Drug · FAERS side-effect profile with label screen
Ibandronate side effects: what 3,077 FDA adverse event reports show
Drug class
Bisphosphonate
FDA label, Indications wording of the closest related product
Label matched
Ibandronate Sodium (Ibandronate 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
3,077 reports · 64% serious · 295 with death outcome · 89% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Ibandronate sodium is a bisphosphonate indicated for the treatment and prevention of postmenopausal osteoporosis. ( 1.1 ) Limitations of Use The optimal duration of use has not been determined. For patients at low -risk for fracture, consider drug discontinuation after 3 to 5 years of use.
FDA label, Indications and Usage
What it is
Ibandronate sodium is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption.
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) 5Likely indication confounding 8Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 22
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.
- 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. 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 |
|---|---|---|---|---|---|---|
| Femur fracture | 219 | 48.4 42.6–55.0ROR 52.0 · χ² 10,054 / p <1e-300 | 47.8 EB05 42.8 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 43.4 | no trial data cached |
| Ocular discomfort | 66 | 41.6 32.8–52.9ROR 42.5 · χ² 2,562 / p <1e-300 | 40.9 EB05 33.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=64 · 95% clinician | no trial data cached |
| Bone disorder | 108 | 40.3 33.4–48.5ROR 41.7 · χ² 4,074 / p <1e-300 | 39.8 EB05 33.9 · IC025 +4.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 42.6 · 79% consumer | no trial data cached |
| Generalised oedema | 69 | 38.4 30.4–48.5ROR 39.2 · χ² 2,461 / p <1e-300 | 37.8 EB05 30.9 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 38.1 · 99% clinician | no trial data cached |
| Osteonecrosis of jaw (jawbone death) | 130 | 35.7 30.2–42.3ROR 37.2 · χ² 4,333 / p <1e-300 | 35.4 EB05 30.5 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 31.8 · 97% clinician | no trial data cached |
| Head discomfort | 74 | 28.7 22.9–36.0ROR 29.4 · χ² 1,946 / p <1e-300 | 28.4 EB05 23.4 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 43.3 · 92% clinician | no trial data cached |
| Metastases to bone | 61 | 25.5 19.9–32.7ROR 26.0 · χ² 1,406 / p <1e-300 | 25.2 EB05 20.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 23.1 | no trial data cached |
| Altered state of consciousness | 66 | 20.9 16.5–26.6ROR 21.4 · χ² 1,229 / p 1e-269 | 20.7 EB05 16.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 18.9 · 97% clinician | no trial data cached |
| Haematemesis (vomiting blood) | 71 | 19.1 15.1–24.0ROR 19.5 · χ² 1,196 / p 3e-262 | 18.9 EB05 15.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 17.5 · 96% clinician | no trial data cached |
| Presyncope (near-fainting) | 64 | 18.1 14.2–23.0ROR 18.4 · χ² 1,013 / p 2e-222 | 17.9 EB05 14.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 20.1 · 94% clinician | no trial data cached |
| Diplopia (double vision) | 65 | 17.1 13.4–21.7ROR 17.4 · χ² 967 / p 1e-212 | 16.9 EB05 13.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 20.7 · 97% clinician | no trial data cached |
| Photophobia (light sensitivity) | 44 | 16.1 12.0–21.6ROR 16.3 · χ² 607 / p 3e-134 | 15.9 EB05 12.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 20.7 | no trial data cached |
| Ascites | 68 | 15.8 12.5–20.0ROR 16.1 · χ² 926 / p 1e-203 | 15.6 EB05 12.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 14.4 · 97% clinician | no trial data cached |
| Metastases to liver | 40 | 15.6 11.4–21.2ROR 15.8 · χ² 530 / p 1e-117 | 15.3 EB05 11.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.7 · 100% clinician | no trial data cached |
| Breast cancer metastatic | 23 | 14.6 9.7–22.0ROR 14.7 · χ² 278 / p 1e-62 | 14.1 EB05 9.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 · 95% clinician | no trial data cached |
| Blindness | 76 | 12.7 10.2–15.9ROR 13.0 · χ² 810 / p 2e-178 | 12.6 EB05 10.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · 93% clinician | no trial data cached |
| Haematuria (blood in urine) | 64 | 12.7 10.0–16.2ROR 13.0 · χ² 680 / p 4e-150 | 12.5 EB05 10.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 · 95% clinician | no trial data cached |
| Eye pain | 89 | 11.0 9.0–13.5ROR 11.3 · χ² 799 / p 4e-176 | 10.8 EB05 9.0 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.5 | no trial data cached |
| Cardio-respiratory arrest | 65 | 10.5 8.3–13.4ROR 10.7 · χ² 552 / p 3e-122 | 10.2 EB05 8.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · 91% clinician | no trial data cached |
| Coma | 71 | 10.2 8.1–12.8ROR 10.4 · χ² 577 / p 7e-128 | 9.9 EB05 8.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 · 97% clinician | no trial data cached |
| Tinnitus (ringing in the ears) | 68 | 10.1 8.0–12.7ROR 10.3 · χ² 547 / p 2e-121 | 9.8 EB05 7.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.5 | no trial data cached |
| Osteonecrosis (bone death) | 46 | 9.5 7.1–12.6ROR 9.6 · χ² 340 / p 4e-76 | 9.0 EB05 6.9 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.6 · 95% clinician | no trial data cached |
| Metastases to lung | 16 | 9.5 5.8–15.4ROR 9.5 · χ² 113 / p 1e-26 | 8.1 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Vitamin d deficiency | 13 | 9.1 5.3–15.6ROR 9.1 · χ² 86 / p 1e-20 | 7.5 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Musculoskeletal chest pain | 20 | 8.8 5.7–13.6ROR 8.9 · χ² 131 / p 2e-30 | 7.8 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Osteoporosis | 51 | 8.4 6.4–11.1ROR 8.6 · χ² 327 / p 2e-73 | 8.0 EB05 6.3 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 7.4 | no trial data cached |
| Spinal fracture | 24 | 8.2 5.5–12.2ROR 8.3 · χ² 145 / p 1e-33 | 7.4 EB05 5.1 · IC025 +2.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 7.4 | no trial data cached |
| Pain in jaw | 31 | 7.5 5.2–10.6ROR 7.5 · χ² 167 / p 2e-38 | 6.8 EB05 5.0 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.3 · 73% consumer | no trial data cached |
| Bone pain | 64 | 7.4 5.8–9.5ROR 7.6 · χ² 351 / p 1e-78 | 7.1 EB05 5.8 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.2 | no trial data cached |
| Wrist fracture | 13 | 7.4 4.3–12.7ROR 7.4 · χ² 66 / p 3e-16 | 6.1 EB05 3.7 · IC025 +1.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 7.8 | no trial data cached |
| Product packaging issue | 10 | 7.3 4.0–13.6ROR 7.4 · χ² 49 / p 2e-12 | 5.8 EB05 3.3 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious n=2 | no trial data cached |
| Glomerular filtration rate decreased | 13 | 7.3 4.3–12.6ROR 7.3 · χ² 65 / p 4e-16 | 6.0 EB05 3.7 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 8.1 | no trial data cached |
| Osteopenia | 16 | 7.1 4.4–11.7ROR 7.2 · χ² 79 / p 4e-19 | 6.1 EB05 3.9 · IC025 +1.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.7 | no trial data cached |
| Hip fracture | 31 | 6.6 4.6–9.3ROR 6.6 · χ² 141 / p 7e-33 | 6.0 EB05 4.4 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.0 | no trial data cached |
| Tooth extraction | 12 | 6.6 3.7–11.6ROR 6.6 · χ² 51 / p 4e-13 | 5.4 EB05 3.3 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.1 | no trial data cached |
| Chills | 109 | 6.3 5.3–7.6ROR 6.5 · χ² 486 / p 6e-108 | 6.2 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Polyneuropathy | 11 | 6.3 3.5–11.4ROR 6.3 · χ² 44 / p 2e-11 | 5.1 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Cardiomegaly | 11 | 6.0 3.3–10.9ROR 6.1 · χ² 41 / p 6e-11 | 4.9 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Fracture | 16 | 5.8 3.5–9.4ROR 5.8 · χ² 58 / p 1e-14 | 5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.7 | no trial data cached |
| Foot fracture | 16 | 5.7 3.5–9.4ROR 5.8 · χ² 58 / p 1e-14 | 5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.8 | 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 |
|---|---|---|---|---|---|---|
| Arthralgia (joint pain) | 261 | 4.3 3.8–4.8ROR 4.6 · χ² 669 / p 1e-147 | 4.3 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Femur fracture | 219 | 48.4 42.6–55.0ROR 52.0 · χ² 10,054 / p <1e-300 | 47.8 EB05 42.8 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 43.4 | no trial data cached |
| Fall | 176 | 3.6 3.1–4.2ROR 3.8 · χ² 334 / p 6e-75 | 3.6 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Myalgia (muscle pain) | 142 | 5.7 4.8–6.7ROR 5.9 · χ² 549 / p 1e-121 | 5.6 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.8 | no trial data cached |
| Pain in extremity | 141 | 3.3 2.8–3.8ROR 3.4 · χ² 221 / p 3e-50 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 · 73% consumer | no trial data cached |
| Back pain | 140 | 4.1 3.5–4.8ROR 4.3 · χ² 329 / p 8e-74 | 4.1 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 · 71% consumer | no trial data cached |
| Abdominal pain upper | 131 | 4.3 3.7–5.1ROR 4.5 · χ² 337 / p 1e-75 | 4.3 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Osteonecrosis of jaw (jawbone death) | 130 | 35.7 30.2–42.3ROR 37.2 · χ² 4,333 / p <1e-300 | 35.4 EB05 30.5 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 31.8 · 97% clinician | no trial data cached |
| Chills | 109 | 6.3 5.3–7.6ROR 6.5 · χ² 486 / p 6e-108 | 6.2 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Bone disorder | 108 | 40.3 33.4–48.5ROR 41.7 · χ² 4,074 / p <1e-300 | 39.8 EB05 33.9 · IC025 +4.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 42.6 · 79% consumer | no trial data cached |
| Blood pressure increased | 91 | 4.0 3.3–5.0ROR 4.1 · χ² 207 / p 3e-47 | 4.0 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.8 | no trial data cached |
| Eye pain | 89 | 11.0 9.0–13.5ROR 11.3 · χ² 799 / p 4e-176 | 10.8 EB05 9.0 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.5 | no trial data cached |
| Blindness | 76 | 12.7 10.2–15.9ROR 13.0 · χ² 810 / p 2e-178 | 12.6 EB05 10.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.7 · 93% clinician | no trial data cached |
| Syncope (fainting) | 75 | 5.1 4.1–6.4ROR 5.2 · χ² 244 / p 2e-55 | 5.0 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 92% clinician | no trial data cached |
| Head discomfort | 74 | 28.7 22.9–36.0ROR 29.4 · χ² 1,946 / p <1e-300 | 28.4 EB05 23.4 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 43.3 · 92% clinician | 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.
- Ocular discomfort — n=66, PRR 41.6
- Head discomfort — n=74, PRR 28.7
- Metastases to bone — n=61, PRR 25.5
- Altered state of consciousness — n=66, PRR 20.9
- Haematemesis — n=71, PRR 19.1
- Presyncope — n=64, PRR 18.1
- Diplopia — n=65, PRR 17.1
- Photophobia — n=44, PRR 16.1
- Ascites — n=68, PRR 15.8
- Metastases to liver — n=40, PRR 15.6
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 Ibandronate?
In FDA FAERS, the most frequently co-reported reaction terms for Ibandronate are arthralgia, femur fracture, fall, myalgia, pain in extremity, back pain. 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 Ibandronate have an FDA boxed warning?
No. The FDA label retrieved for Ibandronate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ibandronate 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 86c0b4ae-5e38-4efe-88af-50ac560e294f, effective 20260318; matched on
openfda.generic_name.exact:"IBANDRONATE 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, fieldpatient.drug.openfda.generic_name.exact, 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
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.