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

Stem definition	Drug id	CAS RN
calcium metabolism regulator, pharmaceutical aid	2387	105462-24-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: risedronate sodium hemi-pentahydrate risedronate sodium monohydrate risedronate sodium anhydrous risedronate sodium hydrate sodium risedronate sodium risedronate hydrate risedronic acid risedronate risedronate sodium actonel risedronic acid monosodium salt risedronic acid monohydrate	A pyridine and diphosphonic acid derivative that acts as a CALCIUM CHANNEL BLOCKER and inhibits BONE RESORPTION. Molecular weight: 283.11 Formula: C7H11NO7P2 CLOGP: -0.77 LIPINSKI: 0 HAC: 8 HDO: 5 TPSA: 148.18 ALOGS: -1.43 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

risedronate sodium hemi-pentahydrate
risedronate sodium monohydrate
risedronate sodium anhydrous
risedronate sodium hydrate
sodium risedronate
sodium risedronate hydrate
risedronic acid
risedronate
risedronate sodium
actonel
risedronic acid monosodium salt
risedronic acid monohydrate

A pyridine and diphosphonic acid derivative that acts as a CALCIUM CHANNEL BLOCKER and inhibits BONE RESORPTION.

Molecular weight: 283.11
Formula: C7H11NO7P2
CLOGP: -0.77
LIPINSKI: 0
HAC: 8
HDO: 5
TPSA: 148.18
ALOGS: -1.43
ROTB: 4

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
5	mg	O
5	mg	O

ADMET properties:

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Property	Value	Reference
EoM (Fraction excreted unchanged in urine)	87 %	Benet LZ, Broccatelli F, Oprea TI
Vd (Volume of distribution)	6.30 L/kg	Lombardo F, Berellini G, Obach RS
S (Water solubility)	5 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
t_half (Half-life)	200 hours	Lombardo F, Berellini G, Obach RS
CL (Clearance)	1.50 mL/min/kg	Lombardo F, Berellini G, Obach RS
BA (Bioavailability)	1 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
fu (Fraction unbound in plasma)	0.76 %	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	0.29 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

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Approvals:

Date	Agency	Company	Orphan
March 27, 1998	FDA	WARNER CHILCOTT LLC

FDA Adverse Event Reporting System (Female)

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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
Femur fracture	726.93	10.58	602	113676	41154	63333590
Atypical femur fracture	652.28	10.58	274	114004	5098	63369646
Low turnover osteopathy	437.42	10.58	192	114086	3993	63370751
Stress fracture	398.09	10.58	221	114057	7742	63367002
Osteonecrosis of jaw	365.21	10.58	380	113898	34743	63340001
Fracture displacement	284.65	10.58	101	114177	1160	63373584
Osteoarthritis	269.85	10.58	556	113722	94787	63279957
Rheumatoid arthritis	263.18	10.58	1027	113251	252792	63121952
Osteoporosis	248.21	10.58	402	113876	56936	63317808
Death	233.14	10.58	199	114079	374182	63000562

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FDA Adverse Event Reporting System (Male)

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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
Blood pressure systolic increased	111.56	13.68	90	16411	22862	34917568
Rheumatoid arthritis	94.65	13.68	103	16398	38135	34902295
Atypical femur fracture	81.90	13.68	21	16480	313	34940117
Sleep disorder due to general medical condition, insomnia type	71.73	13.68	26	16475	1290	34939140
Blood pressure increased	65.81	13.68	135	16366	87967	34852463
Heart rate decreased	62.50	13.68	76	16425	31669	34908761
Pemphigus	59.34	13.68	24	16477	1607	34938823
Impaired work ability	58.50	13.68	38	16463	6892	34933538
Body temperature decreased	54.77	13.68	47	16454	12987	34927443
Toxicity to various agents	50.34	13.68	16	16485	200346	34740084

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FDA Adverse Event Reporting System (Geriatric)

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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
Atypical femur fracture	590.31	11.17	234	109315	4955	79629884
Femur fracture	584.87	11.17	459	109090	38193	79596646
Rheumatoid arthritis	494.55	11.17	964	108585	207506	79427333
Stress fracture	397.54	11.17	189	109360	6291	79628548
Toxicity to various agents	322.64	11.17	90	109459	421450	79213389
Osteonecrosis of jaw	314.78	11.17	341	109208	42885	79591954
Fracture displacement	302.26	11.17	100	109449	1228	79633611
Low turnover osteopathy	299.43	11.17	110	109439	1876	79632963
Death	292.02	11.17	212	109337	566302	79068537
Completed suicide	289.45	11.17	11	109538	245756	79389083

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	M05BA07	MUSCULO-SKELETAL SYSTEM DRUGS FOR TREATMENT OF BONE DISEASES DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION Bisphosphonates
ATC	M05BB02	MUSCULO-SKELETAL SYSTEM DRUGS FOR TREATMENT OF BONE DISEASES DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION Bisphosphonates, combinations
ATC	M05BB04	MUSCULO-SKELETAL SYSTEM DRUGS FOR TREATMENT OF BONE DISEASES DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION Bisphosphonates, combinations
ATC	M05BB07	MUSCULO-SKELETAL SYSTEM DRUGS FOR TREATMENT OF BONE DISEASES DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION Bisphosphonates, combinations
FDA CS	M0006519	Diphosphonates
FDA EPC	N0000175579	Bisphosphonate
MeSH PA	D050071	Bone Density Conservation Agents
MeSH PA	D002121	Calcium Channel Blockers
MeSH PA	D000077264	Calcium-Regulating Hormones and Agents
MeSH PA	D002317	Cardiovascular Agents

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

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Disease	Relation	SNOMED_ID	DOID
Osteitis deformans	indication	2089002	DOID:5408
Osteoporosis	indication	64859006	DOID:11476
Postmenopausal osteoporosis	indication	102447009
Glucocorticoid Induced Osteoporosis	indication
Prevention of Glucocorticoid-Induced Osteoporosis	indication
Gastritis	contraindication	4556007	DOID:4029
Hypocalcemia	contraindication	5291005
Bone pain	contraindication	12584003
Constipation	contraindication	14760008	DOID:2089
Sarcoidosis	contraindication	31541009	DOID:11335

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	2.35	acidic
pKa2	6.42	acidic
pKa3	7.4	acidic
pKa4	11.47	acidic
pKa5	12.45	acidic
pKa6	4.27	Basic

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Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
150MG	ACTONEL	APIL	N020835	April 22, 2008	RX	TABLET	ORAL	7192938	May 6, 2023	PREVENTION AND TREATMENT OF OSTEOPOROSIS
150MG	ACTONEL	APIL	N020835	April 22, 2008	RX	TABLET	ORAL	7718634	May 6, 2023	TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
35MG	ATELVIA	APIL	N022560	Oct. 8, 2010	RX	TABLET, DELAYED RELEASE	ORAL	7645459	Jan. 9, 2028	TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
35MG	ATELVIA	APIL	N022560	Oct. 8, 2010	RX	TABLET, DELAYED RELEASE	ORAL	7645460	Jan. 9, 2028	TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Farnesyl pyrophosphate synthase	Enzyme	P14324	FPPS_HUMAN	INHIBITOR	Ki	9.44	CHEMBL	CHEMBL
Butyrophilin subfamily 3 member A1	Antibody	O00481	BT3A1_HUMAN		EC50	7.10	CHEMBL
Farnesyl pyrophosphate synthase	Enzyme		Q0GKD7_LEIDO		Ki	7.77	CHEMBL
Farnesyl diphosphate synthase	Enzyme		Q197X6_TOXGO		IC50	7.13	CHEMBL
Farnesyl diphosphate synthase	Enzyme		Q8WS26_TRYCR		IC50	7.57	CHEMBL
Farnesyl pyrophosphate synthase, EC 2.5.1.1, EC 2.5.1.10	Unclassified		Q4QBL1_LEIMA		Ki	7.80	CHEMBL

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External reference:

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ID	Source
RIS	PDB_CHEM_ID
007620	NDDF
007621	NDDF
107688	MMSL
115436-72-1	SECONDARY_CAS_RN
11659	MMSL
1269159002	SNOMEDCT_US
1356127	RXNORM
3176	IUPHAR_LIGAND_ID
329003-65-8	SECONDARY_CAS_RN

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Actonel	HUMAN PRESCRIPTION DRUG LABEL	2	0430-0470	TABLET, FILM COATED	25.80 mg	ORAL	NDA	31 sections
Actonel	HUMAN PRESCRIPTION DRUG LABEL	2	0430-0470	TABLET, FILM COATED	25.80 mg	ORAL	NDA	31 sections
Actonel	HUMAN PRESCRIPTION DRUG LABEL	2	0430-0470	TABLET, FILM COATED	4.20 mg	ORAL	NDA	31 sections
Actonel	HUMAN PRESCRIPTION DRUG LABEL	2	0430-0470	TABLET, FILM COATED	4.20 mg	ORAL	NDA	31 sections
Actonel	HUMAN PRESCRIPTION DRUG LABEL	2	0430-0471	TABLET, FILM COATED	0.70 mg	ORAL	NDA	31 sections
Actonel	HUMAN PRESCRIPTION DRUG LABEL	2	0430-0471	TABLET, FILM COATED	4.30 mg	ORAL	NDA	31 sections
Actonel	HUMAN PRESCRIPTION DRUG LABEL	2	0430-0471	TABLET, FILM COATED	4.30 mg	ORAL	NDA	31 sections
Actonel	HUMAN PRESCRIPTION DRUG LABEL	2	0430-0471	TABLET, FILM COATED	0.70 mg	ORAL	NDA	31 sections
Actonel	HUMAN PRESCRIPTION DRUG LABEL	2	0430-0472	TABLET, FILM COATED	30.10 mg	ORAL	NDA	31 sections
Actonel	HUMAN PRESCRIPTION DRUG LABEL	2	0430-0472	TABLET, FILM COATED	30.10 mg	ORAL	NDA	31 sections

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