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

Stem definitionDrug idCAS RN
calcium metabolism regulator, pharmaceutical aid 2387 105462-24-6

Description:

MoleculeDescription

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:

DoseUnitRoute
5 mg O
5 mg O

ADMET properties:

PropertyValueReference
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 ┬ÁM/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:

DateAgencyCompanyOrphan
March 27, 1998 FDA WARNER CHILCOTT LLC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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)

DiseaseRelationSNOMED_IDDOID
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 levelDissociation constantType (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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Farnesyl pyrophosphate synthase Enzyme INHIBITOR Ki 9.44 CHEMBL CHEMBL
Farnesyl diphosphate synthase Enzyme IC50 7.13 CHEMBL
Farnesyl diphosphate synthase Unclassified IC50 7.57 CHEMBL
Farnesyl pyrophosphate synthase Enzyme Ki 7.77 CHEMBL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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