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

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

Stem definition	Drug id	CAS RN
polymers	4324	52757-95-6

Description:

Molecule	Description
Synonyms: sevelamer sevelamer hydrochloride renagel sevelamer HCl	A polymeric amine that binds phosphate and is used to treat HYPERPHOSPHATEMIA in patients with kidney disease. Molecular weight: Formula: (H2N)a()b(C15H31ClN3O)n(ClH)n(ClH)n(ClH)n CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Drug dosage:

Dose	Unit	Route
6.40	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	4	Bocci G, Oprea TI, Benet LZ

Approvals:

Date	Agency	Company	Orphan
Oct. 30, 1998	FDA

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
Nephrogenic systemic fibrosis	415.91	17.66	100	8005	4456	63476461
Skin induration	214.84	17.66	55	8050	3168	63477749
Crystal deposit intestine	182.04	17.66	27	8078	65	63480852
Skin hypertrophy	164.53	17.66	45	8060	3346	63477571
Peritonitis bacterial	161.31	17.66	48	8057	4831	63476086
Calciphylaxis	159.49	17.66	43	8062	3029	63477888
Skin tightness	136.35	17.66	41	8064	4275	63476642
Arteriovenous fistula site complication	135.70	17.66	27	8078	486	63480431
Peritonitis	131.15	17.66	57	8048	17097	63463820
Skin fibrosis	94.24	17.66	22	8083	858	63480059
Fibrosis	83.39	17.66	28	8077	4164	63476753
Joint contracture	74.97	17.66	21	8084	1703	63479214
Skin hyperpigmentation	70.34	17.66	27	8078	5894	63475023
Peritoneal dialysis complication	67.67	17.66	18	8087	1202	63479715
Emotional distress	52.56	17.66	39	8066	32510	63448407
Anhedonia	51.38	17.66	26	8079	10948	63469969
Scar	51.28	17.66	28	8077	13754	63467163
Drug ineffective	49.51	17.66	37	8068	1044728	62436189
Hypocalcaemia	48.98	17.66	37	8068	31676	63449241
Extremity contracture	48.43	17.66	14	8091	1271	63479646
Blood parathyroid hormone increased	47.67	17.66	17	8088	3021	63477896
Dialysis	46.77	17.66	24	8081	10403	63470514
Large intestine perforation	45.36	17.66	22	8083	8460	63472457
Chronic kidney disease	43.14	17.66	40	8065	45358	63435559
Joint range of motion decreased	37.63	17.66	32	8073	32396	63448521
Hypotension	36.45	17.66	96	8009	272508	63208409
Blood phosphorus increased	36.14	17.66	14	8091	3131	63477786
Haemodialysis	35.58	17.66	19	8086	8928	63471989
Histology abnormal	35.44	17.66	7	8098	121	63480796
Gastrointestinal injury	34.41	17.66	9	8096	563	63480354
Hyperphosphataemia	33.09	17.66	12	8093	2236	63478681
Skin discolouration	31.51	17.66	31	8074	37797	63443120
Parathyroidectomy	30.42	17.66	7	8098	256	63480661
Shunt stenosis	30.11	17.66	8	8097	532	63480385
Hypervolaemia	28.87	17.66	26	8079	28387	63452530
Drug intolerance	28.76	17.66	3	8102	308658	63172259
Therapeutic drug monitoring analysis incorrectly performed	28.55	17.66	7	8098	337	63480580
Aplasia pure red cell	28.17	17.66	13	8092	4474	63476443
Sepsis	26.94	17.66	60	8045	153063	63327854
Oncocytoma	24.38	17.66	4	8101	22	63480895
Shunt occlusion	23.97	17.66	7	8098	658	63480259
Oedema peripheral	23.54	17.66	65	8040	189446	63291471
Vomiting	23.26	17.66	136	7969	559481	62921436
Skin plaque	23.18	17.66	14	8091	8306	63472611
Peau d'orange	22.85	17.66	5	8100	145	63480772
Anti-erythropoietin antibody positive	22.45	17.66	6	8099	408	63480509
Therapeutic response decreased	22.26	17.66	33	8072	61492	63419425
Pemphigoid	22.13	17.66	13	8092	7331	63473586
Mental status changes	21.66	17.66	26	8079	39573	63441344
Infusion related reaction	21.35	17.66	3	8102	245518	63235399
Brown tumour	21.32	17.66	4	8101	52	63480865
Fungal peritonitis	20.99	17.66	6	8099	523	63480394
Blood creatinine increased	20.87	17.66	39	8066	87805	63393112
Joint swelling	20.67	17.66	8	8097	327658	63153259
Renal failure	20.57	17.66	46	8059	117606	63363311
Nasopharyngitis	20.13	17.66	4	8101	254253	63226664
Anaemia	19.83	17.66	82	8023	293348	63187569
Unresponsive to stimuli	19.82	17.66	23	8082	33793	63447124
Therapeutic drug monitoring analysis not performed	19.09	17.66	7	8098	1345	63479572
Deformity	18.85	17.66	14	8091	11670	63469247
Muscle contracture	18.80	17.66	7	8098	1404	63479513
Fatigue	18.80	17.66	55	8050	887973	62592944
Alopecia	18.55	17.66	10	8095	337526	63143391
Oral administration complication	18.38	17.66	4	8101	113	63480804
Melaena	18.38	17.66	21	8084	30344	63450573
Renal impairment	18.27	17.66	37	8068	88318	63392599
Dermatitis bullous	17.92	17.66	12	8093	8496	63472421

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
Nephrogenic systemic fibrosis	270.24	16.24	80	8835	3925	34944091
Crystal deposit intestine	200.11	16.24	33	8882	78	34947938
Skin induration	140.85	16.24	42	8873	2109	34945907
Arteriovenous fistula site complication	119.60	16.24	27	8888	440	34947576
Peritonitis	104.28	16.24	60	8855	16305	34931711
Skin hypertrophy	104.17	16.24	35	8880	2594	34945422
Skin fibrosis	93.22	16.24	26	8889	1026	34946990
Skin tightness	89.28	16.24	30	8885	2223	34945793
Peritonitis bacterial	72.43	16.24	34	8881	6076	34941940
Blood parathyroid hormone increased	71.42	16.24	23	8892	1491	34946525
Calciphylaxis	70.08	16.24	21	8894	1071	34946945
Joint range of motion decreased	66.63	16.24	34	8881	7278	34940738
Joint contracture	65.58	16.24	23	8892	1938	34946078
Extremity contracture	62.95	16.24	18	8897	778	34947238
Haemodialysis	62.82	16.24	37	8878	10489	34937527
Fibrosis	56.26	16.24	22	8893	2514	34945502
Hypervolaemia	50.15	16.24	41	8874	19668	34928348
Scar	49.44	16.24	26	8889	5918	34942098
Peritoneal dialysis complication	45.73	16.24	17	8898	1692	34946324
Large intestine perforation	40.79	16.24	26	8889	8477	34939539
Product appearance confusion	40.08	16.24	7	8908	26	34947990
Emotional distress	39.79	16.24	32	8883	14994	34933022
Aplasia pure red cell	37.75	16.24	22	8893	6110	34941906
Shunt occlusion	36.12	16.24	12	8903	858	34947158
Therapeutic response decreased	32.96	16.24	39	8876	29274	34918742
Drug ineffective	29.95	16.24	44	8871	456707	34491309
Peau d'orange	29.42	16.24	7	8908	145	34947871
Shunt stenosis	29.35	16.24	10	8905	772	34947244
Anhedonia	28.67	16.24	20	8895	7565	34940451
Tendon calcification	28.51	16.24	6	8909	69	34947947
Off label use	27.89	16.24	40	8875	419484	34528532
Dialysis	27.84	16.24	23	8892	11185	34936831
Hungry bone syndrome	27.76	16.24	6	8909	79	34947937
Deformity	25.84	16.24	11	8904	1561	34946455
Hypogonadism	25.04	16.24	12	8903	2243	34945773
Diverticulitis	24.81	16.24	28	8887	19976	34928040
Mobility decreased	24.29	16.24	34	8881	30094	34917922
Blood phosphorus increased	23.81	16.24	18	8897	7703	34940313
Skin hyperpigmentation	23.57	16.24	13	8902	3251	34944765
Large intestinal ulcer	23.46	16.24	11	8904	1958	34946058
Procalcitonin abnormal	23.02	16.24	7	8908	375	34947641
Arteriovenous fistula site infection	22.17	16.24	5	8910	81	34947935
Pseudopolyp	21.70	16.24	6	8909	229	34947787
Hospitalisation	21.64	16.24	46	8869	56856	34891160
Muscle fibrosis	21.62	16.24	4	8911	22	34947994
Muscle contracture	21.43	16.24	9	8906	1235	34946781
Chronic kidney disease	21.39	16.24	38	8877	41172	34906844
Renal transplant	21.02	16.24	10	8905	1839	34946177
Encephalomalacia	21.01	16.24	8	8907	850	34947166
Hyperkalaemia	20.74	16.24	51	8864	69338	34878678
Fatigue	20.30	16.24	40	8875	370613	34577403
Peritoneal dialysis	19.90	16.24	7	8908	595	34947421
Hyperphosphataemia	19.88	16.24	13	8902	4424	34943592
Rectal ulcer	19.79	16.24	8	8907	996	34947020
Hypercalcaemia	19.77	16.24	22	8893	15446	34932570
Nephrogenic anaemia	19.32	16.24	10	8905	2201	34945815
Injury	19.19	16.24	25	8890	20662	34927354
Haematocrit decreased	18.41	16.24	31	8884	32185	34915831
Haemoglobin decreased	18.36	16.24	70	8845	120702	34827314
Aplastic anaemia	18.23	16.24	17	8898	9699	34938317
Laryngeal discomfort	17.71	16.24	5	8910	206	34947810
Gastrointestinal haemorrhage	16.63	16.24	55	8860	88422	34859594
Joint stiffness	16.61	16.24	17	8898	10856	34937160
Skin ulcer	16.33	16.24	24	8891	22192	34925824
Encapsulating peritoneal sclerosis	16.28	16.24	6	8909	583	34947433

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
Nephrogenic systemic fibrosis	466.32	16.05	125	14340	6035	79723888
Crystal deposit intestine	369.68	16.05	59	14406	169	79729754
Skin induration	251.14	16.05	72	14393	4453	79725470
Arteriovenous fistula site complication	231.77	16.05	50	14415	939	79728984
Skin hypertrophy	193.41	16.05	60	14405	4868	79725055
Peritonitis bacterial	183.33	16.05	68	14397	9499	79720424
Calciphylaxis	182.71	16.05	54	14411	3716	79726207
Peritonitis	182.63	16.05	93	14372	27943	79701980
Skin tightness	162.42	16.05	54	14411	5468	79724455
Skin fibrosis	129.93	16.05	34	14431	1490	79728433
Peritoneal dialysis complication	93.79	16.05	29	14436	2325	79727598
Haemodialysis	92.08	16.05	51	14414	18117	79711806
Blood parathyroid hormone increased	86.80	16.05	30	14435	3415	79726508
Joint contracture	83.56	16.05	27	14438	2497	79727426
Fibrosis	81.11	16.05	32	14433	5277	79724646
Skin hyperpigmentation	71.26	16.05	32	14433	7271	79722652
Dialysis	70.16	16.05	43	14422	18419	79711504
Extremity contracture	67.58	16.05	21	14444	1711	79728212
Joint range of motion decreased	63.94	16.05	51	14414	33231	79696692
Large intestine perforation	63.34	16.05	37	14428	14530	79715393
Hypervolaemia	62.62	16.05	56	14409	42634	79687289
Scar	61.89	16.05	37	14428	15159	79714764
Shunt stenosis	59.08	16.05	18	14447	1373	79728550
Drug ineffective	56.63	16.05	68	14397	1080845	78649078
Anhedonia	54.83	16.05	34	14431	14864	79715059
Chronic kidney disease	53.56	16.05	63	14402	66091	79663832
Shunt occlusion	53.53	16.05	17	14448	1487	79728436
Emotional distress	51.94	16.05	49	14416	39920	79690003
Hyperphosphataemia	43.98	16.05	22	14443	6354	79723569
Blood phosphorus increased	41.63	16.05	25	14440	10322	79719601
Histology abnormal	41.16	16.05	10	14455	323	79729600
Peau d'orange	40.81	16.05	10	14455	335	79729588
Large intestinal ulcer	40.47	16.05	19	14446	4778	79725145
Parathyroidectomy	39.81	16.05	9	14456	211	79729712
Product appearance confusion	39.41	16.05	7	14458	44	79729879
Gastrointestinal injury	38.69	16.05	12	14453	971	79728952
Gastrointestinal haemorrhage	36.62	16.05	82	14383	147637	79582286
Hypocalcaemia	36.25	16.05	45	14420	49879	79680044
Hungry bone syndrome	35.05	16.05	8	14457	196	79729727
Hospitalisation	35.05	16.05	62	14403	94174	79635749
Hypotension	34.11	16.05	164	14301	440153	79289770
Skin discolouration	33.07	16.05	39	14426	40995	79688928
Encapsulating peritoneal sclerosis	31.87	16.05	10	14455	841	79729082
Hypogonadism	31.84	16.05	12	14453	1748	79728175
Drug intolerance	31.67	16.05	5	14460	264114	79465809
Infusion related reaction	30.92	16.05	3	14462	230234	79499689
Off label use	30.91	16.05	75	14390	907140	78822783
Sepsis	29.89	16.05	112	14353	269316	79460607
Fatigue	29.26	16.05	80	14385	929647	78800276
Muscle contracture	28.65	16.05	12	14453	2305	79727618
Peripheral swelling	28.36	16.05	7	14458	269610	79460313
Oedema peripheral	27.26	16.05	104	14361	252184	79477739
Ileus	26.42	16.05	28	14437	26183	79703740
Tendon calcification	26.17	16.05	6	14459	150	79729773
Intestinal perforation	25.82	16.05	23	14442	17403	79712520
Fungal peritonitis	25.48	16.05	9	14456	1091	79728832
Procalcitonin abnormal	25.24	16.05	7	14458	383	79729540
End stage renal disease	24.05	16.05	19	14446	12201	79717722
Melaena	23.85	16.05	41	14424	60849	79669074
Hypercalcaemia	23.76	16.05	32	14433	38398	79691525
Peritoneal dialysis	23.69	16.05	8	14457	848	79729075
Diverticulitis	23.59	16.05	35	14430	45901	79684022
Myoclonus	23.47	16.05	27	14438	27633	79702290
Nephrogenic anaemia	22.68	16.05	12	14453	3890	79726033
Arteriovenous fistula thrombosis	22.60	16.05	7	14458	564	79729359
Oncocytoma	21.91	16.05	4	14461	30	79729893
Gastrointestinal mucosal disorder	21.74	16.05	8	14457	1091	79728832
Peritoneal cloudy effluent	21.55	16.05	6	14459	333	79729590
Renal transplant	21.21	16.05	10	14455	2537	79727386
Haematocrit decreased	21.08	16.05	39	14426	61273	79668650
Therapeutic drug monitoring analysis incorrectly performed	21.04	16.05	7	14458	709	79729214
Joint stiffness	20.81	16.05	31	14434	40799	79689124
Hepatic enzyme increased	20.70	16.05	4	14461	182606	79547317
Hyperkalaemia	20.39	16.05	56	14409	114342	79615581
Haemoglobin decreased	20.34	16.05	87	14378	222032	79507891
Arteriovenous fistula site infection	20.14	16.05	5	14460	177	79729746
Gangrene	19.96	16.05	15	14450	8949	79720974
Gastric ulcer haemorrhage	19.87	16.05	15	14450	9012	79720911
Brown tumour	19.71	16.05	4	14461	55	79729868
Skin plaque	19.64	16.05	16	14449	10729	79719194
Aplasia pure red cell	19.49	16.05	14	14451	7796	79722127
Nasopharyngitis	19.34	16.05	11	14454	253870	79476053
Peripheral vascular disorder	19.14	16.05	14	14451	8016	79721907
Sinusitis	18.83	16.05	6	14459	195495	79534428
Peripheral arterial occlusive disease	18.79	16.05	14	14451	8244	79721679
Joint swelling	18.66	16.05	15	14450	288631	79441292
Diverticulum intestinal	18.28	16.05	14	14451	8591	79721332
Intestinal obstruction	18.22	16.05	30	14435	42990	79686933
Laryngeal discomfort	18.17	16.05	6	14459	594	79729329
Diverticular perforation	18.09	16.05	12	14453	5881	79724042
Blood pressure decreased	18.03	16.05	49	14416	99417	79630506
Arthropathy	17.85	16.05	5	14460	177106	79552817
Hyperparathyroidism secondary	17.82	16.05	9	14456	2651	79727272
Cardiac arrest	17.80	16.05	70	14395	172026	79557897
International normalised ratio increased	17.68	16.05	44	14421	84677	79645246
Skin disorder	17.62	16.05	26	14439	33917	79696006
Drug hypersensitivity	17.55	16.05	17	14448	298899	79431024
Product use in unapproved indication	17.48	16.05	12	14453	250347	79479576
Constipation	17.42	16.05	99	14366	282951	79446972
Encephalomalacia	17.29	16.05	7	14458	1234	79728689
Steal syndrome	17.16	16.05	3	14462	17	79729906
Rectal ulcer	16.73	16.05	8	14457	2096	79727827
Thrombosis in device	16.51	16.05	11	14454	5431	79724492
Parathyroid tumour benign	16.34	16.05	6	14459	813	79729110
Gastrointestinal necrosis	16.29	16.05	11	14454	5554	79724369
Colitis	16.28	16.05	39	14426	73268	79656655
Alopecia	16.27	16.05	11	14454	231344	79498579
Unresponsive to stimuli	16.15	16.05	33	14432	55755	79674168
Oral administration complication	16.12	16.05	4	14461	141	79729782
Product use issue	16.11	16.05	9	14456	209813	79520110

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	V03AE02	VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Drugs for treatment of hyperkalemia and hyperphosphatemia
FDA MoA	N0000020074	Phosphate Chelating Activity
MeSH PA	D002614	Chelating Agents
MeSH PA	D064449	Sequestering Agents
FDA EPC	N0000175597	Phosphate Binder

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

Disease	Relation	SNOMED_ID	DOID
Renal Osteodystrophy with Hyperphosphatemia	indication
Hypophosphatemia	contraindication	4996001
Vitamin D deficiency	contraindication	34713006
Dysphagia	contraindication	40739000
Gastrointestinal obstruction	contraindication	126765001
Acute constipation	contraindication	197119006
Gastroparesis	contraindication	235675006
Operation on gastrointestinal tract	contraindication	386621005
Gastrointestinal hypomotility	contraindication	421807004

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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:

None

External reference:

ID	Source
4024131	VUID
N0000022136	NUI
D01983	KEGG_DRUG
152751-57-0	SECONDARY_CAS_RN
4021141	VANDF
4024131	VANDF
4030256	VANDF
C0718050	UMLSCUI
CHEBI:32127	CHEBI
CHEMBL1201798	ChEMBL_ID
CHEMBL1201492	ChEMBL_ID
D000069603	MESH_DESCRIPTOR_UI
DB00658	DRUGBANK_ID
7620	INN_ID
941N5DUU5C	UNII
3085017	PUBCHEM_CID
135118	RXNORM
13916	MMSL
307571	MMSL
7783	MMSL
d04363	MMSL
007676	NDDF
007677	NDDF
329195003	SNOMEDCT_US
395871000	SNOMEDCT_US
412304002	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Sevelamer Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1048	TABLET, FILM COATED	800 mg	ORAL	NDA AUTHORIZED GENERIC	26 sections
Sevelamer Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0955-1048	TABLET, FILM COATED	800 mg	ORAL	NDA AUTHORIZED GENERIC	26 sections
Renagel	HUMAN PRESCRIPTION DRUG LABEL	1	17856-0021	TABLET	800 mg	ORAL	NDA	23 sections
Sevelamer Hydrochloride	Human Prescription Drug Label	1	33342-241	TABLET, FILM COATED	400 mg	ORAL	ANDA	26 sections
Sevelamer Hydrochloride	Human Prescription Drug Label	1	33342-242	TABLET, FILM COATED	800 mg	ORAL	ANDA	26 sections
Renagel	HUMAN PRESCRIPTION DRUG LABEL	1	53808-0777	TABLET	800 mg	ORAL	NDA	24 sections
Renagel	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0020	TABLET, FILM COATED	400 mg	ORAL	NDA	26 sections
Renagel	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0020	TABLET, FILM COATED	400 mg	ORAL	NDA	26 sections
Renagel	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0021	TABLET, FILM COATED	800 mg	ORAL	NDA	26 sections
Renagel	HUMAN PRESCRIPTION DRUG LABEL	1	58468-0021	TABLET, FILM COATED	800 mg	ORAL	NDA	26 sections
SEVELAMER HYDROCHLORIDE	Human Prescription Drug Label	1	59651-087	TABLET, FILM COATED	400 mg	ORAL	ANDA	25 sections
SEVELAMER HYDROCHLORIDE	Human Prescription Drug Label	1	59651-088	TABLET, FILM COATED	800 mg	ORAL	ANDA	25 sections
Sevelamer Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	60687-449	TABLET, FILM COATED	800 mg	ORAL	ANDA	26 sections
Renagel	HUMAN PRESCRIPTION DRUG LABEL	1	67544-656	TABLET	800 mg	ORAL	NDA	24 sections
RENAGEL	HUMAN PRESCRIPTION DRUG LABEL	1	68151-4295	TABLET	400 mg	ORAL	NDA	27 sections
sevelamer hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	68462-446	TABLET, FILM COATED	400 mg	ORAL	ANDA	26 sections
sevelamer hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	68462-447	TABLET, FILM COATED	800 mg	PARENTERAL	ANDA	26 sections
Sevelamer hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	70748-172	TABLET	400 mg	ORAL	ANDA	23 sections
Sevelamer hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	70748-173	TABLET	800 mg	ORAL	ANDA	23 sections
sevelamer hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	72603-148	TABLET, FILM COATED	800 mg	ORAL	ANDA	26 sections