Drug · FAERS side-effect profile with label screen
Pamidronate side effects: what 3,386 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Pamidronate Disodium (Pamidronate Disodium)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
3,386 reports · 94% serious · 428 with death outcome · 59% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Hypercalcemia of Malignancy Pamidronate disodium, in conjunction with adequate hydration, is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases. Patients who have either epidermoid or non-epidermoid tumors respond to treatment with pamidronate disodium.
FDA label, Indications and Usage
What it is
DESCRIPTION Pamidronate disodium is a bisphosphonate available in 30 mg, 60 mg, or 90 mg vials for intravenous administration. The pamidronate disodium obtained by combining pamidronic acid and sodium hydroxide is provided in a sterile, ready to use solution for injection.
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 4Labeled (related wording) 9Likely indication confounding 4Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 19
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. 136 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 |
|---|---|---|---|---|---|---|
| Osteonecrosis of jaw (jawbone death) | 435 | 110.0 100.6–120.2ROR 126.0 · χ² 46,091 / p <1e-300 | 107.6 EB05 99.3 · IC025 +6.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 66.2 · 92% clinician | no trial data cached |
| Osteonecrosis (bone death) | 534 | 101.4 93.7–109.7ROR 120.2 · χ² 52,187 / p <1e-300 | 99.4 EB05 92.5 · IC025 +6.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 59.4 · 94% clinician | no trial data cached |
| Tooth extraction | 168 | 84.7 73.0–98.2ROR 89.0 · χ² 13,625 / p <1e-300 | 82.8 EB05 72.8 · IC025 +5.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 68.3 · 98% clinician | no trial data cached |
| Bone disorder | 173 | 58.8 50.8–68.1ROR 61.9 · χ² 9,693 / p <1e-300 | 57.9 EB05 51.0 · IC025 +5.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 42.5 · 95% clinician | no trial data cached |
| Hypercalcaemia | 66 | 33.3 26.2–42.3ROR 33.9 · χ² 2,026 / p <1e-300 | 32.8 EB05 26.7 · IC025 +4.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 20.7 · 92% clinician | no trial data cached |
| Osteomyelitis | 87 | 29.9 24.3–36.8ROR 30.7 · χ² 2,392 / p <1e-300 | 29.6 EB05 24.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 18.0 | no trial data cached |
| Metastases to bone | 73 | 27.7 22.1–34.8ROR 28.3 · χ² 1,848 / p <1e-300 | 27.5 EB05 22.6 · IC025 +4.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 17.0 · ♀ 89% (drug 59%) | no trial data cached |
| Pain in jaw | 115 | 25.2 21.1–30.2ROR 26.1 · χ² 2,642 / p <1e-300 | 25.0 EB05 21.4 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 24.7 | no trial data cached |
| Hypocalcaemia (low calcium) | 73 | 24.0 19.1–30.2ROR 24.5 · χ² 1,583 / p <1e-300 | 23.8 EB05 19.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.4 · 97% clinician | no trial data cached |
| Impaired healing | 113 | 21.4 17.8–25.6ROR 22.1 · χ² 2,170 / p <1e-300 | 21.2 EB05 18.1 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 15.7 · 95% clinician | no trial data cached |
| Deformity | 31 | 20.5 14.5–29.2ROR 20.7 · χ² 555 / p 5e-123 | 20.2 EB05 14.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 14.3 · ♀ 90% (drug 59%) | no trial data cached |
| Body temperature decreased | 27 | 16.9 11.6–24.6ROR 17.0 · χ² 387 / p 2e-86 | 16.5 EB05 11.8 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 11.4 · 96% clinician | no trial data cached |
| Femur fracture | 80 | 16.0 12.9–19.9ROR 16.4 · χ² 1,108 / p 3e-243 | 15.9 EB05 13.1 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.8 · 97% clinician | no trial data cached |
| Fistula | 29 | 16.0 11.1–23.0ROR 16.1 · χ² 391 / p 2e-87 | 15.6 EB05 11.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 · 96% clinician | no trial data cached |
| Tooth abscess | 26 | 15.8 10.8–23.2ROR 15.9 · χ² 345 / p 3e-77 | 15.4 EB05 10.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 | no trial data cached |
| Toothache | 46 | 15.8 11.8–21.0ROR 16.0 · χ² 621 / p 2e-137 | 15.6 EB05 12.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 17.7 · ♀ 84% (drug 59%) | no trial data cached |
| Metastases to lung | 27 | 14.5 10.0–21.1ROR 14.6 · χ² 326 / p 4e-73 | 14.1 EB05 9.9 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.9 | no trial data cached |
| Retinal detachment | 21 | 14.2 9.2–21.7ROR 14.2 · χ² 244 / p 3e-55 | 13.5 EB05 8.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · ♀ 100% (drug 59%) · 100% clinician | no trial data cached |
| Spinal pain | 25 | 13.2 9.0–19.6ROR 13.3 · χ² 270 / p 5e-61 | 12.7 EB05 8.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 · ♀ 100% (drug 59%) · 100% clinician | no trial data cached |
| Poor venous access | 22 | 13.2 8.7–20.1ROR 13.3 · χ² 236 / p 1e-53 | 12.6 EB05 8.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=22 · ♀ 100% (drug 59%) · 100% clinician | no trial data cached |
| Atelectasis | 20 | 12.8 8.3–19.8ROR 12.9 · χ² 205 / p 7e-47 | 12.0 EB05 7.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Hypophagia | 51 | 12.5 9.5–16.4ROR 12.6 · χ² 526 / p 1e-116 | 12.2 EB05 9.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Incontinence | 21 | 12.3 8.0–18.8ROR 12.4 · χ² 206 / p 4e-47 | 11.5 EB05 7.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 · ♀ 100% (drug 59%) · 95% clinician | no trial data cached |
| Peripheral coldness | 26 | 11.7 8.0–17.2ROR 11.8 · χ² 244 / p 3e-55 | 11.0 EB05 7.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 · ♀ 85% (drug 59%) · 100% clinician | no trial data cached |
| Metastases to liver | 33 | 11.7 8.3–16.4ROR 11.8 · χ² 311 / p 6e-70 | 11.2 EB05 8.1 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.2 | no trial data cached |
| Oral candidiasis (oral thrush) | 24 | 11.4 7.7–17.0ROR 11.5 · χ² 218 / p 1e-49 | 10.7 EB05 7.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 · ♀ 29% (drug 59%) | no trial data cached |
| Blood potassium increased | 27 | 10.3 7.1–15.0ROR 10.4 · χ² 218 / p 1e-49 | 9.6 EB05 6.7 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.2 · ♀ 85% (drug 59%) · 100% clinician | no trial data cached |
| Gastritis | 42 | 9.9 7.3–13.4ROR 10.0 · χ² 327 / p 2e-73 | 9.4 EB05 7.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · ♀ 92% (drug 59%) | no trial data cached |
| Neoplasm progression | 56 | 9.9 7.6–12.8ROR 10.0 · χ² 439 / p 1e-97 | 9.5 EB05 7.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Immunodeficiency | 23 | 9.7 6.4–14.6ROR 9.7 · χ² 170 / p 3e-39 | 8.8 EB05 5.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 · ♀ 96% (drug 59%) · 96% clinician | no trial data cached |
| Tooth disorder | 33 | 9.2 6.5–12.9ROR 9.2 · χ² 231 / p 1e-52 | 8.5 EB05 6.2 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.8 | no trial data cached |
| Malignant neoplasm progression | 146 | 8.9 7.6–10.4ROR 9.2 · χ² 1,017 / p 2e-223 | 8.7 EB05 7.6 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 | no trial data cached |
| Plasma cell myeloma | 56 | 8.9 6.8–11.5ROR 9.0 · χ² 384 / p 9e-86 | 8.5 EB05 6.7 · IC025 +2.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.7 | no trial data cached |
| Haematocrit decreased | 28 | 8.7 6.0–12.6ROR 8.8 · χ² 183 / p 6e-42 | 7.9 EB05 5.6 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 6.0 | no trial data cached |
| Abscess | 22 | 8.6 5.6–13.0ROR 8.6 · χ² 139 / p 2e-32 | 7.6 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · ♀ 81% (drug 59%) | no trial data cached |
| Bone pain | 78 | 8.2 6.6–10.3ROR 8.4 · χ² 490 / p 7e-109 | 8.0 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.6 · 94% clinician | no trial data cached |
| Foot fracture | 25 | 8.1 5.5–12.0ROR 8.2 · χ² 150 / p 1e-34 | 7.3 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 100% clinician | no trial data cached |
| Mucosal inflammation | 34 | 8.1 5.8–11.3ROR 8.2 · χ² 204 / p 1e-46 | 7.5 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 · ♀ 94% (drug 59%) · 100% clinician | no trial data cached |
| Anorexia | 17 | 8.1 5.0–13.0ROR 8.1 · χ² 98 / p 2e-23 | 6.9 EB05 4.5 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 | no trial data cached |
| Renal failure acute | 55 | 7.9 6.1–10.3ROR 8.0 · χ² 326 / p 4e-73 | 7.5 EB05 6.0 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 · 94% clinician | 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 |
|---|---|---|---|---|---|---|
| Osteonecrosis (bone death) | 534 | 101.4 93.7–109.7ROR 120.2 · χ² 52,187 / p <1e-300 | 99.4 EB05 92.5 · IC025 +6.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 59.4 · 94% clinician | no trial data cached |
| Osteonecrosis of jaw (jawbone death) | 435 | 110.0 100.6–120.2ROR 126.0 · χ² 46,091 / p <1e-300 | 107.6 EB05 99.3 · IC025 +6.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 66.2 · 92% clinician | no trial data cached |
| Pain | 421 | 4.2 3.9–4.6ROR 4.7 · χ² 1,069 / p 8e-235 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Bone disorder | 173 | 58.8 50.8–68.1ROR 61.9 · χ² 9,693 / p <1e-300 | 57.9 EB05 51.0 · IC025 +5.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 42.5 · 95% clinician | no trial data cached |
| Tooth extraction | 168 | 84.7 73.0–98.2ROR 89.0 · χ² 13,625 / p <1e-300 | 82.8 EB05 72.8 · IC025 +5.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 68.3 · 98% clinician | no trial data cached |
| Malignant neoplasm progression | 146 | 8.9 7.6–10.4ROR 9.2 · χ² 1,017 / p 2e-223 | 8.7 EB05 7.6 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.5 | no trial data cached |
| Infection | 133 | 5.7 4.8–6.8ROR 5.9 · χ² 516 / p 2e-114 | 5.6 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Pain in jaw | 115 | 25.2 21.1–30.2ROR 26.1 · χ² 2,642 / p <1e-300 | 25.0 EB05 21.4 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 24.7 | no trial data cached |
| Impaired healing | 113 | 21.4 17.8–25.6ROR 22.1 · χ² 2,170 / p <1e-300 | 21.2 EB05 18.1 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 15.7 · 95% clinician | no trial data cached |
| Oedema peripheral (swelling of legs/feet) | 109 | 5.5 4.6–6.6ROR 5.7 · χ² 401 / p 2e-89 | 5.4 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 | no trial data cached |
| Osteomyelitis | 87 | 29.9 24.3–36.8ROR 30.7 · χ² 2,392 / p <1e-300 | 29.6 EB05 24.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 18.0 | no trial data cached |
| Femur fracture | 80 | 16.0 12.9–19.9ROR 16.4 · χ² 1,108 / p 3e-243 | 15.9 EB05 13.1 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.8 · 97% clinician | no trial data cached |
| Bone pain | 78 | 8.2 6.6–10.3ROR 8.4 · χ² 490 / p 7e-109 | 8.0 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.6 · 94% clinician | no trial data cached |
| Hypocalcaemia (low calcium) | 73 | 24.0 19.1–30.2ROR 24.5 · χ² 1,583 / p <1e-300 | 23.8 EB05 19.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.4 · 97% clinician | no trial data cached |
| Metastases to bone | 73 | 27.7 22.1–34.8ROR 28.3 · χ² 1,848 / p <1e-300 | 27.5 EB05 22.6 · IC025 +4.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 17.0 · ♀ 89% (drug 59%) | 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.
- Osteomyelitis — n=87, PRR 29.9
- Hypocalcaemia — n=73, PRR 24.0
- Deformity — n=31, PRR 20.5
- Fistula — n=29, PRR 16.0
- Tooth abscess — n=26, PRR 15.8
- Toothache — n=46, PRR 15.8
- Retinal detachment — n=21, PRR 14.2
- Spinal pain — n=25, PRR 13.2
- Poor venous access — n=22, PRR 13.2
- Atelectasis — n=20, PRR 12.8
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 Pamidronate?
In FDA FAERS, the most frequently co-reported reaction terms for Pamidronate are osteonecrosis, osteonecrosis of jaw, pain, bone disorder, tooth extraction, infection. 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 Pamidronate have an FDA boxed warning?
No. The FDA label retrieved for Pamidronate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Pamidronate 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 9b6a9a3b-71c9-4dcb-b857-5d1de25c3a23, effective 20260514; matched on
openfda.generic_name.exact:"PAMIDRONATE DISODIUM") - 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, 176 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.