Romosozumab-Aqqg side effects: what 13,496 FDA adverse event reports show
Drug class
Sclerostin inhibitor
Brand names
Evenity
Who reports
13,496 reports · 58% serious · 724 with death outcome · 93% female
Used for
EVENITY is a sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. ( 1 ) Limitations of Use: Limit duration of use to 12 monthly doses.
What it is
Romosozumab-aqqg is a humanized monoclonal antibody (IgG2) produced in a mammalian cell line (Chinese Hamster Ovary) by recombinant DNA technology that binds to and inhibits sclerostin. Romosozumab-aqqg has an approximate molecular weight of 149 kDa.
Boxed warning
POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH EVENITY may increase the risk of myocardial infarction, stroke, and cardiovascular death [see Warnings and Precautions (5.1) ] . EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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. 957 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Bone density abnormal | 462 | 216.9 197.1–238.8ROR 224.6 · χ² 86,817 / p <1e-300 | 188.7 EB05 174.7 · IC025 +7.1 3/3 methods agree | Lab value / disease marker | serious n=14 · 94% consumer | no trial data cached |
| Pseudarthrosis | 13 | 92.2 52.7–161.4ROR 92.3 · χ² 1,022 / p 1e-224 | 77.5 EB05 48.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Tooth resorption | 10 | 78.2 41.4–147.5ROR 78.2 · χ² 653 / p 2e-144 | 65.5 EB05 38.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Fracture | 661 | 56.2 52.1–60.6ROR 59.0 · χ² 34,536 / p <1e-300 | 54.1 EB05 50.8 · IC025 +5.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 26.2 | no trial data cached |
| Compression fracture | 179 | 55.3 47.7–64.1ROR 56.0 · χ² 9,163 / p <1e-300 | 53.1 EB05 46.9 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=179 | no trial data cached |
| Vertebroplasty | 14 | 50.4 29.6–85.7ROR 50.4 · χ² 609 / p 1e-134 | 45.9 EB05 29.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Atypical fracture | 17 | 44.3 27.4–71.7ROR 44.4 · χ² 658 / p 2e-145 | 41.2 EB05 27.3 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=17 | no trial data cached |
| Thoracic vertebral fracture | 75 | 40.6 32.3–51.0ROR 40.8 · χ² 2,783 / p <1e-300 | 39.2 EB05 32.3 · IC025 +4.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=75 | no trial data cached |
| Radius fracture | 60 | 39.5 30.6–51.1ROR 39.7 · χ² 2,160 / p <1e-300 | 38.1 EB05 30.7 · IC025 +4.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=58 · 92% clinician | no trial data cached |
| Exostosis of jaw | 12 | 39.0 22.0–69.1ROR 39.0 · χ² 397 / p 2e-88 | 36.0 EB05 21.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Femoral neck fracture | 116 | 35.9 29.9–43.1ROR 36.2 · χ² 3,814 / p <1e-300 | 34.9 EB05 29.9 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=116 · 98% clinician | no trial data cached |
| Spinal compression fracture | 166 | 31.3 26.9–36.5ROR 31.7 · χ² 4,746 / p <1e-300 | 30.6 EB05 26.9 · IC025 +4.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 31.3 | no trial data cached |
| Dental restoration failure | 14 | 30.7 18.1–52.1ROR 30.8 · χ² 366 / p 6e-82 | 29.1 EB05 18.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Fracture pain | 10 | 29.8 15.9–55.7ROR 29.8 · χ² 246 / p 1e-55 | 27.8 EB05 15.9 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=8 | no trial data cached |
| Marasmus | 28 | 29.4 20.3–42.8ROR 29.5 · χ² 727 / p 2e-160 | 28.4 EB05 20.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=28 · 100% clinician | no trial data cached |
| Lumbar vertebral fracture | 82 | 28.6 23.0–35.5ROR 28.7 · χ² 2,114 / p <1e-300 | 27.9 EB05 23.2 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=81 | no trial data cached |
| Spinal fracture | 310 | 24.5 22.0–27.4ROR 25.1 · χ² 6,870 / p <1e-300 | 24.1 EB05 22.0 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 24.9 | no trial data cached |
| Ulna fracture | 15 | 23.8 14.3–39.7ROR 23.8 · χ² 301 / p 1e-67 | 22.8 EB05 14.5 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=15 | no trial data cached |
| Intercepted product administration error | 115 | 23.5 19.5–28.2ROR 23.7 · χ² 2,417 / p <1e-300 | 23.1 EB05 19.7 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Blood parathyroid hormone increased | 43 | 23.2 17.2–31.3ROR 23.3 · χ² 878 / p 4e-193 | 22.7 EB05 17.5 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=19 | no trial data cached |
| Fractured sacrum | 17 | 21.6 13.4–34.9ROR 21.7 · χ² 310 / p 1e-69 | 20.8 EB05 13.6 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=16 | no trial data cached |
| Dental care | 25 | 21.3 14.3–31.6ROR 21.3 · χ² 457 / p 1e-101 | 20.7 EB05 14.7 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Osteoporotic fracture | 24 | 19.6 13.1–29.3ROR 19.6 · χ² 400 / p 3e-89 | 19.0 EB05 13.4 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=24 | no trial data cached |
| Physical deconditioning | 31 | 19.5 13.7–27.7ROR 19.5 · χ² 518 / p 6e-115 | 19.0 EB05 14.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=31 | no trial data cached |
| Dental implantation | 20 | 19.3 12.4–29.9ROR 19.3 · χ² 324 / p 8e-73 | 18.6 EB05 12.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Atypical femur fracture | 33 | 18.3 13.0–25.7ROR 18.3 · χ² 516 / p 2e-114 | 17.9 EB05 13.2 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=33 | no trial data cached |
| Pathological fracture | 56 | 17.3 13.3–22.5ROR 17.4 · χ² 835 / p 6e-184 | 17.0 EB05 13.6 · IC025 +3.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=55 | no trial data cached |
| Femur fracture | 295 | 14.9 13.3–16.7ROR 15.2 · χ² 3,779 / p <1e-300 | 14.7 EB05 13.4 · IC025 +3.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 14.8 | no trial data cached |
| Aortic dissection | 39 | 14.7 10.7–20.1ROR 14.7 · χ² 478 / p 2e-106 | 14.3 EB05 10.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=39 · 95% clinician | no trial data cached |
| Humerus fracture | 42 | 13.6 10.0–18.4ROR 13.6 · χ² 473 / p 3e-105 | 13.2 EB05 10.0 · IC025 +3.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=39 | no trial data cached |
| Loose tooth | 27 | 13.1 9.0–19.1ROR 13.1 · χ² 287 / p 1e-64 | 12.5 EB05 8.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Hyperaesthesia teeth | 10 | 12.7 6.8–23.7ROR 12.7 · χ² 96 / p 6e-23 | 10.6 EB05 5.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Pelvic fracture | 61 | 12.3 9.6–15.8ROR 12.3 · χ² 617 / p 2e-136 | 12.0 EB05 9.6 · IC025 +3.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 12.3 | no trial data cached |
| Wrong product administered | 47 | 11.1 8.3–14.7ROR 11.1 · χ² 418 / p 4e-93 | 10.6 EB05 8.2 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious n=4 · 91% clinician | no trial data cached |
| Groin pain | 60 | 10.6 8.3–13.7ROR 10.7 · χ² 511 / p 2e-113 | 10.3 EB05 8.2 · IC025 +2.9 3/3 methods agree | Labeled — boxed warning exact term | serious n=19 | no trial data cached |
| Circumstance or information capable of leading to medication error | 224 | 10.4 9.2–11.9ROR 10.6 · χ² 1,892 / p <1e-300 | 10.3 EB05 9.2 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Blood calcium decreased | 74 | 10.3 8.2–12.9ROR 10.3 · χ² 605 / p 7e-134 | 9.9 EB05 8.1 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 8.2 | no trial data cached |
| Occupational exposure to product | 38 | 9.2 6.7–12.6ROR 9.2 · χ² 267 / p 2e-60 | 8.6 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Injection site oedema | 10 | 9.2 4.9–17.0ROR 9.2 · χ² 64 / p 5e-16 | 7.1 EB05 3.9 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious n=3 | no trial data cached |
| Patella fracture | 13 | 8.7 5.1–15.0ROR 8.7 · χ² 81 / p 1e-19 | 7.1 EB05 4.3 · IC025 +1.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=12 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Fall | 795 | 3.7 3.5–4.0ROR 3.9 · χ² 1,601 / p <1e-300 | 3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Fracture | 661 | 56.2 52.1–60.6ROR 59.0 · χ² 34,536 / p <1e-300 | 54.1 EB05 50.8 · IC025 +5.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 26.2 | no trial data cached |
| Arthralgia (joint pain) | 624 | 2.3 2.2–2.5ROR 2.4 · χ² 487 / p 3e-108 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Injection site pain (pain where injected) | 567 | 2.9 2.7–3.2ROR 3.0 · χ² 716 / p 5e-158 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.0 | no trial data cached |
| Off label use (used outside approved label) | 507 | 0.9 0.8–1.0ROR 0.9 · χ² 5 / p 0.014 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.8 · ♀ 73% (drug 93%) | no trial data cached |
| Bone density abnormal | 462 | 216.9 197.1–238.8ROR 224.6 · χ² 86,817 / p <1e-300 | 188.7 EB05 174.7 · IC025 +7.1 3/3 methods agree | Lab value / disease marker | serious n=14 · 94% consumer | no trial data cached |
| Hospitalisation | 458 | 4.7 4.3–5.1ROR 4.8 · χ² 1,328 / p 5e-291 | 4.6 EB05 4.3 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · 90% clinician | no trial data cached |
| Headache | 457 | 1.1 1.0–1.2ROR 1.1 · χ² 7 / p 0.003 | 1.1 EB05 1.0 · IC025 +0.0 | Labeled adverse reaction exact term | serious PRR 0.9 | no trial data cached |
| Product storage error | 355 | 6.4 5.8–7.1ROR 6.5 · χ² 1,611 / p <1e-300 | 6.3 EB05 5.8 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 1.2 | no trial data cached |
| Pain in extremity | 314 | 1.7 1.5–1.8ROR 1.7 · χ² 82 / p 9e-20 | 1.7 EB05 1.5 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.2 | no trial data cached |
| Death | 310 | 0.6 0.5–0.6ROR 0.5 · χ² 112 / p 2e-26 | 0.6 EB05 0.5 · IC025 -1.0 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 0.5 | no trial data cached |
| Spinal fracture | 310 | 24.5 22.0–27.4ROR 25.1 · χ² 6,870 / p <1e-300 | 24.1 EB05 22.0 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 24.9 | no trial data cached |
| Pain | 301 | 0.8 0.7–0.8ROR 0.8 · χ² 23 / p 7e-7 | 0.8 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Labeled — boxed warning exact term | serious PRR 0.5 | no trial data cached |
| Injection site swelling | 297 | 6.1 5.5–6.8ROR 6.2 · χ² 1,264 / p 4e-277 | 6.0 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.5 | no trial data cached |
| Femur fracture | 295 | 14.9 13.3–16.7ROR 15.2 · χ² 3,779 / p <1e-300 | 14.7 EB05 13.4 · IC025 +3.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 14.8 | 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.
- Marasmus — n=28, PRR 29.4
- Physical deconditioning — n=31, PRR 19.5
- Dental implantation — n=20, PRR 19.3
- Aortic dissection — n=39, PRR 14.7
- Loose tooth — n=27, PRR 13.1
- Occupational exposure to product — n=38, PRR 9.2
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 Romosozumab-Aqqg?
In FDA FAERS, the most frequently co-reported reaction terms for Romosozumab-Aqqg are fall, fracture, arthralgia, injection site pain, bone density abnormal, headache. 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 Romosozumab-Aqqg have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: POTENTIAL RISK OF MYOCARDIAL INFARCTION, STROKE AND CARDIOVASCULAR DEATH EVENITY may increase the risk of myocardial infarction, stroke, and cardiovascular death [see Warnings and Precautions (5.1) ] . EVENITY should not be initiated in patients who have had a myocardial infarction or stroke within the preceding year.
Do FAERS signals prove that Romosozumab-Aqqg 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 471baba2-7154-4488-9891-0db2f46791e7, effective 20260716; matched on
openfda.generic_name.exact:"ROMOSOZUMAB-AQQG") - 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, 997 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.