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 |
|---|---|---|---|
| June 25, 1996 | EMA | Atnahs Pharma Netherlands B.V. | |
| 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 | 1514.99 | 12.09 | 647 | 42592 | 34476 | 63411307 |
| Femur fracture | 1348.16 | 12.09 | 628 | 42611 | 41128 | 63404655 |
| Low turnover osteopathy | 623.82 | 12.09 | 193 | 43046 | 3992 | 63441791 |
| Osteonecrosis | 621.95 | 12.09 | 313 | 42926 | 24217 | 63421566 |
| Bone pain | 600.61 | 12.09 | 405 | 42834 | 54236 | 63391547 |
| Atypical femur fracture | 448.44 | 12.09 | 160 | 43079 | 5212 | 63440571 |
| Stress fracture | 397.41 | 12.09 | 163 | 43076 | 7800 | 63437983 |
| Myalgia | 273.11 | 12.09 | 412 | 42827 | 146117 | 63299666 |
| Intramedullary rod insertion | 266.89 | 12.09 | 86 | 43153 | 2037 | 63443746 |
| Drug ineffective | 248.21 | 12.09 | 210 | 43029 | 1044555 | 62401228 |
| Fracture nonunion | 224.71 | 12.09 | 77 | 43162 | 2218 | 63443565 |
| Exposed bone in jaw | 217.49 | 12.09 | 80 | 43159 | 2845 | 63442938 |
| Osteomyelitis | 190.45 | 12.09 | 151 | 43088 | 25869 | 63419914 |
| Influenza like illness | 182.08 | 12.09 | 226 | 43013 | 66598 | 63379185 |
| Dental caries | 181.80 | 12.09 | 105 | 43134 | 10674 | 63435109 |
| Tooth extraction | 178.50 | 12.09 | 102 | 43137 | 10162 | 63435621 |
| Pain in jaw | 178.31 | 12.09 | 182 | 43057 | 43314 | 63402469 |
| Bone disorder | 165.23 | 12.09 | 128 | 43111 | 21198 | 63424585 |
| Jaw disorder | 164.69 | 12.09 | 78 | 43161 | 5271 | 63440512 |
| Tooth disorder | 159.66 | 12.09 | 141 | 43098 | 28016 | 63417767 |
| Injection site extravasation | 154.12 | 12.09 | 88 | 43151 | 8753 | 63437030 |
| Off label use | 151.81 | 12.09 | 142 | 43097 | 674320 | 62771463 |
| Anaemia postoperative | 150.89 | 12.09 | 57 | 43182 | 2185 | 63443598 |
| Fall | 145.77 | 12.09 | 590 | 42649 | 391744 | 63054039 |
| Foot fracture | 144.13 | 12.09 | 124 | 43115 | 23790 | 63421993 |
| Vitamin D deficiency | 143.00 | 12.09 | 99 | 43140 | 13793 | 63431990 |
| Pain in extremity | 139.80 | 12.09 | 519 | 42720 | 330967 | 63114816 |
| Gastrooesophageal reflux disease | 135.89 | 12.09 | 238 | 43001 | 95401 | 63350382 |
| Maternal exposure during pregnancy | 135.39 | 12.09 | 3 | 43236 | 220059 | 63225724 |
| Metastases to bone | 128.73 | 12.09 | 110 | 43129 | 20909 | 63424874 |
| Back pain | 127.97 | 12.09 | 433 | 42806 | 263712 | 63182071 |
| Acute phase reaction | 126.70 | 12.09 | 31 | 43208 | 252 | 63445531 |
| Tooth fracture | 125.83 | 12.09 | 84 | 43155 | 11026 | 63434757 |
| Fracture delayed union | 122.25 | 12.09 | 50 | 43189 | 2372 | 63443411 |
| Spinal osteoarthritis | 120.72 | 12.09 | 95 | 43144 | 16091 | 63429692 |
| Pathological fracture | 120.30 | 12.09 | 75 | 43164 | 8759 | 63437024 |
| Osteoarthritis | 118.60 | 12.09 | 224 | 43015 | 95119 | 63350664 |
| Open reduction of fracture | 117.72 | 12.09 | 40 | 43199 | 1122 | 63444661 |
| Exostosis of jaw | 117.49 | 12.09 | 41 | 43198 | 1248 | 63444535 |
| Arthralgia | 116.31 | 12.09 | 723 | 42516 | 568987 | 62876796 |
| Infusion related reaction | 111.61 | 12.09 | 17 | 43222 | 245504 | 63200279 |
| Product use issue | 108.08 | 12.09 | 12 | 43227 | 220508 | 63225275 |
| Periodontal disease | 104.08 | 12.09 | 40 | 43199 | 1608 | 63444175 |
| Condition aggravated | 103.54 | 12.09 | 74 | 43165 | 402143 | 63043640 |
| Hyperlipidaemia | 101.07 | 12.09 | 93 | 43146 | 19478 | 63426305 |
| Fracture displacement | 95.64 | 12.09 | 35 | 43204 | 1226 | 63444557 |
| Hand deformity | 94.96 | 12.09 | 3 | 43236 | 159454 | 63286329 |
| Extravasation | 93.23 | 12.09 | 41 | 43198 | 2331 | 63443452 |
| Sequestrectomy | 89.87 | 12.09 | 30 | 43209 | 796 | 63444987 |
| Osteitis | 89.47 | 12.09 | 44 | 43195 | 3230 | 63442553 |
| Spinal compression fracture | 87.97 | 12.09 | 75 | 43164 | 14208 | 63431575 |
| Treatment failure | 87.71 | 12.09 | 15 | 43224 | 199028 | 63246755 |
| Drug intolerance | 87.28 | 12.09 | 51 | 43188 | 308610 | 63137173 |
| Ulna fracture | 83.10 | 12.09 | 31 | 43208 | 1147 | 63444636 |
| Fracture | 82.14 | 12.09 | 83 | 43156 | 19501 | 63426282 |
| Device failure | 81.76 | 12.09 | 51 | 43188 | 5960 | 63439823 |
| Systemic lupus erythematosus | 81.27 | 12.09 | 21 | 43218 | 208897 | 63236886 |
| Rib fracture | 79.15 | 12.09 | 87 | 43152 | 22510 | 63423273 |
| Osteopenia | 76.02 | 12.09 | 80 | 43159 | 19705 | 63426078 |
| Glossodynia | 75.54 | 12.09 | 15 | 43224 | 178861 | 63266922 |
| Atypical fracture | 72.79 | 12.09 | 24 | 43215 | 612 | 63445171 |
| Periprosthetic fracture | 71.67 | 12.09 | 22 | 43217 | 442 | 63445341 |
| Lower respiratory tract infection | 70.73 | 12.09 | 5 | 43234 | 132302 | 63313481 |
| Synovitis | 70.42 | 12.09 | 20 | 43219 | 186898 | 63258885 |
| Femoral neck fracture | 70.05 | 12.09 | 53 | 43186 | 8470 | 63437313 |
| Gingivitis | 68.36 | 12.09 | 52 | 43187 | 8377 | 63437406 |
| Pelvic fracture | 68.09 | 12.09 | 63 | 43176 | 13285 | 63432498 |
| Metastases to liver | 67.64 | 12.09 | 82 | 43157 | 23557 | 63422226 |
| Hepatic enzyme increased | 66.93 | 12.09 | 27 | 43212 | 202301 | 63243482 |
| Temporomandibular joint syndrome | 66.74 | 12.09 | 39 | 43200 | 4050 | 63441733 |
| Carbohydrate antigen 15-3 increased | 66.69 | 12.09 | 28 | 43211 | 1420 | 63444363 |
| Abscess jaw | 64.20 | 12.09 | 27 | 43212 | 1375 | 63444408 |
| Product use in unapproved indication | 64.14 | 12.09 | 21 | 43218 | 179059 | 63266724 |
| Therapeutic product effect decreased | 63.54 | 12.09 | 26 | 43213 | 193161 | 63252622 |
| Resorption bone increased | 63.28 | 12.09 | 26 | 43213 | 1248 | 63444535 |
| Joint swelling | 62.36 | 12.09 | 79 | 43160 | 327587 | 63118196 |
| Toxicity to various agents | 61.58 | 12.09 | 47 | 43192 | 247203 | 63198580 |
| Fibrocystic breast disease | 61.50 | 12.09 | 25 | 43214 | 1167 | 63444616 |
| Actinomycosis | 61.04 | 12.09 | 24 | 43215 | 1026 | 63444757 |
| Bone density decreased | 59.58 | 12.09 | 61 | 43178 | 14551 | 63431232 |
| Gingival disorder | 58.38 | 12.09 | 34 | 43205 | 3508 | 63442275 |
| Periodontitis | 57.89 | 12.09 | 33 | 43206 | 3270 | 63442513 |
| Intervertebral disc degeneration | 57.59 | 12.09 | 62 | 43177 | 15670 | 63430113 |
| Osteoporosis | 57.26 | 12.09 | 123 | 43116 | 57215 | 63388568 |
| Toothache | 57.23 | 12.09 | 68 | 43171 | 19131 | 63426652 |
| Impaired healing | 56.65 | 12.09 | 176 | 43063 | 102366 | 63343417 |
| Therapeutic product effect incomplete | 56.01 | 12.09 | 9 | 43230 | 125047 | 63320736 |
| Injection site inflammation | 55.81 | 12.09 | 34 | 43205 | 3809 | 63441974 |
| Tooth loss | 54.95 | 12.09 | 42 | 43197 | 6814 | 63438969 |
| Bone loss | 54.42 | 12.09 | 31 | 43208 | 3068 | 63442715 |
| Diverticulum | 54.31 | 12.09 | 53 | 43186 | 11938 | 63433845 |
| Spondylolisthesis | 53.20 | 12.09 | 32 | 43207 | 3504 | 63442279 |
| Oral cavity fistula | 52.31 | 12.09 | 19 | 43220 | 651 | 63445132 |
| Musculoskeletal pain | 51.54 | 12.09 | 159 | 43080 | 92118 | 63353665 |
| Jaw operation | 51.39 | 12.09 | 20 | 43219 | 832 | 63444951 |
| Jaw fracture | 50.74 | 12.09 | 28 | 43211 | 2606 | 63443177 |
| Wound | 50.48 | 12.09 | 24 | 43215 | 163239 | 63282544 |
| Spinal fracture | 50.04 | 12.09 | 62 | 43177 | 18209 | 63427574 |
| Dyspepsia | 49.75 | 12.09 | 168 | 43071 | 102028 | 63343755 |
| Loose tooth | 49.22 | 12.09 | 30 | 43209 | 3364 | 63442419 |
| Chest pain | 48.20 | 12.09 | 281 | 42958 | 215678 | 63230105 |
| Discomfort | 48.19 | 12.09 | 27 | 43212 | 167347 | 63278436 |
| Isosthenuria | 47.96 | 12.09 | 12 | 43227 | 108 | 63445675 |
| Tooth abscess | 47.92 | 12.09 | 55 | 43184 | 14914 | 63430869 |
| Fatigue | 47.86 | 12.09 | 382 | 42857 | 887646 | 62558137 |
| Nasopharyngitis | 47.63 | 12.09 | 62 | 43177 | 254195 | 63191588 |
| Hypothyroidism | 46.70 | 12.09 | 95 | 43144 | 42537 | 63403246 |
| Scoliosis | 45.69 | 12.09 | 40 | 43199 | 7848 | 63437935 |
| Oesophagitis | 44.47 | 12.09 | 53 | 43186 | 14955 | 63430828 |
| Hypersensitivity | 43.77 | 12.09 | 83 | 43156 | 292602 | 63153181 |
| Medical device removal | 43.58 | 12.09 | 20 | 43219 | 1257 | 63444526 |
| Fistula | 43.49 | 12.09 | 44 | 43195 | 10349 | 63435434 |
| Calcium deficiency | 42.95 | 12.09 | 19 | 43220 | 1095 | 63444688 |
| Hip fracture | 42.65 | 12.09 | 74 | 43165 | 29400 | 63416383 |
| Metastases to pleura | 42.41 | 12.09 | 21 | 43218 | 1564 | 63444219 |
| Radius fracture | 42.40 | 12.09 | 28 | 43211 | 3607 | 63442176 |
| Bursitis | 42.31 | 12.09 | 84 | 43155 | 36957 | 63408826 |
| Renal cyst | 41.99 | 12.09 | 43 | 43196 | 10259 | 63435524 |
| Blister | 41.82 | 12.09 | 18 | 43221 | 129796 | 63315987 |
| Vertebral foraminal stenosis | 41.80 | 12.09 | 18 | 43221 | 972 | 63444811 |
| Oral infection | 41.06 | 12.09 | 31 | 43208 | 4937 | 63440846 |
| Pyelitis | 40.64 | 12.09 | 12 | 43227 | 210 | 63445573 |
| Groin pain | 40.53 | 12.09 | 42 | 43197 | 10161 | 63435622 |
| Breast cancer recurrent | 40.18 | 12.09 | 29 | 43210 | 4312 | 63441471 |
| Gingival swelling | 39.72 | 12.09 | 29 | 43210 | 4389 | 63441394 |
| Bladder hypertrophy | 39.72 | 12.09 | 12 | 43227 | 228 | 63445555 |
| Rheumatoid arthritis | 39.71 | 12.09 | 70 | 43169 | 253749 | 63192034 |
| Hyperaesthesia teeth | 39.69 | 12.09 | 21 | 43218 | 1797 | 63443986 |
| Lumbar spinal stenosis | 39.66 | 12.09 | 30 | 43209 | 4792 | 63440991 |
| Meniscus injury | 39.07 | 12.09 | 35 | 43204 | 7079 | 63438704 |
| Rotator cuff syndrome | 38.89 | 12.09 | 47 | 43192 | 13455 | 63432328 |
| Drug abuse | 38.01 | 12.09 | 3 | 43236 | 72515 | 63373268 |
| Electrocardiogram PR shortened | 37.77 | 12.09 | 12 | 43227 | 271 | 63445512 |
| Product dose omission issue | 37.21 | 12.09 | 64 | 43175 | 234249 | 63211534 |
| Gastritis | 37.21 | 12.09 | 80 | 43159 | 37223 | 63408560 |
| Folliculitis | 36.60 | 12.09 | 3 | 43236 | 70314 | 63375469 |
| Pulpitis dental | 36.34 | 12.09 | 16 | 43223 | 912 | 63444871 |
| Osteomalacia | 36.31 | 12.09 | 15 | 43224 | 730 | 63445053 |
| Hydrothorax | 36.29 | 12.09 | 16 | 43223 | 915 | 63444868 |
| Pneumonia | 36.21 | 12.09 | 174 | 43065 | 456593 | 62989190 |
| Congenital coronary artery malformation | 36.07 | 12.09 | 10 | 43229 | 138 | 63445645 |
| Compression fracture | 35.96 | 12.09 | 32 | 43207 | 6416 | 63439367 |
| Dental necrosis | 35.81 | 12.09 | 10 | 43229 | 142 | 63445641 |
| Exostosis | 35.72 | 12.09 | 52 | 43187 | 17810 | 63427973 |
| Endodontic procedure | 35.71 | 12.09 | 24 | 43215 | 3183 | 63442600 |
| Intentional product use issue | 34.88 | 12.09 | 22 | 43217 | 127870 | 63317913 |
| Rash | 34.56 | 12.09 | 232 | 43007 | 560639 | 62885144 |
| COVID-19 | 34.38 | 12.09 | 17 | 43222 | 113086 | 63332697 |
| Oxygen saturation decreased | 34.24 | 12.09 | 9 | 43230 | 88576 | 63357207 |
| Hypercholesterolaemia | 34.10 | 12.09 | 56 | 43183 | 21278 | 63424505 |
| Tonsillectomy | 33.98 | 12.09 | 15 | 43224 | 860 | 63444923 |
| Intentional overdose | 33.96 | 12.09 | 5 | 43234 | 74147 | 63371636 |
| Hiatus hernia | 33.60 | 12.09 | 56 | 43183 | 21538 | 63424245 |
| Peripheral swelling | 33.47 | 12.09 | 83 | 43156 | 265859 | 63179924 |
| Oesophageal stenosis | 32.96 | 12.09 | 23 | 43216 | 3243 | 63442540 |
| Phlebitis | 32.87 | 12.09 | 31 | 43208 | 6693 | 63439090 |
| Wrist fracture | 32.32 | 12.09 | 43 | 43196 | 13544 | 63432239 |
| Blood loss anaemia | 32.12 | 12.09 | 35 | 43204 | 8966 | 63436817 |
| Bone sequestrum | 32.11 | 12.09 | 17 | 43222 | 1457 | 63444326 |
| Haemorrhoids | 31.25 | 12.09 | 55 | 43184 | 22095 | 63423688 |
| Dysphagia | 30.96 | 12.09 | 131 | 43108 | 88454 | 63357329 |
| Product administration error | 30.81 | 12.09 | 55 | 43184 | 22342 | 63423441 |
| Hysterectomy | 30.57 | 12.09 | 35 | 43204 | 9464 | 63436319 |
| Liver injury | 30.37 | 12.09 | 3 | 43236 | 60517 | 63385266 |
| Weight increased | 30.07 | 12.09 | 85 | 43154 | 260707 | 63185076 |
| Intervertebral disc protrusion | 29.81 | 12.09 | 56 | 43183 | 23653 | 63422130 |
| Oesophageal disorder | 29.44 | 12.09 | 19 | 43220 | 2354 | 63443429 |
| Metastases to adrenals | 29.34 | 12.09 | 13 | 43226 | 752 | 63445031 |
| Mitral valve prolapse | 29.30 | 12.09 | 19 | 43220 | 2374 | 63443409 |
| Internal fixation of fracture | 29.21 | 12.09 | 13 | 43226 | 760 | 63445023 |
| Drug hypersensitivity | 29.10 | 12.09 | 111 | 43128 | 310576 | 63135207 |
| Osteocalcin decreased | 29.05 | 12.09 | 7 | 43232 | 53 | 63445730 |
| Psoriatic arthropathy | 28.98 | 12.09 | 13 | 43226 | 91507 | 63354276 |
| Arteriosclerosis | 28.93 | 12.09 | 35 | 43204 | 10031 | 63435752 |
| Alopecia | 28.85 | 12.09 | 125 | 43114 | 337411 | 63108372 |
| Jaw fistula | 28.82 | 12.09 | 7 | 43232 | 55 | 63445728 |
| Muscle injury | 28.59 | 12.09 | 5 | 43234 | 65340 | 63380443 |
| Pruritus | 28.43 | 12.09 | 138 | 43101 | 361315 | 63084468 |
| Kyphosis | 28.27 | 12.09 | 19 | 43220 | 2521 | 63443262 |
| Rectocele | 28.22 | 12.09 | 14 | 43225 | 1047 | 63444736 |
| Musculoskeletal chest pain | 28.02 | 12.09 | 51 | 43188 | 21032 | 63424751 |
| Limb asymmetry | 27.89 | 12.09 | 13 | 43226 | 847 | 63444936 |
| Muscle spasms | 27.87 | 12.09 | 192 | 43047 | 155958 | 63289825 |
| Metastases to lymph nodes | 27.86 | 12.09 | 31 | 43208 | 8127 | 63437656 |
| Cough | 27.80 | 12.09 | 104 | 43135 | 292639 | 63153144 |
| Hypotension | 27.78 | 12.09 | 94 | 43145 | 272510 | 63173273 |
| Osteochondrosis | 27.52 | 12.09 | 15 | 43224 | 1362 | 63444421 |
| Lumbar radiculopathy | 27.52 | 12.09 | 17 | 43222 | 1952 | 63443831 |
| Humerus fracture | 27.26 | 12.09 | 32 | 43207 | 8884 | 63436899 |
| Cellulitis | 26.95 | 12.09 | 119 | 43120 | 81839 | 63363944 |
| Carcinoembryonic antigen increased | 26.62 | 12.09 | 16 | 43223 | 1749 | 63444034 |
| Confusional state | 26.55 | 12.09 | 78 | 43161 | 236302 | 63209481 |
| Dental implantation | 26.52 | 12.09 | 12 | 43227 | 730 | 63445053 |
| Febrile neutropenia | 26.42 | 12.09 | 25 | 43214 | 118424 | 63327359 |
| Comminuted fracture | 26.40 | 12.09 | 11 | 43228 | 547 | 63445236 |
| Bone graft | 26.38 | 12.09 | 13 | 43226 | 958 | 63444825 |
| Hormone receptor positive HER2 negative breast cancer | 26.38 | 12.09 | 8 | 43231 | 154 | 63445629 |
| Depression | 26.35 | 12.09 | 226 | 43013 | 196266 | 63249517 |
| Tibia fracture | 25.79 | 12.09 | 24 | 43215 | 5096 | 63440687 |
| Multiple organ dysfunction syndrome | 25.59 | 12.09 | 4 | 43235 | 56748 | 63389035 |
| Calcification metastatic | 25.25 | 12.09 | 8 | 43231 | 179 | 63445604 |
| Creatinine renal clearance increased | 24.97 | 12.09 | 11 | 43228 | 628 | 63445155 |
| Dental fistula | 24.95 | 12.09 | 11 | 43228 | 629 | 63445154 |
| Hypertension | 24.79 | 12.09 | 295 | 42944 | 279008 | 63166775 |
| Lymphoedema | 24.79 | 12.09 | 35 | 43204 | 11657 | 63434126 |
| Invasive ductal breast carcinoma | 24.73 | 12.09 | 27 | 43212 | 6931 | 63438852 |
| Depressed level of consciousness | 24.58 | 12.09 | 6 | 43233 | 62072 | 63383711 |
| Goitre | 24.51 | 12.09 | 25 | 43214 | 5936 | 63439847 |
| Dental plaque | 24.18 | 12.09 | 7 | 43232 | 114 | 63445669 |
| Muscle strain | 24.15 | 12.09 | 29 | 43210 | 8245 | 63437538 |
| Hospitalisation | 24.08 | 12.09 | 14 | 43225 | 85067 | 63360716 |
| Thoracic vertebral fracture | 24.05 | 12.09 | 22 | 43217 | 4570 | 63441213 |
| Injection site swelling | 23.84 | 12.09 | 79 | 43160 | 47493 | 63398290 |
| Patella fracture | 23.62 | 12.09 | 16 | 43223 | 2150 | 63443633 |
| Arthropathy | 23.21 | 12.09 | 82 | 43157 | 234710 | 63211073 |
| Breast calcifications | 23.02 | 12.09 | 13 | 43226 | 1265 | 63444518 |
| Upper limb fracture | 22.85 | 12.09 | 44 | 43195 | 18924 | 63426859 |
| Large intestine polyp | 22.85 | 12.09 | 28 | 43211 | 8129 | 63437654 |
| Wheezing | 22.73 | 12.09 | 19 | 43220 | 95576 | 63350207 |
| Seborrhoeic keratosis | 22.49 | 12.09 | 16 | 43223 | 2326 | 63443457 |
| PIK3CA-activated mutation | 22.46 | 12.09 | 12 | 43227 | 1047 | 63444736 |
| Cataract operation | 22.42 | 12.09 | 23 | 43216 | 5499 | 63440284 |
| Stress urinary incontinence | 22.41 | 12.09 | 16 | 43223 | 2339 | 63443444 |
| Oestrogen deficiency | 22.08 | 12.09 | 7 | 43232 | 157 | 63445626 |
| Suicide attempt | 22.05 | 12.09 | 7 | 43232 | 60911 | 63384872 |
| Sinusitis | 21.84 | 12.09 | 80 | 43159 | 226573 | 63219210 |
| Spondylolysis | 21.77 | 12.09 | 6 | 43233 | 81 | 63445702 |
| Tonsillar disorder | 21.51 | 12.09 | 12 | 43227 | 1141 | 63444642 |
| Lumbar vertebral fracture | 21.44 | 12.09 | 23 | 43216 | 5787 | 63439996 |
| Appendicectomy | 21.37 | 12.09 | 17 | 43222 | 2922 | 63442861 |
| Poor dental condition | 21.35 | 12.09 | 9 | 43230 | 461 | 63445322 |
| Spinal stenosis | 20.98 | 12.09 | 37 | 43202 | 14888 | 63430895 |
| Gastrointestinal tract irritation | 20.80 | 12.09 | 9 | 43230 | 492 | 63445291 |
| Oral surgery | 20.75 | 12.09 | 12 | 43227 | 1222 | 63444561 |
| Varicose vein | 20.63 | 12.09 | 21 | 43218 | 4974 | 63440809 |
| Skeletal injury | 20.60 | 12.09 | 12 | 43227 | 1238 | 63444545 |
| Hand fracture | 20.33 | 12.09 | 22 | 43217 | 5591 | 63440192 |
| Tooth avulsion | 20.29 | 12.09 | 5 | 43234 | 42 | 63445741 |
| Bone fragmentation | 20.04 | 12.09 | 10 | 43229 | 757 | 63445026 |
| Breath odour | 20.00 | 12.09 | 12 | 43227 | 1308 | 63444475 |
| Metastases to spine | 19.88 | 12.09 | 17 | 43222 | 3232 | 63442551 |
| Metastases to skin | 19.86 | 12.09 | 13 | 43226 | 1650 | 63444133 |
| Osteoporotic fracture | 19.72 | 12.09 | 18 | 43221 | 3728 | 63442055 |
| Injection site phlebitis | 19.52 | 12.09 | 6 | 43233 | 121 | 63445662 |
| Bone lesion | 19.49 | 12.09 | 22 | 43217 | 5859 | 63439924 |
| Oral pustule | 19.42 | 12.09 | 5 | 43234 | 51 | 63445732 |
| Spinal meningeal cyst | 19.33 | 12.09 | 5 | 43234 | 52 | 63445731 |
| Somnolence | 19.31 | 12.09 | 60 | 43179 | 178625 | 63267158 |
| Blood pressure fluctuation | 19.29 | 12.09 | 4 | 43235 | 46313 | 63399470 |
| Eructation | 19.25 | 12.09 | 26 | 43213 | 8307 | 63437476 |
| Platelet count decreased | 19.08 | 12.09 | 31 | 43208 | 116091 | 63329692 |
| Polyneuropathy | 19.02 | 12.09 | 35 | 43204 | 14554 | 63431229 |
| Arterial thrombosis | 19.01 | 12.09 | 12 | 43227 | 1431 | 63444352 |
| Postmenopause | 18.99 | 12.09 | 5 | 43234 | 56 | 63445727 |
| Heart rate decreased | 18.84 | 12.09 | 4 | 43235 | 45556 | 63400227 |
| Gingival recession | 18.83 | 12.09 | 12 | 43227 | 1455 | 63444328 |
| Osteogenesis imperfecta | 18.78 | 12.09 | 9 | 43230 | 624 | 63445159 |
| Barrett's oesophagus | 18.75 | 12.09 | 9 | 43230 | 626 | 63445157 |
| Breast mass | 18.73 | 12.09 | 25 | 43214 | 7897 | 63437886 |
| Tooth infection | 18.52 | 12.09 | 39 | 43200 | 17881 | 63427902 |
| Breast cancer metastatic | 18.47 | 12.09 | 31 | 43208 | 11987 | 63433796 |
| Cystocele | 18.47 | 12.09 | 11 | 43228 | 1183 | 63444600 |
| Hypertonic bladder | 18.42 | 12.09 | 17 | 43222 | 3571 | 63442212 |
| Cholecystectomy | 18.39 | 12.09 | 29 | 43210 | 10648 | 63435135 |
| Oral disorder | 18.03 | 12.09 | 26 | 43213 | 8828 | 63436955 |
| White blood cell count decreased | 17.80 | 12.09 | 43 | 43196 | 139061 | 63306722 |
| Drug-induced liver injury | 17.77 | 12.09 | 3 | 43236 | 40219 | 63405564 |
| Fractured sacrum | 17.60 | 12.09 | 13 | 43226 | 2003 | 63443780 |
| Malaise | 17.49 | 12.09 | 190 | 43049 | 415764 | 63030019 |
| Blood bilirubin abnormal | 17.48 | 12.09 | 10 | 43229 | 997 | 63444786 |
| Bone formation increased | 17.40 | 12.09 | 6 | 43233 | 176 | 63445607 |
| Pancreatic steatosis | 17.40 | 12.09 | 10 | 43229 | 1006 | 63444777 |
| Spinal disorder | 17.20 | 12.09 | 27 | 43212 | 9875 | 63435908 |
| Abdominal discomfort | 17.17 | 12.09 | 138 | 43101 | 320747 | 63125036 |
| Wound haemorrhage | 17.12 | 12.09 | 14 | 43225 | 2502 | 63443281 |
| Dyslipidaemia | 16.98 | 12.09 | 23 | 43216 | 7370 | 63438413 |
| Arthritis | 16.95 | 12.09 | 136 | 43103 | 115785 | 63329998 |
| Erosive oesophagitis | 16.91 | 12.09 | 12 | 43227 | 1738 | 63444045 |
| Rhinorrhoea | 16.90 | 12.09 | 12 | 43227 | 65565 | 63380218 |
| Atrophic vulvovaginitis | 16.80 | 12.09 | 12 | 43227 | 1756 | 63444027 |
| Cerumen impaction | 16.72 | 12.09 | 10 | 43229 | 1084 | 63444699 |
| Anxiety disorder | 16.68 | 12.09 | 17 | 43222 | 4033 | 63441750 |
| Gingival pain | 16.67 | 12.09 | 24 | 43215 | 8138 | 63437645 |
| Neck pain | 16.62 | 12.09 | 92 | 43147 | 69226 | 63376557 |
| Mediastinal disorder | 16.50 | 12.09 | 7 | 43232 | 364 | 63445419 |
| Injection site thrombosis | 16.40 | 12.09 | 5 | 43234 | 98 | 63445685 |
| Chronic hepatic failure | 16.32 | 12.09 | 8 | 43231 | 583 | 63445200 |
| Hypophosphataemic osteomalacia | 16.29 | 12.09 | 6 | 43233 | 214 | 63445569 |
| Oesophageal pain | 16.09 | 12.09 | 16 | 43223 | 3685 | 63442098 |
| Hyperparathyroidism | 16.04 | 12.09 | 14 | 43225 | 2735 | 63443048 |
| Bone metabolism disorder | 16.03 | 12.09 | 7 | 43232 | 391 | 63445392 |
| Loss of personal independence in daily activities | 15.96 | 12.09 | 26 | 43213 | 97264 | 63348519 |
| Bone lesion excision | 15.89 | 12.09 | 4 | 43235 | 37 | 63445746 |
| Mobility decreased | 15.86 | 12.09 | 37 | 43202 | 121122 | 63324661 |
| No adverse event | 15.86 | 12.09 | 63 | 43176 | 41342 | 63404441 |
| Death | 15.74 | 12.09 | 171 | 43068 | 374210 | 63071573 |
| Purulence | 15.69 | 12.09 | 11 | 43228 | 1563 | 63444220 |
| Oesophageal rupture | 15.60 | 12.09 | 8 | 43231 | 642 | 63445141 |
| Pulmonary oedema | 15.57 | 12.09 | 9 | 43230 | 54864 | 63390919 |
| Tooth deposit | 15.54 | 12.09 | 6 | 43233 | 244 | 63445539 |
| Cardio-respiratory arrest | 15.42 | 12.09 | 11 | 43228 | 59948 | 63385835 |
| Vascular procedure complication | 15.27 | 12.09 | 3 | 43236 | 7 | 63445776 |
| Ankle fracture | 15.24 | 12.09 | 36 | 43203 | 17819 | 63427964 |
| Tendonitis | 15.09 | 12.09 | 38 | 43201 | 19577 | 63426206 |
| Chest wall tumour | 15.02 | 12.09 | 4 | 43235 | 47 | 63445736 |
| Jaw cyst | 15 | 12.09 | 5 | 43234 | 132 | 63445651 |
| Drug interaction | 14.96 | 12.09 | 93 | 43146 | 229038 | 63216745 |
| Synovial cyst | 14.84 | 12.09 | 26 | 43213 | 10407 | 63435376 |
| Fibula fracture | 14.83 | 12.09 | 15 | 43224 | 3527 | 63442256 |
| Induration | 14.79 | 12.09 | 10 | 43229 | 1340 | 63444443 |
| Therapy non-responder | 14.72 | 12.09 | 18 | 43221 | 75883 | 63369900 |
| Cognitive disorder | 14.67 | 12.09 | 10 | 43229 | 55805 | 63389978 |
| Metastases to the mediastinum | 14.67 | 12.09 | 7 | 43232 | 481 | 63445302 |
| Metastases to lung | 14.66 | 12.09 | 29 | 43210 | 12721 | 63433062 |
| Ligament sprain | 14.58 | 12.09 | 29 | 43210 | 12771 | 63433012 |
| Peritoneal disorder | 14.48 | 12.09 | 7 | 43232 | 495 | 63445288 |
| Oral fibroma | 14.44 | 12.09 | 4 | 43235 | 55 | 63445728 |
| Ovarian cancer stage III | 14.43 | 12.09 | 6 | 43233 | 297 | 63445486 |
| Tendon calcification | 14.31 | 12.09 | 4 | 43235 | 57 | 63445726 |
| Dental care | 14.21 | 12.09 | 9 | 43230 | 1080 | 63444703 |
| Disease progression | 14.14 | 12.09 | 40 | 43199 | 122718 | 63323065 |
| Suicidal ideation | 14.12 | 12.09 | 13 | 43226 | 62408 | 63383375 |
| Agitation | 14.05 | 12.09 | 12 | 43227 | 59745 | 63386038 |
| Biopsy bone | 14.00 | 12.09 | 4 | 43235 | 62 | 63445721 |
| Sinus arrhythmia | 14.00 | 12.09 | 10 | 43229 | 1463 | 63444320 |
| Type V hyperlipidaemia | 13.99 | 12.09 | 7 | 43232 | 533 | 63445250 |
| Septic shock | 13.78 | 12.09 | 15 | 43224 | 66614 | 63379169 |
| Acute kidney injury | 13.76 | 12.09 | 114 | 43125 | 263301 | 63182482 |
| Appendix disorder | 13.72 | 12.09 | 10 | 43229 | 1509 | 63444274 |
| Macular hole | 13.71 | 12.09 | 8 | 43231 | 828 | 63444955 |
| Dental prosthesis user | 13.66 | 12.09 | 4 | 43235 | 68 | 63445715 |
| Rhinoplasty | 13.51 | 12.09 | 3 | 43236 | 15 | 63445768 |
| Malignant neoplasm progression | 13.48 | 12.09 | 99 | 43140 | 82022 | 63363761 |
| Intentional product misuse | 13.41 | 12.09 | 13 | 43226 | 60904 | 63384879 |
| Blood alkaline phosphatase decreased | 13.38 | 12.09 | 9 | 43230 | 1196 | 63444587 |
| Metabolic acidosis | 13.35 | 12.09 | 7 | 43232 | 45062 | 63400721 |
| Parkinson's disease | 13.28 | 12.09 | 9 | 43230 | 1210 | 63444573 |
| Peri-implantitis | 13.19 | 12.09 | 4 | 43235 | 77 | 63445706 |
| Cardiac arrest | 13.15 | 12.09 | 27 | 43212 | 92518 | 63353265 |
| Swelling | 13.14 | 12.09 | 122 | 43117 | 275256 | 63170527 |
| Oesophageal discomfort | 13.08 | 12.09 | 5 | 43234 | 198 | 63445585 |
| Bone marrow oedema | 13.06 | 12.09 | 9 | 43230 | 1243 | 63444540 |
| Injection site cellulitis | 13.05 | 12.09 | 9 | 43230 | 1245 | 63444538 |
| Blood parathyroid hormone increased | 12.96 | 12.09 | 13 | 43226 | 3025 | 63442758 |
| Radiotherapy | 12.84 | 12.09 | 6 | 43233 | 393 | 63445390 |
| Tongue geographic | 12.78 | 12.09 | 4 | 43235 | 86 | 63445697 |
| Oral neoplasm | 12.73 | 12.09 | 4 | 43235 | 87 | 63445696 |
| Oral dysaesthesia | 12.73 | 12.09 | 4 | 43235 | 87 | 63445696 |
| Respiratory failure | 12.63 | 12.09 | 32 | 43207 | 101826 | 63343957 |
| Illness | 12.61 | 12.09 | 9 | 43230 | 49050 | 63396733 |
| Serratia infection | 12.59 | 12.09 | 8 | 43231 | 965 | 63444818 |
| Cataract | 12.54 | 12.09 | 74 | 43165 | 56979 | 63388804 |
| Malocclusion | 12.52 | 12.09 | 4 | 43235 | 92 | 63445691 |
| General physical health deterioration | 12.50 | 12.09 | 83 | 43156 | 201319 | 63244464 |
| Eustachian tube dysfunction | 12.49 | 12.09 | 6 | 43233 | 418 | 63445365 |
| Post procedural constipation | 12.48 | 12.09 | 4 | 43235 | 93 | 63445690 |
| Neutrophil count decreased | 12.46 | 12.09 | 12 | 43227 | 56394 | 63389389 |
| X-ray of pelvis and hip abnormal | 12.42 | 12.09 | 3 | 43236 | 23 | 63445760 |
| Arthroscopy | 12.28 | 12.09 | 7 | 43232 | 693 | 63445090 |
| Eustachian tube disorder | 12.21 | 12.09 | 4 | 43235 | 100 | 63445683 |
| Oedema peripheral | 12.20 | 12.09 | 189 | 43050 | 189322 | 63256461 |
| Drug ineffective for unapproved indication | 12.17 | 12.09 | 4 | 43235 | 34059 | 63411724 |
| Chromatopsia | 12.14 | 12.09 | 6 | 43233 | 445 | 63445338 |
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 | 151.50 | 21.96 | 53 | 2206 | 17836 | 34936836 |
| Osteonecrosis | 99.28 | 21.96 | 37 | 2222 | 14853 | 34939819 |
| Appetite disorder | 40.03 | 21.96 | 12 | 2247 | 2459 | 34952213 |
| Femur fracture | 39.25 | 21.96 | 16 | 2243 | 8108 | 34946564 |
| Rectal polyp | 38.46 | 21.96 | 9 | 2250 | 710 | 34953962 |
| Jaw fracture | 30.18 | 21.96 | 8 | 2251 | 1050 | 34953622 |
| Fall | 25.09 | 21.96 | 46 | 2213 | 202839 | 34751833 |
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 | 1517.85 | 12.81 | 575 | 28322 | 42651 | 79672840 |
| Femur fracture | 828.12 | 12.81 | 361 | 28536 | 38291 | 79677200 |
| Osteonecrosis | 521.65 | 12.81 | 245 | 28652 | 30850 | 79684641 |
| Atypical femur fracture | 465.64 | 12.81 | 140 | 28757 | 5049 | 79710442 |
| Bone pain | 402.60 | 12.81 | 251 | 28646 | 55491 | 79660000 |
| Low turnover osteopathy | 297.71 | 12.81 | 80 | 28817 | 1906 | 79713585 |
| Stress fracture | 251.63 | 12.81 | 93 | 28804 | 6387 | 79709104 |
| Exposed bone in jaw | 215.85 | 12.81 | 72 | 28825 | 3648 | 79711843 |
| Osteomyelitis | 183.36 | 12.81 | 126 | 28771 | 32739 | 79682752 |
| Dental caries | 155.65 | 12.81 | 79 | 28818 | 11741 | 79703750 |
| Pain in jaw | 153.54 | 12.81 | 130 | 28767 | 46021 | 79669470 |
| Myalgia | 150.01 | 12.81 | 253 | 28644 | 185388 | 79530103 |
| Fracture nonunion | 144.90 | 12.81 | 43 | 28854 | 1479 | 79714012 |
| Jaw disorder | 144.83 | 12.81 | 58 | 28839 | 4948 | 79710543 |
| Bone disorder | 135.16 | 12.81 | 85 | 28812 | 19028 | 79696463 |
| Tooth disorder | 133.32 | 12.81 | 95 | 28802 | 26138 | 79689353 |
| Influenza like illness | 130.52 | 12.81 | 145 | 28752 | 71562 | 79643929 |
| Arthralgia | 127.52 | 12.81 | 475 | 28422 | 571328 | 79144163 |
| Pain in extremity | 122.00 | 12.81 | 348 | 28549 | 364190 | 79351301 |
| Acute phase reaction | 121.26 | 12.81 | 28 | 28869 | 348 | 79715143 |
| Tooth fracture | 117.64 | 12.81 | 65 | 28832 | 11465 | 79704026 |
| Injection site extravasation | 116.84 | 12.81 | 61 | 28836 | 9608 | 79705883 |
| Exostosis of jaw | 113.19 | 12.81 | 34 | 28863 | 1220 | 79714271 |
| Drug ineffective | 111.91 | 12.81 | 137 | 28760 | 1080776 | 78634715 |
| Tooth extraction | 109.48 | 12.81 | 61 | 28836 | 10934 | 79704557 |
| Fall | 108.53 | 12.81 | 405 | 28492 | 487224 | 79228267 |
| Pathological fracture | 100.95 | 12.81 | 57 | 28840 | 10480 | 79705011 |
| Sequestrectomy | 98.21 | 12.81 | 28 | 28869 | 834 | 79714657 |
| Fracture displacement | 94.48 | 12.81 | 30 | 28867 | 1298 | 79714193 |
| Osteitis | 91.42 | 12.81 | 39 | 28858 | 3904 | 79711587 |
| Foot fracture | 90.17 | 12.81 | 70 | 28827 | 21911 | 79693580 |
| Fracture delayed union | 88.27 | 12.81 | 32 | 28865 | 2078 | 79713413 |
| Back pain | 87.11 | 12.81 | 275 | 28622 | 303905 | 79411586 |
| Metastases to bone | 83.67 | 12.81 | 70 | 28827 | 24357 | 79691134 |
| Actinomycosis | 82.60 | 12.81 | 26 | 28871 | 1093 | 79714398 |
| Off label use | 80.71 | 12.81 | 128 | 28769 | 907087 | 78808404 |
| Ulna fracture | 77.89 | 12.81 | 25 | 28872 | 1120 | 79714371 |
| Atypical fracture | 76.26 | 12.81 | 22 | 28875 | 684 | 79714807 |
| Impaired healing | 75.43 | 12.81 | 123 | 28774 | 87532 | 79627959 |
| Gastrooesophageal reflux disease | 68.59 | 12.81 | 130 | 28767 | 104116 | 79611375 |
| Spinal compression fracture | 67.38 | 12.81 | 53 | 28844 | 16905 | 79698586 |
| Jaw fracture | 67.17 | 12.81 | 29 | 28868 | 2988 | 79712503 |
| Femoral neck fracture | 67.08 | 12.81 | 43 | 28854 | 9941 | 79705550 |
| Gingivitis | 65.99 | 12.81 | 41 | 28856 | 8980 | 79706511 |
| Oral cavity fistula | 63.08 | 12.81 | 19 | 28878 | 688 | 79714803 |
| Periodontal disease | 62.30 | 12.81 | 24 | 28873 | 1846 | 79713645 |
| Carbohydrate antigen 15-3 increased | 61.23 | 12.81 | 21 | 28876 | 1158 | 79714333 |
| Jaw operation | 60.10 | 12.81 | 19 | 28878 | 810 | 79714681 |
| Toxicity to various agents | 59.38 | 12.81 | 40 | 28857 | 421500 | 79293991 |
| Fracture | 55.82 | 12.81 | 53 | 28844 | 21748 | 79693743 |
| Isosthenuria | 55.19 | 12.81 | 12 | 28885 | 111 | 79715380 |
| Breast cancer recurrent | 54.67 | 12.81 | 25 | 28872 | 2952 | 79712539 |
| Temporomandibular joint syndrome | 54.04 | 12.81 | 27 | 28870 | 3878 | 79711613 |
| Anaemia postoperative | 51.75 | 12.81 | 21 | 28876 | 1853 | 79713638 |
| Fistula | 50.46 | 12.81 | 40 | 28857 | 12900 | 79702591 |
| Abscess jaw | 49.70 | 12.81 | 20 | 28877 | 1727 | 79713764 |
| Oral infection | 49.66 | 12.81 | 29 | 28868 | 5678 | 79709813 |
| Extravasation | 49.17 | 12.81 | 25 | 28872 | 3725 | 79711766 |
| Vitamin D deficiency | 49.06 | 12.81 | 41 | 28856 | 14238 | 79701253 |
| Gingival disorder | 46.89 | 12.81 | 24 | 28873 | 3627 | 79711864 |
| Tooth abscess | 46.52 | 12.81 | 42 | 28855 | 16168 | 79699323 |
| Infusion related reaction | 46.35 | 12.81 | 13 | 28884 | 230224 | 79485267 |
| Hydrothorax | 45.93 | 12.81 | 18 | 28879 | 1450 | 79714041 |
| Condition aggravated | 45.08 | 12.81 | 70 | 28827 | 501054 | 79214437 |
| Periodontitis | 44.91 | 12.81 | 25 | 28872 | 4471 | 79711020 |
| Congenital coronary artery malformation | 44.76 | 12.81 | 10 | 28887 | 106 | 79715385 |
| Device failure | 44.64 | 12.81 | 28 | 28869 | 6233 | 79709258 |
| Periprosthetic fracture | 43.99 | 12.81 | 14 | 28883 | 610 | 79714881 |
| Electrocardiogram PR shortened | 43.98 | 12.81 | 12 | 28885 | 303 | 79715188 |
| Fibrocystic breast disease | 43.01 | 12.81 | 14 | 28883 | 656 | 79714835 |
| Pyelitis | 42.97 | 12.81 | 12 | 28885 | 331 | 79715160 |
| Resorption bone increased | 42.35 | 12.81 | 17 | 28880 | 1458 | 79714033 |
| Osteoarthritis | 42.27 | 12.81 | 96 | 28801 | 87213 | 79628278 |
| Injection site inflammation | 42.17 | 12.81 | 23 | 28874 | 3953 | 79711538 |
| Bone sequestrum | 41.75 | 12.81 | 16 | 28881 | 1213 | 79714278 |
| Groin pain | 41.75 | 12.81 | 36 | 28861 | 13044 | 79702447 |
| Drug abuse | 41.67 | 12.81 | 5 | 28892 | 162686 | 79552805 |
| Tooth loss | 41.52 | 12.81 | 28 | 28869 | 7047 | 79708444 |
| Loose tooth | 41.51 | 12.81 | 21 | 28876 | 3096 | 79712395 |
| Spinal osteoarthritis | 41.16 | 12.81 | 40 | 28857 | 16887 | 79698604 |
| Toothache | 40.89 | 12.81 | 43 | 28854 | 19927 | 79695564 |
| Product use in unapproved indication | 40.57 | 12.81 | 20 | 28877 | 250339 | 79465152 |
| Gingival swelling | 39.00 | 12.81 | 23 | 28874 | 4586 | 79710905 |
| Maternal exposure during pregnancy | 38.11 | 12.81 | 3 | 28894 | 136535 | 79578956 |
| Pelvic fracture | 37.76 | 12.81 | 33 | 28864 | 12171 | 79703320 |
| Exostosis | 37.59 | 12.81 | 38 | 28859 | 16820 | 79698671 |
| Treatment failure | 37.48 | 12.81 | 8 | 28889 | 170478 | 79545013 |
| Musculoskeletal pain | 37.34 | 12.81 | 101 | 28796 | 102253 | 79613238 |
| Bone density decreased | 37.16 | 12.81 | 34 | 28863 | 13313 | 79702178 |
| Febrile neutropenia | 36.61 | 12.81 | 19 | 28878 | 230980 | 79484511 |
| Hyperaesthesia teeth | 35.47 | 12.81 | 16 | 28881 | 1830 | 79713661 |
| Bladder hypertrophy | 35.25 | 12.81 | 12 | 28885 | 647 | 79714844 |
| Product use issue | 35.16 | 12.81 | 16 | 28881 | 209806 | 79505685 |
| Osteopenia | 33.15 | 12.81 | 37 | 28860 | 18327 | 79697164 |
| Hyperlipidaemia | 33.13 | 12.81 | 44 | 28853 | 26049 | 79689442 |
| Lower respiratory tract infection | 33.02 | 12.81 | 4 | 28893 | 129216 | 79586275 |
| Carcinoembryonic antigen increased | 32.73 | 12.81 | 16 | 28881 | 2193 | 79713298 |
| Spondylolisthesis | 32.66 | 12.81 | 18 | 28879 | 3157 | 79712334 |
| Dyspepsia | 32.63 | 12.81 | 100 | 28797 | 108587 | 79606904 |
| Hormone receptor positive HER2 negative breast cancer | 32.59 | 12.81 | 8 | 28889 | 131 | 79715360 |
| Multiple organ dysfunction syndrome | 32.58 | 12.81 | 3 | 28894 | 120243 | 79595248 |
| Calcification metastatic | 32.48 | 12.81 | 8 | 28889 | 133 | 79715358 |
| Renal cyst | 32.46 | 12.81 | 33 | 28864 | 14699 | 79700792 |
| Rib fracture | 32.26 | 12.81 | 45 | 28852 | 27902 | 79687589 |
| Hiatus hernia | 32.23 | 12.81 | 41 | 28856 | 23271 | 79692220 |
| Diverticulum | 32.16 | 12.81 | 33 | 28864 | 14863 | 79700628 |
| Hypotension | 32.02 | 12.81 | 70 | 28827 | 440247 | 79275244 |
| Spinal fracture | 31.95 | 12.81 | 36 | 28861 | 18018 | 79697473 |
| Metastases to lymph nodes | 31.94 | 12.81 | 28 | 28869 | 10369 | 79705122 |
| Drug intolerance | 30.98 | 12.81 | 30 | 28867 | 264089 | 79451402 |
| Oesophageal stenosis | 29.86 | 12.81 | 19 | 28878 | 4335 | 79711156 |
| Dental fistula | 29.68 | 12.81 | 10 | 28887 | 522 | 79714969 |
| Compression fracture | 29.64 | 12.81 | 22 | 28875 | 6438 | 79709053 |
| Osteomalacia | 28.98 | 12.81 | 13 | 28884 | 1467 | 79714024 |
| Jaw fistula | 28.79 | 12.81 | 7 | 28890 | 110 | 79715381 |
| Acute kidney injury | 28.42 | 12.81 | 95 | 28802 | 519309 | 79196182 |
| Radius fracture | 28.11 | 12.81 | 17 | 28880 | 3547 | 79711944 |
| Creatinine renal clearance increased | 27.88 | 12.81 | 11 | 28886 | 902 | 79714589 |
| Therapeutic product effect incomplete | 26.69 | 12.81 | 9 | 28888 | 141636 | 79573855 |
| Hip fracture | 26.22 | 12.81 | 43 | 28854 | 30718 | 79684773 |
| Lymphoedema | 25.90 | 12.81 | 27 | 28870 | 12386 | 79703105 |
| Chest pain | 25.84 | 12.81 | 183 | 28714 | 282121 | 79433370 |
| Pancreatic steatosis | 25.47 | 12.81 | 11 | 28886 | 1134 | 79714357 |
| Intentional overdose | 25.37 | 12.81 | 4 | 28893 | 105956 | 79609535 |
| Injection site swelling | 25.26 | 12.81 | 54 | 28843 | 47078 | 79668413 |
| Vertebral foraminal stenosis | 25.07 | 12.81 | 11 | 28886 | 1178 | 79714313 |
| Oesophagitis | 24.95 | 12.81 | 37 | 28860 | 24252 | 79691239 |
| Bone loss | 24.89 | 12.81 | 14 | 28883 | 2553 | 79712938 |
| Oral disorder | 24.81 | 12.81 | 24 | 28873 | 10071 | 79705420 |
| Rectocele | 24.37 | 12.81 | 9 | 28888 | 616 | 79714875 |
| Pulpitis dental | 24.03 | 12.81 | 11 | 28886 | 1302 | 79714189 |
| Bursitis | 23.92 | 12.81 | 45 | 28852 | 35799 | 79679692 |
| Intervertebral disc degeneration | 23.81 | 12.81 | 29 | 28868 | 15756 | 79699735 |
| COVID-19 | 23.48 | 12.81 | 14 | 28883 | 157660 | 79557831 |
| Pain | 23.32 | 12.81 | 371 | 28526 | 703431 | 79012060 |
| Mucosal ulceration | 23.15 | 12.81 | 12 | 28885 | 1861 | 79713630 |
| Osteoporotic fracture | 23.03 | 12.81 | 16 | 28881 | 4224 | 79711267 |
| Synovitis | 22.99 | 12.81 | 13 | 28884 | 150721 | 79564770 |
| Scoliosis | 22.72 | 12.81 | 20 | 28877 | 7444 | 79708047 |
| Osteocalcin decreased | 22.65 | 12.81 | 5 | 28892 | 50 | 79715441 |
| Metastases to pleura | 22.26 | 12.81 | 11 | 28886 | 1543 | 79713948 |
| Osteogenesis imperfecta | 22.16 | 12.81 | 8 | 28889 | 513 | 79714978 |
| Thoracic vertebral fracture | 22.13 | 12.81 | 17 | 28880 | 5236 | 79710255 |
| Pneumonia | 21.79 | 12.81 | 145 | 28752 | 660101 | 79055390 |
| Purulence | 21.52 | 12.81 | 12 | 28885 | 2153 | 79713338 |
| Dental necrosis | 21.40 | 12.81 | 6 | 28891 | 168 | 79715323 |
| Gastritis | 21.28 | 12.81 | 51 | 28846 | 47942 | 79667549 |
| Tonsillar disorder | 21.28 | 12.81 | 10 | 28887 | 1256 | 79714235 |
| Haemorrhoids | 21.25 | 12.81 | 38 | 28859 | 29090 | 79686401 |
| Blood parathyroid hormone increased | 21.09 | 12.81 | 14 | 28883 | 3431 | 79712060 |
| Metastases to liver | 20.73 | 12.81 | 37 | 28860 | 28277 | 79687214 |
| Systemic lupus erythematosus | 20.66 | 12.81 | 9 | 28888 | 121140 | 79594351 |
| Dorsal ramus syndrome | 20.53 | 12.81 | 4 | 28893 | 20 | 79715471 |
| Confusional state | 20.37 | 12.81 | 54 | 28843 | 317943 | 79397548 |
| Breast mass | 20.37 | 12.81 | 18 | 28879 | 6736 | 79708755 |
| Tooth avulsion | 20.20 | 12.81 | 5 | 28892 | 85 | 79715406 |
| Joint swelling | 20.06 | 12.81 | 47 | 28850 | 288599 | 79426892 |
| Therapeutic product effect decreased | 19.92 | 12.81 | 18 | 28879 | 163845 | 79551646 |
| Induration | 19.90 | 12.81 | 11 | 28886 | 1941 | 79713550 |
| Oxygen saturation decreased | 19.87 | 12.81 | 11 | 28886 | 129036 | 79586455 |
| Dysphagia | 19.62 | 12.81 | 92 | 28805 | 122044 | 79593447 |
| Intentional product use issue | 19.36 | 12.81 | 16 | 28881 | 152096 | 79563395 |
| Hepatic enzyme increased | 18.90 | 12.81 | 23 | 28874 | 182587 | 79532904 |
| Ovarian cancer stage III | 18.86 | 12.81 | 6 | 28891 | 261 | 79715230 |
| Fractured sacrum | 18.81 | 12.81 | 10 | 28887 | 1633 | 79713858 |
| Barrett's oesophagus | 18.75 | 12.81 | 8 | 28889 | 801 | 79714690 |
| Wound haemorrhage | 18.71 | 12.81 | 14 | 28883 | 4147 | 79711344 |
| Uterine disorder | 18.64 | 12.81 | 11 | 28886 | 2196 | 79713295 |
| Breath odour | 18.51 | 12.81 | 10 | 28887 | 1686 | 79713805 |
| Cataract | 18.49 | 12.81 | 57 | 28840 | 62063 | 79653428 |
| Breast cancer | 18.45 | 12.81 | 39 | 28858 | 33742 | 79681749 |
| Meniscus injury | 18.37 | 12.81 | 17 | 28880 | 6751 | 79708740 |
| Atrophic vulvovaginitis | 18.28 | 12.81 | 9 | 28888 | 1252 | 79714239 |
| Muscle spasms | 18.21 | 12.81 | 117 | 28780 | 174613 | 79540878 |
| Eructation | 18.03 | 12.81 | 21 | 28876 | 10888 | 79704603 |
| Bone lesion excision | 17.94 | 12.81 | 4 | 28893 | 42 | 79715449 |
| Spondylolysis | 17.93 | 12.81 | 5 | 28892 | 137 | 79715354 |
| Lumbar vertebral fracture | 17.84 | 12.81 | 17 | 28880 | 7005 | 79708486 |
| Chest wall tumour | 17.77 | 12.81 | 4 | 28893 | 44 | 79715447 |
| Poor dental condition | 17.70 | 12.81 | 7 | 28890 | 577 | 79714914 |
| Musculoskeletal chest pain | 17.67 | 12.81 | 32 | 28865 | 24732 | 79690759 |
| Infusion site extravasation | 17.62 | 12.81 | 20 | 28877 | 10088 | 79705403 |
| Respiratory failure | 17.47 | 12.81 | 24 | 28873 | 180887 | 79534604 |
| Hypothyroidism | 17.42 | 12.81 | 50 | 28847 | 52342 | 79663149 |
| Cellulitis | 17.40 | 12.81 | 82 | 28815 | 108978 | 79606513 |
| Hypophosphataemic osteomalacia | 17.10 | 12.81 | 6 | 28891 | 354 | 79715137 |
| Chronic hepatic failure | 16.98 | 12.81 | 8 | 28889 | 1011 | 79714480 |
| Tooth infection | 16.97 | 12.81 | 27 | 28870 | 18805 | 79696686 |
| Injection site phlebitis | 16.93 | 12.81 | 5 | 28892 | 169 | 79715322 |
| Arterial thrombosis | 16.69 | 12.81 | 11 | 28886 | 2663 | 79712828 |
| Product dose omission issue | 16.64 | 12.81 | 41 | 28856 | 247496 | 79467995 |
| Sinus arrhythmia | 16.48 | 12.81 | 10 | 28887 | 2100 | 79713391 |
| Cardiac arrest | 16.45 | 12.81 | 23 | 28874 | 172073 | 79543418 |
| Intramedullary rod insertion | 16.44 | 12.81 | 5 | 28892 | 187 | 79715304 |
| Bone lesion | 16.32 | 12.81 | 15 | 28882 | 5904 | 79709587 |
| Phlebitis | 16.30 | 12.81 | 18 | 28879 | 8812 | 79706679 |
| Peritoneal disorder | 16.15 | 12.81 | 7 | 28890 | 728 | 79714763 |
| Suicide attempt | 16.10 | 12.81 | 5 | 28892 | 82927 | 79632564 |
| Pulmonary oedema | 15.95 | 12.81 | 6 | 28891 | 88248 | 79627243 |
| Blister | 15.91 | 12.81 | 12 | 28885 | 119464 | 79596027 |
| Helicobacter infection | 15.88 | 12.81 | 3 | 28894 | 69701 | 79645790 |
| Platelet count decreased | 15.79 | 12.81 | 29 | 28868 | 194635 | 79520856 |
| Lumbar spinal stenosis | 15.77 | 12.81 | 14 | 28883 | 5268 | 79710223 |
| Cardio-respiratory arrest | 15.64 | 12.81 | 10 | 28887 | 108500 | 79606991 |
| Nasopharyngitis | 15.59 | 12.81 | 44 | 28853 | 253837 | 79461654 |
| Cerumen impaction | 15.41 | 12.81 | 8 | 28889 | 1244 | 79714247 |
| X-ray of pelvis and hip abnormal | 15.40 | 12.81 | 3 | 28894 | 15 | 79715476 |
| Rotator cuff syndrome | 15.24 | 12.81 | 22 | 28875 | 14073 | 79701418 |
| Teeth brittle | 15.18 | 12.81 | 6 | 28891 | 494 | 79714997 |
| Stress urinary incontinence | 15.06 | 12.81 | 9 | 28888 | 1837 | 79713654 |
| Wrist fracture | 14.97 | 12.81 | 20 | 28877 | 11901 | 79703590 |
| Arteriosclerosis | 14.89 | 12.81 | 25 | 28872 | 18202 | 79697289 |
| Drug-induced liver injury | 14.73 | 12.81 | 3 | 28894 | 66114 | 79649377 |
| Death | 14.65 | 12.81 | 133 | 28764 | 566381 | 79149110 |
| Macular scar | 14.62 | 12.81 | 4 | 28893 | 102 | 79715389 |
| Skeletal injury | 14.62 | 12.81 | 8 | 28889 | 1384 | 79714107 |
| Osteoporosis | 14.59 | 12.81 | 48 | 28849 | 54064 | 79661427 |
| Hospitalisation | 14.55 | 12.81 | 8 | 28889 | 94228 | 79621263 |
| Lumbar radiculopathy | 14.40 | 12.81 | 9 | 28888 | 1990 | 79713501 |
| Hypercholesterolaemia | 14.19 | 12.81 | 28 | 28869 | 23067 | 79692424 |
| Breast disorder | 14.07 | 12.81 | 9 | 28888 | 2072 | 79713419 |
| Metastases to the mediastinum | 14.03 | 12.81 | 6 | 28891 | 604 | 79714887 |
| Therapy non-responder | 14.02 | 12.81 | 8 | 28889 | 92297 | 79623194 |
| Humerus fracture | 13.87 | 12.81 | 17 | 28880 | 9296 | 79706195 |
| Hand fracture | 13.82 | 12.81 | 14 | 28883 | 6211 | 79709280 |
| Comminuted fracture | 13.72 | 12.81 | 6 | 28891 | 637 | 79714854 |
| Tendonitis | 13.58 | 12.81 | 28 | 28869 | 23802 | 79691689 |
| Bone fragmentation | 13.49 | 12.81 | 6 | 28891 | 664 | 79714827 |
| Uterine leiomyoma | 13.41 | 12.81 | 14 | 28883 | 6429 | 79709062 |
| Injection site erythema | 13.37 | 12.81 | 60 | 28837 | 78137 | 79637354 |
| Injection site thrombosis | 13.36 | 12.81 | 4 | 28893 | 142 | 79715349 |
| Spinal stenosis | 13.35 | 12.81 | 22 | 28875 | 15769 | 79699722 |
| Oral surgery | 13.33 | 12.81 | 7 | 28890 | 1114 | 79714377 |
| Spinal meningeal cyst | 13.33 | 12.81 | 3 | 28894 | 33 | 79715458 |
| Rectal polyp | 13.23 | 12.81 | 8 | 28889 | 1669 | 79713822 |
| Tendon calcification | 13.09 | 12.81 | 4 | 28893 | 152 | 79715339 |
| Hypercalcaemia | 13.09 | 12.81 | 37 | 28860 | 38393 | 79677098 |
| Past-pointing | 13.04 | 12.81 | 4 | 28893 | 154 | 79715337 |
| Appendix disorder | 13.03 | 12.81 | 8 | 28889 | 1716 | 79713775 |
| Dental prosthesis user | 13.01 | 12.81 | 3 | 28894 | 37 | 79715454 |
| Jaw cyst | 12.99 | 12.81 | 4 | 28893 | 156 | 79715335 |
| Hypoxia | 12.96 | 12.81 | 11 | 28886 | 103232 | 79612259 |
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 | 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 | 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 | 60505-2795 | 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 | 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 |
| IBANDRONATE SODIUM | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69452-378 | TABLET | 150 mg | ORAL | ANDA | 27 sections |