Drug · FAERS side-effect profile with label screen
Abaloparatide side effects: what 29,256 FDA adverse event reports show
Drug class
Parathyroid Hormone-Related Peptide Analog
FDA label (Established Pharmacologic Class)
Brand names
Tymlos
openFDA label
Who reports
29,256 reports · 17% serious · 313 with death outcome · 94% female
openFDA FAERS counts, all years, deduplication not applied
Used for
TYMLOS is a human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated for the: Treatment of postmenopausal women with osteoporosis at high risk for fracture or patients who have failed or are intolerant to other available osteoporosis therapy.
FDA label, Indications and Usage
What it is
TYMLOS injection for subcutaneous administration contains abaloparatide, a synthetic 34 amino acid peptide. Abaloparatide is an analog of human parathyroid hormone related peptide, PTHrP(1-34).
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) 4Likely indication confounding 4Reporting / coding artifact 4Lab value / disease marker 3Not 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. 982 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 |
|---|---|---|---|---|---|---|
| C-telopeptide increased | 11 | 87.3 46.7–163.3ROR 87.3 · χ² 760 / p 1e-167 | 68.9 EB05 41.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=2 | not reported in cached trials |
| Product information content complaint | 22 | 85.8 55.2–133.6ROR 85.9 · χ² 1,570 / p <1e-300 | 72.0 EB05 50.2 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | 82% consumer | not reported in cached trials |
| Growing pains | 28 | 84.5 57.1–125.0ROR 84.6 · χ² 1,990 / p <1e-300 | 72.0 EB05 52.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=3 · 71% consumer | not reported in cached trials |
| Urine calcium increased | 27 | 67.1 45.3–99.6ROR 67.2 · χ² 1,547 / p <1e-300 | 59.0 EB05 42.6 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious n=4 · 78% consumer | not reported in cached trials |
| Jaw clicking | 14 | 54.0 31.4–93.0ROR 54.1 · χ² 628 / p 5e-139 | 47.2 EB05 29.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Increased need for sleep | 14 | 48.9 28.5–84.1ROR 49.0 · χ² 571 / p 2e-126 | 43.3 EB05 27.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Injection site streaking | 12 | 35.8 20.0–63.9ROR 35.8 · χ² 353 / p 4e-79 | 32.5 EB05 19.8 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Waist circumference increased | 45 | 32.2 23.9–43.4ROR 32.3 · χ² 1,273 / p 5e-279 | 30.5 EB05 23.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | 96% consumer | not reported in cached trials |
| Blood calcium increased | 369 | 31.4 28.3–34.8ROR 31.8 · χ² 10,378 / p <1e-300 | 30.1 EB05 27.6 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=90 · 84% consumer | not reported in cached trials |
| Needle track marks | 14 | 25.5 15.0–43.4ROR 25.5 · χ² 295 / p 2e-66 | 23.9 EB05 15.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Fat tissue increased | 49 | 25.0 18.8–33.2ROR 25.0 · χ² 1,068 / p 2e-234 | 24.0 EB05 18.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | 88% consumer | not reported in cached trials |
| Injection site hypertrophy | 10 | 23.7 12.6–44.5ROR 23.7 · χ² 189 / p 3e-43 | 21.8 EB05 12.1 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Bone pain | 1,812 | 22.8 21.8–23.9ROR 24.3 · χ² 36,720 / p <1e-300 | 22.1 EB05 21.3 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.0 · 89% consumer | not reported in cached trials |
| Medial tibial stress syndrome | 10 | 21.3 11.4–40.0ROR 21.3 · χ² 169 / p 6e-39 | 19.5 EB05 10.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=2 | not reported in cached trials |
| Vitamin d increased | 17 | 20.3 12.6–33.0ROR 20.4 · χ² 285 / p 2e-64 | 19.3 EB05 12.5 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Hypercalciuria | 13 | 19.4 11.2–33.6ROR 19.4 · χ² 203 / p 2e-46 | 18.1 EB05 10.7 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=5 | NCT04064411: 13/252 (5.2%) on Abaloparatide |
| Heart rate increased | 2,593 | 19.3 18.5–20.0ROR 21.0 · χ² 43,864 / p <1e-300 | 18.8 EB05 18.2 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.0 · 87% consumer | not reported in cached trials |
| Intentional dose omission | 703 | 18.9 17.5–20.3ROR 19.3 · χ² 11,598 / p <1e-300 | 18.4 EB05 17.3 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 32.8 · 90% consumer | not reported in cached trials |
| Fear of falling | 20 | 18.2 11.7–28.4ROR 18.3 · χ² 301 / p 9e-68 | 17.4 EB05 11.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=3 | not reported in cached trials |
| Fracture pain | 13 | 18.0 10.4–31.2ROR 18.0 · χ² 187 / p 8e-43 | 16.7 EB05 9.7 · IC025 +2.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=2 | not reported in cached trials |
| Product dose omission in error | 634 | 17.3 16.0–18.7ROR 17.7 · χ² 9,505 / p <1e-300 | 16.9 EB05 15.8 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 20.0 · 93% consumer | not reported in cached trials |
| Emergency care | 66 | 16.3 12.7–20.7ROR 16.3 · χ² 909 / p 6e-200 | 15.8 EB05 12.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=24 · 94% consumer | not reported in cached trials |
| Shoulder fracture | 30 | 14.1 9.8–20.2ROR 14.1 · χ² 344 / p 4e-77 | 13.4 EB05 9.6 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=19 · 85% consumer | not reported in cached trials |
| Palpitations (pounding heartbeat) | 2,225 | 13.9 13.3–14.4ROR 14.9 · χ² 26,208 / p <1e-300 | 13.6 EB05 13.2 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.6 · 82% consumer | NCT04064411: 6/252 (2.4%) on Abaloparatide |
| Orthostatic hypertension | 11 | 13.7 7.5–24.9ROR 13.7 · χ² 115 / p 4e-27 | 11.8 EB05 6.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Sacral pain | 11 | 13.5 7.5–24.6ROR 13.5 · χ² 113 / p 9e-27 | 11.6 EB05 6.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Vertigo positional | 31 | 12.9 9.1–18.4ROR 12.9 · χ² 323 / p 1e-72 | 12.3 EB05 8.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=6 · 81% consumer | not reported in cached trials |
| Loss of personal independence in daily activities | 837 | 12.8 12.0–13.7ROR 13.2 · χ² 8,972 / p <1e-300 | 12.6 EB05 11.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · 94% consumer | not reported in cached trials |
| Brain fog | 251 | 12.5 11.1–14.2ROR 12.6 · χ² 2,607 / p <1e-300 | 12.3 EB05 11.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · 88% consumer | NCT04064411: 1/252 (0.4%) on Abaloparatide (serious AE) |
| Product administered at inappropriate site | 302 | 12.1 10.8–13.6ROR 12.2 · χ² 3,016 / p <1e-300 | 11.9 EB05 10.8 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=47 · 91% consumer | not reported in cached trials |
| Spinal fracture | 330 | 12.0 10.8–13.4ROR 12.2 · χ² 3,279 / p <1e-300 | 11.8 EB05 10.8 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 29.0 · 94% consumer | NCT04064411: 1/252 (0.4%) on Abaloparatide (serious AE) |
| Hyperaesthesia teeth | 20 | 11.8 7.6–18.4ROR 11.8 · χ² 185 / p 3e-42 | 10.7 EB05 6.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=2 · 100% consumer | not reported in cached trials |
| Joint noise | 31 | 11.6 8.2–16.6ROR 11.6 · χ² 286 / p 2e-64 | 10.9 EB05 7.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=2 · 93% consumer | not reported in cached trials |
| Forearm fracture | 11 | 11.5 6.3–20.8ROR 11.5 · χ² 94 / p 2e-22 | 9.4 EB05 5.1 · IC025 +1.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=8 | not reported in cached trials |
| Spinal pain | 183 | 11.4 9.8–13.1ROR 11.4 · χ² 1,693 / p <1e-300 | 11.1 EB05 9.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · 87% consumer | NCT01343004: 1/822 (0.1%) on Abaloparatide (serious AE) |
| Head discomfort | 275 | 11.4 10.1–12.8ROR 11.5 · χ² 2,547 / p <1e-300 | 11.1 EB05 10.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 91% consumer | not reported in cached trials |
| Physical deconditioning | 39 | 11.3 8.3–15.5ROR 11.3 · χ² 351 / p 1e-78 | 10.7 EB05 8.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=35 · 85% consumer | not reported in cached trials |
| Injection site bruising | 1,201 | 11.1 10.5–11.7ROR 11.5 · χ² 10,864 / p <1e-300 | 10.9 EB05 10.4 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.6 · 89% consumer | NCT04064411: 1/252 (0.4%) on Abaloparatide |
| Ophthalmic migraine | 10 | 10.9 5.8–20.3ROR 10.9 · χ² 79 / p 4e-19 | 8.6 EB05 4.5 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=2 | not reported in cached trials |
| Sensory disturbance | 239 | 10.8 9.5–12.2ROR 10.8 · χ² 2,078 / p <1e-300 | 10.6 EB05 9.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 · 84% consumer | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Abaloparatide 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 (6 of 40 signal terms matched).
- NCT04064411 — Efficacy & Safety of Abaloparatide-Solid Microstructured Transdermal System in Postmenopausal Women With Osteo (N=511, PHASE3; 70 AE terms posted; arms: Abaloparatide-SC; Abaloparatide-sMTS)
- NCT01343004 — Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausa (N=2463, PHASE3; 195 AE terms posted; arms: Placebo; BA058 80 mcg (Abaloparatide); Teriparatide)
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 |
|---|---|---|---|---|---|---|
| Headache | 5,123 | 5.9 5.8–6.1ROR 6.9 · χ² 21,331 / p <1e-300 | 5.9 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 · 86% consumer | NCT04064411: 25/252 (9.9%) on Abaloparatide |
| Nausea | 3,913 | 3.6 3.5–3.7ROR 4.0 · χ² 7,473 / p <1e-300 | 3.6 EB05 3.5 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 · 84% consumer | NCT04064411: 14/252 (5.6%) on Abaloparatide |
| Dizziness | 3,860 | 5.6 5.4–5.8ROR 6.3 · χ² 14,791 / p <1e-300 | 5.6 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 · 87% consumer | NCT04064411: 17/252 (6.7%) on Abaloparatide |
| Fatigue (tiredness) | 3,419 | 3.2 3.1–3.3ROR 3.5 · χ² 5,229 / p <1e-300 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 · 86% consumer | NCT04064411: 6/252 (2.4%) on Abaloparatide |
| Product dose omission issue | 2,654 | 6.7 6.5–7.0ROR 7.3 · χ² 13,009 / p <1e-300 | 6.7 EB05 6.5 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 11.1 · 88% consumer | not reported in cached trials |
| Heart rate increased | 2,593 | 19.3 18.5–20.0ROR 21.0 · χ² 43,864 / p <1e-300 | 18.8 EB05 18.2 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.0 · 87% consumer | not reported in cached trials |
| Arthralgia (joint pain) | 2,343 | 4.1 3.9–4.2ROR 4.3 · χ² 5,501 / p <1e-300 | 4.0 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 · 88% consumer | NCT04064411: 25/252 (9.9%) on Abaloparatide |
| Palpitations (pounding heartbeat) | 2,225 | 13.9 13.3–14.4ROR 14.9 · χ² 26,208 / p <1e-300 | 13.6 EB05 13.2 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.6 · 82% consumer | NCT04064411: 6/252 (2.4%) on Abaloparatide |
| Bone pain | 1,812 | 22.8 21.8–23.9ROR 24.3 · χ² 36,720 / p <1e-300 | 22.1 EB05 21.3 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.0 · 89% consumer | not reported in cached trials |
| Pain | 1,566 | 1.8 1.7–1.9ROR 1.9 · χ² 601 / p 6e-133 | 1.8 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.4 · 85% consumer | NCT04064411: 1/254 (0.4%) on Abaloparatide (serious AE) |
| Back pain | 1,539 | 4.8 4.5–5.0ROR 5.0 · χ² 4,602 / p <1e-300 | 4.7 EB05 4.5 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.6 · 83% consumer | NCT04064411: 14/252 (5.6%) on Abaloparatide |
| Injection site bruising | 1,201 | 11.1 10.5–11.7ROR 11.5 · χ² 10,864 / p <1e-300 | 10.9 EB05 10.4 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.6 · 89% consumer | NCT04064411: 1/252 (0.4%) on Abaloparatide |
| Pain in extremity | 1,169 | 2.8 2.7–3.0ROR 2.9 · χ² 1,412 / p <1e-300 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.1 · 84% consumer | NCT04064411: 11/252 (4.4%) on Abaloparatide |
| Injection site pain (pain where injected) | 1,077 | 2.5 2.4–2.7ROR 2.6 · χ² 1,023 / p 9e-225 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 · 90% consumer | NCT04064411: 1/254 (0.4%) on Abaloparatide (serious AE) |
| Product quality issue | 919 | 4.9 4.6–5.2ROR 5.0 · χ² 2,859 / p <1e-300 | 4.9 EB05 4.6 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 · 81% consumer | not reported in cached trials |
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.
- Growing pains — n=28, PRR 84.5
- Waist circumference increased — n=45, PRR 32.2
- Fat tissue increased — n=49, PRR 25.0
- Fear of falling — n=20, PRR 18.2
- Emergency care — n=66, PRR 16.3
- Vertigo positional — n=31, PRR 12.9
- Loss of personal independence in daily activities — n=837, PRR 12.8
- Brain fog — n=251, PRR 12.5 (also seen in trial arm)
- Hyperaesthesia teeth — n=20, PRR 11.8
- Joint noise — n=31, PRR 11.6
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 Abaloparatide?
In FDA FAERS, the most frequently co-reported reaction terms for Abaloparatide are headache, nausea, dizziness, fatigue, heart rate increased, arthralgia. 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 Abaloparatide have an FDA boxed warning?
No. The FDA label retrieved for Abaloparatide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Abaloparatide 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 712143d9-e21e-4013-bb3b-3426a21060a8, effective 20260811; matched on
openfda.generic_name.exact:"ABALOPARATIDE") - 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, 1,022 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
ABALOPARATIDE, results-bearing studies sorted by enrollment)
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.