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

Stem definition	Drug id	CAS RN
	4585	587-26-8

Description:

Molecule	Description
Synonyms: lanthanum carbonate fosrenol	a phosphate binder used for hyperphosphatemia treatment in end-stage renal disease Molecular weight: 457.84 Formula: C3La2O9 CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: 63.19 ALOGS: ROTB: None

Molecule

Description

Synonyms:

lanthanum carbonate
fosrenol

a phosphate binder used for hyperphosphatemia treatment in end-stage renal disease

Molecular weight: 457.84
Formula: C3La2O9
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA: 63.19
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
2.25	g	O

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Oct. 26, 2004	FDA	SHIRE LLC
Oct. 16, 2008	PMDA	Bayer Yakuhin

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
Shunt stenosis	340.88	23.89	51	2735	489	63485747
Shunt occlusion	249.24	23.89	40	2746	625	63485611
Nephrogenic systemic fibrosis	125.73	23.89	31	2755	4525	63481711
Blood phosphorus increased	79.73	23.89	20	2766	3125	63483111
Peritonitis	74.14	23.89	28	2758	17126	63469110
Skin induration	69.43	23.89	18	2768	3205	63483031
Blood parathyroid hormone increased	51.33	23.89	14	2772	3024	63483212
Skin hypertrophy	49.80	23.89	14	2772	3377	63482859
Skin tightness	46.47	23.89	14	2772	4302	63481934
Peripheral arterial occlusive disease	42.54	23.89	13	2773	4188	63482048
Skin fibrosis	40.12	23.89	9	2777	871	63485365
Death	37.15	23.89	62	2724	374319	63111917
Angina unstable	32.16	23.89	12	2774	7083	63479153
Hypocalcaemia	32.11	23.89	19	2767	31694	63454542
Shunt malfunction	31.13	23.89	5	2781	78	63486158
Joint contracture	29.38	23.89	8	2778	1716	63484520
Dialysis	27.68	23.89	12	2774	10415	63475821
Scar	27.51	23.89	13	2773	13769	63472467
Vomiting	27.20	23.89	69	2717	559548	62926688
Ileus	26.70	23.89	13	2773	14712	63471524
Peritonitis bacterial	24.88	23.89	9	2777	4870	63481366
Shunt infection	24.21	23.89	4	2782	75	63486161

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
Appendicolith	487.90	22.87	144	7290	8457	34941040
Shunt stenosis	427.07	22.87	82	7352	700	34948797
Appendicitis	426.39	22.87	148	7286	14659	34934838
Cardiogenic shock	335.51	22.87	146	7288	26472	34923025
Stress	323.43	22.87	148	7286	30199	34919298
Shunt occlusion	270.03	22.87	57	7377	813	34948684
Ascites	266.16	22.87	149	7285	46422	34903075
Abdominal distension	257.47	22.87	158	7276	58334	34891163
Ventricular fibrillation	244.56	22.87	112	7322	22842	34926655
Multiple organ dysfunction syndrome	198.34	22.87	149	7285	76417	34873080
Hyponatraemia	186.00	22.87	148	7286	82543	34866954
Constipation	167.54	22.87	174	7260	136808	34812689
General physical health deterioration	151.53	22.87	160	7274	128109	34821388
Abdominal pain	148.74	22.87	178	7256	163440	34786057
Sepsis	142.92	22.87	176	7258	166385	34783112
Vomiting	126.49	22.87	204	7230	247417	34702080
Dry mouth	106.38	22.87	71	7363	30094	34919403
Myasthenia gravis	90.27	22.87	39	7395	6901	34942596
X-ray abnormal	85.64	22.87	20	7414	461	34949036
Nausea	85.38	22.87	208	7226	339700	34609797
Blood uric acid increased	84.04	22.87	41	7393	9583	34939914
Peripheral arterial occlusive disease	76.36	22.87	33	7401	5841	34943656
Hyperphosphataemia	67.92	22.87	28	7406	4409	34945088
Drug therapy	51.28	22.87	16	7418	1125	34948372
Analgesic therapy	49.10	22.87	15	7419	983	34948514
Blood cholesterol increased	48.64	22.87	38	7396	20505	34928992
Product residue present	47.77	22.87	19	7415	2727	34946770
Incorrect route of product administration	47.67	22.87	33	7401	14812	34934685
Acute kidney injury	47.29	22.87	5	7429	304983	34644514
Nephrogenic systemic fibrosis	47.19	22.87	21	7413	3984	34945513
Shunt infection	45.37	22.87	9	7425	92	34949405
Sleep disorder therapy	44.53	22.87	14	7420	1009	34948488
Fatigue	39.21	22.87	15	7419	370638	34578859
X-ray gastrointestinal tract abnormal	37.28	22.87	5	7429	0	34949497
Blood phosphorus increased	36.76	22.87	22	7412	7699	34941798
Somnolence	36.60	22.87	76	7358	111040	34838457
Iron deficiency	35.55	22.87	19	7415	5362	34944135
Dialysis hypotension	34.70	22.87	6	7428	26	34949471
Haemoglobin increased	34.25	22.87	16	7418	3393	34946104
Peritonitis	33.90	22.87	28	7406	16337	34933160
Drug ineffective	32.19	22.87	30	7404	456721	34492776
Hyperparathyroidism secondary	31.34	22.87	12	7422	1556	34947941
Blood parathyroid hormone increased	28.17	22.87	11	7423	1503	34947994
Shunt aneurysm	28.17	22.87	5	7429	26	34949471
Aplasia pure red cell	27.97	22.87	17	7417	6115	34943382
Wrong technique in product usage process	27.45	22.87	36	7398	35950	34913547
Hypophosphataemia	27.41	22.87	21	7413	11005	34938492
Condition aggravated	27.05	22.87	96	7338	192100	34757397
Neuralgia	25.50	22.87	23	7411	15090	34934407
Bacterial infection	25.00	22.87	24	7410	17039	34932458
Hypocalcaemia	24.53	22.87	28	7406	24261	34925236
Gangrene	24.28	22.87	14	7420	4572	34944925
Mucosal atrophy	23.31	22.87	5	7429	77	34949420
Peritonitis bacterial	23.01	22.87	15	7419	6095	34943402

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
Shunt stenosis	756.48	20.85	133	9446	1258	79733551
Appendicolith	564.94	20.85	143	9436	8408	79726401
Shunt occlusion	494.56	20.85	94	9485	1410	79733399
Appendicitis	463.82	20.85	149	9430	20645	79714164
Cardiogenic shock	351.70	20.85	146	9433	41768	79693041
Ascites	278.04	20.85	149	9430	75413	79659396
Ventricular fibrillation	273.76	20.85	113	9466	31813	79702996
Stress	270.74	20.85	149	9430	79463	79655346
Abdominal distension	233.82	20.85	157	9422	119493	79615316
Multiple organ dysfunction syndrome	207.10	20.85	146	9433	120100	79614709
Sepsis	181.76	20.85	191	9388	269237	79465572
Hyponatraemia	164.58	20.85	150	9429	177698	79557111
Constipation	158.48	20.85	182	9397	282868	79451941
General physical health deterioration	152.43	20.85	176	9403	275062	79459747
Abdominal pain	142.97	20.85	203	9376	389366	79345443
Peripheral arterial occlusive disease	127.76	20.85	45	9534	8213	79726596
Vomiting	125.82	20.85	258	9321	665570	79069239
Nephrogenic systemic fibrosis	104.65	20.85	36	9543	6124	79728685
Myasthenia gravis	96.53	20.85	39	9540	10360	79724449
Hyperphosphataemia	92.01	20.85	33	9546	6343	79728466
Blood uric acid increased	90.32	20.85	40	9539	13320	79721489
Peritonitis	75.12	20.85	45	9534	27991	79706818
Product residue present	73.28	20.85	24	9555	3512	79731297
Dry mouth	73.07	20.85	70	9509	87949	79646860
Shunt infection	68.09	20.85	13	9566	199	79734610
Nausea	66.58	20.85	258	9321	956938	78777871
X-ray abnormal	65.18	20.85	25	9554	5788	79729021
Blood parathyroid hormone increased	61.90	20.85	21	9558	3424	79731385
Drug therapy	59.50	20.85	16	9563	1185	79733624
Analgesic therapy	57.41	20.85	15	9564	994	79733815
Fatigue	52.75	20.85	23	9556	929704	78805105
Skin induration	52.67	20.85	20	9559	4505	79730304
Sleep disorder therapy	52.42	20.85	14	9565	1010	79733799
Angina unstable	50.79	20.85	29	9550	16498	79718311
Blood phosphorus increased	48.33	20.85	24	9555	10323	79724486
Drug ineffective	48.13	20.85	36	9543	1080877	78653932
Incorrect route of product administration	47.80	20.85	37	9542	34892	79699917
Hypocalcaemia	47.78	20.85	43	9536	49881	79684928
Skin hypertrophy	47.52	20.85	19	9560	4909	79729900
Haemoglobin increased	46.79	20.85	20	9559	6112	79728697
X-ray gastrointestinal tract abnormal	45.73	20.85	6	9573	3	79734806
Shunt aneurysm	43.49	20.85	7	9572	36	79734773
Acute kidney injury	40.24	20.85	7	9572	519397	79215412
Somnolence	39.47	20.85	88	9491	238893	79495916
Cerebral infarction	39.16	20.85	37	9542	45639	79689170
Aplasia pure red cell	39.11	20.85	19	9560	7791	79727018
Shunt malfunction	36.07	20.85	8	9571	263	79734546
Skin tightness	35.61	20.85	16	9563	5506	79729303
Hyperparathyroidism secondary	35.50	20.85	13	9566	2647	79732162
Diverticulum intestinal haemorrhagic	33.66	20.85	14	9565	3997	79730812
Iron deficiency	33.55	20.85	19	9560	10635	79724174
Peritonitis bacterial	32.69	20.85	18	9561	9549	79725260
Mucosal atrophy	32.63	20.85	6	9573	74	79734735
Joint contracture	32.45	20.85	12	9567	2512	79732297
Ileus	32.07	20.85	26	9553	26185	79708624
Dialysis hypotension	31.93	20.85	6	9573	84	79734725
Hypophosphataemia	31.47	20.85	23	9556	19890	79714919
Gangrene	31.00	20.85	17	9562	8947	79725862
Dialysis	30.72	20.85	22	9557	18440	79716369
Wrong technique in product usage process	30.68	20.85	41	9538	73834	79660975
Bacterial infection	30.03	20.85	27	9552	31253	79703556
Shunt blood flow excessive	27.40	20.85	4	9575	9	79734800
Skin fibrosis	26.24	20.85	9	9570	1515	79733294
Large intestine polyp	25.51	20.85	17	9562	12691	79722118
Cardiac failure	25.51	20.85	57	9522	154785	79580024
Toxicity to various agents	24.50	20.85	10	9569	421530	79313279
Joint swelling	24.38	20.85	3	9576	288643	79446166
Blood cholesterol increased	23.96	20.85	39	9540	83681	79651128
Fibrosis	23.86	20.85	12	9567	5297	79729512
Sudden death	22.74	20.85	20	9559	22491	79712318
Gastric mucosal lesion	21.91	20.85	7	9572	946	79733863
Renal cyst infection	21.40	20.85	5	9574	208	79734601
Bezoar	21.28	20.85	9	9570	2679	79732130
Enterocolitis	21.22	20.85	16	9563	14496	79720313
Neuralgia	21.20	20.85	23	9556	33361	79701448
Weight increased	20.89	20.85	4	9575	277382	79457427

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	V03AE03	VARIOUS ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS Drugs for treatment of hyperkalemia and hyperphosphatemia

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

Disease	Relation	SNOMED_ID	DOID
Renal Osteodystrophy with Hyperphosphatemia	indication
Hyperphosphatemia associated with administration of FGFR inhibitor	indication
Constipation	contraindication	14760008	DOID:2089
Fecal impaction	contraindication	44635007
Intestinal obstruction	contraindication	81060008	DOID:8437
Gastrointestinal obstruction	contraindication	126765001

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 1GM BASE	FOSRENOL	TAKEDA PHARMS USA	N021468	Nov. 23, 2005	RX	TABLET, CHEWABLE	ORAL	7381428	Aug. 26, 2024	REDUCTION OF SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE
EQ 250MG BASE	FOSRENOL	TAKEDA PHARMS USA	N021468	Oct. 26, 2004	DISCN	TABLET, CHEWABLE	ORAL	7381428	Aug. 26, 2024	REDUCTION OF SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE
EQ 500MG BASE	FOSRENOL	TAKEDA PHARMS USA	N021468	Oct. 26, 2004	RX	TABLET, CHEWABLE	ORAL	7381428	Aug. 26, 2024	REDUCTION OF SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE
EQ 750MG BASE	FOSRENOL	TAKEDA PHARMS USA	N021468	Nov. 23, 2005	RX	TABLET, CHEWABLE	ORAL	7381428	Aug. 26, 2024	REDUCTION OF SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

None

External reference:

ID	Source
4021512	VUID
N0000179691	NUI
4021512	VANDF
CHEMBL2096647	ChEMBL_ID
C119467	MESH_SUPPLEMENTAL_RECORD_UI
DB06792	DRUGBANK_ID
490D9F069T	UNII
234416	RXNORM
18979	MMSL
35731	MMSL
62060	MMSL
79763	MMSL
d05395	MMSL
008767	NDDF
414570008	SNOMEDCT_US
414571007	SNOMEDCT_US
C0768119	UMLSCUI
168924	PUBCHEM_CID
54451-24-0	SECONDARY_CAS_RN

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Lanthanum carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5938	TABLET, CHEWABLE	500 mg	ORAL	ANDA	27 sections
Lanthanum carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5939	TABLET, CHEWABLE	750 mg	ORAL	ANDA	27 sections
Lanthanum carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	0093-5940	TABLET, CHEWABLE	1000 mg	ORAL	ANDA	27 sections
Fosrenol	HUMAN PRESCRIPTION DRUG LABEL	1	54092-252	TABLET, CHEWABLE	500 mg	ORAL	NDA	31 sections
Fosrenol	HUMAN PRESCRIPTION DRUG LABEL	1	54092-252	TABLET, CHEWABLE	500 mg	ORAL	NDA	31 sections
Fosrenol	HUMAN PRESCRIPTION DRUG LABEL	1	54092-253	TABLET, CHEWABLE	750 mg	ORAL	NDA	31 sections
Fosrenol	HUMAN PRESCRIPTION DRUG LABEL	1	54092-253	TABLET, CHEWABLE	750 mg	ORAL	NDA	31 sections
Fosrenol	HUMAN PRESCRIPTION DRUG LABEL	1	54092-254	TABLET, CHEWABLE	1000 mg	ORAL	NDA	31 sections
Fosrenol	HUMAN PRESCRIPTION DRUG LABEL	1	54092-254	TABLET, CHEWABLE	1000 mg	ORAL	NDA	31 sections
Fosrenol	HUMAN PRESCRIPTION DRUG LABEL	1	54092-256	POWDER	750 mg	ORAL	NDA	31 sections
Fosrenol	HUMAN PRESCRIPTION DRUG LABEL	1	54092-256	POWDER	750 mg	ORAL	NDA	31 sections
Fosrenol	HUMAN PRESCRIPTION DRUG LABEL	1	54092-257	POWDER	1000 mg	ORAL	NDA	31 sections
Fosrenol	HUMAN PRESCRIPTION DRUG LABEL	1	54092-257	POWDER	1000 mg	ORAL	NDA	31 sections
Lanthanum carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	66993-422	TABLET, CHEWABLE	500 mg	ORAL	NDA authorized generic	31 sections
Lanthanum carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	66993-422	TABLET, CHEWABLE	500 mg	ORAL	NDA authorized generic	31 sections
Lanthanum carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	66993-423	TABLET, CHEWABLE	750 mg	ORAL	NDA authorized generic	31 sections
Lanthanum carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	66993-423	TABLET, CHEWABLE	750 mg	ORAL	NDA authorized generic	31 sections
Lanthanum carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	66993-424	TABLET, CHEWABLE	1000 mg	ORAL	NDA authorized generic	31 sections
Lanthanum carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	66993-424	TABLET, CHEWABLE	1000 mg	ORAL	NDA authorized generic	31 sections
Lanthanum Carbonate	Human Prescription Drug Label	1	68180-819	TABLET, CHEWABLE	500 mg	ORAL	ANDA	26 sections
Lanthanum Carbonate	Human Prescription Drug Label	1	68180-820	TABLET, CHEWABLE	750 mg	ORAL	ANDA	26 sections
Lanthanum Carbonate	Human Prescription Drug Label	1	68180-821	TABLET, CHEWABLE	1000 mg	ORAL	ANDA	26 sections
Lanthanum carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	69097-934	TABLET, CHEWABLE	500 mg	ORAL	ANDA	30 sections
Lanthanum carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	69097-934	TABLET, CHEWABLE	500 mg	ORAL	ANDA	30 sections
Lanthanum carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	69097-935	TABLET, CHEWABLE	750 mg	ORAL	ANDA	30 sections
Lanthanum carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	69097-935	TABLET, CHEWABLE	750 mg	ORAL	ANDA	30 sections
Lanthanum carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	69097-936	TABLET, CHEWABLE	1000 mg	ORAL	ANDA	30 sections
Lanthanum carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	69097-936	TABLET, CHEWABLE	1000 mg	ORAL	ANDA	30 sections
Lanthanum carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	76282-476	TABLET, CHEWABLE	500 mg	ORAL	ANDA	30 sections
Lanthanum carbonate	HUMAN PRESCRIPTION DRUG LABEL	1	76282-476	TABLET, CHEWABLE	500 mg	ORAL	ANDA	30 sections