risedronic acid 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: -2.62 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: -2.62
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:

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

Approvals:

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

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
Femur fracture	2208.03	31.20	444	2657	6295	2348689
Arthralgia	1140.54	31.20	406	2695	53879	2301105
Fall	1117.65	31.20	386	2715	46713	2308271
Atypical femur fracture	1105.21	31.20	188	2913	914	2354070
Low turnover osteopathy	971.42	31.20	168	2933	913	2354071
Stress fracture	968.47	31.20	172	2929	1117	2353867
Osteonecrosis	820.45	31.20	202	2899	7140	2347844
Pain in extremity	749.46	31.20	281	2820	42259	2312725
Osteonecrosis of jaw	743.66	31.20	190	2911	7806	2347178
Pathological fracture	684.53	31.20	128	2973	1136	2353848
Osteoporosis	660.64	31.20	154	2947	4260	2350724
Bone disorder	644.39	31.20	143	2958	3149	2351835
Osteoarthritis	581.55	31.20	152	2949	6794	2348190
Fracture displacement	578.74	31.20	83	3018	77	2354907
Impaired healing	563.65	31.20	141	2960	5270	2349714
Gastrooesophageal reflux disease	531.82	31.20	150	2951	8945	2346039
Osteomyelitis	512.82	31.20	121	2980	3512	2351472
Jaw disorder	506.81	31.20	100	3001	1201	2353783
Myalgia	440.55	31.20	163	2938	23170	2331814
Back pain	423.08	31.20	172	2929	31487	2323497
Pain	414.04	31.20	207	2894	61650	2293334
Bone pain	408.40	31.20	122	2979	8874	2346110
Pain in jaw	403.46	31.20	112	2989	6260	2348724
Fracture nonunion	371.72	31.20	67	3034	469	2354515
Gait disturbance	361.82	31.20	140	2961	22405	2332579
Foot fracture	350.77	31.20	85	3016	2753	2352231
Condition aggravated	347.17	31.20	150	2951	31829	2323155
Fracture delayed union	308.66	31.20	53	3048	268	2354716
Tooth disorder	305.03	31.20	82	3019	4041	2350943
Dental caries	299.25	31.20	69	3032	1791	2353193
Arthritis	296.64	31.20	98	3003	9870	2345114
Drug ineffective	295.91	31.20	198	2903	101426	2253558
Depression	292.07	31.20	128	2973	28004	2326980
Hypertension	288.92	31.20	126	2975	27235	2327749
Tooth extraction	288.14	31.20	72	3029	2648	2352336
Bursitis	276.35	31.20	65	3036	1843	2353141
Rheumatoid arthritis	275.50	31.20	110	2991	19030	2335954
Nausea	266.52	31.20	193	2908	111996	2242988
Tooth fracture	259.97	31.20	61	3040	1710	2353274
Oedema peripheral	252.52	31.20	110	2991	23653	2331331
Spinal osteoarthritis	244.71	31.20	58	3043	1699	2353285
Drug hypersensitivity	244.46	31.20	133	2968	46510	2308474
Bone sequestrum	236.72	31.20	44	3057	371	2354613
Arthropathy	233.89	31.20	76	3025	7240	2347744
Osteoporotic fracture	229.38	31.20	42	3059	323	2354661
Chest pain	225.42	31.20	107	2994	28030	2326954
Anaemia postoperative	223.39	31.20	43	3058	445	2354539
Vitamin D deficiency	221.40	31.20	52	3049	1462	2353522
Mobility decreased	216.16	31.20	75	3026	8735	2346249
Dyspepsia	215.57	31.20	77	3024	9767	2345217
Bedridden	213.68	31.20	50	3051	1382	2353602
Intramedullary rod insertion	213.39	31.20	44	3057	662	2354322
Hiatus hernia	209.83	31.20	53	3048	2031	2352953
Groin pain	200.70	31.20	47	3054	1303	2353681
Tooth abscess	200.07	31.20	51	3050	2028	2352956
Periodontal disease	193.61	31.20	37	3064	367	2354617
Fracture	190.94	31.20	52	3049	2679	2352305
Dysphagia	188.82	31.20	75	3026	12730	2342254
Device failure	188.18	31.20	47	3054	1718	2353266
Hyperlipidaemia	182.68	31.20	50	3051	2624	2352360
Anaemia	181.28	31.20	99	3002	34693	2320291
Lower limb fracture	180.49	31.20	47	3054	2034	2352950
Anxiety	179.60	31.20	93	3008	29266	2325718
Resorption bone increased	179.15	31.20	32	3069	210	2354774
Asthenia	179.14	31.20	109	2992	46817	2308167
Purulent discharge	177.07	31.20	39	3062	814	2354170
Diverticulum	175.89	31.20	43	3058	1436	2353548
Loss of personal independence in daily activities	172.99	31.20	56	3045	5255	2349729
Abdominal discomfort	169.60	31.20	76	3025	17380	2337604
Toothache	169.34	31.20	47	3054	2597	2352387
Headache	169.30	31.20	129	2972	80050	2274934
Osteopenia	169.25	31.20	44	3057	1891	2353093
Exostosis	168.64	31.20	41	3060	1337	2353647
Gingivitis	167.38	31.20	41	3060	1380	2353604
Drug intolerance	166.84	31.20	70	3031	13647	2341337
Vomiting	161.72	31.20	120	2981	71482	2283502
Hypothyroidism	161.60	31.20	51	3050	4406	2350578
Synovitis	158.82	31.20	45	3056	2681	2352303
Infection	157.80	31.20	73	3028	17956	2337028
Bone erosion	157.79	31.20	33	3068	533	2354451
Spinal fracture	157.33	31.20	45	3056	2774	2352210
Musculoskeletal pain	154.59	31.20	62	3039	10768	2344216
Dizziness	152.16	31.20	107	2994	58558	2296426
Fatigue	152.06	31.20	124	2977	84749	2270235
Pyrexia	151.10	31.20	103	2998	53605	2301379
Nodule	149.13	31.20	41	3060	2185	2352799
Muscular weakness	148.29	31.20	66	3035	14831	2340153
Joint swelling	146.84	31.20	68	3033	16751	2338233
Periodontitis	146.45	31.20	32	3069	642	2354342
Comminuted fracture	146.29	31.20	23	3078	58	2354926
Atypical fracture	145.72	31.20	25	3076	125	2354859
Tooth loss	144.10	31.20	36	3065	1315	2353669
Muscle spasms	139.48	31.20	71	3030	21495	2333489
Cellulitis	139.38	31.20	55	3046	9146	2345838
Pelvic fracture	138.50	31.20	35	3066	1340	2353644
Hypercholesterolaemia	137.65	31.20	36	3065	1582	2353402
C-reactive protein increased	137.04	31.20	49	3052	6206	2348778
Bone density decreased	133.68	31.20	34	3067	1336	2353648
Intervertebral disc degeneration	133.04	31.20	35	3066	1574	2353410
Oral pain	132.01	31.20	41	3060	3356	2351628
Oesophagitis	129.98	31.20	36	3065	1970	2353014
Loose tooth	129.53	31.20	29	3072	653	2354331
Open reduction of fracture	129.13	31.20	26	3075	344	2354640
Urinary tract infection	125.50	31.20	74	3027	29868	2325116
Carpal tunnel syndrome	125.07	31.20	35	3066	1990	2352994
Renal cyst	124.63	31.20	31	3070	1111	2353873
Muscle fatigue	122.26	31.20	25	3076	359	2354625
Hypoaesthesia	120.42	31.20	63	3038	20152	2334832
Rotator cuff syndrome	119.38	31.20	33	3068	1792	2353192
Malaise	118.17	31.20	90	3011	55495	2299489
Cataract	117.13	31.20	43	3058	5865	2349119
Oral infection	117.10	31.20	28	3073	848	2354136
Hypersensitivity	116.74	31.20	65	3036	23528	2331456
Constipation	116.41	31.20	63	3038	21566	2333418
Bone graft	115.09	31.20	22	3079	218	2354766
Mouth ulceration	114.21	31.20	38	3063	3874	2351110
Chronic sinusitis	112.64	31.20	25	3076	540	2354444
Insomnia	108.70	31.20	64	3037	25723	2329261
Cough	108.59	31.20	70	3031	33047	2321937
Gingival disorder	108.21	31.20	25	3076	650	2354334
Chills	105.71	31.20	53	3048	15499	2339485
Dental fistula	104.17	31.20	19	3082	142	2354842
Therapeutic product effect variable	103.82	31.20	19	3082	145	2354839
Abdominal pain	103.77	31.20	69	3032	34305	2320679
Fistula discharge	103.48	31.20	20	3081	211	2354773
Asthma	102.56	31.20	47	3054	11267	2343717
Bone loss	102.53	31.20	23	3078	522	2354462
Dyspnoea	102.32	31.20	96	3005	78637	2276347
Exostosis of jaw	102.08	31.20	21	3080	311	2354673
Diarrhoea	101.22	31.20	98	3003	83466	2271518
Sleep apnoea syndrome	101.16	31.20	30	3071	2096	2352888
Jaw fracture	100.11	31.20	22	3079	453	2354531
Device breakage	99.56	31.20	28	3073	1619	2353365
Oral disorder	98.98	31.20	27	3074	1394	2353590
Gingival swelling	98.49	31.20	24	3077	788	2354196
Decreased appetite	96.97	31.20	62	3039	28829	2326155
Temporomandibular joint syndrome	96.97	31.20	23	3078	672	2354312
Limb asymmetry	95.61	31.20	18	3083	163	2354821
Immobile	94.67	31.20	22	3079	587	2354397
Scoliosis	93.91	31.20	24	3077	960	2354024
Pubis fracture	93.71	31.20	20	3081	357	2354627
Adverse drug reaction	93.03	31.20	40	3061	8243	2346741
Eczema	93.01	31.20	31	3070	3174	2351810
Joint range of motion decreased	91.84	31.20	27	3074	1829	2353155
Emphysema	91.58	31.20	24	3077	1061	2353923
Tendonitis	91.22	31.20	28	3073	2199	2352785
Gingival pain	90.76	31.20	24	3077	1099	2353885
Tooth infection	90.28	31.20	27	3074	1941	2353043
Neck pain	89.17	31.20	38	3063	7659	2347325
Blood alkaline phosphatase increased	88.23	31.20	36	3065	6509	2348475
Rib fracture	87.11	31.20	28	3073	2557	2352427
Intervertebral disc protrusion	86.60	31.20	29	3072	3012	2351972
Ankle fracture	86.54	31.20	27	3074	2238	2352746
Gastritis	85.83	31.20	32	3069	4549	2350435
Abdominal pain upper	85.67	31.20	52	3049	22048	2332936
Vertigo	85.08	31.20	39	3062	9345	2345639
Gait inability	84.54	31.20	34	3067	5921	2349063
Abscess jaw	84.08	31.20	18	3083	326	2354658
General physical health deterioration	83.92	31.20	44	3057	14095	2340889
Red blood cell sedimentation rate increased	83.85	31.20	26	3075	2111	2352873
Osteogenesis imperfecta	83.35	31.20	14	3087	60	2354924
Gingival ulceration	82.84	31.20	16	3085	168	2354816
Bone fragmentation	82.60	31.20	15	3086	109	2354875
Hepatitis	82.50	31.20	34	3067	6303	2348681
Osteitis	81.85	31.20	20	3081	664	2354320
Swelling face	81.53	31.20	38	3063	9455	2345529
Oral cavity fistula	81.51	31.20	16	3085	184	2354800
Hysterectomy	81.48	31.20	24	3077	1636	2353348
Musculoskeletal chest pain	81.14	31.20	26	3075	2350	2352634
Eye pain	80.21	31.20	31	3070	4860	2350124
Sinusitis	80.20	31.20	45	3056	16481	2338503
Periprosthetic fracture	80.15	31.20	14	3087	79	2354905
Iron deficiency anaemia	80.10	31.20	25	3076	2074	2352910
Spinal disorder	79.67	31.20	22	3079	1188	2353796
Gastric ulcer	78.94	31.20	27	3074	2989	2351995
Hypercalcaemia	78.92	31.20	26	3075	2566	2352418
Tibia fracture	78.66	31.20	20	3081	783	2354201
Joint effusion	78.51	31.20	22	3079	1254	2353730
Femoral neck fracture	78.12	31.20	22	3079	1277	2353707
Adverse event	76.29	31.20	34	3067	7625	2347359
Chronic obstructive pulmonary disease	75.60	31.20	33	3068	7044	2347940
White blood cell count increased	75.60	31.20	33	3068	7045	2347939
Ligament sprain	75.54	31.20	22	3079	1441	2353543
Bruxism	75.07	31.20	19	3082	730	2354254
Palpitations	74.97	31.20	43	3058	16413	2338571
Therapeutic product effect incomplete	74.78	31.20	37	3064	10494	2344490
Gastrointestinal disorder	74.42	31.20	35	3066	8882	2346102
Nasal polyps	74.30	31.20	15	3086	201	2354783
Weight decreased	73.80	31.20	52	3049	28319	2326665
Atrial fibrillation	73.69	31.20	40	3061	13728	2341256
Aortic arteriosclerosis	73.24	31.20	18	3083	612	2354372
Foot deformity	73.02	31.20	23	3078	1966	2353018
Osteosclerosis	72.72	31.20	16	3085	331	2354653
Spondylolisthesis	72.49	31.20	17	3084	472	2354512
Obstructive airways disorder	72.45	31.20	21	3080	1352	2353632
Muscle strain	72.26	31.20	20	3081	1089	2353895
Sinusitis fungal	71.76	31.20	13	3088	93	2354891
Skeletal injury	71.64	31.20	15	3086	243	2354741
Sciatica	71.52	31.20	23	3078	2102	2352882
Blood cholesterol increased	71.21	31.20	29	3072	5212	2349772
Spinal compression fracture	70.43	31.20	22	3079	1829	2353155
Weight increased	70.11	31.20	46	3055	22291	2332693
Inflammation	69.72	31.20	30	3071	6183	2348801
Gamma-glutamyltransferase increased	69.54	31.20	29	3072	5533	2349451
Hyperaesthesia teeth	69.45	31.20	16	3085	410	2354574
Mastication disorder	68.87	31.20	16	3085	426	2354558
Barrett's oesophagus	68.75	31.20	15	3086	298	2354686
Tricuspid valve incompetence	68.57	31.20	21	3080	1635	2353349
Balance disorder	68.47	31.20	34	3067	9713	2345271
Radius fracture	68.37	31.20	17	3084	607	2354377
Angina pectoris	67.97	31.20	26	3075	3961	2351023
Salpingo-oophorectomy unilateral	67.84	31.20	10	3091	13	2354971
Synovial cyst	67.48	31.20	18	3083	852	2354132
Contraindicated product administered	67.36	31.20	24	3077	2997	2351987
Loss of consciousness	67.19	31.20	42	3059	18725	2336259
Blood urea increased	66.85	31.20	25	3076	3580	2351404
Irritable bowel syndrome	66.38	31.20	21	3080	1820	2353164
Interstitial lung disease	66.22	31.20	31	3070	7781	2347203
Ulna fracture	66.12	31.20	14	3087	240	2354744
Haematocrit decreased	65.96	31.20	26	3075	4292	2350692
Fracture malunion	65.70	31.20	11	3090	46	2354938
Sputum increased	64.97	31.20	13	3088	166	2354818
Facial pain	64.34	31.20	19	3082	1306	2353678
Cataract operation	64.07	31.20	17	3084	788	2354196
Musculoskeletal stiffness	63.91	31.20	35	3066	12212	2342772
Limb injury	63.85	31.20	22	3079	2488	2352496
Chest discomfort	63.43	31.20	37	3064	14558	2340426
Calcium deficiency	63.21	31.20	13	3088	192	2354792
Diastolic dysfunction	62.98	31.20	16	3085	624	2354360
Humerus fracture	62.74	31.20	18	3083	1117	2353867
Multiple fractures	62.61	31.20	16	3085	639	2354345
Gingival recession	62.55	31.20	14	3087	314	2354670
Contusion	62.44	31.20	35	3066	12775	2342209
Deep vein thrombosis	62.13	31.20	35	3066	12897	2342087
Atrophy	62.05	31.20	14	3087	326	2354658
Bone lesion	62.04	31.20	16	3085	663	2354321
Respiratory symptom	61.94	31.20	13	3088	213	2354771
Hyperparathyroidism	61.82	31.20	15	3086	483	2354501
Hip arthroplasty	61.70	31.20	20	3081	1874	2353110
Cardiomegaly	60.95	31.20	21	3080	2375	2352609
Bone marrow oedema	60.89	31.20	12	3089	141	2354843
Acute kidney injury	60.55	31.20	46	3055	28076	2326908
Dental necrosis	59.86	31.20	11	3090	86	2354898
Swelling	59.55	31.20	37	3064	16313	2338671
Red blood cell count decreased	59.30	31.20	24	3077	4242	2350742
Paraesthesia	58.59	31.20	41	3060	22047	2332937
Haemoglobin decreased	58.45	31.20	38	3063	18113	2336871
Joint dislocation	58.31	31.20	18	3083	1438	2353546
Blood loss anaemia	58.14	31.20	17	3084	1128	2353856
Haemorrhoids	57.91	31.20	20	3081	2277	2352707
Aspartate aminotransferase increased	57.53	31.20	33	3068	12579	2342405
Hip fracture	56.99	31.20	24	3077	4688	2350296
Joint injury	56.86	31.20	20	3081	2404	2352580
Embolism venous	56.62	31.20	13	3088	328	2354656
Liver disorder	56.05	31.20	26	3075	6388	2348596
Dry mouth	55.63	31.20	28	3073	8225	2346759
Type V hyperlipidaemia	54.55	31.20	10	3091	77	2354907
Nephrolithiasis	54.48	31.20	23	3078	4520	2350464
Large intestine polyp	54.42	31.20	16	3085	1082	2353902
Meniscus injury	54.42	31.20	16	3085	1082	2353902
Pulpitis dental	53.57	31.20	11	3090	161	2354823
Influenza like illness	53.39	31.20	31	3070	12083	2342901
Jaundice	53.39	31.20	24	3077	5484	2349500
Trismus	53.31	31.20	15	3086	867	2354117
Abscess	53.01	31.20	19	3082	2412	2352572
Oesophageal stenosis	52.97	31.20	13	3088	439	2354545
Hypotension	52.70	31.20	45	3056	32391	2322593
Gastrointestinal haemorrhage	52.64	31.20	31	3070	12404	2342580
Uveitis	52.48	31.20	17	3084	1588	2353396
Metaphyseal corner fracture	52.38	31.20	7	3094	1	2354983
Gingival bleeding	52.22	31.20	18	3083	2037	2352947
Malocclusion	52.11	31.20	9	3092	47	2354937
Female genital tract fistula	52.01	31.20	13	3088	474	2354510
Herpes zoster	51.29	31.20	28	3073	9697	2345287
Walking aid user	51.19	31.20	14	3087	728	2354256
Vertebral foraminal stenosis	50.78	31.20	10	3091	117	2354867
Pre-existing condition improved	50.70	31.20	13	3088	526	2354458
Cerumen impaction	50.53	31.20	11	3090	216	2354768
Impaired work ability	50.48	31.20	17	3084	1793	2353191
Spinal stenosis	50.39	31.20	16	3085	1402	2353582
Patellofemoral pain syndrome	50.39	31.20	10	3091	122	2354862
Joint stiffness	50.36	31.20	21	3080	4002	2350982
Candida infection	49.91	31.20	19	3082	2854	2352130
Blood lactate dehydrogenase increased	49.79	31.20	20	3081	3464	2351520
Diverticulitis	49.65	31.20	21	3080	4144	2350840
Fibrocystic breast disease	49.52	31.20	11	3090	238	2354746
Abdominal distension	49.51	31.20	28	3073	10383	2344601
Dehydration	49.14	31.20	37	3064	22258	2332726
Weight bearing difficulty	48.62	31.20	12	3089	415	2354569
Cholecystectomy	48.18	31.20	16	3085	1616	2353368
Fibromyalgia	47.36	31.20	19	3082	3281	2351703
Wrist fracture	47.33	31.20	16	3085	1707	2353277
Wound dehiscence	47.28	31.20	13	3088	690	2354294
Parkinson's disease	47.28	31.20	15	3086	1311	2353673
Procedural pain	47.25	31.20	16	3085	1716	2353268
Oral herpes	47.22	31.20	17	3084	2185	2352799
Medical device removal	47.18	31.20	12	3089	470	2354514
Wheezing	46.99	31.20	23	3078	6361	2348623
Radiculopathy	46.76	31.20	13	3088	719	2354265
Essential hypertension	46.74	31.20	12	3089	488	2354496
Hand fracture	46.69	31.20	13	3088	723	2354261
Sleep disorder	46.63	31.20	23	3078	6466	2348518
Oesophageal ulcer	46.56	31.20	13	3088	730	2354254
Fungal infection	46.42	31.20	21	3080	4868	2350116
Lymphadenopathy	46.39	31.20	22	3079	5676	2349308
Agranulocytosis	46.37	31.20	19	3082	3463	2351521
Dyspnoea exertional	46.31	31.20	22	3079	5698	2349286
Uterine disorder	45.96	31.20	12	3089	522	2354462
Stomatitis	45.86	31.20	26	3075	9684	2345300
Road traffic accident	45.70	31.20	20	3081	4288	2350696
Tenderness	45.65	31.20	16	3085	1902	2353082
Heart rate irregular	45.60	31.20	17	3084	2410	2352574
Exposed bone in jaw	45.20	31.20	13	3088	813	2354171
Cholestasis	45.15	31.20	19	3082	3702	2351282
Mitral valve incompetence	44.78	31.20	17	3084	2533	2352451
Breast disorder	44.58	31.20	11	3090	380	2354604
Therapeutic response unexpected	44.48	31.20	19	3082	3840	2351144
Alanine aminotransferase increased	44.23	31.20	29	3072	14003	2340981
Pulmonary fibrosis	44.21	31.20	17	3084	2623	2352361
Rash	44.02	31.20	54	3047	59504	2295480
Syncope	43.97	31.20	31	3070	16844	2338140
Hypophagia	43.83	31.20	19	3082	3981	2351003
Intervertebral disc disorder	43.78	31.20	12	3089	629	2354355
Hepatic cyst	43.38	31.20	12	3089	651	2354333
Cerebrovascular accident	43.37	31.20	33	3068	20153	2334831
Lacrimation increased	43.06	31.20	17	3084	2813	2352171
Blood albumin decreased	42.82	31.20	15	3086	1780	2353204
Urinary incontinence	42.79	31.20	19	3082	4214	2350770
Sacroiliitis	42.76	31.20	10	3091	274	2354710
Plantar fasciitis	42.64	31.20	11	3090	456	2354528
Knee arthroplasty	42.46	31.20	17	3084	2918	2352066
Hepatic cirrhosis	42.46	31.20	16	3085	2337	2352647
Cholangiocarcinoma	42.40	31.20	9	3092	156	2354828
Endodontic procedure	42.18	31.20	11	3090	476	2354508
Fractured sacrum	42.11	31.20	10	3091	293	2354691
Lumbar radiculopathy	42.08	31.20	10	3091	294	2354690
Scleritis	41.95	31.20	10	3091	298	2354686
Rhinitis allergic	41.76	31.20	12	3089	748	2354236
Rheumatoid factor positive	41.64	31.20	11	3090	501	2354483
Blood bilirubin increased	41.57	31.20	20	3081	5325	2349659
Adjustment disorder	41.28	31.20	9	3092	178	2354806
Carotid artery stenosis	41.15	31.20	12	3089	788	2354196
Monocyte count increased	41.01	31.20	11	3090	531	2354453
Gastric ulcer haemorrhage	40.58	31.20	12	3089	828	2354156
Glaucoma	40.55	31.20	15	3086	2080	2352904
Anti-cyclic citrullinated peptide antibody positive	40.54	31.20	9	3092	194	2354790
Sinus disorder	40.44	31.20	16	3085	2662	2352322
Bronchitis	39.98	31.20	27	3074	13687	2341297
Vitamin B12 decreased	39.94	31.20	10	3091	367	2354617
Hypoaesthesia oral	39.93	31.20	15	3086	2171	2352813
Fistula	39.93	31.20	14	3087	1665	2353319
Pulmonary embolism	39.81	31.20	30	3071	18053	2336931
Actinic keratosis	39.76	31.20	10	3091	374	2354610
Cystocele	39.58	31.20	9	3092	217	2354767
Coronary artery disease	39.57	31.20	20	3081	5919	2349065
Injury	39.52	31.20	20	3081	5934	2349050
Oedema	39.44	31.20	24	3077	10179	2344805
Restless legs syndrome	39.38	31.20	15	3086	2256	2352728
Haematoma	39.33	31.20	19	3082	5102	2349882
Mitral valve prolapse	39.23	31.20	10	3091	395	2354589
Blood pressure increased	39.22	31.20	29	3072	16957	2338027
Dysstasia	39.00	31.20	16	3085	2923	2352061
Carotid bruit	38.65	31.20	8	3093	122	2354862
Bone fissure	38.64	31.20	7	3094	50	2354934
Osteomyelitis chronic	38.59	31.20	8	3093	123	2354861
Pneumonia	38.52	31.20	46	3055	49250	2305734
Diverticulum intestinal	38.51	31.20	11	3090	671	2354313
Myocardial infarction	38.47	31.20	30	3071	18983	2336001
Actinomycosis	38.46	31.20	9	3092	247	2354737
Pollakiuria	38.42	31.20	17	3084	3739	2351245
Oroantral fistula	38.17	31.20	7	3094	54	2354930
Monoclonal gammopathy	38.06	31.20	8	3093	132	2354852
Varicose vein	37.21	31.20	11	3090	758	2354226
Fibula fracture	36.96	31.20	10	3091	499	2354485
Skin laceration	36.95	31.20	15	3086	2667	2352317
Ill-defined disorder	36.86	31.20	16	3085	3362	2351622
Red blood cell sedimentation rate abnormal	36.69	31.20	10	3091	513	2354471
Neutrophilia	36.62	31.20	10	3091	517	2354467
Disease recurrence	36.53	31.20	16	3085	3435	2351549
Visual impairment	36.32	31.20	24	3077	11731	2343253
Blood creatine phosphokinase increased	36.29	31.20	18	3083	5118	2349866
Type 2 diabetes mellitus	36.28	31.20	14	3087	2180	2352804
Hepatic function abnormal	36.21	31.20	19	3082	6073	2348911
Edentulous	36.10	31.20	7	3094	75	2354909
Kyphosis	35.57	31.20	9	3092	345	2354639
Aortic valve incompetence	35.56	31.20	11	3090	884	2354100
Post procedural complication	35.56	31.20	15	3086	2939	2352045
Gastric disorder	35.42	31.20	16	3085	3694	2351290
Lower respiratory tract infection	35.36	31.20	18	3083	5406	2349578
Glucose tolerance impaired	35.22	31.20	10	3091	597	2354387
Joint noise	34.95	31.20	10	3091	614	2354370
Purulence	34.84	31.20	9	3092	375	2354609
Hypocalcaemia	34.72	31.20	16	3085	3867	2351117
Ulcer	34.70	31.20	13	3088	1867	2353117
Cerebral thrombosis	34.70	31.20	9	3092	381	2354603
Odynophagia	34.67	31.20	11	3090	961	2354023
Scar	34.46	31.20	13	3088	1904	2353080
Dry eye	34.43	31.20	16	3085	3940	2351044
Skin lesion	34.17	31.20	16	3085	4009	2350975
Oral candidiasis	34.14	31.20	13	3088	1952	2353032
Head injury	34.13	31.20	16	3085	4018	2350966
Lumbar spinal stenosis	33.85	31.20	10	3091	687	2354297
Vitamin D decreased	33.72	31.20	11	3090	1050	2353934
Basal cell carcinoma	33.53	31.20	14	3087	2673	2352311
Upper limb fracture	33.35	31.20	14	3087	2709	2352275
Lichen planus	33.31	31.20	9	3092	447	2354537
Night sweats	33.11	31.20	15	3086	3485	2351499
Bone formation decreased	32.98	31.20	6	3095	44	2354940
Blood calcium decreased	32.96	31.20	13	3088	2145	2352839
Visual acuity reduced	32.85	31.20	17	3084	5281	2349703
Back disorder	32.82	31.20	12	3089	1610	2353374
Gallbladder disorder	32.81	31.20	14	3087	2820	2352164
Acute sinusitis	32.77	31.20	9	3092	475	2354509
Seasonal allergy	32.76	31.20	12	3089	1618	2353366
Abscess oral	32.65	31.20	8	3093	268	2354716
Diabetes mellitus	32.53	31.20	19	3082	7476	2347508
Abdominal pain lower	32.35	31.20	14	3087	2919	2352065
Appendicectomy	32.29	31.20	9	3092	502	2354482
Eating disorder	32.26	31.20	13	3088	2268	2352716
Renal failure	32.14	31.20	26	3075	17323	2337661
Neuropathy peripheral	32.10	31.20	22	3079	11410	2343574
Tooth discolouration	31.99	31.20	8	3093	292	2354692
Viral infection	31.89	31.20	16	3085	4660	2350324
Gingival abscess	31.84	31.20	7	3094	144	2354840
Polyarthritis	31.60	31.20	10	3091	866	2354118
Glossitis	31.51	31.20	9	3092	549	2354435
Cholelithiasis	31.39	31.20	17	3084	5786	2349198
Bipolar disorder	31.38	31.20	11	3090	1307	2353677
Hyperglycaemia	31.23	31.20	16	3085	4869	2350115

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
Atypical femur fracture	98.93	43.85	13	316	63	1746389
Femur fracture	81.77	43.85	16	313	1131	1745321
Osteonecrosis	66.94	43.85	17	312	3945	1742507
Osteonecrosis of jaw	65.55	43.85	17	312	4286	1742166
Fall	60.86	43.85	25	304	27189	1719263
Pathological fracture	46.76	43.85	9	320	577	1745875
Distal intestinal obstruction syndrome	45.28	43.85	6	323	31	1746421
Oesophageal rupture	44.40	43.85	7	322	137	1746315

Pharmacologic Action:

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
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
MeSH PA	D049990	Membrane Transport Modulators
FDA EPC	N0000175579	Bisphosphonate
FDA Chemical/Ingredient	N0000007707	Diphosphonates

Drug Use (View source of the data)

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
Dehydration	contraindication	34095006
Dysphagia	contraindication	40739000
Achalasia of esophagus	contraindication	45564002	DOID:9164
Joint pain	contraindication	57676002
Acute nephropathy	contraindication	58574008
Stricture of esophagus	contraindication	63305008
Hypercalcemia	contraindication	66931009	DOID:12678
Hyperparathyroidism	contraindication	66999008	DOID:13543
Muscle pain	contraindication	68962001
Fracture of femur	contraindication	71620000
Duodenitis	contraindication	72007001	DOID:8643
Kidney disease	contraindication	90708001	DOID:557
Kidney stone	contraindication	95570007
Bed-ridden	contraindication	160685001
Osteolysis	contraindication	203522001
Esophageal dysmotility	contraindication	266434009	DOID:9192
Aseptic necrosis of bone of jaw	contraindication	441809006

Acid dissociation constants calculated using MoKa v3.0.0

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

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
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

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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
Farnesyl diphosphate synthase	Enzyme		Q197X6_TOXGO		IC50	7.13	CHEMBL
Farnesyl diphosphate synthase	Unclassified		Q8WS26_TRYCR		IC50	7.57	CHEMBL
Farnesyl pyrophosphate synthase	Enzyme		Q0GKD7_LEIDO		Ki	7.77	CHEMBL

External reference:

ID	Source
D000068296	MESH_DESCRIPTOR_UI
C0140610	UMLSCUI
D00942	KEGG_DRUG
768538005	SNOMEDCT_US
768539002	SNOMEDCT_US
55685	RXNORM
007620	NDDF
CHEBI:8869	CHEBI
CHEMBL923	ChEMBL_ID
DB00884	DRUGBANK_ID
CHEMBL1654	ChEMBL_ID
F67L43UT5C	UNII
353228-19-0	SECONDARY_CAS_RN
6522	INN_ID
RIS	PDB_CHEM_ID
5245	PUBCHEM_CID
3176	IUPHAR_LIGAND_ID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
ACTONEL	HUMAN PRESCRIPTION DRUG LABEL	1	0149-0470	TABLET, FILM COATED	30 mg	ORAL	NDA	18 sections
ACTONEL	HUMAN PRESCRIPTION DRUG LABEL	1	0149-0471	TABLET, FILM COATED	5 mg	ORAL	NDA	18 sections
ACTONEL	HUMAN PRESCRIPTION DRUG LABEL	1	0149-0472	TABLET, FILM COATED	35 mg	ORAL	NDA	18 sections
ACTONEL	HUMAN PRESCRIPTION DRUG LABEL	1	0149-0477	TABLET, FILM COATED	75 mg	ORAL	NDA	18 sections
ACTONEL	HUMAN PRESCRIPTION DRUG LABEL	1	0149-0478	TABLET, FILM COATED	150 mg	ORAL	NDA	18 sections
Risedronate Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	16714-870	TABLET, DELAYED RELEASE	35 mg	ORAL	ANDA	18 sections
Risedronate Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	33342-107	TABLET, FILM COATED	5 mg	ORAL	ANDA	17 sections
Risedronate Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	33342-108	TABLET, FILM COATED	30 mg	ORAL	ANDA	17 sections
Risedronate Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	33342-109	TABLET, FILM COATED	35 mg	ORAL	ANDA	17 sections
Actonel	HUMAN PRESCRIPTION DRUG LABEL	1	54868-4386	TABLET, FILM COATED	5 mg	ORAL	NDA	18 sections
Actonel	HUMAN PRESCRIPTION DRUG LABEL	1	54868-4671	TABLET, FILM COATED	35 mg	ORAL	NDA	18 sections
Actonel	HUMAN PRESCRIPTION DRUG LABEL	1	54868-6069	TABLET, FILM COATED	150 mg	ORAL	NDA	18 sections
Risedronate Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	60505-3096	TABLET, FILM COATED	75 mg	ORAL	ANDA	17 sections
Risedronate Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	60505-3097	TABLET, FILM COATED	150 mg	ORAL	ANDA	17 sections
Risedronate Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	60505-3165	TABLET, FILM COATED	35 mg	ORAL	ANDA	17 sections
RISEDRONATE SODIUM	HUMAN PRESCRIPTION DRUG LABEL	1	63304-440	TABLET, DELAYED RELEASE	35 mg	ORAL	ANDA	18 sections
Risedronate Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	65862-517	TABLET, FILM COATED	5 mg	ORAL	ANDA	17 sections
Risedronate Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	65862-518	TABLET, FILM COATED	30 mg	ORAL	ANDA	17 sections
Risedronate Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	65862-519	TABLET, FILM COATED	35 mg	ORAL	ANDA	17 sections
Risedronate Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	65862-870	TABLET, FILM COATED	150 mg	ORAL	ANDA	17 sections
Risedronate Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	68382-075	TABLET, DELAYED RELEASE	35 mg	ORAL	ANDA	19 sections
Risedronate Sodium	HUMAN PRESCRIPTION DRUG LABEL	1	70771-1436	TABLET, DELAYED RELEASE	35 mg	ORAL	ANDA	19 sections