	15.92	15	26932	248497	79468944
Sickle cell disease	43.10	15.92	10	26937	137	79717304
Acute chest syndrome	42.57	15.92	17	26930	1544	79715897
Fanconi syndrome	41.60	15.92	20	26927	2836	79714605
Contraindicated product administered	38.93	15.92	4	26943	157534	79559907
Product use in unapproved indication	38.83	15.92	18	26929	250341	79467100
Sepsis	38.81	15.92	187	26760	269241	79448200
Cardiac iron overload	37.80	15.92	6	26941	6	79717435
Joint swelling	37.26	15.92	26	26921	288620	79428821
Musculoskeletal stiffness	37.25	15.92	7	26940	175001	79542440
Hepatic siderosis	36.87	15.92	9	26938	155	79717286
Liver iron concentration increased	36.46	15.92	6	26941	9	79717432
Hypophosphataemia	36.28	15.92	39	26908	19874	79697567
Arthralgia	36.22	15.92	88	26859	571715	79145726
Therapeutic product effect decreased	36.08	15.92	6	26941	163857	79553584
Overdose	35.89	15.92	9	26938	184197	79533244
Hepatic failure	34.85	15.92	69	26878	61143	79656298
Transaminases increased	34.00	15.92	62	26885	51681	79665760
Sinusitis	33.65	15.92	12	26935	195489	79521952
Blood pressure increased	33.07	15.92	15	26932	211345	79506096
Disease progression	32.58	15.92	136	26811	184226	79533215
Intentional product use issue	32.55	15.92	6	26941	152106	79565335
Hypoacusis	32.06	15.92	45	26902	30105	79687336
Thrombocytopenia	31.85	15.92	175	26772	265084	79452357
Hypotension	31.79	15.92	63	26884	440254	79277187
Transformation to acute myeloid leukaemia	31.21	15.92	12	26935	985	79716456
Reticulocyte count increased	30.68	15.92	13	26934	1373	79716068
Arthropathy	30.26	15.92	11	26936	177100	79540341
Bone marrow transplant	30.13	15.92	13	26934	1435	79716006
Investigation	29.87	15.92	15	26932	2336	79715105
Hypersplenism	29.39	15.92	10	26937	578	79716863
Ocular icterus	29.38	15.92	20	26927	5480	79711961
Pneumonia	29.21	15.92	346	26601	659900	79057541
Gastrointestinal pain	28.74	15.92	25	26922	9830	79707611
Depression	28.67	15.92	19	26928	216771	79500670
Reticulocyte count decreased	28.61	15.92	11	26936	903	79716538
Treatment failure	28.44	15.92	11	26936	170475	79546966
Hyperhidrosis	28.38	15.92	8	26939	151484	79565957
Mobility decreased	27.97	15.92	4	26943	122171	79595270
Alloimmunisation	27.97	15.92	4	26943	0	79717441
Hepatomegaly	27.63	15.92	33	26914	18841	79698600
Infective aneurysm	27.57	15.92	11	26936	997	79716444
Asthma	27.51	15.92	6	26941	135089	79582352
Cholelithiasis	27.18	15.92	57	26890	52607	79664834
Nephrolithiasis	26.71	15.92	57	26890	53234	79664207
Hepatic function abnormal	26.61	15.92	69	26878	73038	79644403
Wheezing	26.29	15.92	4	26943	116660	79600781
Hypertension	25.96	15.92	45	26902	330947	79386494
Faeces discoloured	25.95	15.92	40	26907	29087	79688354
Malaise	25.42	15.92	265	26682	489604	79227837
Aplasia pure red cell	25.20	15.92	21	26926	7789	79709652
Fungal endocarditis	25.14	15.92	9	26938	605	79716836
Platelet count increased	24.65	15.92	34	26913	22372	79695069
Gamma-glutamyltransferase increased	24.60	15.92	56	26891	54624	79662817
Glossodynia	24.58	15.92	3	26944	103334	79614107
Blood product transfusion dependent	24.20	15.92	8	26939	423	79717018
Therapeutic product effect incomplete	23.85	15.92	9	26938	141636	79575805
Extramedullary haemopoiesis	23.19	15.92	6	26941	132	79717309
Beta 2 microglobulin urine increased	22.90	15.92	6	26941	139	79717302
Thalassaemia beta	22.19	15.92	4	26943	13	79717428
Bradycardia	22.19	15.92	9	26938	135548	79581893
Intentional product misuse	22.06	15.92	3	26944	95162	79622279
Febrile neutropenia	21.71	15.92	143	26804	230856	79486585
Eye infection bacterial	21.32	15.92	7	26940	362	79717079
Retinopathy sickle cell	21.25	15.92	5	26942	73	79717368
Tremor	21.05	15.92	16	26931	170067	79547374
Haemoglobin S increased	20.98	15.92	3	26944	0	79717441
Confusional state	20.84	15.92	48	26899	317949	79399492
Injection site pain	20.64	15.92	9	26938	129829	79587612
Lower respiratory tract infection	20.47	15.92	9	26938	129211	79588230
Psoriasis	20.35	15.92	3	26944	89584	79627857
Hypouricaemia	20.24	15.92	7	26940	425	79717016
Loss of personal independence in daily activities	20.00	15.92	5	26942	102575	79614866
Flushing	19.95	15.92	3	26944	88265	79629176
Chest discomfort	19.78	15.92	11	26936	138033	79579408
Pancytopenia	19.64	15.92	109	26838	165636	79551805
Disease complication	19.62	15.92	15	26932	4922	79712519
Ammonia increased	19.55	15.92	18	26929	7617	79709824
Concomitant disease progression	19.44	15.92	13	26934	3460	79713981
Retinal dystrophy	19.09	15.92	4	26943	33	79717408
Urine calcium	18.90	15.92	3	26944	3	79717438
Protein urine present	18.76	15.92	20	26927	10092	79707349
Insomnia	18.61	15.92	34	26913	245136	79472305
Arthritis	18.20	15.92	8	26939	114872	79602569
Urine output decreased	17.84	15.92	26	26921	17996	79699445
Foetal haemoglobin increased	17.69	15.92	3	26944	6	79717435
Hepatitis	17.68	15.92	50	26897	55677	79661764
Nausea	17.57	15.92	435	26512	956761	78760680
Fall	17.00	15.92	96	26851	487533	79229908
Product use issue	16.92	15.92	28	26919	209794	79507647
Nasopharyngitis	16.89	15.92	38	26909	253843	79463598
Alopecia	16.76	15.92	33	26914	231322	79486119
Eye colour change	16.74	15.92	6	26941	405	79717036
Infection	16.64	15.92	139	26808	241573	79475868
Peripheral swelling	16.63	15.92	42	26905	269575	79447866
Rhabdomyolysis	16.63	15.92	7	26940	103124	79614317
Aplastic anaemia	16.53	15.92	25	26922	17880	79699561
Suicidal ideation	16.35	15.92	3	26944	76337	79641104
Hypoaesthesia	16.34	15.92	22	26925	179330	79538111
Allergic transfusion reaction	16.27	15.92	4	26943	71	79717370

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	V03AC03	VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Iron chelating agents
FDA MoA	N0000000144	Iron Chelating Activity
FDA EPC	N0000175522	Iron Chelator
MeSH PA	D002614	Chelating Agents
MeSH PA	D007502	Iron Chelating Agents
MeSH PA	D064449	Sequestering Agents
FDA MoA	N0000182138	Cytochrome P450 1A2 Inhibitors
FDA MoA	N0000185506	Cytochrome P450 3A4 Inducers
FDA MoA	N0000187062	Cytochrome P450 2C8 Inhibitors
CHEBI has role	CHEBI:38157	iron chelating agents

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

Disease	Relation	SNOMED_ID	DOID
beta Thalassemia	indication	65959000	DOID:12241
Chronic Iron Overload	indication
Ocular hypertension	contraindication	4210003	DOID:9282
Hyperbilirubinemia	contraindication	14783006	DOID:2741
Hearing loss	contraindication	15188001
Agranulocytosis	contraindication	17182001	DOID:12987
Cirrhosis of liver	contraindication	19943007	DOID:5082
Proteinuria	contraindication	29738008	DOID:576
Dehydration	contraindication	34095006
Gastrointestinal ulcer	contraindication	40845000
Multiple organ failure	contraindication	57653000
Acute nephropathy	contraindication	58574008
Hepatic failure	contraindication	59927004
Gastrointestinal hemorrhage	contraindication	74474003
Kidney disease	contraindication	90708001	DOID:557
Bilateral cataracts	contraindication	95722004
Myelodysplastic syndrome	contraindication	109995007
Liver function tests abnormal	contraindication	166603001
Impaired renal function disorder	contraindication	197663003
Disease of liver	contraindication	235856003	DOID:409
Anemia	contraindication	271737000	DOID:2355
Thrombocytopenic disorder	contraindication	302215000	DOID:1588
Neutropenic disorder	contraindication	303011007	DOID:1227
Primary malignant neoplasm	contraindication	372087000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.84	acidic
pKa2	9.3	acidic
pKa3	9.91	acidic
pKa4	1.72	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
125MG	EXJADE	NOVARTIS	N021882	Nov. 2, 2005	RX	TABLET, FOR SUSPENSION	ORAL	July 23, 2023	REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY ICL670E2419 (THETIS TRIAL) TO SUPPORT PMR 3342-2 AND 3342-3
250MG	EXJADE	NOVARTIS	N021882	Nov. 2, 2005	RX	TABLET, FOR SUSPENSION	ORAL	July 23, 2023	REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY ICL670E2419 (THETIS TRIAL) TO SUPPORT PMR 3342-2 AND 3342-3
500MG	EXJADE	NOVARTIS	N021882	Nov. 2, 2005	RX	TABLET, FOR SUSPENSION	ORAL	July 23, 2023	REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY ICL670E2419 (THETIS TRIAL) TO SUPPORT PMR 3342-2 AND 3342-3
180MG	JADENU	NOVARTIS PHARMS CORP	N206910	March 30, 2015	RX	TABLET	ORAL	July 23, 2023	REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY ICL670E2419 (THETIS TRIAL) TO SUPPORT PMR 3342-2 AND 3342-3
360MG	JADENU	NOVARTIS PHARMS CORP	N206910	March 30, 2015	RX	TABLET	ORAL	July 23, 2023	REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY ICL670E2419 (THETIS TRIAL) TO SUPPORT PMR 3342-2 AND 3342-3
90MG	JADENU	NOVARTIS PHARMS CORP	N206910	March 30, 2015	RX	TABLET	ORAL	July 23, 2023	REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY ICL670E2419 (THETIS TRIAL) TO SUPPORT PMR 3342-2 AND 3342-3
180MG	JADENU SPRINKLE	NOVARTIS	N207968	May 18, 2017	RX	GRANULE	ORAL	July 23, 2023	REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY ICL670E2419 (THETIS TRIAL) TO SUPPORT PMR 3342-2 AND 3342-3
360MG	JADENU SPRINKLE	NOVARTIS	N207968	May 18, 2017	RX	GRANULE	ORAL	July 23, 2023	REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY ICL670E2419 (THETIS TRIAL) TO SUPPORT PMR 3342-2 AND 3342-3
90MG	JADENU SPRINKLE	NOVARTIS	N207968	May 18, 2017	RX	GRANULE	ORAL	July 23, 2023	REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY ICL670E2419 (THETIS TRIAL) TO SUPPORT PMR 3342-2 AND 3342-3

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Flavin reductase (NADPH)	Enzyme	P30043	BLVRB_HUMAN		Kd	5.77		CHEMBL
Lysine-specific demethylase 5A	Enzyme	P29375	KDM5A_HUMAN		IC50	5.30		CHEMBL

External reference:

ID	Source
4024936	VUID
N0000171608	NUI
D03669	KEGG_DRUG
4024936	VANDF
C1619629	UMLSCUI
CHEBI:49005	CHEBI
JBL	PDB_CHEM_ID
CHEMBL550348	ChEMBL_ID
DB01609	DRUGBANK_ID
D000077588	MESH_DESCRIPTOR_UI
214348	PUBCHEM_CID
8193	INN_ID
V8G4MOF2V9	UNII
614084	RXNORM
20643	MMSL
244676	MMSL
72666	MMSL
d05659	MMSL
011097	NDDF
417910004	SNOMEDCT_US
419985007	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Exjade	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0468	TABLET, FOR SUSPENSION	125 mg	ORAL	NDA	33 sections
Exjade	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0468	TABLET, FOR SUSPENSION	125 mg	ORAL	NDA	33 sections
Exjade	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0468	TABLET, FOR SUSPENSION	125 mg	ORAL	NDA	33 sections
Exjade	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0469	TABLET, FOR SUSPENSION	250 mg	ORAL	NDA	33 sections
Exjade	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0469	TABLET, FOR SUSPENSION	250 mg	ORAL	NDA	33 sections
Exjade	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0469	TABLET, FOR SUSPENSION	250 mg	ORAL	NDA	33 sections
Exjade	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0470	TABLET, FOR SUSPENSION	500 mg	ORAL	NDA	33 sections
Exjade	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0470	TABLET, FOR SUSPENSION	500 mg	ORAL	NDA	33 sections
Exjade	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0470	TABLET, FOR SUSPENSION	500 mg	ORAL	NDA	33 sections
Jadenu	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0654	TABLET, FILM COATED	90 mg	ORAL	NDA	33 sections
Jadenu	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0654	TABLET, FILM COATED	90 mg	ORAL	NDA	33 sections
Jadenu	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0654	TABLET, FILM COATED	90 mg	ORAL	NDA	33 sections
Jadenu	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0655	TABLET, FILM COATED	180 mg	ORAL	NDA	33 sections
Jadenu	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0655	TABLET, FILM COATED	180 mg	ORAL	NDA	33 sections
Jadenu	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0655	TABLET, FILM COATED	180 mg	ORAL	NDA	33 sections
Jadenu	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0656	TABLET, FILM COATED	360 mg	ORAL	NDA	33 sections
Jadenu	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0656	TABLET, FILM COATED	360 mg	ORAL	NDA	33 sections
Jadenu	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0656	TABLET, FILM COATED	360 mg	ORAL	NDA	33 sections
Jadenu	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0713	GRANULE	180 mg	ORAL	NDA	33 sections
Jadenu	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0713	GRANULE	180 mg	ORAL	NDA	33 sections
Jadenu	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0713	GRANULE	180 mg	ORAL	NDA	33 sections
Jadenu	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0720	GRANULE	360 mg	ORAL	NDA	33 sections
Jadenu	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0720	GRANULE	360 mg	ORAL	NDA	33 sections
Jadenu	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0720	GRANULE	360 mg	ORAL	NDA	33 sections
Jadenu	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0727	GRANULE	90 mg	ORAL	NDA	33 sections
Jadenu	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0727	GRANULE	90 mg	ORAL	NDA	33 sections
Jadenu	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0727	GRANULE	90 mg	ORAL	NDA	33 sections
Deferasirox	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3853	TABLET, FILM COATED	180 mg	ORAL	ANDA	28 sections
deferasirox	HUMAN PRESCRIPTION DRUG LABEL	1	16714-993	TABLET, FILM COATED	90 mg	ORAL	ANDA	27 sections
deferasirox	HUMAN PRESCRIPTION DRUG LABEL	1	16714-994	TABLET, FILM COATED	180 mg	ORAL	ANDA	27 sections