darbepoetin alfa Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
erythropoietin type blood factors	5157	209810-58-2

Description:

Molecule	Description
Synonyms: darbepoetin alfa aranesp	acts exactly like the natural erythropoietin made by the body to stimulate red blood cell production, but it is very slightly different in its structure Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

darbepoetin alfa
aranesp

acts exactly like the natural erythropoietin made by the body to stimulate red blood cell production, but it is very slightly different in its structure

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
4.50	mcg	P

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Sept. 17, 2001	FDA	AMGEN

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
Death	10098.22	12.86	5053	34319	330495	46316195
Hospitalisation	4484.43	12.86	1761	37611	61624	46585066
Investigation	1115.14	12.86	262	39110	1372	46645318
Haemodialysis	972.77	12.86	345	39027	8872	46637818
Aplasia pure red cell	894.94	12.86	271	39101	4154	46642536
Transplant	483.32	12.86	112	39260	545	46646145
Arteriovenous fistula site complication	462.45	12.86	103	39269	404	46646286
Dialysis	356.53	12.86	173	39199	9943	46636747
Haemoglobin decreased	257.50	12.86	420	38952	128529	46518161
Anaemia	241.82	12.86	610	38762	255169	46391521
Terminal state	228.66	12.86	82	39290	2172	46644518
Peritoneal dialysis	210.09	12.86	51	39321	313	46646377
Renal transplant	185.07	12.86	61	39311	1244	46645446
Renal disorder	180.52	12.86	162	39210	26524	46620166
Drug ineffective	176.47	12.86	188	39184	677650	45969040
Rheumatoid arthritis	172.51	12.86	7	39365	240208	46406482
Haemoglobin abnormal	160.91	12.86	77	39295	4286	46642404
Therapeutic response decreased	150.88	12.86	184	39188	42961	46603729
Palliative care	147.97	12.86	37	39335	261	46646429
Shunt occlusion	131.73	12.86	37	39335	427	46646263
Shunt stenosis	123.36	12.86	32	39340	266	46646424
Drug hypersensitivity	109.02	12.86	35	39337	243790	46402900
Anti-erythropoietin antibody positive	107.63	12.86	31	39341	394	46646296
Headache	100.94	12.86	155	39217	478197	46168493
Arteriovenous fistula operation	88.56	12.86	24	39348	240	46646450
Toxicity to various agents	88.46	12.86	34	39338	211732	46434958
Transfusion	86.84	12.86	79	39293	13152	46633538
Haemoglobin increased	83.39	12.86	42	39330	2613	46644077
Renal impairment	82.40	12.86	189	39183	74183	46572507
Myelodysplastic syndrome	80.78	12.86	82	39290	15629	46631061
Renal failure	78.33	12.86	242	39130	113352	46533338
Condition aggravated	72.73	12.86	60	39312	244992	46401698
Mineral supplementation	69.65	12.86	24	39348	563	46646127
Peritonitis	67.02	12.86	85	39287	20629	46626061
Arthralgia	65.97	12.86	130	39242	364473	46282217
Drug intolerance	60.72	12.86	24	39348	147025	46499665
Rehabilitation therapy	59.59	12.86	26	39346	1166	46645524
Psoriasis	54.05	12.86	3	39369	78601	46568089
Joint swelling	53.94	12.86	37	39335	166036	46480654
Unevaluable event	52.96	12.86	119	39253	46056	46600634
Sinusitis	52.24	12.86	22	39350	129746	46516944
Hip fracture	52.16	12.86	86	39286	26470	46620220
Nephrogenic systemic fibrosis	51.36	12.86	38	39334	4734	46641956
Product use issue	51.24	12.86	9	39363	94635	46552055
Azotaemia	47.62	12.86	35	39337	4316	46642374
Refractory cytopenia with unilineage dysplasia	47.18	12.86	18	39354	569	46646121
Infusion related reaction	46.11	12.86	14	39358	101194	46545496
Pain	45.76	12.86	227	39145	476721	46169969
Weight increased	45.46	12.86	43	39329	164430	46482260
Drug interaction	45.42	12.86	63	39309	203031	46443659
Injection site erythema	45.16	12.86	5	39367	74422	46572268
Cardiac failure	44.94	12.86	159	39213	79789	46566901
Nausea	42.80	12.86	373	38999	687081	45959609
Cardiac output decreased	42.71	12.86	19	39353	893	46645797
Somnolence	42.01	12.86	42	39330	156479	46490211
Reticulocyte count decreased	41.65	12.86	15	39357	402	46646288
Anti-erythropoietin antibody negative	40.31	12.86	10	39362	68	46646622
Transformation to acute myeloid leukaemia	39.72	12.86	11	39361	120	46646570
Living in residential institution	38.88	12.86	14	39358	375	46646315
Arteriovenous fistula site infection	38.30	12.86	9	39363	47	46646643
Drug specific antibody absent	37.53	12.86	9	39363	52	46646638
Haemodialysis complication	35.98	12.86	12	39360	254	46646436
Depression	35.83	12.86	55	39317	170049	46476641
Hepatic cyst infection	35.32	12.86	10	39362	119	46646571
End stage renal disease	34.49	12.86	33	39339	5853	46640837
Dizziness	33.75	12.86	160	39212	340254	46306436
Alopecia	33.74	12.86	53	39319	162361	46484329
Reticulocyte count abnormal	32.56	12.86	8	39364	52	46646638
Blood parathyroid hormone increased	32.48	12.86	24	39348	2984	46643706
Renal cyst infection	32.43	12.86	9	39363	99	46646591
Off label use	31.98	12.86	473	38899	379368	46267322
Arthropathy	31.53	12.86	16	39356	84684	46562006
Disease progression	31.23	12.86	156	39216	91144	46555546
Treatment failure	31.20	12.86	20	39352	93067	46553623
Thrombocytopenia	31.18	12.86	198	39174	126383	46520307
Hepatic enzyme increased	31.13	12.86	15	39357	81772	46564918
Abdominal discomfort	30.76	12.86	50	39322	151115	46495575
Nasopharyngitis	30.35	12.86	52	39320	153946	46492744
Musculoskeletal stiffness	30.27	12.86	23	39349	97970	46548720
Therapeutic product effect incomplete	30.25	12.86	14	39358	78139	46568551
Cardiac disorder	29.78	12.86	93	39279	43765	46602925
Pleural effusion	29.27	12.86	143	39229	82809	46563881
Chronic kidney disease	28.99	12.86	88	39284	40783	46605907
Shunt infection	28.69	12.86	7	39365	44	46646646
Anti-erythropoietin antibody	28.05	12.86	5	39367	3	46646687
Product dose omission issue	27.14	12.86	64	39308	168456	46478234
Iron deficiency	26.51	12.86	28	39344	5585	46641105
Lower respiratory tract infection	26.31	12.86	104	39268	54985	46591705
Occupational exposure to product	26.29	12.86	17	39355	1704	46644986
Serum ferritin increased	26.11	12.86	27	39345	5256	46641434
Neoplasm malignant	25.20	12.86	59	39313	23440	46623250
Asthma	25.20	12.86	24	39348	91518	46555172
Migraine	24.93	12.86	14	39358	70012	46576678
Pain in extremity	24.79	12.86	123	39249	258557	46388133
Fungal endocarditis	24.69	12.86	9	39363	250	46646440
Peripheral swelling	24.69	12.86	61	39311	158010	46488680
Home care	24.32	12.86	4	39368	0	46646690
Leukopenia	24.23	12.86	118	39254	68225	46578465
Visual impairment	24.22	12.86	13	39359	66676	46580014
Memory impairment	24.08	12.86	18	39354	77319	46569371
Diabetic complication	23.69	12.86	13	39359	964	46645726
Swelling	23.66	12.86	43	39329	124468	46522222
Overdose	23.41	12.86	31	39341	101948	46544742
Injection site pruritus	23.29	12.86	3	39369	39740	46606950
Transplant failure	23.22	12.86	14	39358	1240	46645450
Injection site reaction	22.93	12.86	6	39366	47843	46598847
Eye infection bacterial	22.93	12.86	7	39365	110	46646580
Arthritis	22.80	12.86	19	39353	77297	46569393
Intentional product use issue	22.80	12.86	8	39364	52772	46593918
Pancytopenia	22.79	12.86	136	39236	84922	46561768
Fluid overload	22.63	12.86	62	39310	27123	46619567
Fall	22.48	12.86	396	38976	328701	46317989
Arteriovenous fistula thrombosis	22.37	12.86	8	39364	210	46646480
Anxiety	22.07	12.86	79	39293	181878	46464812
Skin induration	21.99	12.86	19	39353	2955	46643735
Hypertension	21.66	12.86	257	39115	196099	46450591
Insomnia	21.09	12.86	70	39302	164854	46481836
Systemic lupus erythematosus	20.51	12.86	15	39357	65165	46581525
Parakeratosis	20.40	12.86	7	39365	162	46646528
Product use in unapproved indication	20.15	12.86	28	39344	90245	46556445
Infective aneurysm	20.11	12.86	9	39363	429	46646261
Nephrogenic anaemia	20.06	12.86	15	39357	1898	46644792
Exposure during pregnancy	20.00	12.86	38	39334	108174	46538516
Agitation	19.84	12.86	11	39361	55404	46591286
Myelodysplastic syndrome transformation	19.67	12.86	9	39363	452	46646238
Nasal congestion	19.60	12.86	8	39364	48105	46598585
Marasmus	19.34	12.86	9	39363	470	46646220
Bone marrow failure	19.30	12.86	62	39310	29607	46617083
Blood cholesterol increased	19.21	12.86	5	39367	40008	46606682
Hyperphosphataemia	19.15	12.86	14	39358	1712	46644978
Urinary tract infection	19.15	12.86	276	39096	219990	46426700
Therapeutic product effect decreased	19.07	12.86	25	39347	82576	46564114
Blood erythropoietin increased	19.04	12.86	4	39368	11	46646679
Extramedullary haemopoiesis	18.92	12.86	5	39367	45	46646645
Sleep disorder	18.71	12.86	8	39364	46787	46599903
Kidney transplant rejection	18.49	12.86	20	39352	4098	46642592
Gait disturbance	18.33	12.86	62	39310	145201	46501489
Abortion spontaneous	18.20	12.86	7	39365	43639	46603051
Myalgia	18.06	12.86	49	39323	123039	46523651
Rash	18.05	12.86	203	39169	356309	46290381
Product quality issue	18.00	12.86	4	39368	35644	46611046
Blood creatinine increased	17.87	12.86	118	39254	76285	46570405
Product storage error	17.75	12.86	34	39338	11758	46634932
Sepsis	17.72	12.86	184	39188	135830	46510860
Blood test abnormal	17.58	12.86	30	39342	9490	46637200
Cough	17.48	12.86	118	39254	230131	46416559
Angina pectoris	17.46	12.86	56	39316	26719	46619971
Chronic kidney disease-mineral and bone disorder	17.21	12.86	7	39365	263	46646427
Hypersensitivity	17.09	12.86	67	39305	150254	46496436
Urine odour abnormal	17.06	12.86	21	39351	4941	46641749
Hypervolaemia	16.95	12.86	13	39359	1709	46644981
Pneumonia	16.93	12.86	426	38946	375894	46270796
Haemolysis	16.71	12.86	23	39349	6036	46640654
Blood product transfusion dependent	16.65	12.86	6	39366	161	46646529
Amegakaryocytic thrombocytopenia	16.55	12.86	4	39368	24	46646666
Natural killer cell count	16.55	12.86	4	39368	24	46646666
Wrong technique in product usage process	16.51	12.86	13	39359	54409	46592281
Dialysis related complication	16.41	12.86	5	39367	78	46646612
Renovascular hypertension	16.16	12.86	3	39369	3	46646687
Dry eye	16.15	12.86	3	39369	30319	46616371
Macrophages increased	16.15	12.86	4	39368	27	46646663
Cellulitis	16.10	12.86	108	39264	70180	46576510
Arteriovenous fistula occlusion	15.87	12.86	7	39365	322	46646368
Maternal condition affecting foetus	15.75	12.86	6	39366	189	46646501
Glossodynia	15.61	12.86	9	39363	44364	46602326
Hyperparathyroidism secondary	15.60	12.86	11	39361	1271	46645419
Skin hypertrophy	15.55	12.86	16	39356	3095	46643595
Blood potassium increased	15.44	12.86	40	39332	16927	46629763
Arteriovenous fistula site haemorrhage	15.31	12.86	6	39366	204	46646486
Osteoarthritis	15.12	12.86	18	39354	62007	46584683
Leg amputation	14.89	12.86	13	39359	2050	46644640
Epistaxis	14.84	12.86	99	39273	64206	46582484
Alanine aminotransferase increased	14.70	12.86	33	39339	88418	46558272
Shunt thrombosis	14.67	12.86	4	39368	41	46646649
Vascular shunt	14.63	12.86	3	39369	7	46646683
Medication error	14.58	12.86	4	39368	30907	46615783
Anaphylactic reaction	14.52	12.86	14	39358	53098	46593592
Plasma cell myeloma	14.49	12.86	75	39297	44403	46602287
Flushing	14.46	12.86	20	39352	64594	46582096
Intermittent claudication	14.21	12.86	12	39360	1808	46644882
Upper respiratory tract infection	13.90	12.86	20	39352	63536	46583154
Renal transplant failure	13.89	12.86	8	39364	651	46646039
Hepatitis	13.71	12.86	5	39367	32210	46614480
Skin ulcer	13.70	12.86	59	39313	32399	46614291
Skin fibrosis	13.62	12.86	9	39363	936	46645754
Loss of personal independence in daily activities	13.51	12.86	17	39355	57166	46589524
Pulmonary arterial hypertension	12.91	12.86	3	39369	25925	46620765

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
Death	12374.60	13.69	6931	34658	350352	29560537
Hospitalisation	5084.15	13.69	2004	39585	42315	29868574
Aplasia pure red cell	1160.38	13.69	394	41195	5232	29905657
Haemodialysis	1016.46	13.69	429	41160	10644	29900245
Investigation	885.84	13.69	214	41375	697	29910192
Arteriovenous fistula site complication	716.53	13.69	157	41432	279	29910610
Transplant	443.17	13.69	115	41474	537	29910352
Dialysis	377.37	13.69	218	41371	10778	29900111
Peritoneal dialysis	264.35	13.69	73	41516	450	29910439
Haemoglobin abnormal	246.72	13.69	109	41480	3020	29907869
Haemoglobin decreased	227.59	13.69	494	41095	113604	29797285
Anti-erythropoietin antibody positive	193.65	13.69	65	41524	828	29910061
Therapeutic response decreased	184.34	13.69	197	41392	24152	29886737
Renal disorder	171.85	13.69	187	41402	23397	29887492
Terminal state	158.01	13.69	84	41505	3520	29907369
Anaemia	144.58	13.69	621	40968	207371	29703518
Transfusion	139.46	13.69	101	41488	7360	29903529
Palliative care	123.49	13.69	37	41552	316	29910573
Toxicity to various agents	118.42	13.69	49	41540	177134	29733755
Shunt stenosis	112.72	13.69	35	41554	341	29910548
Renal transplant	105.66	13.69	51	41538	1737	29909152
Arteriovenous fistula operation	101.37	13.69	27	41562	142	29910747
Reticulocyte count decreased	91.08	13.69	33	41556	534	29910355
Myelodysplastic syndrome	89.37	13.69	120	41469	18658	29892231
Haemoglobin increased	85.05	13.69	52	41537	2850	29908039
Drug interaction	80.80	13.69	95	41494	199473	29711416
Lower respiratory tract infection	74.04	13.69	133	41456	26581	29884308
Shunt occlusion	69.59	13.69	28	41561	610	29910279
Neoplasm malignant	68.74	13.69	103	41486	17711	29893178
Living in residential institution	68.43	13.69	21	41568	196	29910693
Hip fracture	65.43	13.69	79	41510	11045	29899844
Mineral supplementation	61.94	13.69	16	41573	73	29910816
Headache	59.61	13.69	101	41488	182205	29728684
Drug ineffective	57.79	13.69	260	41329	340127	29570762
Product use in unapproved indication	56.72	13.69	16	41573	73677	29837212
Transformation to acute myeloid leukaemia	55.79	13.69	24	41565	622	29910267
Nephrogenic systemic fibrosis	55.30	13.69	47	41542	4324	29906565
Azotaemia	52.17	13.69	48	41541	4904	29905985
Overdose	52.07	13.69	26	41563	84311	29826578
Chronic kidney disease	48.87	13.69	139	41450	37699	29873190
Arteriovenous fistula site infection	48.87	13.69	13	41576	68	29910821
Arteriovenous fistula thrombosis	48.01	13.69	18	41571	322	29910567
Peritonitis	46.43	13.69	96	41493	21279	29889610
Product use issue	46.20	13.69	5	41584	46011	29864878
Appendicolith	44.79	13.69	23	41566	896	29909993
Rehabilitation therapy	44.31	13.69	20	41569	583	29910306
Alanine aminotransferase increased	42.78	13.69	25	41564	74251	29836638
Unevaluable event	42.25	13.69	118	41471	31667	29879222
Product storage error	41.92	13.69	48	41541	6343	29904546
Angina pectoris	41.64	13.69	112	41477	29406	29881483
Somnolence	40.23	13.69	45	41544	96718	29814171
Aggression	39.76	13.69	3	41586	36904	29873985
Suicidal ideation	38.72	13.69	3	41586	36111	29874778
Refractory cytopenia with unilineage dysplasia	38.60	13.69	17	41572	467	29910422
Nausea	37.05	13.69	251	41338	296706	29614183
Zoonotic bacterial infection	36.58	13.69	10	41579	59	29910830
Depression	35.51	13.69	44	41545	90393	29820496
Hyperhidrosis	35.33	13.69	25	41564	67065	29843824
Intermittent claudication	34.53	13.69	27	41562	2207	29908682
Product dose omission issue	34.51	13.69	46	41543	91585	29819304
Hallucination	33.62	13.69	13	41576	49046	29861843
Rheumatoid arthritis	33.49	13.69	8	41581	41189	29869700
Home care	33.49	13.69	6	41583	0	29910889
Normochromic normocytic anaemia	33.38	13.69	34	41555	3936	29906953
Aspartate aminotransferase increased	32.91	13.69	24	41565	63398	29847491
Leg amputation	32.73	13.69	26	41563	2175	29908714
Fluid overload	32.72	13.69	78	41511	19014	29891875
Dizziness	32.29	13.69	150	41439	194759	29716130
Hepatic cyst infection	32.09	13.69	7	41582	12	29910877
Urinary tract infection	31.93	13.69	193	41396	73466	29837423
Arthralgia	30.64	13.69	92	41497	135699	29775190
Myalgia	30.41	13.69	37	41552	76630	29834259
Mycobacterium marinum infection	30.41	13.69	12	41577	248	29910641
Erythropoiesis abnormal	29.91	13.69	11	41578	186	29910703
Weight increased	29.88	13.69	36	41553	74877	29836012
Intentional product use issue	29.77	13.69	7	41582	36433	29874456
Angiodysplasia	29.46	13.69	14	41575	460	29910429
Tachycardia	28.81	13.69	36	41553	73703	29837186
Agitation	28.66	13.69	20	41569	54053	29856836
Interstitial lung disease	28.45	13.69	25	41564	60172	29850717
Drug hypersensitivity	28.32	13.69	32	41557	68487	29842402
Reticulocytopenia	28.22	13.69	8	41581	55	29910834
Joint swelling	28.18	13.69	15	41574	46931	29863958
Condition aggravated	27.92	13.69	98	41491	137768	29773121
Infusion related reaction	27.38	13.69	11	41578	40553	29870336
Tremor	26.23	13.69	40	41549	75323	29835566
Rhabdomyolysis	25.94	13.69	30	41559	63550	29847339
Treatment failure	25.81	13.69	8	41581	34671	29876218
Catheter removal	25.74	13.69	10	41579	198	29910691
Lactic acidosis	25.49	13.69	6	41583	31207	29879682
Cardio-respiratory arrest	24.52	13.69	26	41563	57280	29853609
Hepatic enzyme increased	24.44	13.69	8	41581	33486	29877403
Sinusitis	24.27	13.69	8	41581	33337	29877552
Transferrin saturation increased	23.88	13.69	7	41582	55	29910834
Blood iron abnormal	23.76	13.69	7	41582	56	29910833
End stage renal disease	23.17	13.69	39	41550	7396	29903493
Gangrene	22.73	13.69	30	41559	4584	29906305
Chest discomfort	22.58	13.69	18	41571	45462	29865427
Anti-erythropoietin antibody	22.32	13.69	4	41585	0	29910889
Blood creatine phosphokinase increased	22.22	13.69	17	41572	43831	29867058
Irritability	21.91	13.69	3	41586	23047	29887842
Anxiety	21.64	13.69	59	41530	89812	29821077
Pleural effusion	21.47	13.69	176	41413	73890	29836999
Catheter placement	21.27	13.69	13	41576	712	29910177
Non-neutralising antibodies positive	20.93	13.69	7	41582	88	29910801
Pyrexia	20.84	13.69	286	41303	294203	29616686
Angioedema	20.61	13.69	11	41578	34373	29876516
Renal cyst infection	19.95	13.69	6	41583	52	29910837
Insomnia	19.80	13.69	65	41524	93271	29817618
Hyperparathyroidism secondary	19.74	13.69	15	41574	1175	29909714
Drug-induced liver injury	19.69	13.69	3	41586	21271	29889618
Asthma	19.67	13.69	13	41576	36161	29874728
Respiratory failure	19.39	13.69	73	41516	100569	29810320
Parvovirus B19 test positive	19.28	13.69	7	41582	114	29910775
Renal transplant failure	19.12	13.69	14	41575	1037	29909852
Foetal exposure during pregnancy	19.06	13.69	14	41575	36857	29874032
Iron overload	18.76	13.69	15	41574	1266	29909623
Coronary artery disease	18.66	13.69	25	41564	49687	29861202
Skin induration	18.65	13.69	19	41570	2200	29908689
Skin fibrosis	18.63	13.69	14	41575	1079	29909810
Psoriasis	18.50	13.69	19	41570	42487	29868402
Cognitive disorder	18.48	13.69	5	41584	23685	29887204
Acute respiratory distress syndrome	18.23	13.69	5	41584	23467	29887422
Electrocardiogram QT prolonged	18.02	13.69	14	41575	35821	29875068
Arteriovenous fistula occlusion	17.77	13.69	7	41582	144	29910745
Blood product transfusion dependent	17.73	13.69	9	41580	342	29910547
Muscle spasms	17.61	13.69	40	41549	64798	29846091
Cardiac valve disease	17.43	13.69	21	41568	2928	29907961
Bradycardia	17.33	13.69	41	41548	65485	29845404
Reticulocyte count abnormal	17.33	13.69	4	41585	10	29910879
Acute kidney injury	17.26	13.69	272	41317	273570	29637319
Abnormal behaviour	17.21	13.69	7	41582	25616	29885273
Benign neoplasm	17.09	13.69	7	41582	160	29910729
Fall	16.89	13.69	350	41239	181522	29729367
Oedema due to renal disease	16.74	13.69	3	41586	0	29910889
Depressed level of consciousness	16.73	13.69	17	41572	38205	29872684
Toe amputation	16.71	13.69	18	41571	2223	29908666
Disturbance in attention	16.66	13.69	5	41584	22124	29888765
Abdominal pain upper	16.65	13.69	39	41550	62512	29848377
Heart valve operation	16.55	13.69	5	41584	44	29910845
Metastatic neoplasm	16.51	13.69	20	41569	2805	29908084
Blood bilirubin increased	16.38	13.69	16	41573	36620	29874269
Skin tightness	16.36	13.69	17	41572	2015	29908874
Rash	16.33	13.69	179	41410	191710	29719179
Oxygen saturation decreased	16.15	13.69	22	41567	43418	29867471
Sleep disorder	15.94	13.69	7	41582	24472	29886417
Inadequate osteointegration	15.91	13.69	4	41585	16	29910873
Pain in extremity	15.85	13.69	89	41500	110132	29800757
Memory impairment	15.75	13.69	17	41572	37157	29873732
Vision blurred	15.72	13.69	21	41568	41795	29869094
Delirium	15.69	13.69	20	41569	40611	29870278
Kidney infection	15.60	13.69	25	41564	4553	29906336
Serotonin syndrome	15.51	13.69	3	41586	17888	29893001
Fracture	15.49	13.69	29	41560	5977	29904912
Surgery	15.45	13.69	43	41546	11508	29899381
Weight decreased	15.26	13.69	135	41454	150786	29760103
Arteriovenous fistula site haemorrhage	15.25	13.69	6	41583	123	29910766
Visual impairment	15.17	13.69	12	41577	30426	29880463
Skin hypertrophy	14.93	13.69	18	41571	2511	29908378
Hyperphosphataemia	14.87	13.69	17	41572	2242	29908647
Hepatic function abnormal	14.84	13.69	22	41567	41923	29868966
Cardiac failure	14.79	13.69	179	41410	83239	29827650
Dysgeusia	14.77	13.69	8	41581	24793	29886096
Gallbladder disorder	14.72	13.69	28	41561	5839	29905050
Arteriovenous graft thrombosis	14.67	13.69	3	41586	3	29910886
Dyskinesia	14.60	13.69	6	41583	21828	29889061
Musculoskeletal stiffness	14.56	13.69	17	41572	35864	29875025
Depressed mood	14.46	13.69	3	41586	17026	29893863
Pneumonia	14.23	13.69	583	41006	333723	29577166
Dry mouth	14.16	13.69	7	41582	22843	29888046
Haematochezia	14.11	13.69	16	41573	34206	29876683
Dental restoration failure	14.05	13.69	4	41585	28	29910861
Dialysis device insertion	13.92	13.69	4	41585	29	29910860
Inappropriate schedule of product administration	13.90	13.69	21	41568	39707	29871182
Social problem	13.86	13.69	10	41579	724	29910165
Hepatotoxicity	13.84	13.69	4	41585	18141	29892748
Serum ferritin increased	13.71	13.69	26	41563	5411	29905478

Pharmacologic Action:

Source	Code	Description
ATC	B03XA02	BLOOD AND BLOOD FORMING ORGANS ANTIANEMIC PREPARATIONS OTHER ANTIANEMIC PREPARATIONS Other antianemic preparations
FDA CS	M0007726	Erythropoietin
FDA PE	N0000009319	Increased Erythroid Cell Production
FDA EPC	N0000175665	Erythropoiesis-stimulating Agent
MeSH PA	D006397	Hematinics
MeSH PA	D006401	Hematologic Agents

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Anemia of renal disease	indication	234348004
Anemia due to and following chemotherapy	indication	767657005
Hypertensive disorder	contraindication	38341003	DOID:10763

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Erythropoietin receptor	Membrane receptor	P19235	EPOR_HUMAN	AGONIST				DRUG LABEL	DRUG LABEL

External reference:

ID	Source
4021274	VANDF
C0937950	UMLSCUI
CHEMBL1201566	ChEMBL_ID
DB00012	DRUGBANK_ID
D000068256	MESH_DESCRIPTOR_UI
D03651	KEGG_DRUG
8073	INN_ID
15UQ94PT4P	UNII
283838	RXNORM
16174	MMSL
235606	MMSL
42263	MMSL
d04771	MMSL
009195	NDDF
385608005	SNOMEDCT_US
385610007	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
ARANESP	HUMAN PRESCRIPTION DRUG LABEL	1	55513-002	SOLUTION	25 ug	INTRAVENOUS	BLA	29 sections
ARANESP	HUMAN PRESCRIPTION DRUG LABEL	1	55513-003	SOLUTION	40 ug	INTRAVENOUS	BLA	29 sections
ARANESP	HUMAN PRESCRIPTION DRUG LABEL	1	55513-004	SOLUTION	60 ug	INTRAVENOUS	BLA	29 sections
ARANESP	HUMAN PRESCRIPTION DRUG LABEL	1	55513-005	SOLUTION	100 ug	INTRAVENOUS	BLA	29 sections
ARANESP	HUMAN PRESCRIPTION DRUG LABEL	1	55513-006	SOLUTION	200 ug	INTRAVENOUS	BLA	29 sections
ARANESP	HUMAN PRESCRIPTION DRUG LABEL	1	55513-021	INJECTION, SOLUTION	40 ug	INTRAVENOUS	BLA	29 sections
ARANESP	HUMAN PRESCRIPTION DRUG LABEL	1	55513-023	INJECTION, SOLUTION	60 ug	INTRAVENOUS	BLA	29 sections
ARANESP	HUMAN PRESCRIPTION DRUG LABEL	1	55513-025	INJECTION, SOLUTION	100 ug	INTRAVENOUS	BLA	29 sections
ARANESP	HUMAN PRESCRIPTION DRUG LABEL	1	55513-027	INJECTION, SOLUTION	150 ug	INTRAVENOUS	BLA	29 sections
ARANESP	HUMAN PRESCRIPTION DRUG LABEL	1	55513-028	INJECTION, SOLUTION	200 ug	INTRAVENOUS	BLA	29 sections
ARANESP	HUMAN PRESCRIPTION DRUG LABEL	1	55513-032	INJECTION, SOLUTION	500 ug	INTRAVENOUS	BLA	29 sections
ARANESP	HUMAN PRESCRIPTION DRUG LABEL	1	55513-057	INJECTION, SOLUTION	25 ug	INTRAVENOUS	BLA	29 sections
ARANESP	HUMAN PRESCRIPTION DRUG LABEL	1	55513-098	INJECTION, SOLUTION	10 ug	INTRAVENOUS	BLA	29 sections
ARANESP	HUMAN PRESCRIPTION DRUG LABEL	1	55513-110	SOLUTION	300 ug	INTRAVENOUS	BLA	29 sections
ARANESP	HUMAN PRESCRIPTION DRUG LABEL	1	55513-111	INJECTION, SOLUTION	300 ug	INTRAVENOUS	BLA	29 sections