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

sevelamer 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

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
Crystal deposit intestine	219.00	25.83	28	3187	89	90625143
Calciphylaxis	198.65	25.83	41	3174	3335	90621897
Arteriovenous fistula site complication	99.47	25.83	17	3198	492	90624740
Peritonitis	61.65	25.83	24	3191	19681	90605551
Gastrointestinal injury	48.40	25.83	10	3205	814	90624418
Peritonitis bacterial	46.90	25.83	14	3201	5157	90620075
Pemphigoid	43.06	25.83	15	3200	9011	90616221
Dialysis	39.73	25.83	15	3200	11314	90613918
Death	39.12	25.83	63	3152	456488	90168744
Therapeutic drug monitoring analysis incorrectly performed	37.55	25.83	7	3208	334	90624898
Histology abnormal	35.94	25.83	6	3209	150	90625082
Hypocalcaemia	35.94	25.83	21	3194	42347	90582885
Microstomia	35.60	25.83	5	3210	37	90625195
Upper gastrointestinal haemorrhage	35.50	25.83	17	3198	22959	90602273
Shunt stenosis	34.09	25.83	7	3208	552	90624680
Brown tumour	33.90	25.83	5	3210	54	90625178
Oncocytoma	30.55	25.83	4	3211	16	90625216
Dermatitis bullous	30.27	25.83	12	3203	10304	90614928
Renal impairment	30.20	25.83	27	3188	105394	90519838
Hypervolaemia	29.81	25.83	17	3198	32740	90592492
Renal failure	28.84	25.83	29	3186	130978	90494254
Colitis ischaemic	28.19	25.83	12	3203	12334	90612898
Therapeutic drug monitoring analysis not performed	28.06	25.83	7	3208	1322	90623910
Shunt occlusion	26.35	25.83	6	3209	769	90624463
Sepsis	26.09	25.83	32	3183	179782	90445450

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
Crystal deposit intestine	296.98	18.41	42	4528	81	42616684
Arteriovenous fistula site complication	129.50	18.41	25	4545	460	42616305
Calciphylaxis	76.50	18.41	19	4551	1154	42615611
Peritonitis bacterial	53.38	18.41	22	4548	6893	42609872
Large intestinal ulcer	45.88	18.41	15	4555	2448	42614317
Product appearance confusion	44.45	18.41	7	4563	35	42616730
Shunt occlusion	44.42	18.41	12	4558	1015	42615750
Gastrointestinal injury	43.29	18.41	12	4558	1117	42615648
Hypervolaemia	42.43	18.41	28	4542	23097	42593668
Blood parathyroid hormone increased	41.07	18.41	13	4557	1914	42614851
Hospitalisation	41.02	18.41	45	4525	74285	42542480
Shunt stenosis	37.97	18.41	10	4560	767	42615998
Peritonitis	37.71	18.41	24	4546	18609	42598156
Ischaemic enteritis	37.04	18.41	6	4564	37	42616728
Hypogonadism	34.22	18.41	12	4558	2422	42614343
Tendon calcification	33.47	18.41	6	4564	72	42616693
Procalcitonin abnormal	28.80	18.41	7	4563	388	42616377
Hungry bone syndrome	27.89	18.41	6	4564	192	42616573
Colitis ischaemic	27.31	18.41	14	4556	7212	42609553
Dialysis	25.66	18.41	16	4554	11970	42604795
Pseudopolyp	25.15	18.41	6	4564	307	42616458
Large intestine perforation	23.68	18.41	14	4556	9522	42607243
Tumour lysis syndrome	22.85	18.41	19	4551	22212	42594553
Hyperkalaemia	22.72	18.41	35	4535	80423	42536342
Encephalomalacia	21.96	18.41	7	4563	1054	42615711
Rectal ulcer	21.24	18.41	7	4563	1171	42615594
International normalised ratio increased	21.24	18.41	26	4544	48142	42568623
Colitis	20.31	18.41	25	4545	46547	42570218
Gastrointestinal haemorrhage	20.24	18.41	37	4533	97689	42519076
Mucosal necrosis	19.86	18.41	4	4566	92	42616673
PO2 decreased	18.97	18.41	7	4563	1634	42615131
Melaena	18.86	18.41	22	4548	38724	42578041
Peritoneal cloudy effluent	18.84	18.41	5	4565	395	42616370

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
Crystal deposit intestine	498.25	19.61	69	7457	205	110581568
Arteriovenous fistula site complication	233.21	19.61	43	7483	987	110580786
Calciphylaxis	229.68	19.61	54	7472	4133	110577640
Gastrointestinal injury	91.13	19.61	22	7504	1881	110579892
Large intestinal ulcer	79.31	19.61	25	7501	5736	110576037
Peritonitis	77.99	19.61	40	7486	32567	110549206
Peritonitis bacterial	71.74	19.61	27	7499	10506	110571267
Shunt stenosis	71.05	19.61	17	7509	1399	110580374
Hospitalisation	62.91	19.61	62	7464	142431	110439342
Shunt occlusion	62.66	19.61	16	7510	1721	110580052
Dialysis	58.59	19.61	28	7498	19591	110562182
Hypervolaemia	55.14	19.61	37	7489	49423	110532350
Colitis ischaemic	55.05	19.61	26	7500	17724	110564049
Gastrointestinal haemorrhage	53.47	19.61	61	7465	165457	110416316
Blood parathyroid hormone increased	52.57	19.61	17	7509	4231	110577542
Colitis	44.17	19.61	44	7482	102279	110479494
Peritoneal cloudy effluent	43.52	19.61	10	7516	690	110581083
Histology abnormal	43.17	19.61	9	7517	394	110581379
Hypogonadism	41.93	19.61	12	7514	1982	110579791
Product appearance confusion	40.35	19.61	7	7519	112	110581661
Myoclonus	39.96	19.61	26	7500	32972	110548801
Hypocalcaemia	39.66	19.61	34	7492	65332	110516441
Hungry bone syndrome	38.82	19.61	8	7518	331	110581442
Death	37.12	19.61	118	7408	698751	109883022
End stage renal disease	36.46	19.61	21	7505	21452	110560321
Haematochezia	36.32	19.61	42	7484	115482	110466291
Peritoneal dialysis complication	34.84	19.61	11	7515	2535	110579238
Melaena	34.25	19.61	32	7494	68725	110513048
Brown tumour	33.27	19.61	6	7520	121	110581652
Microstomia	32.22	19.61	5	7521	38	110581735
Ischaemic enteritis	31.96	19.61	6	7520	152	110581621
Procalcitonin abnormal	31.72	19.61	7	7519	402	110581371
International normalised ratio increased	31.48	19.61	34	7492	86738	110495035
Tendon calcification	30.55	19.61	6	7520	194	110581579
Hyperphosphataemia	30.45	19.61	17	7509	16364	110565409
Calcinosis	29.62	19.61	10	7516	2842	110578931
Hyperkalaemia	29.39	19.61	41	7485	135755	110446018
Parathyroidectomy	28.26	19.61	6	7520	287	110581486
Therapeutic drug monitoring analysis incorrectly performed	27.86	19.61	7	7519	705	110581068
Oncocytoma	27.05	19.61	4	7522	21	110581752
Sepsis	27.00	19.61	65	7461	327281	110254492
Haemoglobin decreased	25.66	19.61	54	7472	248673	110333100
Pemphigoid	25.02	19.61	16	7510	19691	110562082
Tumour lysis syndrome	25.00	19.61	19	7507	30782	110550991
Hypotension	24.67	19.61	85	7441	523764	110058009
Nephrogenic systemic fibrosis	23.26	19.61	10	7516	5473	110576300
Encephalomalacia	22.69	19.61	7	7519	1495	110580278
Anaemia	22.55	19.61	85	7441	547001	110034772
Large intestine perforation	22.36	19.61	14	7512	16615	110565158
Nephrogenic anaemia	21.59	19.61	9	7517	4568	110577205
Blood creatinine increased	21.59	19.61	42	7484	182847	110398926
Therapeutic drug monitoring analysis not performed	20.96	19.61	7	7519	1924	110579849
Joint swelling	20.27	19.61	3	7523	442842	110138931
Intermittent claudication	19.92	19.61	8	7518	3693	110578080

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
CHEBI has role	CHEBI:231911	renoprotective agent
CHEBI has role	CHEBI:50864	insulin-sensitizing drug

Related Drugs by ATC class:

V03AE Drugs for treatment of hyperkalemia and hyperphosphatemia 10 drugs

calcium acetatecalcium acetate and magnesium carbonatecalcium polystyrene sulfonatecolestilanferric citratelanthanum carbonatepatiromer calciumsodium polystyrene sulfonatesodium zirconium cyclosilicatesucroferric oxyhydroxide

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:759084	CHEBI
CHEMBL5314349	ChEMBL_ID
CHEMBL1201492	ChEMBL_ID
D000069603	MESH_DESCRIPTOR_UI
DB00658	DRUGBANK_ID
7620	INN_ID
941N5DUU5C	UNII
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	0904-7209	TABLET, FILM COATED	800 mg	PARENTERAL	ANDA	25 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
sevelamer hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	55154-2647	TABLET, FILM COATED	800 mg	PARENTERAL	ANDA	25 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	25 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	25 sections
sevelamer hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	68462-447	TABLET, FILM COATED	800 mg	PARENTERAL	ANDA	25 sections
Sevelamer Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	70710-2058	TABLET, FILM COATED	800 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	72162-2500	TABLET, FILM COATED	400 mg	ORAL	ANDA	26 sections
Sevelamer Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	72162-2501	TABLET, FILM COATED	800 mg	ORAL	ANDA	26 sections
sevelamer hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	72603-148	TABLET, FILM COATED	800 mg	ORAL	ANDA	24 sections