ibandronic acid 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| calcium metabolism regulator, pharmaceutical aid | 1404 | 114084-78-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Aminobisphosphonate that is a potent inhibitor of BONE RESORPTION. It is used in the treatment of HYPERCALCEMIA associated with malignancy, for the prevention of fracture and bone complications in patients with breast cancer and bone metastases, and for the treatment and prevention of POSTMENOPAUSAL OSTEOPOROSIS.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 5 | mg | O |
| 6 | mg | P |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 3 | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 55 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.13 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) | 0.55 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 1.80 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.15 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 14 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 16, 2003 | FDA | HOFFMANN LA ROCHE |
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 |
|---|---|---|---|---|---|---|
| Osteonecrosis of jaw | 1393.50 | 12.36 | 617 | 41343 | 32741 | 56217366 |
| Femur fracture | 1275.41 | 12.36 | 610 | 41350 | 38685 | 56211422 |
| Osteonecrosis | 608.66 | 12.36 | 312 | 41648 | 22903 | 56227204 |
| Bone pain | 596.35 | 12.36 | 404 | 41556 | 49781 | 56200326 |
| Low turnover osteopathy | 581.67 | 12.36 | 185 | 41775 | 3823 | 56246284 |
| Atypical femur fracture | 425.40 | 12.36 | 155 | 41805 | 4892 | 56245215 |
| Stress fracture | 382.55 | 12.36 | 158 | 41802 | 7019 | 56243088 |
| Myalgia | 274.65 | 12.36 | 410 | 41550 | 131615 | 56118492 |
| Intramedullary rod insertion | 254.14 | 12.36 | 84 | 41876 | 1967 | 56248140 |
| Drug ineffective | 251.73 | 12.36 | 192 | 41768 | 918797 | 55331310 |
| Fracture nonunion | 216.34 | 12.36 | 76 | 41884 | 2151 | 56247956 |
| Exposed bone in jaw | 201.70 | 12.36 | 77 | 41883 | 2771 | 56247336 |
| Osteomyelitis | 183.06 | 12.36 | 149 | 41811 | 24197 | 56225910 |
| Pain in jaw | 177.19 | 12.36 | 182 | 41778 | 39854 | 56210253 |
| Dental caries | 176.06 | 12.36 | 104 | 41856 | 10064 | 56240043 |
| Tooth extraction | 174.68 | 12.36 | 101 | 41859 | 9392 | 56240715 |
| Influenza like illness | 172.72 | 12.36 | 220 | 41740 | 60768 | 56189339 |
| Bone disorder | 167.08 | 12.36 | 129 | 41831 | 19414 | 56230693 |
| Jaw disorder | 161.78 | 12.36 | 78 | 41882 | 5005 | 56245102 |
| Osteoporosis | 158.94 | 12.36 | 195 | 41765 | 51857 | 56198250 |
| Tooth disorder | 158.48 | 12.36 | 140 | 41820 | 25413 | 56224694 |
| Injection site extravasation | 153.05 | 12.36 | 88 | 41872 | 8096 | 56242011 |
| Anaemia postoperative | 144.37 | 12.36 | 56 | 41904 | 2105 | 56248002 |
| Vitamin D deficiency | 139.65 | 12.36 | 96 | 41864 | 12074 | 56238033 |
| Fall | 139.52 | 12.36 | 581 | 41379 | 356929 | 55893178 |
| Pain in extremity | 138.41 | 12.36 | 511 | 41449 | 296920 | 55953187 |
| Foot fracture | 134.27 | 12.36 | 119 | 41841 | 21690 | 56228417 |
| Off label use | 133.62 | 12.36 | 131 | 41829 | 556049 | 55694058 |
| Gastrooesophageal reflux disease | 129.77 | 12.36 | 227 | 41733 | 83030 | 56167077 |
| Maternal exposure during pregnancy | 126.96 | 12.36 | 3 | 41957 | 189550 | 56060557 |
| Acute phase reaction | 125.71 | 12.36 | 31 | 41929 | 236 | 56249871 |
| Osteoarthritis | 125.24 | 12.36 | 219 | 41741 | 80077 | 56170030 |
| Tooth fracture | 122.51 | 12.36 | 83 | 41877 | 10193 | 56239914 |
| Arthralgia | 121.83 | 12.36 | 712 | 41248 | 500957 | 55749150 |
| Rheumatoid arthritis | 118.84 | 12.36 | 69 | 41891 | 382535 | 55867572 |
| Exostosis of jaw | 115.85 | 12.36 | 41 | 41919 | 1186 | 56248921 |
| Pathological fracture | 115.13 | 12.36 | 73 | 41887 | 8016 | 56242091 |
| Spinal osteoarthritis | 114.05 | 12.36 | 92 | 41868 | 14744 | 56235363 |
| Fracture delayed union | 112.63 | 12.36 | 48 | 41912 | 2305 | 56247802 |
| Back pain | 112.34 | 12.36 | 410 | 41550 | 236760 | 56013347 |
| Open reduction of fracture | 111.40 | 12.36 | 39 | 41921 | 1092 | 56249015 |
| Metastases to bone | 109.38 | 12.36 | 101 | 41859 | 19407 | 56230700 |
| Infusion related reaction | 103.56 | 12.36 | 16 | 41944 | 208915 | 56041192 |
| Periodontal disease | 103.51 | 12.36 | 40 | 41920 | 1488 | 56248619 |
| Product use issue | 97.50 | 12.36 | 12 | 41948 | 186029 | 56064078 |
| Hyperlipidaemia | 96.22 | 12.36 | 91 | 41869 | 18018 | 56232089 |
| Fracture displacement | 94.88 | 12.36 | 35 | 41925 | 1143 | 56248964 |
| Extravasation | 93.60 | 12.36 | 41 | 41919 | 2106 | 56248001 |
| Condition aggravated | 92.59 | 12.36 | 73 | 41887 | 344825 | 55905282 |
| Sequestrectomy | 87.46 | 12.36 | 30 | 41930 | 789 | 56249318 |
| Osteitis | 87 | 12.36 | 44 | 41916 | 3130 | 56246977 |
| Hand deformity | 86.84 | 12.36 | 3 | 41957 | 134489 | 56115618 |
| Spinal compression fracture | 85.52 | 12.36 | 74 | 41886 | 13060 | 56237047 |
| Therapeutic product effect decreased | 83.90 | 12.36 | 13 | 41947 | 169439 | 56080668 |
| Osteopenia | 83.01 | 12.36 | 84 | 41876 | 18057 | 56232050 |
| Treatment failure | 82.29 | 12.36 | 14 | 41946 | 170378 | 56079729 |
| Drug intolerance | 80.38 | 12.36 | 49 | 41911 | 264769 | 55985338 |
| Fracture | 76.24 | 12.36 | 80 | 41880 | 17938 | 56232169 |
| Device failure | 75.57 | 12.36 | 49 | 41911 | 5590 | 56244517 |
| Systemic lupus erythematosus | 74.43 | 12.36 | 21 | 41939 | 180057 | 56070050 |
| Atypical fracture | 71.88 | 12.36 | 24 | 41936 | 580 | 56249527 |
| Rib fracture | 71.73 | 12.36 | 82 | 41878 | 20227 | 56229880 |
| Glossodynia | 68.38 | 12.36 | 15 | 41945 | 152443 | 56097664 |
| Gingivitis | 68.31 | 12.36 | 52 | 41908 | 7657 | 56242450 |
| Femoral neck fracture | 67.94 | 12.36 | 52 | 41908 | 7719 | 56242388 |
| Temporomandibular joint syndrome | 66.66 | 12.36 | 39 | 41921 | 3705 | 56246402 |
| Lower respiratory tract infection | 66.45 | 12.36 | 5 | 41955 | 114789 | 56135318 |
| Periprosthetic fracture | 65.94 | 12.36 | 21 | 41939 | 435 | 56249672 |
| Synovitis | 64.48 | 12.36 | 20 | 41940 | 161285 | 56088822 |
| Carbohydrate antigen 15-3 increased | 64.40 | 12.36 | 27 | 41933 | 1244 | 56248863 |
| Impaired healing | 62.93 | 12.36 | 174 | 41786 | 86667 | 56163440 |
| Abscess jaw | 62.47 | 12.36 | 27 | 41933 | 1342 | 56248765 |
| Toxicity to various agents | 62.15 | 12.36 | 46 | 41914 | 224518 | 56025589 |
| Resorption bone increased | 61.49 | 12.36 | 26 | 41934 | 1224 | 56248883 |
| Hepatic enzyme increased | 60.48 | 12.36 | 26 | 41934 | 171358 | 56078749 |
| Dyspepsia | 60.24 | 12.36 | 167 | 41793 | 83304 | 56166803 |
| Joint swelling | 59.82 | 12.36 | 77 | 41883 | 289723 | 55960384 |
| Bone loss | 58.58 | 12.36 | 33 | 41927 | 2918 | 56247189 |
| Bone density decreased | 58.22 | 12.36 | 59 | 41901 | 12701 | 56237406 |
| Gingival disorder | 57.45 | 12.36 | 34 | 41926 | 3299 | 56246808 |
| Injection site inflammation | 56.68 | 12.36 | 34 | 41926 | 3382 | 56246725 |
| Periodontitis | 56.45 | 12.36 | 33 | 41927 | 3130 | 56246977 |
| Actinomycosis | 56.34 | 12.36 | 23 | 41937 | 990 | 56249117 |
| Toothache | 56.18 | 12.36 | 68 | 41892 | 17812 | 56232295 |
| Ulna fracture | 55.67 | 12.36 | 23 | 41937 | 1021 | 56249086 |
| Musculoskeletal pain | 55.27 | 12.36 | 159 | 41801 | 80993 | 56169114 |
| Bursitis | 54.84 | 12.36 | 84 | 41876 | 27498 | 56222609 |
| Tooth loss | 54.51 | 12.36 | 42 | 41918 | 6295 | 56243812 |
| Fibrocystic breast disease | 54.47 | 12.36 | 23 | 41937 | 1079 | 56249028 |
| Fatigue | 53.42 | 12.36 | 357 | 41603 | 788195 | 55461912 |
| Diverticulum | 52.01 | 12.36 | 52 | 41908 | 11014 | 56239093 |
| Product use in unapproved indication | 51.90 | 12.36 | 20 | 41940 | 140802 | 56109305 |
| Chest pain | 51.49 | 12.36 | 278 | 41682 | 189519 | 56060588 |
| Pelvic fracture | 51.27 | 12.36 | 54 | 41906 | 12159 | 56237948 |
| Oral cavity fistula | 51.23 | 12.36 | 19 | 41941 | 630 | 56249477 |
| Spinal fracture | 50.85 | 12.36 | 62 | 41898 | 16362 | 56233745 |
| Therapeutic product effect incomplete | 50.54 | 12.36 | 9 | 41951 | 106022 | 56144085 |
| Jaw operation | 49.79 | 12.36 | 20 | 41940 | 825 | 56249282 |
| Intervertebral disc degeneration | 49.40 | 12.36 | 57 | 41903 | 14197 | 56235910 |
| Loose tooth | 47.69 | 12.36 | 30 | 41930 | 3248 | 56246859 |
| Spondylolisthesis | 47.18 | 12.36 | 30 | 41930 | 3309 | 56246798 |
| Jaw fracture | 47.05 | 12.36 | 27 | 41933 | 2473 | 56247634 |
| Tooth abscess | 46.25 | 12.36 | 54 | 41906 | 13621 | 56236486 |
| Metastases to liver | 46.13 | 12.36 | 68 | 41892 | 21518 | 56228589 |
| Hypercholesterolaemia | 45.40 | 12.36 | 55 | 41905 | 14418 | 56235689 |
| Oesophagitis | 45.04 | 12.36 | 54 | 41906 | 14003 | 56236104 |
| Scoliosis | 45.01 | 12.36 | 39 | 41921 | 6894 | 56243213 |
| Wound | 44.47 | 12.36 | 24 | 41936 | 138780 | 56111327 |
| Nasopharyngitis | 44.25 | 12.36 | 60 | 41900 | 220899 | 56029208 |
| Fistula | 44.20 | 12.36 | 43 | 41917 | 8812 | 56241295 |
| Metastases to pleura | 43.35 | 12.36 | 21 | 41939 | 1361 | 56248746 |
| Hypothyroidism | 43.26 | 12.36 | 91 | 41869 | 38105 | 56212002 |
| Isosthenuria | 43.07 | 12.36 | 11 | 41949 | 98 | 56250009 |
| Radius fracture | 42.76 | 12.36 | 28 | 41932 | 3247 | 56246860 |
| Hip fracture | 42.57 | 12.36 | 74 | 41886 | 26899 | 56223208 |
| Vertebral foraminal stenosis | 42.48 | 12.36 | 18 | 41942 | 852 | 56249255 |
| Discomfort | 41.90 | 12.36 | 27 | 41933 | 141734 | 56108373 |
| Oral infection | 41.31 | 12.36 | 31 | 41929 | 4467 | 56245640 |
| Medical device removal | 39.98 | 12.36 | 19 | 41941 | 1180 | 56248927 |
| Calcium deficiency | 39.77 | 12.36 | 18 | 41942 | 999 | 56249108 |
| Lumbar spinal stenosis | 39.55 | 12.36 | 30 | 41930 | 4393 | 56245714 |
| Exostosis | 39.28 | 12.36 | 52 | 41908 | 14891 | 56235216 |
| Hypersensitivity | 39.04 | 12.36 | 83 | 41877 | 256325 | 55993782 |
| Drug abuse | 38.96 | 12.36 | 3 | 41957 | 67607 | 56182500 |
| Rotator cuff syndrome | 37.85 | 12.36 | 46 | 41914 | 12097 | 56238010 |
| Blister | 37.64 | 12.36 | 17 | 41943 | 108870 | 56141237 |
| Pyelitis | 37.31 | 12.36 | 11 | 41949 | 174 | 56249933 |
| Hyperaesthesia teeth | 37.26 | 12.36 | 20 | 41940 | 1608 | 56248499 |
| Breast cancer recurrent | 37.24 | 12.36 | 28 | 41932 | 4047 | 56246060 |
| Hydrothorax | 36.93 | 12.36 | 16 | 41944 | 800 | 56249307 |
| Groin pain | 36.91 | 12.36 | 40 | 41920 | 9300 | 56240807 |
| Pulpitis dental | 36.12 | 12.36 | 16 | 41944 | 844 | 56249263 |
| Rash | 35.93 | 12.36 | 218 | 41742 | 492829 | 55757278 |
| Product dose omission issue | 35.78 | 12.36 | 61 | 41899 | 204692 | 56045415 |
| Pneumonia | 35.75 | 12.36 | 169 | 41791 | 406929 | 55843178 |
| Endodontic procedure | 35.67 | 12.36 | 24 | 41936 | 2912 | 56247195 |
| Osteomalacia | 35.64 | 12.36 | 15 | 41945 | 698 | 56249409 |
| Dental necrosis | 35.45 | 12.36 | 10 | 41950 | 134 | 56249973 |
| Gastritis | 35.10 | 12.36 | 79 | 41881 | 34623 | 56215484 |
| Bladder hypertrophy | 35.04 | 12.36 | 11 | 41949 | 217 | 56249890 |
| Oxygen saturation decreased | 34.99 | 12.36 | 8 | 41952 | 79059 | 56171048 |
| Meniscus injury | 34.92 | 12.36 | 33 | 41927 | 6525 | 56243582 |
| Intentional overdose | 34.21 | 12.36 | 5 | 41955 | 68112 | 56181995 |
| Electrocardiogram PR shortened | 33.92 | 12.36 | 11 | 41949 | 242 | 56249865 |
| Renal cyst | 33.57 | 12.36 | 38 | 41922 | 9271 | 56240836 |
| Oesophageal stenosis | 32.90 | 12.36 | 23 | 41937 | 2970 | 56247137 |
| Phlebitis | 32.56 | 12.36 | 31 | 41929 | 6185 | 56243922 |
| Compression fracture | 31.63 | 12.36 | 30 | 41930 | 5959 | 56244148 |
| Muscle spasms | 31.19 | 12.36 | 192 | 41768 | 137179 | 56112928 |
| Tonsillectomy | 31.02 | 12.36 | 14 | 41946 | 772 | 56249335 |
| Peripheral swelling | 30.92 | 12.36 | 82 | 41878 | 234644 | 56015463 |
| Wrist fracture | 30.31 | 12.36 | 41 | 41919 | 11985 | 56238122 |
| Folliculitis | 30.16 | 12.36 | 3 | 41957 | 54976 | 56195131 |
| Haemorrhoids | 30.03 | 12.36 | 54 | 41906 | 20152 | 56229955 |
| Febrile neutropenia | 29.98 | 12.36 | 21 | 41939 | 105524 | 56144583 |
| Product administration error | 29.92 | 12.36 | 55 | 41905 | 20874 | 56229233 |
| Intentional product use issue | 29.46 | 12.36 | 19 | 41941 | 99714 | 56150393 |
| Oesophageal disorder | 29.35 | 12.36 | 19 | 41941 | 2161 | 56247946 |
| Hysterectomy | 29.18 | 12.36 | 34 | 41926 | 8557 | 56241550 |
| Mitral valve prolapse | 29.14 | 12.36 | 19 | 41941 | 2187 | 56247920 |
| Gingival swelling | 29.01 | 12.36 | 24 | 41936 | 3982 | 56246125 |
| Hypotension | 29.01 | 12.36 | 93 | 41867 | 250415 | 55999692 |
| Osteochondrosis | 28.72 | 12.36 | 15 | 41945 | 1141 | 56248966 |
| Alopecia | 28.66 | 12.36 | 117 | 41843 | 293341 | 55956766 |
| Osteocalcin decreased | 28.65 | 12.36 | 7 | 41953 | 51 | 56250056 |
| Dysphagia | 28.58 | 12.36 | 129 | 41831 | 81818 | 56168289 |
| Hiatus hernia | 28.54 | 12.36 | 52 | 41908 | 19600 | 56230507 |
| Blood loss anaemia | 28.45 | 12.36 | 33 | 41927 | 8264 | 56241843 |
| Weight increased | 28.21 | 12.36 | 83 | 41877 | 229620 | 56020487 |
| Jaw fistula | 28.19 | 12.36 | 7 | 41953 | 55 | 56250052 |
| Rectocele | 28.17 | 12.36 | 14 | 41946 | 959 | 56249148 |
| Pruritus | 27.44 | 12.36 | 132 | 41828 | 316491 | 55933616 |
| Dental implantation | 27.02 | 12.36 | 12 | 41948 | 637 | 56249470 |
| Lumbar radiculopathy | 26.91 | 12.36 | 17 | 41943 | 1854 | 56248253 |
| Drug hypersensitivity | 26.69 | 12.36 | 110 | 41850 | 275095 | 55975012 |
| Internal fixation of fracture | 26.58 | 12.36 | 12 | 41948 | 662 | 56249445 |
| Psoriatic arthropathy | 26.45 | 12.36 | 11 | 41949 | 73997 | 56176110 |
| Bone graft | 26.37 | 12.36 | 13 | 41947 | 875 | 56249232 |
| Hypertension | 26.26 | 12.36 | 288 | 41672 | 243990 | 56006117 |
| Metastases to lymph nodes | 26.25 | 12.36 | 30 | 41930 | 7393 | 56242714 |
| Multiple organ dysfunction syndrome | 26.21 | 12.36 | 4 | 41956 | 52766 | 56197341 |
| Cellulitis | 26.14 | 12.36 | 118 | 41842 | 74831 | 56175276 |
| Intervertebral disc protrusion | 26.10 | 12.36 | 53 | 41907 | 21641 | 56228466 |
| Cough | 25.78 | 12.36 | 103 | 41857 | 259858 | 55990249 |
| Humerus fracture | 25.77 | 12.36 | 31 | 41929 | 8066 | 56242041 |
| Hormone receptor positive HER2 negative breast cancer | 25.67 | 12.36 | 8 | 41952 | 154 | 56249953 |
| Comminuted fracture | 25.58 | 12.36 | 11 | 41949 | 540 | 56249567 |
| Suicide attempt | 25.30 | 12.36 | 6 | 41954 | 57830 | 56192277 |
| Musculoskeletal chest pain | 24.85 | 12.36 | 49 | 41911 | 19592 | 56230515 |
| Invasive ductal breast carcinoma | 24.84 | 12.36 | 28 | 41932 | 6798 | 56243309 |
| Calcification metastatic | 24.67 | 12.36 | 8 | 41952 | 176 | 56249931 |
| Depressed level of consciousness | 24.40 | 12.36 | 6 | 41954 | 56427 | 56193680 |
| Dental fistula | 24.33 | 12.36 | 11 | 41949 | 609 | 56249498 |
| Muscle strain | 24.31 | 12.36 | 29 | 41931 | 7479 | 56242628 |
| Confusional state | 24.28 | 12.36 | 77 | 41883 | 208078 | 56042029 |
| Bone marrow oedema | 24.27 | 12.36 | 13 | 41947 | 1041 | 56249066 |
| Limb asymmetry | 24.11 | 12.36 | 12 | 41948 | 825 | 56249282 |
| Carcinoembryonic antigen increased | 24.07 | 12.36 | 15 | 41945 | 1597 | 56248510 |
| Hospitalisation | 23.96 | 12.36 | 13 | 41947 | 74987 | 56175120 |
| Muscle injury | 23.86 | 12.36 | 5 | 41955 | 52495 | 56197612 |
| Tibia fracture | 23.76 | 12.36 | 23 | 41937 | 4685 | 56245422 |
| Injection site swelling | 23.72 | 12.36 | 79 | 41881 | 43499 | 56206608 |
| Kyphosis | 23.70 | 12.36 | 17 | 41943 | 2285 | 56247822 |
| Dental plaque | 23.67 | 12.36 | 7 | 41953 | 112 | 56249995 |
| Depression | 23.00 | 12.36 | 220 | 41740 | 179897 | 56070210 |
| Osteogenesis imperfecta | 22.79 | 12.36 | 9 | 41951 | 355 | 56249752 |
| PIK3CA-activated mutation | 22.58 | 12.36 | 12 | 41948 | 946 | 56249161 |
| Spondylolysis | 22.44 | 12.36 | 6 | 41954 | 65 | 56250042 |
| Goitre | 22.25 | 12.36 | 24 | 41936 | 5549 | 56244558 |
| Therapy non-responder | 22.12 | 12.36 | 9 | 41951 | 61346 | 56188761 |
| Breast cancer | 21.84 | 12.36 | 83 | 41877 | 48750 | 56201357 |
| Thoracic vertebral fracture | 21.84 | 12.36 | 21 | 41939 | 4242 | 56245865 |
| Poor dental condition | 21.81 | 12.36 | 9 | 41951 | 398 | 56249709 |
| Seborrhoeic keratosis | 21.70 | 12.36 | 15 | 41945 | 1902 | 56248205 |
| Cataract operation | 21.61 | 12.36 | 22 | 41938 | 4760 | 56245347 |
| White blood cell count decreased | 21.57 | 12.36 | 38 | 41922 | 125952 | 56124155 |
| Oestrogen deficiency | 21.50 | 12.36 | 7 | 41953 | 156 | 56249951 |
| Creatinine renal clearance increased | 21.39 | 12.36 | 10 | 41950 | 598 | 56249509 |
| COVID-19 | 21.22 | 12.36 | 15 | 41945 | 75043 | 56175064 |
| Liver injury | 21.18 | 12.36 | 3 | 41957 | 41845 | 56208262 |
| Tonsillar disorder | 21.13 | 12.36 | 12 | 41948 | 1078 | 56249029 |
| Sinusitis | 21.06 | 12.36 | 76 | 41884 | 197505 | 56052602 |
| Bone sequestrum | 20.86 | 12.36 | 13 | 41947 | 1384 | 56248723 |
| Large intestine polyp | 20.76 | 12.36 | 27 | 41933 | 7600 | 56242507 |
| Upper limb fracture | 20.75 | 12.36 | 42 | 41918 | 17113 | 56232994 |
| Hand fracture | 20.67 | 12.36 | 22 | 41938 | 5011 | 56245096 |
| Gastrointestinal tract irritation | 20.60 | 12.36 | 9 | 41951 | 459 | 56249648 |
| Arteriosclerosis | 20.51 | 12.36 | 30 | 41930 | 9423 | 56240684 |
| Metastases to skin | 20.35 | 12.36 | 13 | 41947 | 1445 | 56248662 |
| Spinal stenosis | 20.25 | 12.36 | 37 | 41923 | 13977 | 56236130 |
| Skeletal injury | 20.24 | 12.36 | 12 | 41948 | 1168 | 56248939 |
| Osteoporotic fracture | 20.19 | 12.36 | 18 | 41942 | 3303 | 56246804 |
| Congenital coronary artery malformation | 20.17 | 12.36 | 6 | 41954 | 98 | 56250009 |
| Platelet count decreased | 20.17 | 12.36 | 30 | 41930 | 106353 | 56143754 |
| Stress urinary incontinence | 20.10 | 12.36 | 15 | 41945 | 2143 | 56247964 |
| Somnolence | 20.09 | 12.36 | 59 | 41901 | 163354 | 56086753 |
| Tooth avulsion | 19.84 | 12.36 | 5 | 41955 | 42 | 56250065 |
| Metastases to spine | 19.78 | 12.36 | 17 | 41943 | 2972 | 56247135 |
| Bone fragmentation | 19.75 | 12.36 | 10 | 41950 | 713 | 56249394 |
| Metastases to adrenals | 19.74 | 12.36 | 10 | 41950 | 714 | 56249393 |
| Tooth infection | 19.57 | 12.36 | 39 | 41921 | 15713 | 56234394 |
| Breath odour | 19.50 | 12.36 | 12 | 41948 | 1250 | 56248857 |
| Spinal meningeal cyst | 19.43 | 12.36 | 5 | 41955 | 46 | 56250061 |
| Breast mass | 19.34 | 12.36 | 25 | 41935 | 6994 | 56243113 |
| Oral pustule | 19.34 | 12.36 | 5 | 41955 | 47 | 56250060 |
| Patella fracture | 19.33 | 12.36 | 14 | 41946 | 1911 | 56248196 |
| Appendicectomy | 19.24 | 12.36 | 16 | 41944 | 2674 | 56247433 |
| Lumbar vertebral fracture | 19.16 | 12.36 | 21 | 41939 | 4943 | 56245164 |
| Injection site phlebitis | 18.99 | 12.36 | 6 | 41954 | 121 | 56249986 |
| Gingival recession | 18.95 | 12.36 | 12 | 41948 | 1314 | 56248793 |
| Breast cancer metastatic | 18.86 | 12.36 | 38 | 41922 | 15431 | 56234676 |
| Arthropathy | 18.82 | 12.36 | 81 | 41879 | 200194 | 56049913 |
| Arthritis | 18.68 | 12.36 | 133 | 41827 | 99719 | 56150388 |
| Hypertonic bladder | 18.63 | 12.36 | 17 | 41943 | 3215 | 56246892 |
| Oral surgery | 18.42 | 12.36 | 11 | 41949 | 1085 | 56249022 |
| Barrett's oesophagus | 18.25 | 12.36 | 9 | 41951 | 606 | 56249501 |
| Dyslipidaemia | 18.09 | 12.36 | 23 | 41937 | 6330 | 56243777 |
| Heart rate decreased | 18.07 | 12.36 | 4 | 41956 | 40423 | 56209684 |
| Blood pressure fluctuation | 18.02 | 12.36 | 4 | 41956 | 40356 | 56209751 |
| Gingival pain | 17.99 | 12.36 | 23 | 41937 | 6365 | 56243742 |
| Oral disorder | 17.82 | 12.36 | 26 | 41934 | 8149 | 56241958 |
| Eructation | 17.81 | 12.36 | 25 | 41935 | 7563 | 56242544 |
| Breast calcifications | 17.66 | 12.36 | 11 | 41949 | 1170 | 56248937 |
| Bone lesion | 17.63 | 12.36 | 21 | 41939 | 5409 | 56244698 |
| Spinal disorder | 17.59 | 12.36 | 27 | 41933 | 8851 | 56241256 |
| Fractured sacrum | 17.47 | 12.36 | 13 | 41947 | 1850 | 56248257 |
| No adverse event | 17.25 | 12.36 | 63 | 41897 | 36311 | 56213796 |
| Death | 17.23 | 12.36 | 167 | 41793 | 341259 | 55908848 |
| Neck pain | 17.22 | 12.36 | 91 | 41869 | 61464 | 56188643 |
| Hypophosphataemic osteomalacia | 17.20 | 12.36 | 6 | 41954 | 166 | 56249941 |
| Bone formation increased | 17.04 | 12.36 | 6 | 41954 | 171 | 56249936 |
| Lymphoedema | 16.76 | 12.36 | 29 | 41931 | 10501 | 56239606 |
| Acute kidney injury | 16.68 | 12.36 | 108 | 41852 | 240655 | 56009452 |
| Erosive oesophagitis | 16.63 | 12.36 | 12 | 41948 | 1628 | 56248479 |
| Oesophageal pain | 16.53 | 12.36 | 16 | 41944 | 3259 | 56246848 |
| Atrophic vulvovaginitis | 16.50 | 12.36 | 12 | 41948 | 1649 | 56248458 |
| Cerumen impaction | 16.49 | 12.36 | 10 | 41950 | 1014 | 56249093 |
| Wheezing | 16.43 | 12.36 | 19 | 41941 | 75007 | 56175100 |
| Chronic hepatic failure | 16.32 | 12.36 | 8 | 41952 | 532 | 56249575 |
| Drug-induced liver injury | 16.25 | 12.36 | 3 | 41957 | 34459 | 56215648 |
| Pulmonary oedema | 16.14 | 12.36 | 9 | 41951 | 51134 | 56198973 |
| Injection site thrombosis | 15.96 | 12.36 | 5 | 41955 | 98 | 56250009 |
| Mediastinal disorder | 15.95 | 12.36 | 7 | 41953 | 361 | 56249746 |
| Bone metabolism disorder | 15.90 | 12.36 | 7 | 41953 | 364 | 56249743 |
| Cholecystectomy | 15.84 | 12.36 | 27 | 41933 | 9657 | 56240450 |
| Suicidal ideation | 15.73 | 12.36 | 12 | 41948 | 57730 | 56192377 |
| Cystocele | 15.72 | 12.36 | 10 | 41950 | 1103 | 56249004 |
| Cardio-respiratory arrest | 15.71 | 12.36 | 11 | 41949 | 55310 | 56194797 |
| Purulence | 15.69 | 12.36 | 11 | 41949 | 1426 | 56248681 |
| Hyperparathyroidism | 15.66 | 12.36 | 14 | 41946 | 2578 | 56247529 |
| Drug interaction | 15.61 | 12.36 | 92 | 41868 | 209663 | 56040444 |
| Bone lesion excision | 15.53 | 12.36 | 4 | 41956 | 37 | 56250070 |
| Tooth deposit | 15.35 | 12.36 | 6 | 41954 | 230 | 56249877 |
| Rhinorrhoea | 15.35 | 12.36 | 12 | 41948 | 57025 | 56193082 |
| Radiculopathy | 15.33 | 12.36 | 20 | 41940 | 5645 | 56244462 |
| Vascular procedure complication | 15.32 | 12.36 | 3 | 41957 | 6 | 56250101 |
| Induration | 15.28 | 12.36 | 10 | 41950 | 1159 | 56248948 |
| Varicose vein | 15.19 | 12.36 | 18 | 41942 | 4611 | 56245496 |
| Ankle fracture | 15.11 | 12.36 | 36 | 41924 | 16367 | 56233740 |
| Malaise | 14.96 | 12.36 | 189 | 41771 | 367671 | 55882436 |
| Fibula fracture | 14.93 | 12.36 | 15 | 41945 | 3195 | 56246912 |
| Chest wall tumour | 14.90 | 12.36 | 4 | 41956 | 44 | 56250063 |
| Agitation | 14.81 | 12.36 | 12 | 41948 | 56024 | 56194083 |
| Polyneuropathy | 14.66 | 12.36 | 31 | 41929 | 13019 | 56237088 |
| Jaw cyst | 14.63 | 12.36 | 5 | 41955 | 130 | 56249977 |
| Anxiety disorder | 14.47 | 12.36 | 16 | 41944 | 3804 | 56246303 |
| Peritoneal disorder | 14.43 | 12.36 | 7 | 41953 | 455 | 56249652 |
| Disease progression | 14.40 | 12.36 | 36 | 41924 | 105137 | 56144970 |
| Respiratory failure | 14.25 | 12.36 | 31 | 41929 | 95031 | 56155076 |
| Dental care | 14.23 | 12.36 | 9 | 41951 | 983 | 56249124 |
| Postmenopause | 14.22 | 12.36 | 4 | 41956 | 53 | 56250054 |
| Metastases to the mediastinum | 14.22 | 12.36 | 7 | 41953 | 470 | 56249637 |
| Synovial cyst | 14.17 | 12.36 | 25 | 41935 | 9189 | 56240918 |
| Type V hyperlipidaemia | 14.11 | 12.36 | 7 | 41953 | 478 | 56249629 |
| Ovarian cancer stage III | 14.10 | 12.36 | 6 | 41954 | 287 | 56249820 |
| Oral fibroma | 14.09 | 12.36 | 4 | 41956 | 55 | 56250052 |
| Neutrophil count decreased | 14.03 | 12.36 | 10 | 41950 | 49812 | 56200295 |
| Tendon calcification | 14.02 | 12.36 | 4 | 41956 | 56 | 56250051 |
| Cardiac arrest | 13.91 | 12.36 | 27 | 41933 | 86287 | 56163820 |
| Biopsy bone | 13.89 | 12.36 | 4 | 41956 | 58 | 56250049 |
| Tendonitis | 13.83 | 12.36 | 37 | 41923 | 18060 | 56232047 |
| Dental prosthesis user | 13.83 | 12.36 | 4 | 41956 | 59 | 56250048 |
| Abdominal discomfort | 13.82 | 12.36 | 136 | 41824 | 277138 | 55972969 |
| Septic shock | 13.76 | 12.36 | 15 | 41945 | 60820 | 56189287 |
| Cognitive disorder | 13.65 | 12.36 | 10 | 41950 | 49123 | 56200984 |
| Macular hole | 13.63 | 12.36 | 8 | 41952 | 764 | 56249343 |
| Radiotherapy | 13.54 | 12.36 | 6 | 41954 | 317 | 56249790 |
| Seizure | 13.41 | 12.36 | 48 | 41912 | 125071 | 56125036 |
| Appendix disorder | 13.34 | 12.36 | 10 | 41950 | 1439 | 56248668 |
| Rhinoplasty | 13.24 | 12.36 | 3 | 41957 | 15 | 56250092 |
| Oral neoplasm | 13.14 | 12.36 | 4 | 41956 | 71 | 56250036 |
| Dyspnoea | 13.12 | 12.36 | 339 | 41621 | 592238 | 55657869 |
| Rhinitis allergic | 13.04 | 12.36 | 23 | 41937 | 8451 | 56241656 |
| Oesophageal discomfort | 13.04 | 12.36 | 5 | 41955 | 182 | 56249925 |
| Metabolic acidosis | 12.94 | 12.36 | 7 | 41953 | 40447 | 56209660 |
| Wound haemorrhage | 12.87 | 12.36 | 12 | 41948 | 2333 | 56247774 |
| Sepsis | 12.86 | 12.36 | 57 | 41903 | 139783 | 56110324 |
| Tongue geographic | 12.79 | 12.36 | 4 | 41956 | 78 | 56250029 |
| Oral dysaesthesia | 12.74 | 12.36 | 4 | 41956 | 79 | 56250028 |
| Injection site cellulitis | 12.70 | 12.36 | 9 | 41951 | 1187 | 56248920 |
| Eustachian tube dysfunction | 12.68 | 12.36 | 6 | 41954 | 369 | 56249738 |
| Loss of personal independence in daily activities | 12.64 | 12.36 | 26 | 41934 | 81343 | 56168764 |
| Ligament sprain | 12.59 | 12.36 | 27 | 41933 | 11448 | 56238659 |
| Unresponsive to stimuli | 12.54 | 12.36 | 4 | 41956 | 31721 | 56218386 |
| Serratia infection | 12.54 | 12.36 | 8 | 41952 | 887 | 56249220 |
| Illness | 12.54 | 12.36 | 5 | 41955 | 34506 | 56215601 |
| X-ray of pelvis and hip abnormal | 12.51 | 12.36 | 3 | 41957 | 20 | 56250087 |
| Cataract | 12.49 | 12.36 | 73 | 41887 | 51174 | 56198933 |
| Psoriasis | 12.48 | 12.36 | 32 | 41928 | 92660 | 56157447 |
| Spinal cord herniation | 12.38 | 12.36 | 3 | 41957 | 21 | 56250086 |
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 |
|---|---|---|---|---|---|---|
| Osteonecrosis of jaw | 145.93 | 23.82 | 52 | 2169 | 17019 | 31678104 |
| Osteonecrosis | 102.56 | 23.82 | 38 | 2183 | 13846 | 31681277 |
| Appetite disorder | 40.31 | 23.82 | 12 | 2209 | 2213 | 31692910 |
| Femur fracture | 39.17 | 23.82 | 16 | 2205 | 7517 | 31687606 |
| Rectal polyp | 38.85 | 23.82 | 9 | 2212 | 626 | 31694497 |
| Breast cancer | 38.55 | 23.82 | 8 | 2213 | 333 | 31694790 |
| Jaw fracture | 30.34 | 23.82 | 8 | 2213 | 949 | 31694174 |
| Fall | 25.28 | 23.82 | 46 | 2175 | 186043 | 31509080 |
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 |
|---|---|---|---|---|---|---|
| Osteonecrosis of jaw | 1393.72 | 13.42 | 546 | 27590 | 40456 | 70859852 |
| Femur fracture | 794.36 | 13.42 | 353 | 27783 | 35779 | 70864529 |
| Osteonecrosis | 515.54 | 13.42 | 245 | 27891 | 28915 | 70871393 |
| Atypical femur fracture | 445.57 | 13.42 | 136 | 28000 | 4707 | 70895601 |
| Bone pain | 403.07 | 13.42 | 251 | 27885 | 50571 | 70849737 |
| Low turnover osteopathy | 290.13 | 13.42 | 79 | 28057 | 1803 | 70898505 |
| Stress fracture | 249.02 | 13.42 | 92 | 28044 | 5758 | 70894550 |
| Exposed bone in jaw | 201.04 | 13.42 | 69 | 28067 | 3480 | 70896828 |
| Osteomyelitis | 179.90 | 13.42 | 125 | 28011 | 30193 | 70870115 |
| Dental caries | 153.11 | 13.42 | 79 | 28057 | 11092 | 70889216 |
| Pain in jaw | 152.18 | 13.42 | 130 | 28006 | 42539 | 70857769 |
| Myalgia | 150.56 | 13.42 | 252 | 27884 | 167640 | 70732668 |
| Jaw disorder | 142.75 | 13.42 | 58 | 28078 | 4688 | 70895620 |
| Fracture nonunion | 142.42 | 13.42 | 43 | 28093 | 1431 | 70898877 |
| Bone disorder | 137.54 | 13.42 | 86 | 28050 | 17404 | 70882904 |
| Tooth disorder | 133.41 | 13.42 | 95 | 28041 | 23843 | 70876465 |
| Arthralgia | 131.59 | 13.42 | 468 | 27668 | 502922 | 70397386 |
| Acute phase reaction | 124.12 | 13.42 | 28 | 28108 | 282 | 70900026 |
| Influenza like illness | 122.30 | 13.42 | 140 | 27996 | 65191 | 70835117 |
| Pain in extremity | 120.35 | 13.42 | 343 | 27793 | 327739 | 70572569 |
| Injection site extravasation | 117.41 | 13.42 | 61 | 28075 | 8685 | 70891623 |
| Tooth fracture | 117.10 | 13.42 | 65 | 28071 | 10562 | 70889746 |
| Exostosis of jaw | 111.71 | 13.42 | 34 | 28102 | 1163 | 70899145 |
| Fall | 107.58 | 13.42 | 403 | 27733 | 443693 | 70456615 |
| Drug ineffective | 106.89 | 13.42 | 130 | 28006 | 939622 | 69960686 |
| Tooth extraction | 106.41 | 13.42 | 60 | 28076 | 10047 | 70890261 |
| Metastases to bone | 96.16 | 13.42 | 76 | 28060 | 22300 | 70878008 |
| Sequestrectomy | 96.00 | 13.42 | 28 | 28108 | 825 | 70899483 |
| Fracture displacement | 94.36 | 13.42 | 30 | 28106 | 1188 | 70899120 |
| Pathological fracture | 93.14 | 13.42 | 54 | 28082 | 9529 | 70890779 |
| Osteitis | 89.58 | 13.42 | 39 | 28097 | 3744 | 70896564 |
| Foot fracture | 89.48 | 13.42 | 69 | 28067 | 19531 | 70880777 |
| Fracture delayed union | 86.21 | 13.42 | 32 | 28104 | 2027 | 70898281 |
| Back pain | 83.77 | 13.42 | 267 | 27869 | 270885 | 70629423 |
| Impaired healing | 80.84 | 13.42 | 122 | 28014 | 74252 | 70826056 |
| Actinomycosis | 79.42 | 13.42 | 25 | 28111 | 958 | 70899350 |
| Atypical fracture | 75.72 | 13.42 | 22 | 28114 | 639 | 70899669 |
| Off label use | 70.22 | 13.42 | 117 | 28019 | 742943 | 70157365 |
| Spinal compression fracture | 67.19 | 13.42 | 53 | 28083 | 15500 | 70884808 |
| Jaw fracture | 66.52 | 13.42 | 29 | 28107 | 2792 | 70897516 |
| Gingivitis | 65.85 | 13.42 | 41 | 28095 | 8229 | 70892079 |
| Gastrooesophageal reflux disease | 65.41 | 13.42 | 124 | 28012 | 90715 | 70809593 |
| Femoral neck fracture | 64.82 | 13.42 | 42 | 28094 | 9031 | 70891277 |
| Oral cavity fistula | 61.98 | 13.42 | 19 | 28117 | 666 | 70899642 |
| Periodontal disease | 61.74 | 13.42 | 24 | 28112 | 1726 | 70898582 |
| Toxicity to various agents | 59.88 | 13.42 | 39 | 28097 | 382133 | 70518175 |
| Jaw operation | 58.64 | 13.42 | 19 | 28117 | 800 | 70899508 |
| Carbohydrate antigen 15-3 increased | 57.71 | 13.42 | 20 | 28116 | 1038 | 70899270 |
| Osteoporosis | 57.12 | 13.42 | 83 | 28053 | 48824 | 70851484 |
| Temporomandibular joint syndrome | 53.90 | 13.42 | 27 | 28109 | 3560 | 70896748 |
| Fracture | 53.86 | 13.42 | 52 | 28084 | 19892 | 70880416 |
| Fistula | 53.40 | 13.42 | 40 | 28096 | 10841 | 70889467 |
| Breast cancer recurrent | 50.93 | 13.42 | 24 | 28112 | 2769 | 70897539 |
| Anaemia postoperative | 50.90 | 13.42 | 21 | 28115 | 1764 | 70898544 |
| Vitamin D deficiency | 50.63 | 13.42 | 41 | 28095 | 12446 | 70887862 |
| Isosthenuria | 49.68 | 13.42 | 11 | 28125 | 101 | 70900207 |
| Oral infection | 49.43 | 13.42 | 29 | 28107 | 5230 | 70895078 |
| Extravasation | 49.37 | 13.42 | 25 | 28111 | 3372 | 70896936 |
| Abscess jaw | 48.49 | 13.42 | 20 | 28116 | 1679 | 70898629 |
| Osteoarthritis | 48.24 | 13.42 | 97 | 28039 | 74050 | 70826258 |
| Tooth abscess | 47.06 | 13.42 | 42 | 28094 | 14547 | 70885761 |
| Ulna fracture | 46.89 | 13.42 | 17 | 28119 | 1007 | 70899301 |
| Gingival disorder | 46.17 | 13.42 | 24 | 28112 | 3418 | 70896890 |
| Infusion related reaction | 45.84 | 13.42 | 11 | 28125 | 197523 | 70702785 |
| Hydrothorax | 45.73 | 13.42 | 18 | 28118 | 1338 | 70898970 |
| Device failure | 44.13 | 13.42 | 28 | 28108 | 5807 | 70894501 |
| Periodontitis | 43.69 | 13.42 | 25 | 28111 | 4303 | 70896005 |
| Injection site inflammation | 43.35 | 13.42 | 23 | 28113 | 3415 | 70896893 |
| Fibrocystic breast disease | 43.19 | 13.42 | 14 | 28122 | 590 | 70899718 |
| Periprosthetic fracture | 43.06 | 13.42 | 14 | 28122 | 596 | 70899712 |
| Febrile neutropenia | 42.55 | 13.42 | 14 | 28122 | 204304 | 70696004 |
| Resorption bone increased | 41.90 | 13.42 | 17 | 28119 | 1368 | 70898940 |
| Tooth loss | 41.57 | 13.42 | 28 | 28108 | 6422 | 70893886 |
| Spinal osteoarthritis | 41.41 | 13.42 | 40 | 28096 | 15308 | 70885000 |
| Drug abuse | 41.17 | 13.42 | 5 | 28131 | 147251 | 70753057 |
| Loose tooth | 40.65 | 13.42 | 21 | 28115 | 2953 | 70897355 |
| Toothache | 40.52 | 13.42 | 43 | 28093 | 18387 | 70881921 |
| Exostosis | 39.86 | 13.42 | 38 | 28098 | 14307 | 70886001 |
| Musculoskeletal pain | 39.57 | 13.42 | 101 | 28035 | 90226 | 70810082 |
| Dyspepsia | 39.44 | 13.42 | 100 | 28036 | 88977 | 70811331 |
| Electrocardiogram PR shortened | 39.40 | 13.42 | 11 | 28125 | 276 | 70900032 |
| Pyelitis | 39.17 | 13.42 | 11 | 28125 | 282 | 70900026 |
| Condition aggravated | 38.75 | 13.42 | 69 | 28067 | 427566 | 70472742 |
| Osteopenia | 38.57 | 13.42 | 40 | 28096 | 16657 | 70883651 |
| Groin pain | 37.52 | 13.42 | 34 | 28102 | 12008 | 70888300 |
| Pelvic fracture | 37.47 | 13.42 | 33 | 28103 | 11228 | 70889080 |
| Therapeutic product effect decreased | 37.30 | 13.42 | 6 | 28130 | 143012 | 70757296 |
| Bone density decreased | 36.94 | 13.42 | 33 | 28103 | 11441 | 70888867 |
| Hyperaesthesia teeth | 35.82 | 13.42 | 16 | 28120 | 1632 | 70898676 |
| Product use in unapproved indication | 35.52 | 13.42 | 19 | 28117 | 207459 | 70692849 |
| Treatment failure | 35.52 | 13.42 | 7 | 28129 | 144135 | 70756173 |
| Maternal exposure during pregnancy | 34.61 | 13.42 | 3 | 28133 | 115342 | 70784966 |
| Hyperlipidaemia | 33.09 | 13.42 | 44 | 28092 | 23819 | 70876489 |
| Acute kidney injury | 32.77 | 13.42 | 89 | 28047 | 474535 | 70425773 |
| Hormone receptor positive HER2 negative breast cancer | 32.59 | 13.42 | 8 | 28128 | 119 | 70900189 |
| Spondylolisthesis | 32.51 | 13.42 | 18 | 28118 | 2908 | 70897400 |
| Hypotension | 32.51 | 13.42 | 70 | 28066 | 404311 | 70495997 |
| Rheumatoid arthritis | 32.30 | 13.42 | 41 | 28095 | 291764 | 70608544 |
| Diverticulum | 31.99 | 13.42 | 33 | 28103 | 13660 | 70886648 |
| Calcification metastatic | 31.93 | 13.42 | 8 | 28128 | 130 | 70900178 |
| Product use issue | 31.51 | 13.42 | 16 | 28120 | 179921 | 70720387 |
| Bladder hypertrophy | 31.50 | 13.42 | 11 | 28125 | 584 | 70899724 |
| Rib fracture | 31.01 | 13.42 | 44 | 28092 | 25312 | 70874996 |
| Spinal fracture | 30.82 | 13.42 | 35 | 28101 | 16132 | 70884176 |
| Lower respiratory tract infection | 30.80 | 13.42 | 4 | 28132 | 111909 | 70788399 |
| Bursitis | 30.75 | 13.42 | 45 | 28091 | 26628 | 70873680 |
| Metastases to lymph nodes | 30.60 | 13.42 | 27 | 28109 | 9211 | 70891097 |
| Oesophageal stenosis | 29.75 | 13.42 | 19 | 28117 | 3985 | 70896323 |
| Carcinoembryonic antigen increased | 29.68 | 13.42 | 15 | 28121 | 2015 | 70898293 |
| Hiatus hernia | 29.36 | 13.42 | 39 | 28097 | 21095 | 70879213 |
| Compression fracture | 29.21 | 13.42 | 22 | 28114 | 6009 | 70894299 |
| Dental fistula | 29.08 | 13.42 | 10 | 28126 | 507 | 70899801 |
| Drug intolerance | 29.05 | 13.42 | 28 | 28108 | 225659 | 70674649 |
| Jaw fistula | 28.46 | 13.42 | 7 | 28129 | 105 | 70900203 |
| Osteomalacia | 28.25 | 13.42 | 13 | 28123 | 1421 | 70898887 |
| Radius fracture | 28.06 | 13.42 | 17 | 28119 | 3249 | 70897059 |
| Osteogenesis imperfecta | 27.48 | 13.42 | 8 | 28128 | 234 | 70900074 |
| Chest pain | 27.38 | 13.42 | 182 | 27954 | 251078 | 70649230 |
| Bone sequestrum | 27.34 | 13.42 | 12 | 28124 | 1174 | 70899134 |
| Bone loss | 27.16 | 13.42 | 15 | 28121 | 2412 | 70897896 |
| Gingival swelling | 26.79 | 13.42 | 18 | 28118 | 4111 | 70896197 |
| Congenital coronary artery malformation | 26.11 | 13.42 | 6 | 28130 | 66 | 70900242 |
| Hip fracture | 26.03 | 13.42 | 43 | 28093 | 28220 | 70872088 |
| Intentional overdose | 25.96 | 13.42 | 4 | 28132 | 98431 | 70801877 |
| Osteoporotic fracture | 25.77 | 13.42 | 17 | 28119 | 3767 | 70896541 |
| Renal cyst | 25.63 | 13.42 | 29 | 28107 | 13316 | 70886992 |
| Vertebral foraminal stenosis | 25.39 | 13.42 | 11 | 28125 | 1043 | 70899265 |
| Pulpitis dental | 25.34 | 13.42 | 11 | 28125 | 1048 | 70899260 |
| Injection site swelling | 25.18 | 13.42 | 54 | 28082 | 43103 | 70857205 |
| Oral disorder | 24.80 | 13.42 | 24 | 28112 | 9205 | 70891103 |
| Oesophagitis | 24.37 | 13.42 | 37 | 28099 | 22615 | 70877693 |
| Rectocele | 24.14 | 13.42 | 9 | 28127 | 577 | 70899731 |
| Creatinine renal clearance increased | 24.01 | 13.42 | 10 | 28126 | 860 | 70899448 |
| Therapeutic product effect incomplete | 23.60 | 13.42 | 9 | 28127 | 119873 | 70780435 |
| Scoliosis | 23.53 | 13.42 | 20 | 28116 | 6491 | 70893817 |
| Metastases to pleura | 23.04 | 13.42 | 11 | 28125 | 1307 | 70899001 |
| Intervertebral disc degeneration | 23.02 | 13.42 | 28 | 28108 | 13872 | 70886436 |
| Pain | 22.86 | 13.42 | 363 | 27773 | 628453 | 70271855 |
| Pneumonia | 22.75 | 13.42 | 141 | 27995 | 596091 | 70304217 |
| Mucosal ulceration | 22.57 | 13.42 | 12 | 28124 | 1789 | 70898519 |
| Haemorrhoids | 22.33 | 13.42 | 38 | 28098 | 25550 | 70874758 |
| Osteocalcin decreased | 22.20 | 13.42 | 5 | 28131 | 50 | 70900258 |
| Breast cancer | 21.94 | 13.42 | 44 | 28092 | 33505 | 70866803 |
| Tonsillar disorder | 21.81 | 13.42 | 10 | 28126 | 1084 | 70899224 |
| Purulence | 21.38 | 13.42 | 12 | 28124 | 1991 | 70898317 |
| Breast mass | 21.37 | 13.42 | 18 | 28118 | 5767 | 70894541 |
| Dental necrosis | 21.18 | 13.42 | 6 | 28130 | 159 | 70900149 |
| Gastritis | 20.71 | 13.42 | 51 | 28085 | 44540 | 70855768 |
| Tooth avulsion | 20.46 | 13.42 | 5 | 28131 | 73 | 70900235 |
| Synovitis | 20.45 | 13.42 | 13 | 28123 | 129215 | 70771093 |
| Dorsal ramus syndrome | 20.17 | 13.42 | 4 | 28132 | 20 | 70900288 |
| Muscle spasms | 20.16 | 13.42 | 117 | 28019 | 153929 | 70746379 |
| Infusion site extravasation | 19.98 | 13.42 | 20 | 28116 | 7988 | 70892320 |
| Induration | 19.94 | 13.42 | 11 | 28125 | 1765 | 70898543 |
| Thoracic vertebral fracture | 19.92 | 13.42 | 16 | 28120 | 4798 | 70895510 |
| Oxygen saturation decreased | 19.43 | 13.42 | 11 | 28125 | 116418 | 70783890 |
| Suicide attempt | 19.29 | 13.42 | 4 | 28132 | 79506 | 70820802 |
| Cataract | 19.17 | 13.42 | 57 | 28079 | 55588 | 70844720 |
| Confusional state | 19.09 | 13.42 | 54 | 28082 | 284344 | 70615964 |
| Ovarian cancer stage III | 18.98 | 13.42 | 6 | 28130 | 233 | 70900075 |
| Uterine disorder | 18.72 | 13.42 | 11 | 28125 | 1988 | 70898320 |
| Fractured sacrum | 18.65 | 13.42 | 10 | 28126 | 1516 | 70898792 |
| Joint swelling | 18.57 | 13.42 | 46 | 28090 | 253165 | 70647143 |
| Meniscus injury | 18.41 | 13.42 | 17 | 28119 | 6150 | 70894158 |
| Blood parathyroid hormone increased | 18.38 | 13.42 | 13 | 28123 | 3224 | 70897084 |
| Dysphagia | 18.37 | 13.42 | 91 | 28045 | 112743 | 70787565 |
| Respiratory failure | 18.35 | 13.42 | 24 | 28112 | 168711 | 70731597 |
| Breath odour | 18.30 | 13.42 | 10 | 28126 | 1574 | 70898734 |
| Barrett's oesophagus | 18.28 | 13.42 | 8 | 28128 | 777 | 70899531 |
| Metastases to liver | 18.21 | 13.42 | 35 | 28101 | 25843 | 70874465 |
| Spondylolysis | 17.92 | 13.42 | 5 | 28131 | 125 | 70900183 |
| Systemic lupus erythematosus | 17.92 | 13.42 | 9 | 28127 | 101893 | 70798415 |
| Tooth infection | 17.86 | 13.42 | 27 | 28109 | 16436 | 70883872 |
| Hypothyroidism | 17.83 | 13.42 | 49 | 28087 | 45706 | 70854602 |
| Atrophic vulvovaginitis | 17.83 | 13.42 | 9 | 28127 | 1206 | 70899102 |
| Platelet count decreased | 17.74 | 13.42 | 27 | 28109 | 178195 | 70722113 |
| Poor dental condition | 17.74 | 13.42 | 7 | 28129 | 524 | 70899784 |
| Cellulitis | 17.71 | 13.42 | 82 | 28054 | 98846 | 70801462 |
| Bone lesion excision | 17.58 | 13.42 | 4 | 28132 | 42 | 70900266 |
| Hypophosphataemic osteomalacia | 17.51 | 13.42 | 6 | 28130 | 301 | 70900007 |
| Chest wall tumour | 17.41 | 13.42 | 4 | 28132 | 44 | 70900264 |
| Invasive ductal breast carcinoma | 17.31 | 13.42 | 16 | 28120 | 5793 | 70894515 |
| Hypercholesterolaemia | 17.27 | 13.42 | 28 | 28108 | 18089 | 70882219 |
| Cardiac arrest | 17.11 | 13.42 | 23 | 28113 | 159811 | 70740497 |
| Chronic hepatic failure | 16.93 | 13.42 | 8 | 28128 | 928 | 70899380 |
| Lumbar vertebral fracture | 16.90 | 13.42 | 16 | 28120 | 5971 | 70894337 |
| White blood cell count decreased | 16.72 | 13.42 | 26 | 28110 | 170115 | 70730193 |
| Eructation | 16.72 | 13.42 | 20 | 28116 | 9740 | 70890568 |
| Injection site phlebitis | 16.60 | 13.42 | 5 | 28131 | 165 | 70900143 |
| Intentional product use issue | 16.53 | 13.42 | 14 | 28122 | 120128 | 70780180 |
| Pulmonary oedema | 16.49 | 13.42 | 6 | 28130 | 82272 | 70818036 |
| Hepatic enzyme increased | 16.39 | 13.42 | 23 | 28113 | 156967 | 70743341 |
| Product dose omission issue | 16.34 | 13.42 | 39 | 28097 | 217429 | 70682879 |
| COVID-19 | 16.24 | 13.42 | 11 | 28125 | 105746 | 70794562 |
| Lymphoedema | 16.11 | 13.42 | 21 | 28115 | 11148 | 70889160 |
| Cardio-respiratory arrest | 16.11 | 13.42 | 10 | 28126 | 100667 | 70799641 |
| Peritoneal disorder | 16.10 | 13.42 | 7 | 28129 | 669 | 70899639 |
| Phlebitis | 16.06 | 13.42 | 18 | 28118 | 8176 | 70892132 |
| Intramedullary rod insertion | 16.05 | 13.42 | 5 | 28131 | 185 | 70900123 |
| X-ray of pelvis and hip abnormal | 15.68 | 13.42 | 3 | 28133 | 12 | 70900296 |
| Lumbar spinal stenosis | 15.58 | 13.42 | 14 | 28122 | 4889 | 70895419 |
| Rotator cuff syndrome | 15.43 | 13.42 | 22 | 28114 | 12712 | 70887596 |
| Stress urinary incontinence | 15.10 | 13.42 | 9 | 28127 | 1671 | 70898637 |
| Cerumen impaction | 15.09 | 13.42 | 8 | 28128 | 1186 | 70899122 |
| Nasopharyngitis | 15.05 | 13.42 | 42 | 28094 | 222164 | 70678144 |
| Musculoskeletal chest pain | 14.95 | 13.42 | 30 | 28106 | 22851 | 70877457 |
| Death | 14.92 | 13.42 | 130 | 28006 | 509931 | 70390377 |
| Teeth brittle | 14.89 | 13.42 | 6 | 28130 | 474 | 70899834 |
| Skeletal injury | 14.67 | 13.42 | 8 | 28128 | 1255 | 70899053 |
| Wound haemorrhage | 14.58 | 13.42 | 12 | 28124 | 3725 | 70896583 |
| Hand fracture | 14.37 | 13.42 | 14 | 28122 | 5413 | 70894895 |
| Bone lesion | 14.36 | 13.42 | 14 | 28122 | 5416 | 70894892 |
| Macular scar | 14.30 | 13.42 | 4 | 28132 | 101 | 70900207 |
| Metastases to the mediastinum | 14.17 | 13.42 | 6 | 28130 | 538 | 70899770 |
| Humerus fracture | 14.08 | 13.42 | 17 | 28119 | 8361 | 70891947 |
| Wrist fracture | 13.98 | 13.42 | 19 | 28117 | 10497 | 70889811 |
| Lumbar radiculopathy | 13.96 | 13.42 | 9 | 28127 | 1917 | 70898391 |
| Breast disorder | 13.87 | 13.42 | 9 | 28127 | 1940 | 70898368 |
| Uterine leiomyoma | 13.77 | 13.42 | 14 | 28122 | 5693 | 70894615 |
| Bone marrow oedema | 13.71 | 13.42 | 8 | 28128 | 1427 | 70898881 |
| Hypercalcaemia | 13.57 | 13.42 | 37 | 28099 | 34348 | 70865960 |
| Gingival pain | 13.51 | 13.42 | 15 | 28121 | 6742 | 70893566 |
| Hospitalisation | 13.49 | 13.42 | 8 | 28128 | 82560 | 70817748 |
| Rectal polyp | 13.48 | 13.42 | 8 | 28128 | 1472 | 70898836 |
| Blister | 13.48 | 13.42 | 12 | 28124 | 100514 | 70799794 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | M05BA06 | MUSCULO-SKELETAL SYSTEM DRUGS FOR TREATMENT OF BONE DISEASES DRUGS AFFECTING BONE STRUCTURE AND MINERALIZATION Bisphosphonates |
| ATC | M05BB09 | 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 |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Hypercalcemia | indication | 66931009 | DOID:12678 |
| Postmenopausal osteoporosis | indication | 102447009 | |
| Gastritis | contraindication | 4556007 | DOID:4029 |
| Hypocalcemia | contraindication | 5291005 | |
| Bone pain | contraindication | 12584003 | |
| Heartburn | contraindication | 16331000 | |
| Esophagitis | contraindication | 16761005 | DOID:11963 |
| Swallowing painful | contraindication | 30233002 | |
| Ulcer of esophagus | contraindication | 30811009 | |
| Vitamin D deficiency | contraindication | 34713006 | |
| Dysphagia | contraindication | 40739000 | |
| Achalasia of esophagus | contraindication | 45564002 | DOID:9164 |
| Joint pain | contraindication | 57676002 | |
| Acute nephropathy | contraindication | 58574008 | |
| Stricture of esophagus | contraindication | 63305008 | |
| Muscle pain | contraindication | 68962001 | |
| Fracture of femur | contraindication | 71620000 | |
| Duodenitis | contraindication | 72007001 | DOID:8643 |
| Bed-ridden | contraindication | 160685001 | |
| Acute peptic ulcer | contraindication | 196682000 | |
| Tooth disorder | contraindication | 234947003 | DOID:1091 |
| Esophageal dysmotility | contraindication | 266434009 | DOID:9192 |
| Primary malignant neoplasm | contraindication | 372087000 | |
| Aseptic necrosis of bone of jaw | contraindication | 441809006 | |
| Invasive Dental Procedure | contraindication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 3.98 | acidic |
| pKa2 | 4.97 | acidic |
| pKa3 | 9.03 | acidic |
| pKa4 | 13.3 | acidic |
| pKa5 | 7.94 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BONIVA | HOFFMANN LA ROCHE | N021455 | March 24, 2005 | DISCN | TABLET | ORAL | 7192938 | May 6, 2023 | TREATMENT AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN BY ONCE-MONTHLY ORAL ADMINISTRATION OF IBANDRONATE SODIUM MONOHYDRATE EQUIVALENT TO 150MG OF IBANDRONIC ACID |
| EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BONIVA | HOFFMANN LA ROCHE | N021455 | March 24, 2005 | DISCN | TABLET | ORAL | 7410957 | May 6, 2023 | TREATMENT AND PREVENTION OF OSTEOPOROSIS |
| EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | BONIVA | HOFFMANN LA ROCHE | N021455 | March 24, 2005 | DISCN | TABLET | ORAL | 7718634 | May 6, 2023 | TREATMENT AND PREVENTION OF OSTEOPOROSIS |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Farnesyl pyrophosphate synthase | Enzyme | INHIBITOR | Ki | 8.44 | CHEMBL | CHEMBL | |||
| Geranylgeranyl pyrophosphate synthase | Enzyme | IC50 | 4.10 | CHEMBL | |||||
| Squalene synthase | Enzyme | IC50 | 6.19 | CHEMBL | |||||
| Farnesyl pyrophosphate synthase | Enzyme | INHIBITOR | IC50 | 5.13 | IUPHAR |
External reference:
| ID | Source |
|---|---|
| D08056 | KEGG_DRUG |
| 138926-19-9 | SECONDARY_CAS_RN |
| 4021407 | VANDF |
| C0379200 | UMLSCUI |
| BFQ | PDB_CHEM_ID |
| CHEMBL997 | ChEMBL_ID |
| CHEMBL3989569 | ChEMBL_ID |
| CHEMBL1201008 | ChEMBL_ID |
| DB00710 | DRUGBANK_ID |
| D000077557 | MESH_DESCRIPTOR_UI |
| 60852 | PUBCHEM_CID |
| 3059 | IUPHAR_LIGAND_ID |
| 7189 | INN_ID |
| UMD7G2653W | UNII |
| 115264 | RXNORM |
| 188271 | MMSL |
| 67270 | MMSL |
| d05357 | MMSL |
| 007178 | NDDF |
| 007179 | NDDF |
| 395271007 | SNOMEDCT_US |
| 404839003 | SNOMEDCT_US |
| 420936009 | SNOMEDCT_US |
| 96287002 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Boniva | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0004-0186 | TABLET, FILM COATED | 150 mg | ORAL | NDA | 27 sections |
| ibandronate sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 25021-827 | INJECTION, SOLUTION | 3 mg | INTRAVENOUS | ANDA | 30 sections |
| IBANDRONATE SODIUM | Human Prescription Drug Label | 1 | 33342-150 | TABLET, FILM COATED | 150 mg | ORAL | ANDA | 27 sections |
| IBANDRONATE SODIUM | Human Prescription Drug Label | 1 | 33342-150 | TABLET, FILM COATED | 150 mg | ORAL | ANDA | 27 sections |
| IBANDRONATE SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 47781-103 | TABLET | 150 mg | ORAL | ANDA | 27 sections |
| IBANDRONATE SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 47781-103 | TABLET | 150 mg | ORAL | ANDA | 27 sections |
| IBANDRONATE SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51224-008 | INJECTION, SOLUTION | 3 mg | INTRAVENOUS | ANDA | 31 sections |
| IBANDRONATE SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51224-008 | INJECTION, SOLUTION | 3 mg | INTRAVENOUS | ANDA | 31 sections |
| Boniva | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-5322 | TABLET, FILM COATED | 150 mg | ORAL | NDA | 28 sections |
| Ibandronate sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 55111-575 | TABLET | 150 mg | ORAL | ANDA | 26 sections |
| Ibandronate Sodium | Human Prescription Drug Label | 1 | 55150-191 | INJECTION, SOLUTION | 3 mg | INTRAVENOUS | ANDA | 27 sections |
| Ibandronate Sodium | Human Prescription Drug Label | 1 | 55150-191 | INJECTION, SOLUTION | 3 mg | INTRAVENOUS | ANDA | 27 sections |
| IBANDRONATE SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60429-643 | TABLET, FILM COATED | 150 mg | ORAL | ANDA | 28 sections |
| IBANDRONATE SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-2795 | TABLET, FILM COATED | 150 mg | ORAL | ANDA | 28 sections |
| Ibandronate Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-6097 | INJECTION | 3 mg | INTRAVENOUS | ANDA | 28 sections |
| Ibandronate Sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-6097 | INJECTION | 3 mg | INTRAVENOUS | ANDA | 28 sections |
| IBANDRONATE SODIUM | Human Prescription Drug Label | 1 | 62756-218 | INJECTION, SOLUTION | 3 mg | INTRAVENOUS | ANDA | 28 sections |
| Ibandronate Sodium | Human Prescription Drug Label | 1 | 65862-237 | TABLET, FILM COATED | 150 mg | ORAL | ANDA | 27 sections |
| ibandronate sodium | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67457-524 | INJECTION, SOLUTION | 3 mg | INTRAVENOUS | ANDA | 23 sections |