Drug · FAERS side-effect profile with label screen
Alendronate side effects: what 18,421 FDA adverse event reports show
Drug class
Bisphosphonate
FDA label, Indications wording of the closest related product
Label matched
Alendronate Sodium Tablet (Alendronate)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
18,421 reports · 71% serious · 1,663 with death outcome · 79% female
openFDA FAERS counts, all years, deduplication not applied
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.
FDA label, Indications and Usage
What it is
Alendronate sodium is a bisphosphonate that acts as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 2Labeled (related wording) 1Likely indication confounding 5Lab value / disease marker 12Not in label — unassessed 20
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,122 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Atypical femur fracture | 279 | 124.2 109.8–140.4ROR 126.1 · χ² 30,589 / p <1e-300 | 111.1 EB05 100.6 · IC025 +6.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=279 · 94% clinician | not reported in cached trials |
| Atypical fracture | 54 | 110.0 83.2–145.4ROR 110.3 · χ² 5,212 / p <1e-300 | 96.9 EB05 77.1 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=54 · 100% clinician | not reported in cached trials |
| Granuloma skin | 55 | 80.9 61.5–106.3ROR 81.1 · χ² 3,974 / p <1e-300 | 73.7 EB05 58.7 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=55 · ♀ 100% (drug 79%) | not reported in cached trials |
| Periprosthetic fracture | 24 | 77.2 51.0–116.7ROR 77.3 · χ² 1,618 / p <1e-300 | 68.5 EB05 48.4 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=24 · 100% clinician | not reported in cached trials |
| Red blood cell sedimentation rate | 14 | 59.5 34.8–101.8ROR 59.6 · χ² 710 / p 9e-157 | 52.7 EB05 33.4 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=14 | not reported in cached trials |
| Reversible airways obstruction | 24 | 55.6 36.9–83.8ROR 55.7 · χ² 1,175 / p 6e-258 | 51.0 EB05 36.1 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=24 | not reported in cached trials |
| Blood parathyroid hormone decreased | 67 | 53.5 41.9–68.3ROR 53.7 · χ² 3,246 / p <1e-300 | 50.4 EB05 41.1 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious n=66 | not reported in cached trials |
| Fracture displacement | 19 | 51.7 32.7–81.9ROR 51.8 · χ² 856 / p 2e-188 | 47.3 EB05 32.0 · IC025 +3.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=19 | not reported in cached trials |
| Total lung capacity abnormal | 16 | 49.9 30.2–82.3ROR 49.9 · χ² 688 / p 7e-152 | 45.4 EB05 29.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Pulmonary vasculitis | 20 | 44.7 28.6–69.9ROR 44.8 · χ² 780 / p 5e-172 | 41.5 EB05 28.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Lupus vulgaris | 45 | 44.7 33.2–60.2ROR 44.8 · χ² 1,807 / p <1e-300 | 42.3 EB05 32.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=45 · ♀ 100% (drug 79%) · 100% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 25 | 44.2 29.7–66.0ROR 44.3 · χ² 975 / p 2e-214 | 41.4 EB05 29.5 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=25 · ♀ 100% (drug 79%) · 100% clinician | not reported in cached trials |
| Vital capacity decreased | 16 | 41.9 25.4–68.9ROR 41.9 · χ² 576 / p 1e-127 | 38.7 EB05 25.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Mycotic allergy | 29 | 40.5 28.0–58.7ROR 40.6 · χ² 1,041 / p 1e-228 | 38.2 EB05 27.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 52% (drug 79%) | not reported in cached trials |
| C-reactive protein | 31 | 40.2 28.1–57.5ROR 40.3 · χ² 1,107 / p 5e-243 | 38.0 EB05 28.1 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious n=31 · ♀ 100% (drug 79%) · 100% clinician | not reported in cached trials |
| Rheumatic fever | 145 | 39.0 33.1–46.0ROR 39.3 · χ² 5,159 / p <1e-300 | 37.6 EB05 32.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=145 · ♀ 100% (drug 79%) · 93% clinician | not reported in cached trials |
| Spirometry abnormal | 19 | 38.0 24.1–60.0ROR 38.0 · χ² 627 / p 1e-138 | 35.6 EB05 24.1 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=19 | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 215 | 35.5 31.0–40.6ROR 35.9 · χ² 6,952 / p <1e-300 | 34.3 EB05 30.6 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious PRR 28.1 · ♀ 100% (drug 79%) | not reported in cached trials |
| Adjustment disorder with depressed mood | 59 | 34.3 26.5–44.4ROR 34.4 · χ² 1,818 / p <1e-300 | 33.0 EB05 26.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=59 · ♀ 100% (drug 79%) · 100% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 57 | 34.0 26.2–44.3ROR 34.1 · χ² 1,742 / p <1e-300 | 32.7 EB05 26.2 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=57 · ♀ 100% (drug 79%) · 100% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 210 | 33.5 29.2–38.4ROR 33.9 · χ² 6,398 / p <1e-300 | 32.5 EB05 28.9 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 26.4 · ♀ 100% (drug 79%) | NCT01631214: 1/2,040 (0.0%) on Alendronate (serious AE) |
| Swollen joint count increased | 88 | 33.0 26.7–40.8ROR 33.2 · χ² 2,623 / p <1e-300 | 31.9 EB05 26.7 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=88 · ♀ 100% (drug 79%) · 100% clinician | not reported in cached trials |
| Facet joint syndrome | 81 | 30.0 24.1–37.4ROR 30.1 · χ² 2,183 / p <1e-300 | 29.1 EB05 24.1 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=81 · ♀ 100% (drug 79%) | not reported in cached trials |
| Dislocation of vertebra | 57 | 29.9 23.0–38.9ROR 30.0 · χ² 1,523 / p <1e-300 | 28.9 EB05 23.1 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=57 · ♀ 100% (drug 79%) · 91% clinician | not reported in cached trials |
| Mite allergy | 16 | 29.2 17.8–48.0ROR 29.3 · χ² 398 / p 7e-89 | 27.7 EB05 18.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Antineutrophil cytoplasmic antibody positive | 18 | 28.8 18.1–46.0ROR 28.8 · χ² 444 / p 6e-99 | 27.4 EB05 18.3 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious n=18 | not reported in cached trials |
| Panniculitis | 59 | 28.5 22.0–36.9ROR 28.6 · χ² 1,502 / p <1e-300 | 27.6 EB05 22.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=59 · ♀ 100% (drug 79%) | not reported in cached trials |
| Rheumatoid nodule | 68 | 28.5 22.4–36.2ROR 28.6 · χ² 1,731 / p <1e-300 | 27.6 EB05 22.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=68 · ♀ 100% (drug 79%) | not reported in cached trials |
| Amaurosis fugax | 26 | 28.3 19.2–41.8ROR 28.4 · χ² 642 / p 6e-142 | 27.2 EB05 19.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=26 · 100% clinician | not reported in cached trials |
| Rheumatoid factor positive | 133 | 26.8 22.6–31.8ROR 27.0 · χ² 3,206 / p <1e-300 | 26.1 EB05 22.6 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=133 · ♀ 100% (drug 79%) · 92% clinician | not reported in cached trials |
| Ulna fracture | 22 | 25.8 16.9–39.3ROR 25.8 · χ² 488 / p 2e-108 | 24.7 EB05 17.2 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=22 | NCT01631214: 5/2,040 (0.2%) on Alendronate (serious AE) |
| X-ray abnormal | 39 | 25.4 18.5–34.9ROR 25.5 · χ² 870 / p 1e-191 | 24.6 EB05 18.8 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=39 · ♀ 100% (drug 79%) · 100% clinician | not reported in cached trials |
| Sputum culture positive | 17 | 23.9 14.8–38.7ROR 24.0 · χ² 344 / p 5e-77 | 22.9 EB05 15.0 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious n=16 | not reported in cached trials |
| Muscle injury | 166 | 23.5 20.1–27.4ROR 23.7 · χ² 3,478 / p <1e-300 | 23.0 EB05 20.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 20.3 · ♀ 100% (drug 79%) | not reported in cached trials |
| Pemphigus | 250 | 23.3 20.6–26.4ROR 23.6 · χ² 5,218 / p <1e-300 | 22.8 EB05 20.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 18.6 · ♀ 100% (drug 79%) | not reported in cached trials |
| Helicobacter infection | 204 | 23.2 20.2–26.7ROR 23.5 · χ² 4,230 / p <1e-300 | 22.7 EB05 20.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 19.5 · ♀ 100% (drug 79%) | not reported in cached trials |
| Drug tolerance decreased | 56 | 23.2 17.8–30.2ROR 23.3 · χ² 1,144 / p 4e-251 | 22.6 EB05 18.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=56 · ♀ 100% (drug 79%) | not reported in cached trials |
| Fracture nonunion | 27 | 22.8 15.6–33.3ROR 22.8 · χ² 530 / p 2e-117 | 22.0 EB05 15.9 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=27 | not reported in cached trials |
| C-reactive protein abnormal | 123 | 22.3 18.6–26.6ROR 22.4 · χ² 2,429 / p <1e-300 | 21.8 EB05 18.7 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious n=123 | not reported in cached trials |
| Folliculitis | 198 | 22.2 19.3–25.6ROR 22.5 · χ² 3,917 / p <1e-300 | 21.8 EB05 19.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 20.8 · ♀ 100% (drug 79%) | not reported in cached trials |
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 |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 1,391 | 2.0 1.9–2.1ROR 2.1 · χ² 763 / p 3e-168 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled (related wording) related wording | serious PRR 2.3 | not reported in cached trials |
| Drug ineffective (drug did not work) | 1,296 | 1.1 1.1–1.2ROR 1.1 · χ² 18 / p 1e-5 | 1.1 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.8 | not reported in cached trials |
| Pain | 1,245 | 2.3 2.2–2.4ROR 2.4 · χ² 945 / p 8e-208 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | NCT01631214: 5/2,040 (0.2%) on Alendronate (serious AE) |
| Arthralgia (joint pain) | 1,232 | 3.4 3.2–3.6ROR 3.6 · χ² 2,110 / p <1e-300 | 3.4 EB05 3.2 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | NCT01631214: 2/2,040 (0.1%) on Alendronate (serious AE) |
| Off label use (used outside approved label) | 1,197 | 1.6 1.5–1.7ROR 1.6 · χ² 258 / p 2e-58 | 1.6 EB05 1.5 · IC025 +0.6 | Reporting / coding artifact | serious PRR 1.9 | not reported in cached trials |
| Fall | 1,186 | 4.1 3.9–4.3ROR 4.3 · χ² 2,779 / p <1e-300 | 4.1 EB05 3.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | NCT01631214: 13/2,040 (0.6%) on Alendronate (serious AE) |
| Diarrhoea (diarrhea) | 1,167 | 2.1 2.0–2.2ROR 2.1 · χ² 661 / p 5e-146 | 2.1 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.1 | NCT01631214: 6/2,040 (0.3%) on Alendronate (serious AE) |
| Nausea | 1,130 | 1.6 1.5–1.7ROR 1.7 · χ² 286 / p 2e-64 | 1.6 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.8 | NCT01631214: 1/2,014 (0.0%) on Alendronate (serious AE) |
| Dyspnoea (shortness of breath) | 1,075 | 2.2 2.0–2.3ROR 2.2 · χ² 690 / p 2e-152 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | NCT01631214: 1/2,040 (0.0%) on Alendronate (serious AE) |
| Headache | 955 | 1.7 1.6–1.8ROR 1.8 · χ² 307 / p 6e-69 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.1 | NCT01631214: 163/2,040 (8.0%) on Alendronate |
| Dizziness | 806 | 1.8 1.7–2.0ROR 1.9 · χ² 318 / p 2e-71 | 1.8 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.9 | NCT01631214: 9/2,040 (0.4%) on Alendronate (serious AE) |
| Pneumonia (lung infection) | 799 | 2.8 2.6–3.0ROR 2.9 · χ² 948 / p 2e-208 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.3 | NCT01631214: 54/2,040 (2.6%) on Alendronate (serious AE) |
| Pain in extremity | 786 | 3.0 2.8–3.3ROR 3.1 · χ² 1,084 / p 6e-238 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | NCT01631214: 1/2,040 (0.0%) on Alendronate (serious AE) |
| Asthenia (weakness) | 748 | 2.3 2.1–2.4ROR 2.3 · χ² 537 / p 5e-119 | 2.3 EB05 2.1 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | NCT01631214: 3/2,040 (0.1%) on Alendronate (serious AE) |
| Malaise (feeling unwell) | 716 | 1.9 1.7–2.0ROR 1.9 · χ² 287 / p 1e-64 | 1.9 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.1 | NCT01631214: 2/2,040 (0.1%) 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.
- Granuloma skin — n=55, PRR 80.9
- Reversible airways obstruction — n=24, PRR 55.6
- Pulmonary vasculitis — n=20, PRR 44.7
- Lupus vulgaris — n=45, PRR 44.7
- Mycotic allergy — n=29, PRR 40.5
- Rheumatic fever — n=145, PRR 39.0
- Adjustment disorder with depressed mood — n=59, PRR 34.3
- Deep vein thrombosis postoperative — n=57, PRR 34.0
- Facet joint syndrome — n=81, PRR 30.0
- Panniculitis — n=59, PRR 28.5
✓ 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 fatigue, pain, arthralgia, fall, diarrhoea, nausea. 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 b63421af-ec03-1de7-e053-2a95a90abec6, effective 20250910; matched on
openfda.generic_name.exact:"ALENDRONATE SODIUM TABLET") - 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, 1,162 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 2026-10-08. 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.