Drug · FAERS side-effect profile with label screen

Alendronate and Cholecalciferol side effects: what 2,764 FDA adverse event reports show

Alendronate Sodium And Cholecalciferol · 397 reaction terms · 25,399 drug–reaction co-reports · data 2026-09-14

Drug class

Vitamin D

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Alendronate Sodium And Cholecalciferol (Fosamax Plus D)

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

Who reports

2,764 reports · 93% serious · 128 with death outcome · 92% female

openFDA FAERS counts, all years, deduplication not applied

Used for

FOSAMAX PLUS D is a combination of a bisphosphonate and vitamin D indicated for: Treatment of osteoporosis in postmenopausal women ( 1.1 ) Treatment to increase bone mass in men with osteoporosis ( 1.2 ) Limitations of use : FOSAMAX PLUS D alone should not be used to treat vitamin D deficiency. ( 1.3 ) Optimal duration of use has not been determined.

FDA label, Indications and Usage

What it is

FOSAMAX PLUS D contains alendronate sodium, a bisphosphonate, and cholecalciferol (vitamin D 3 ). 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 3Labeled (related wording) 3Likely indication confounding 7Reporting / coding artifact 2Not in label — unassessed 25

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.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
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. 357 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
Femur fracture	1,407	360.1 346.5–374.2ROR 732.2 · χ² 481,089 / p <1e-300	342.0 EB05 327.3 · IC025 +8.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 214.7	no trial data cached
Vitamin d deficiency	260	207.9 184.8–233.8ROR 229.3 · χ² 51,900 / p <1e-300	199.3 EB05 179.8 · IC025 +7.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 151.3	no trial data cached
Hyperlipidaemia	304	197.4 177.2–219.8ROR 221.6 · χ² 57,711 / p <1e-300	190.0 EB05 172.8 · IC025 +7.0 3/3 methods agree	Not in label — unassessed	serious PRR 131.8	no trial data cached
Intervertebral disc degeneration	214	178.5 156.7–203.4ROR 193.4 · χ² 36,735 / p <1e-300	171.7 EB05 153.3 · IC025 +6.7 3/3 methods agree	Not in label — unassessed	serious PRR 124.3	no trial data cached
Hypercholesterolaemia	201	162.7 142.2–186.2ROR 175.4 · χ² 31,478 / p <1e-300	156.9 EB05 139.6 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious PRR 105.4	no trial data cached
Bursitis	228	146.1 128.8–165.6ROR 159.1 · χ² 32,096 / p <1e-300	141.6 EB05 126.8 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious PRR 105.0	no trial data cached
Osteopenia	260	131.5 117.0–147.8ROR 145.0 · χ² 32,982 / p <1e-300	128.0 EB05 115.5 · IC025 +6.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 94.6	no trial data cached
Osteoarthritis	655	118.8 111.0–127.1ROR 155.3 · χ² 75,342 / p <1e-300	116.6 EB05 109.3 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious PRR 81.5	no trial data cached
Dental caries	157	109.3 93.8–127.4ROR 115.8 · χ² 16,509 / p <1e-300	106.4 EB05 93.1 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious PRR 103.0	no trial data cached
Foot fracture	232	93.7 82.7–106.0ROR 102.2 · χ² 20,935 / p <1e-300	91.8 EB05 82.3 · IC025 +6.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 68.6	no trial data cached
Bone disorder	215	89.8 78.9–102.2ROR 97.3 · χ² 18,579 / p <1e-300	88.1 EB05 78.6 · IC025 +6.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 66.9	no trial data cached
Tooth disorder	258	88.6 78.8–99.5ROR 97.6 · χ² 22,012 / p <1e-300	87.0 EB05 78.4 · IC025 +6.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 93.6	no trial data cached
Tooth fracture	124	86.3 72.6–102.6ROR 90.3 · χ² 10,253 / p <1e-300	84.2 EB05 72.5 · IC025 +5.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 79.8	no trial data cached
Osteoporosis	428	79.6 73.0–86.9ROR 94.0 · χ² 32,872 / p <1e-300	78.5 EB05 72.5 · IC025 +6.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 55.9	no trial data cached
Rotator cuff syndrome	130	77.3 65.3–91.5ROR 81.0 · χ² 9,615 / p <1e-300	75.7 EB05 65.4 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious PRR 55.3	no trial data cached
Ligament sprain	88	68.2 55.5–83.9ROR 70.4 · χ² 5,714 / p <1e-300	66.7 EB05 55.8 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=88	no trial data cached
Device failure	135	68.1 57.7–80.3ROR 71.5 · χ² 8,783 / p <1e-300	66.9 EB05 57.9 · IC025 +5.5 3/3 methods agree	Reporting / coding artifact	serious PRR 93.1	no trial data cached
Impaired healing	265	61.7 55.0–69.2ROR 68.1 · χ² 15,658 / p <1e-300	60.9 EB05 55.0 · IC025 +5.6 3/3 methods agree	Reporting / coding artifact	serious PRR 45.9	no trial data cached
Tooth extraction	99	60.8 50.0–73.8ROR 63.0 · χ² 5,717 / p <1e-300	59.6 EB05 50.4 · IC025 +5.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 51.5	no trial data cached
Wrist fracture	95	60.6 49.7–73.9ROR 62.7 · χ² 5,464 / p <1e-300	59.4 EB05 50.0 · IC025 +5.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 43.4	no trial data cached
Rib fracture	160	59.6 51.2–69.3ROR 63.2 · χ² 9,092 / p <1e-300	58.7 EB05 51.5 · IC025 +5.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 39.4	no trial data cached
Osteonecrosis of jaw (jawbone death)	190	58.3 50.8–66.9ROR 62.5 · χ² 10,565 / p <1e-300	57.5 EB05 51.0 · IC025 +5.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 36.1	no trial data cached
Hiatus hernia	95	55.9 45.9–68.2ROR 57.9 · χ² 5,036 / p <1e-300	54.9 EB05 46.3 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 38.8	no trial data cached
Foot deformity	80	55.1 44.3–68.4ROR 56.7 · χ² 4,164 / p <1e-300	54.0 EB05 44.8 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 39.5	no trial data cached
Cholecystectomy	80	53.8 43.3–66.8ROR 55.3 · χ² 4,064 / p <1e-300	52.8 EB05 43.7 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 34.4	no trial data cached
Haemorrhoids	123	48.0 40.4–57.1ROR 50.2 · χ² 5,586 / p <1e-300	47.4 EB05 40.8 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 36.6	no trial data cached
Hypothyroidism	200	47.9 41.9–54.8ROR 51.6 · χ² 9,098 / p <1e-300	47.4 EB05 42.2 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 32.6	no trial data cached
Osteomyelitis	113	47.7 39.8–57.1ROR 49.6 · χ² 5,087 / p <1e-300	47.0 EB05 40.2 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 30.0	no trial data cached
Spinal disorder	59	47.4 36.8–61.1ROR 48.4 · χ² 2,620 / p <1e-300	46.5 EB05 37.4 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 34.1	no trial data cached
Sciatica	95	45.7 37.5–55.7ROR 47.3 · χ² 4,086 / p <1e-300	45.0 EB05 37.9 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 37.6	no trial data cached
Intervertebral disc protrusion	129	44.9 37.9–53.2ROR 47.0 · χ² 5,465 / p <1e-300	44.4 EB05 38.3 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 32.5	no trial data cached
Increased tendency to bruise	54	44.7 34.3–58.2ROR 45.5 · χ² 2,250 / p <1e-300	43.8 EB05 34.8 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=54	no trial data cached
Atelectasis	55	43.3 33.3–56.2ROR 44.1 · χ² 2,216 / p <1e-300	42.4 EB05 33.8 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 27.1	no trial data cached
Body height decreased	61	43.0 33.5–55.2ROR 44.0 · χ² 2,449 / p <1e-300	42.3 EB05 34.1 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=60	no trial data cached
Osteonecrosis (bone death)	184	42.3 36.8–48.7ROR 45.3 · χ² 7,353 / p <1e-300	41.9 EB05 37.1 · IC025 +5.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 26.2	no trial data cached
Hip arthroplasty	84	42.2 34.1–52.1ROR 43.5 · χ² 3,319 / p <1e-300	41.6 EB05 34.6 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 26.9	no trial data cached
Tooth abscess	56	41.8 32.2–54.2ROR 42.6 · χ² 2,177 / p <1e-300	41.0 EB05 32.8 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 34.0	no trial data cached
Gastrooesophageal reflux disease (acid reflux)	437	41.6 38.1–45.3ROR 49.2 · χ² 17,225 / p <1e-300	41.3 EB05 38.1 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 40.6	no trial data cached
Tendonitis	84	41.2 33.3–50.9ROR 42.4 · χ² 3,237 / p <1e-300	40.6 EB05 33.8 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 32.5	no trial data cached
Laceration	51	40.8 31.0–53.5ROR 41.5 · χ² 1,929 / p <1e-300	40.0 EB05 31.6 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=51	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Femur fracture	1,407	360.1 346.5–374.2ROR 732.2 · χ² 481,089 / p <1e-300	342.0 EB05 327.3 · IC025 +8.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 214.7	no trial data cached
Fall	809	18.5 17.5–19.6ROR 25.7 · χ² 13,555 / p <1e-300	18.4 EB05 17.4 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 13.7	no trial data cached
Osteoarthritis	655	118.8 111.0–127.1ROR 155.3 · χ² 75,342 / p <1e-300	116.6 EB05 109.3 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious PRR 81.5	no trial data cached
Hypertension (high blood pressure)	552	19.8 18.4–21.3ROR 24.5 · χ² 9,905 / p <1e-300	19.7 EB05 18.4 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 15.4	no trial data cached
Arthralgia (joint pain)	466	8.5 7.9–9.3ROR 10.1 · χ² 3,152 / p <1e-300	8.5 EB05 7.9 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.4	no trial data cached
Gastrooesophageal reflux disease (acid reflux)	437	41.6 38.1–45.3ROR 49.2 · χ² 17,225 / p <1e-300	41.3 EB05 38.1 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 40.6	no trial data cached
Osteoporosis	428	79.6 73.0–86.9ROR 94.0 · χ² 32,872 / p <1e-300	78.5 EB05 72.5 · IC025 +6.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 55.9	no trial data cached
Depression	404	13.4 12.3–14.7ROR 15.6 · χ² 4,678 / p <1e-300	13.4 EB05 12.3 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 11.6	no trial data cached
Anxiety	402	10.7 9.8–11.7ROR 12.4 · χ² 3,569 / p <1e-300	10.6 EB05 9.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 9.8	no trial data cached
Pain in extremity	396	10.2 9.3–11.2ROR 11.7 · χ² 3,314 / p <1e-300	10.1 EB05 9.3 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 10.9	no trial data cached
Back pain	388	12.7 11.6–13.9ROR 14.6 · χ² 4,201 / p <1e-300	12.6 EB05 11.6 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 12.9	no trial data cached
Hyperlipidaemia	304	197.4 177.2–219.8ROR 221.6 · χ² 57,711 / p <1e-300	190.0 EB05 172.8 · IC025 +7.0 3/3 methods agree	Not in label — unassessed	serious PRR 131.8	no trial data cached
Pain	281	3.5 3.1–3.9ROR 3.7 · χ² 505 / p 4e-112	3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.3	no trial data cached
Impaired healing	265	61.7 55.0–69.2ROR 68.1 · χ² 15,658 / p <1e-300	60.9 EB05 55.0 · IC025 +5.6 3/3 methods agree	Reporting / coding artifact	serious PRR 45.9	no trial data cached
Osteopenia	260	131.5 117.0–147.8ROR 145.0 · χ² 32,982 / p <1e-300	128.0 EB05 115.5 · IC025 +6.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 94.6	no trial data cached

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.

Hyperlipidaemia — n=304, PRR 197.4
Intervertebral disc degeneration — n=214, PRR 178.5
Hypercholesterolaemia — n=201, PRR 162.7
Bursitis — n=228, PRR 146.1
Osteoarthritis — n=655, PRR 118.8
Dental caries — n=157, PRR 109.3
Rotator cuff syndrome — n=130, PRR 77.3
Ligament sprain — n=88, PRR 68.2
Hiatus hernia — n=95, PRR 55.9
Foot deformity — n=80, PRR 55.1

✓ 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 and Cholecalciferol?

In FDA FAERS, the most frequently co-reported reaction terms for Alendronate and Cholecalciferol are femur fracture, fall, osteoarthritis, hypertension, arthralgia, gastrooesophageal reflux disease. 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 and Cholecalciferol have an FDA boxed warning?

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

Do FAERS signals prove that Alendronate and Cholecalciferol 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 10307e7e-9a84-4aa1-8c5c-4b209cffe4d1, effective 20260203; matched on openfda.generic_name.exact:"ALENDRONATE SODIUM AND CHOLECALCIFEROL")
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, 397 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

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.