Alendronate side effects: what 100,301 FDA adverse event reports show
Drug class
Bisphosphonate
Label matched
Alendronate Sodium (Alendronate Sodium)
Who reports
100,301 reports · 78% serious · 11,882 with death outcome · 86% female
Used for
Alendronate sodium is a bisphosphonate indicated for: Treatment and prevention of osteoporosis in postmenopausal women (1.1 , 1.2) Treatment to increase bone mass in men with osteoporosis (1.3) Treatment of glucocorticoid-induced osteoporosis (1.4) Treatment of Paget's disease of bone (1.5) Limitations of use: Optimal duration of use has not been determined.
What it is
Alendronic acid is a 1,1-bis(phosphonic acid) that is methanebis(phosphonic acid) in which the two methylene hydrogens are replaced by hydroxy and 3-aminopropyl groups.
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,273 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Intramedullary rod insertion | 1,972 | 4,997.2 4,001.9–6,240.1ROR 5,097.4 · calibrated p 4e-26 ✓ | 197.7 EB05 190.5 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious n=1,972 | not reported in cached trials |
| Low turnover osteopathy | 3,765 | 3,302.6 2,894.5–3,768.3ROR 3,431.3 · calibrated p 4e-24 ✓ | 194.0 EB05 188.9 · IC025 +7.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=3,761 | not reported in cached trials |
| Open reduction of fracture | 1,018 | 1,645.3 1,368.3–1,978.4ROR 1,662.2 · calibrated p 9e-20 ✓ | 182.8 EB05 173.5 · IC025 +7.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=1,018 | not reported in cached trials |
| Oral torus | 214 | 1,464.2 999.2–2,145.5ROR 1,467.3 · calibrated p 4e-18 ✓ | 178.0 EB05 158.9 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=214 · 100% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 5,368 | 669.0 633.3–706.7ROR 706.8 · calibrated p 1e-15 ✓ | 157.7 EB05 154.2 · IC025 +7.2 3/3 methods agree | Lab value / disease marker | serious PRR 116.1 · 93% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 494 | 614.5 515.3–732.9ROR 617.6 · calibrated p 9e-15 ✓ | 153.7 EB05 142.7 · IC025 +6.9 3/3 methods agree | Lab value / disease marker | serious n=494 · 100% clinician | not reported in cached trials |
| Swollen joint count increased | 2,291 | 596.8 550.5–646.9ROR 610.7 · calibrated p 7e-15 ✓ | 153.3 EB05 148.1 · IC025 +7.1 3/3 methods agree | Lab value / disease marker | serious n=2,290 · 96% clinician | not reported in cached trials |
| Rheumatic fever | 3,184 | 579.4 541.5–619.9ROR 598.3 · calibrated p 9e-15 ✓ | 152.2 EB05 147.8 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=3,183 · 95% clinician | not reported in cached trials |
| Pemphigus | 9,017 | 569.0 546.9–591.9ROR 625.1 · calibrated p 5e-15 ✓ | 151.5 EB05 148.9 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious PRR 111.5 | not reported in cached trials |
| Deep vein thrombosis postoperative | 1,368 | 494.4 448.4–545.1ROR 501.2 · calibrated p 6e-14 ✓ | 145.5 EB05 139.1 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious n=1,368 · 93% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 4,964 | 446.5 425.1–469.0ROR 469.7 · calibrated p 1e-13 ✓ | 141.2 EB05 138.0 · IC025 +7.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 103.5 · 94% clinician | NCT01631214: 1/2,040 (0.0%) on Alendronate (serious AE) |
| Lupus vulgaris | 797 | 432.8 383.0–489.1ROR 436.2 · calibrated p 3e-13 ✓ | 139.4 EB05 131.5 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=797 · 96% clinician | not reported in cached trials |
| Fracture nonunion | 911 | 418.3 373.6–468.4ROR 422.2 · calibrated p 4e-13 ✓ | 138.0 EB05 130.6 · IC025 +6.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=910 | not reported in cached trials |
| Removal of internal fixation | 114 | 371.4 273.1–505.2ROR 371.8 · calibrated p 4e-12 ✓ | 130.0 EB05 111.2 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=114 · 100% consumer | not reported in cached trials |
| C-reactive protein | 576 | 369.5 322.3–423.5ROR 371.6 · calibrated p 1e-12 ✓ | 132.0 EB05 123.2 · IC025 +6.8 3/3 methods agree | Lab value / disease marker | serious n=576 · 100% clinician | not reported in cached trials |
| Facet joint syndrome | 1,998 | 368.1 342.2–396.0ROR 375.6 · calibrated p 1e-12 ✓ | 132.3 EB05 127.5 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=1,998 · 93% clinician | not reported in cached trials |
| Anaemia postoperative | 829 | 363.6 324.7–407.2ROR 366.6 · calibrated p 2e-12 ✓ | 131.4 EB05 124.1 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=829 | not reported in cached trials |
| Rheumatoid factor positive | 3,539 | 336.9 319.5–355.3ROR 349.2 · calibrated p 2e-12 ✓ | 128.1 EB05 124.6 · IC025 +6.9 3/3 methods agree | Lab value / disease marker | serious n=3,537 · 94% clinician | not reported in cached trials |
| Grip strength | 142 | 335.0 256.6–437.5ROR 335.5 · calibrated p 7e-12 ✓ | 125.8 EB05 109.3 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=142 · 100% clinician | not reported in cached trials |
| Granuloma skin | 484 | 297.4 258.8–341.9ROR 298.9 · calibrated p 1e-11 ✓ | 121.5 EB05 112.7 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=484 | not reported in cached trials |
| Red blood cell sedimentation rate | 162 | 286.7 225.9–363.8ROR 287.1 · calibrated p 3e-11 ✓ | 118.5 EB05 104.0 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious n=162 · 100% clinician | not reported in cached trials |
| Internal fixation of fracture | 318 | 263.2 223.0–310.7ROR 264.0 · calibrated p 4e-11 ✓ | 115.1 EB05 104.9 · IC025 +6.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=318 | not reported in cached trials |
| Hand deformity | 7,215 | 259.9 251.2–268.9ROR 280.0 · calibrated p 2e-11 ✓ | 115.2 EB05 113.0 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious PRR 91.9 · 92% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 1,052 | 230.2 210.9–251.3ROR 232.6 · calibrated p 1e-10 ✓ | 108.8 EB05 103.4 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=1,051 · 96% clinician | not reported in cached trials |
| Swollen joint count | 127 | 224.7 174.7–289.0ROR 225.0 · calibrated p 3e-10 ✓ | 106.1 EB05 91.5 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=127 · 100% clinician | not reported in cached trials |
| Fracture delayed union | 439 | 223.6 195.3–255.9ROR 224.6 · calibrated p 2e-10 ✓ | 107.0 EB05 98.9 · IC025 +6.4 3/3 methods agree | Labeled (related wording) related wording | serious n=437 | not reported in cached trials |
| Helicobacter infection | 4,968 | 200.2 192.6–208.1ROR 210.6 · calibrated p 2e-10 ✓ | 101.8 EB05 99.4 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious PRR 78.9 · 94% clinician | not reported in cached trials |
| Dislocation of vertebra | 1,035 | 183.0 168.3–198.9ROR 184.9 · calibrated p 8e-10 ✓ | 97.0 EB05 92.2 · IC025 +6.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=1,035 · 95% clinician | not reported in cached trials |
| X-ray abnormal | 771 | 159.7 145.4–175.4ROR 160.9 · calibrated p 3e-9 ✓ | 90.1 EB05 84.8 · IC025 +6.3 3/3 methods agree | Lab value / disease marker | serious n=771 · 100% clinician | not reported in cached trials |
| Muscle injury | 3,521 | 157.8 151.1–164.8ROR 163.5 · calibrated p 2e-9 ✓ | 89.6 EB05 87.1 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 71.2 · 94% clinician | not reported in cached trials |
| Retinitis | 672 | 141.3 128.1–155.9ROR 142.3 · calibrated p 8e-9 ✓ | 83.9 EB05 78.7 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=672 · 100% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 2,559 | 138.4 131.7–145.4ROR 142.0 · calibrated p 7e-9 ✓ | 83.0 EB05 80.3 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=2,554 · 95% clinician | not reported in cached trials |
| Blood parathyroid hormone decreased | 590 | 137.3 123.7–152.4ROR 138.1 · calibrated p 1e-8 ✓ | 82.5 EB05 77.0 · IC025 +6.1 3/3 methods agree | Lab value / disease marker | serious n=588 | not reported in cached trials |
| Stress fracture | 2,142 | 136.6 129.4–144.2ROR 139.5 · calibrated p 8e-9 ✓ | 82.4 EB05 79.5 · IC025 +6.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=2,124 | not reported in cached trials |
| Folliculitis | 4,010 | 133.1 128.0–138.4ROR 138.6 · calibrated p 9e-9 ✓ | 81.1 EB05 79.0 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious PRR 69.9 · 94% clinician | not reported in cached trials |
| Pulmonary vasculitis | 204 | 131.7 110.5–157.0ROR 131.9 · calibrated p 2e-8 ✓ | 80.0 EB05 71.2 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=204 · ♀ 0% (drug 86%) | not reported in cached trials |
| Subcutaneous drug absorption impaired | 210 | 131.4 110.5–156.3ROR 131.7 · calibrated p 2e-8 ✓ | 79.9 EB05 71.3 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=209 · 100% clinician | not reported in cached trials |
| Glossodynia (burning tongue/mouth pain) | 8,381 | 125.7 122.4–129.1ROR 137.1 · calibrated p 9e-9 ✓ | 78.3 EB05 76.9 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 82.8 · 90% clinician | not reported in cached trials |
| Femur fracture | 11,361 | 120.9 118.3–123.7ROR 136.3 · calibrated p 1e-8 ✓ | 76.5 EB05 75.3 · IC025 +6.2 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 41.9 · serious PRR 56.3 | NCT01631214: 42/2,040 (2.1%) on Alendronate (serious AE) |
| Peripheral venous disease | 1,436 | 117.6 110.3–125.5ROR 119.3 · calibrated p 3e-8 ✓ | 75.1 EB05 71.9 · IC025 +6.1 3/3 methods agree | Labeled (related wording) related wording | serious n=1,434 · 93% clinician | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Osteonecrosis | 5,969 | 24.023.4–24.7 | signal |
| Fall / fracture | 17,479 | 10.09.9–10.2 | signal |
| Liver injury | 9,125 | 6.56.4–6.6 | signal |
| Interstitial lung disease | 2,783 | 6.26.0–6.5 | signal |
| Tendon disorder | 953 | 5.35.0–5.7 | signal |
| Depression | 5,234 | 3.93.8–4.0 | signal |
| Serious infection | 12,624 | 3.53.4–3.5 | signal |
| Hyperglycaemia / diabetes | 5,617 | 3.43.3–3.5 | signal |
| Gi bleeding | 2,266 | 2.62.5–2.7 | signal |
| Anaemia | 3,372 | 2.42.3–2.4 | signal |
| Opportunistic infection | 1,521 | 2.32.2–2.5 | signal |
| Hyponatraemia | 886 | 2.32.2–2.5 | signal |
| Rhabdomyolysis / myopathy | 848 | 2.22.1–2.4 | signal |
| Arrhythmia / qt | 1,758 | 1.91.8–2.0 | raised |
| Heart failure | 1,597 | 1.91.8–2.0 | raised |
| Venous thromboembolism | 1,917 | 1.91.8–1.9 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Alendronate as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (2 of 40 signal terms matched).
- NCT01631214 — Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteop (N=4093, PHASE3; 673 AE terms posted; arms: Double-blind Period: Alendronate 70 mg Q; Double-blind Period: Romosozumab 210 mg ; Overall Study: Alendronate / Alendronate; Overall Study: Romosozumab / Alendronate)
- NCT00680953 — Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis (N=1262, PHASE3; 148 AE terms posted; arms: Denosumab; Placebo; Alendronate)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Pain | 13,848 | 4.8 4.7–4.9ROR 5.4 · calibrated p 0.195 | 4.7 EB05 4.6 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 4.5 · serious PRR 5.1 | NCT01631214: 5/2,040 (0.2%) on Alendronate (serious AE) |
| Fatigue (tiredness) | 13,187 | 3.6 3.5–3.7ROR 4.0 · calibrated p 0.380 | 3.5 EB05 3.5 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 3.0 · serious PRR 4.5 | not reported in cached trials |
| Drug ineffective (drug did not work) | 12,683 | 2.0 2.0–2.1ROR 2.2 · calibrated p 0.966 | 2.0 EB05 2.0 · IC025 +1.0 | Reporting / coding artifact | age-adj. PRR 2.4 · serious PRR 3.6 | not reported in cached trials |
| Femur fracture | 11,361 | 120.9 118.3–123.7ROR 136.3 · calibrated p 1e-8 ✓ | 76.5 EB05 75.3 · IC025 +6.2 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 41.9 · serious PRR 56.3 | NCT01631214: 42/2,040 (2.1%) on Alendronate (serious AE) |
| Arthralgia (joint pain) | 11,308 | 5.8 5.7–5.9ROR 6.5 · calibrated p 0.124 | 5.7 EB05 5.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | age-adj. PRR 5.2 · serious PRR 6.9 | NCT01631214: 2/2,040 (0.1%) on Alendronate (serious AE) |
| Rheumatoid arthritis | 10,282 | 20.8 20.4–21.2ROR 23.1 · calibrated p 1e-3 ✓ | 19.0 EB05 18.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | age-adj. PRR 17.3 · serious PRR 16.9 | NCT01631214: 1/2,040 (0.0%) on Alendronate (serious AE) |
| Alopecia (hair loss) | 10,151 | 11.3 11.1–11.5ROR 12.5 · calibrated p 0.014 ✓ | 10.8 EB05 10.6 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 9.4 · serious PRR 16.2 | not reported in cached trials |
| Abdominal discomfort | 10,069 | 13.3 13.1–13.6ROR 14.7 · calibrated p 0.008 ✓ | 12.6 EB05 12.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | age-adj. PRR 10.3 · serious PRR 19.9 | not reported in cached trials |
| Systemic lupus erythematosus | 9,315 | 74.7 73.0–76.4ROR 82.2 · calibrated p 5e-7 ✓ | 55.0 EB05 54.1 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | age-adj. PRR 75.1 · serious PRR 41.4 | not reported in cached trials |
| Rash | 9,099 | 4.5 4.4–4.5ROR 4.8 · calibrated p 0.257 | 4.4 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 4.4 · serious PRR 6.7 | not reported in cached trials |
| Pemphigus | 9,017 | 569.0 546.9–591.9ROR 625.1 · calibrated p 5e-15 ✓ | 151.5 EB05 148.9 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious PRR 111.5 | not reported in cached trials |
| Glossodynia (burning tongue/mouth pain) | 8,381 | 125.7 122.4–129.1ROR 137.1 · calibrated p 9e-9 ✓ | 78.3 EB05 76.9 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 82.8 · 90% clinician | not reported in cached trials |
| Arthropathy | 8,317 | 36.5 35.7–37.4ROR 39.7 · calibrated p 5e-5 ✓ | 31.2 EB05 30.6 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | age-adj. PRR 29.6 · serious PRR 27.7 | NCT01631214: 1/2,014 (0.0%) on Alendronate (serious AE) |
| Fall | 8,280 | 5.3 5.2–5.4ROR 5.7 · calibrated p 0.171 | 5.2 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | age-adj. PRR 3.4 · serious PRR 4.4 | NCT01631214: 13/2,040 (0.6%) on Alendronate (serious AE) |
| Swelling | 7,884 | 19.2 18.8–19.6ROR 20.8 · calibrated p 0.002 ✓ | 17.6 EB05 17.3 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 16.5 · serious PRR 20.7 | NCT01631214: 1/2,014 (0.0%) on Alendronate (serious AE) |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Intramedullary rod insertion — n=1,972, PRR 4,997.2
- Oral torus — n=214, PRR 1,464.2
- Rheumatic fever — n=3,184, PRR 579.4
- Pemphigus — n=9,017, PRR 569.0
- Deep vein thrombosis postoperative — n=1,368, PRR 494.4
- Lupus vulgaris — n=797, PRR 432.8
- Removal of internal fixation — n=114, PRR 371.4
- Facet joint syndrome — n=1,998, PRR 368.1
- Anaemia postoperative — n=829, PRR 363.6
- Grip strength — n=142, PRR 335.0
✓ A hand-written Bradford Hill causality assessment exists for this drug: Alendronate (bisphosphonates) ↔ Atypical femoral fracture.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Alendronate?
In FDA FAERS, the most frequently co-reported reaction terms for Alendronate are pain, fatigue, femur fracture, arthralgia, rheumatoid arthritis, alopecia. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Alendronate have an FDA boxed warning?
No. The FDA label retrieved for Alendronate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Alendronate causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 4323d3aa-cbb0-41e2-aba7-7a94a0516993, effective 20260612; matched on
openfda.generic_name.exact:"ALENDRONATE SODIUM") - PubChem CID 2088 description (ChEBI)
- Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,313 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
ALENDRONATE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.