Drug · FAERS side-effect profile with label screen

Risedronate side effects: what 30,905 FDA adverse event reports show

Risedronate Sodium · 1,255 reaction terms · 290,166 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Risedronate Sodium (Risedronate Sodium)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

30,905 reports · 83% serious · 2,904 with death outcome · 86% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Risedronate sodium tablets, USP are a bisphosphonate indicated for: Treatment and prevention of postmenopausal osteoporosis ( 1.1 ) Treatment to increase bone mass in men with osteoporosis ( 1.2 ) • Treatment and prevention of glucocorticoid-induced osteoporosis ( 1.3 ) • Treatment of Paget's disease ( 1.4 ) Limitations of Use Optimal duration of use has not been determined.

FDA label, Indications and Usage

What it is

Risedronate sodium tablets, USP are pyridinyl bisphosphonates that inhibit osteoclast-mediated bone resorption and modulate bone metabolism. Each risedronate sodium tablet, USP for oral administration contains the equivalent of 35, 75, or 150 mg of anhydrous risedronate sodium in the form of the hemi-pentahydrate.

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 (related wording) 3Likely indication confounding 4Lab value / disease marker 13Not in label — unassessed 20

What the badges mean

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). 1,215 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Hepatic enzyme	59	499.4 356.5–699.5ROR 500.3 · calibrated p 3e-13 ✓	262.0 EB05 210.5 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=59 · 100% clinician	not reported in cached trials
Eosinophilic bronchitis	80	445.7 336.0–591.4ROR 446.9 · calibrated p 5e-13 ✓	251.8 EB05 208.8 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious n=80	not reported in cached trials
Presbyacusis	119	423.2 336.5–532.3ROR 424.9 · calibrated p 6e-13 ✓	249.2 EB05 213.8 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious n=119	not reported in cached trials
Salpingo-oophorectomy unilateral	42	419.1 285.0–616.3ROR 419.7 · calibrated p 2e-12 ✓	231.0 EB05 178.1 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=42	not reported in cached trials
Fracture displacement	153	368.0 302.2–448.1ROR 369.8 · calibrated p 2e-12 ✓	230.9 EB05 201.8 · IC025 +6.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=153	not reported in cached trials
Hypocholesterolaemia	93	294.7 231.0–376.0ROR 295.6 · calibrated p 2e-11 ✓	196.6 EB05 165.3 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious n=93 · 100% clinician	not reported in cached trials
C-reactive protein	256	267.4 231.5–309.0ROR 269.7 · calibrated p 3e-11 ✓	188.6 EB05 170.0 · IC025 +6.9 3/3 methods agree	Lab value / disease marker	serious n=256 · 93% clinician	not reported in cached trials
Red blood cell sedimentation rate	76	251.6 193.3–327.4ROR 252.2 · calibrated p 1e-10 ✓	175.1 EB05 144.5 · IC025 +6.0 3/3 methods agree	Lab value / disease marker	serious n=76 · 100% clinician	not reported in cached trials
Deep vein thrombosis postoperative	489	226.0 204.1–250.2ROR 229.6 · calibrated p 1e-10 ✓	168.0 EB05 155.9 · IC025 +7.0 3/3 methods agree	Not in label — unassessed	serious n=489 · 93% clinician	not reported in cached trials
Lupus vulgaris	248	178.9 155.6–205.7ROR 180.3 · calibrated p 1e-9 ✓	139.8 EB05 125.8 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious n=248 · 95% clinician	not reported in cached trials
Ankle arthroplasty	70	164.8 126.9–214.0ROR 165.2 · calibrated p 4e-9 ✓	127.9 EB05 104.6 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=70 · 100% clinician	not reported in cached trials
Swollen joint count increased	608	164.5 150.7–179.7ROR 167.8 · calibrated p 2e-9 ✓	131.7 EB05 123.1 · IC025 +6.8 3/3 methods agree	Lab value / disease marker	serious n=608 · 94% clinician	not reported in cached trials
Anti-cyclic citrullinated peptide antibody	130	164.3 135.7–199.0ROR 165.0 · calibrated p 3e-9 ✓	129.6 EB05 112.0 · IC025 +6.2 3/3 methods agree	Lab value / disease marker	serious n=130 · 100% clinician	not reported in cached trials
Swollen joint count	46	156.1 113.3–215.2ROR 156.4 · calibrated p 8e-9 ✓	120.5 EB05 94.0 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=46 · 100% clinician	not reported in cached trials
Adjustment disorder with depressed mood	352	143.7 128.1–161.1ROR 145.3 · calibrated p 7e-9 ✓	117.7 EB05 107.7 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	serious n=352 · 96% clinician	not reported in cached trials
Rheumatoid factor positive	982	139.3 130.2–149.1ROR 143.9 · calibrated p 7e-9 ✓	115.2 EB05 109.3 · IC025 +6.7 3/3 methods agree	Lab value / disease marker	serious n=982 · 95% clinician	not reported in cached trials
Granuloma skin	137	134.5 112.0–161.6ROR 135.1 · calibrated p 1e-8 ✓	110.5 EB05 95.8 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=137 · 93% clinician	not reported in cached trials
Rheumatic fever	685	126.3 116.5–136.9ROR 129.1 · calibrated p 2e-8 ✓	106.1 EB05 99.6 · IC025 +6.5 3/3 methods agree	Not in label — unassessed	serious n=685 · 94% clinician	not reported in cached trials
Dislocation of vertebra	338	121.6 108.4–136.5ROR 123.0 · calibrated p 3e-8 ✓	102.5 EB05 93.6 · IC025 +6.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=338 · 93% clinician	not reported in cached trials
Comminuted fracture	49	117.0 86.4–158.5ROR 117.2 · calibrated p 7e-8 ✓	96.1 EB05 75.6 · IC025 +5.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=49	not reported in cached trials
Anti-cyclic citrullinated peptide antibody positive	1,031	115.2 107.9–123.0ROR 119.1 · calibrated p 3e-8 ✓	98.2 EB05 93.3 · IC025 +6.5 3/3 methods agree	Lab value / disease marker	serious PRR 68.4 · 96% clinician	not reported in cached trials
Pleural thickening	94	108.6 87.3–134.9ROR 108.9 · calibrated p 8e-8 ✓	91.8 EB05 77.3 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=94	not reported in cached trials
Nasal oedema	234	101.9 88.8–116.8ROR 102.6 · calibrated p 1e-7 ✓	87.9 EB05 78.9 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=234 · 93% clinician	not reported in cached trials
Facet joint syndrome	411	101.7 91.8–112.8ROR 103.1 · calibrated p 1e-7 ✓	88.1 EB05 81.2 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious n=411 · 91% clinician	not reported in cached trials
Low turnover osteopathy	517	99.3 90.6–108.8ROR 100.9 · calibrated p 1e-7 ✓	86.3 EB05 80.2 · IC025 +6.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=515	not reported in cached trials
Blood pressure diastolic abnormal	326	98.6 87.8–110.7ROR 99.6 · calibrated p 1e-7 ✓	85.6 EB05 78.1 · IC025 +6.1 3/3 methods agree	Lab value / disease marker	serious n=312	not reported in cached trials
Pleural fibrosis	129	97.1 80.8–116.8ROR 97.5 · calibrated p 2e-7 ✓	83.9 EB05 72.4 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=129	not reported in cached trials
X-ray abnormal	223	96.9 84.2–111.4ROR 97.6 · calibrated p 2e-7 ✓	84.2 EB05 75.3 · IC025 +5.9 3/3 methods agree	Lab value / disease marker	serious n=223 · 95% clinician	not reported in cached trials
Peripheral venous disease	493	95.6 87.0–105.0ROR 97.1 · calibrated p 1e-7 ✓	83.5 EB05 77.5 · IC025 +6.1 3/3 methods agree	Labeled (related wording) related wording	serious n=493 · 93% clinician	not reported in cached trials
Systemic lupus erythematosus rash	96	92.2 74.5–114.1ROR 92.5 · calibrated p 3e-7 ✓	79.9 EB05 67.4 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=96 · 91% clinician	NCT01709110: 1/683 (0.1%) on Risedronate (serious AE)
Joint destruction	185	91.0 78.1–106.1ROR 91.6 · calibrated p 3e-7 ✓	79.6 EB05 70.4 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=184 · 100% clinician	not reported in cached trials
Blood pressure systolic abnormal	294	90.8 80.5–102.6ROR 91.7 · calibrated p 2e-7 ✓	79.7 EB05 72.3 · IC025 +5.9 3/3 methods agree	Lab value / disease marker	serious n=284	not reported in cached trials
Red blood cell sedimentation rate abnormal	256	83.9 73.7–95.5ROR 84.6 · calibrated p 4e-7 ✓	74.2 EB05 66.9 · IC025 +5.8 3/3 methods agree	Lab value / disease marker	serious n=256	not reported in cached trials
Fracture delayed union	91	81.0 65.2–100.7ROR 81.3 · calibrated p 7e-7 ✓	71.3 EB05 59.9 · IC025 +5.4 3/3 methods agree	Labeled (related wording) related wording	serious n=90	not reported in cached trials
Blood parathyroid hormone decreased	158	80.4 68.2–94.8ROR 80.8 · calibrated p 6e-7 ✓	71.3 EB05 62.4 · IC025 +5.6 3/3 methods agree	Lab value / disease marker	serious n=158 · 92% clinician	not reported in cached trials
Bronchopulmonary aspergillosis allergic	96	79.3 64.2–98.0ROR 79.6 · calibrated p 8e-7 ✓	70.1 EB05 59.1 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious n=96	not reported in cached trials
Duodenal ulcer perforation	763	78.7 73.1–84.8ROR 80.7 · calibrated p 6e-7 ✓	70.4 EB05 66.3 · IC025 +6.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 48.8 · 95% clinician	not reported in cached trials
C-reactive protein abnormal	662	78.2 72.2–84.7ROR 79.9 · calibrated p 6e-7 ✓	70.0 EB05 65.6 · IC025 +5.9 3/3 methods agree	Lab value / disease marker	serious n=662 · 93% clinician	not reported in cached trials
Blood magnesium increased	92	76.9 62.0–95.4ROR 77.1 · calibrated p 1e-6 ✓	68.1 EB05 57.2 · IC025 +5.3 3/3 methods agree	Lab value / disease marker	serious n=91	not reported in cached trials
Rheumatoid nodule	280	75.8 67.0–85.8ROR 76.5 · calibrated p 9e-7 ✓	67.9 EB05 61.5 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=278	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
Interstitial lung disease	1,313	9.48.9–9.9	signal
Osteonecrosis	773	9.28.6–9.9	signal
Fall / fracture	3,170	5.75.5–5.9	signal
Tendon disorder	296	5.34.7–5.9	signal
Liver injury	2,201	5.04.8–5.2	signal
Serious infection	4,884	4.34.2–4.4	signal
Hyperglycaemia / diabetes	1,646	3.23.1–3.4	signal
Depression	1,310	3.23.0–3.3	signal
Opportunistic infection	578	2.92.7–3.1	signal
Hyponatraemia	316	2.72.4–3.0	signal
Rhabdomyolysis / myopathy	300	2.52.2–2.8	signal
Anaemia	1,051	2.42.2–2.5	signal
Gi bleeding	607	2.32.1–2.4	signal
Pancreatitis	246	2.11.8–2.3	raised
Arrhythmia / qt	587	2.11.9–2.2	raised
Kidney injury	1,320	2.01.9–2.1	raised

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Risedronate 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 (1 of 40 signal terms matched).

NCT02089997 — Special Drug Use Surveillance on Long-term Use of Sodium Risedronate Tablets (Benet 75 mg Tablets) (12-month T (N=3304, phase n/a; 15 AE terms posted; arms: Sodium Risedronate 75 mg)
NCT01709110 — VERtebral Fracture Treatment Comparisons in Osteoporotic Women (N=1366, PHASE4; 226 AE terms posted; arms: Teriparatide; Risedronate)

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
Arthralgia (joint pain)	3,877	6.4 6.2–6.6ROR 7.2 · calibrated p 0.092	6.3 EB05 6.2 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 6.0 · serious PRR 7.3	NCT01709110: 51/683 (7.5%) on Risedronate
Pain	3,778	4.2 4.1–4.3ROR 4.6 · calibrated p 0.279	4.2 EB05 4.1 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 4.8 · serious PRR 4.3	NCT02089997: 1/3,058 (0.0%) on Risedronate (serious AE)
Drug ineffective (drug did not work)	3,731	1.9 1.9–2.0ROR 2.1 · calibrated p 0.973	1.9 EB05 1.9 · IC025 +0.9	Reporting / coding artifact	age-adj. PRR 2.6 · serious PRR 3.4	not reported in cached trials
Nausea	3,084	2.7 2.6–2.7ROR 2.8 · calibrated p 0.679	2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.4 · serious PRR 3.1	NCT02089997: 28/3,058 (0.9%) on Risedronate
Dyspnoea (shortness of breath)	3,028	3.6 3.5–3.8ROR 3.9 · calibrated p 0.390	3.6 EB05 3.5 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	age-adj. PRR 3.3 · serious PRR 3.3	NCT01709110: 1/683 (0.1%) on Risedronate (serious AE)
Fatigue (tiredness)	3,025	2.6 2.6–2.7ROR 2.8 · calibrated p 0.685	2.6 EB05 2.6 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 2.5 · serious PRR 3.2	not reported in cached trials
Off label use (used outside approved label)	2,958	2.3 2.2–2.4ROR 2.5 · calibrated p 0.832	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 2.3 · serious PRR 2.9	not reported in cached trials
Vomiting	2,948	4.3 4.1–4.4ROR 4.6 · calibrated p 0.278	4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 4.4 · serious PRR 4.2	NCT01709110: 1/683 (0.1%) on Risedronate (serious AE)
Diarrhoea (diarrhea)	2,800	3.0 2.9–3.1ROR 3.2 · calibrated p 0.577	3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.6 · serious PRR 3.2	NCT02089997: 19/3,058 (0.6%) on Risedronate
Drug hypersensitivity	2,614	9.2 8.9–9.6ROR 10.0 · calibrated p 0.032 ✓	9.1 EB05 8.8 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 10.1 · serious PRR 16.8	not reported in cached trials
Pneumonia (lung infection)	2,598	5.5 5.3–5.7ROR 5.9 · calibrated p 0.156	5.4 EB05 5.3 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 4.7 · serious PRR 3.9	NCT02089997: 1/3,058 (0.0%) on Risedronate (serious AE)
Malaise (feeling unwell)	2,447	3.8 3.7–3.9ROR 4.0 · calibrated p 0.371	3.8 EB05 3.7 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	age-adj. PRR 3.9 · serious PRR 4.1	NCT02089997: 1/3,058 (0.0%) on Risedronate (serious AE)
Rheumatoid arthritis	2,434	14.9 14.3–15.5ROR 16.1 · calibrated p 0.005 ✓	14.6 EB05 14.1 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	age-adj. PRR 15.9 · serious PRR 12.2	NCT01709110: 1/683 (0.1%) on Risedronate (serious AE)
Headache	2,413	2.6 2.5–2.7ROR 2.8 · calibrated p 0.710	2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.7 · serious PRR 3.3	not reported in cached trials
Pain in extremity	2,182	5.0 4.8–5.3ROR 5.4 · calibrated p 0.200	5.0 EB05 4.8 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	age-adj. PRR 4.5 · serious PRR 5.5	NCT01709110: 37/683 (5.4%) on Risedronate

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.

Hepatic enzyme — n=59, PRR 499.4
Eosinophilic bronchitis — n=80, PRR 445.7
Presbyacusis — n=119, PRR 423.2
Salpingo-oophorectomy unilateral — n=42, PRR 419.1
Hypocholesterolaemia — n=93, PRR 294.7
Deep vein thrombosis postoperative — n=489, PRR 226.0
Lupus vulgaris — n=248, PRR 178.9
Ankle arthroplasty — n=70, PRR 164.8
Swollen joint count — n=46, PRR 156.1
Adjustment disorder with depressed mood — n=352, PRR 143.7

✓ A hand-written Bradford Hill causality assessment exists for this drug: Methotrexate Sodium ↔ Rheumatoid Arthritis.

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 Risedronate?

In FDA FAERS, the most frequently co-reported reaction terms for Risedronate are arthralgia, pain, nausea, dyspnoea, fatigue, vomiting. 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 Risedronate have an FDA boxed warning?

No. The FDA label retrieved for Risedronate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Risedronate 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 81702f21-3117-49ce-8e9b-2aa2648ba7c3, effective 20221101; matched on openfda.generic_name.exact:"RISEDRONATE SODIUM")
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, field patient.drug.openfda.generic_name.exact, 1,255 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 RISEDRONATE, 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.