abaloparatide Side Effects
Also known as: Tymlos
Analysis of 24,667 adverse event reports submitted to the FDA from 2015 to 2025.
Total Reports
24,667
Death-Related
266
1.1% of reports
Hospitalizations
1,677
6.8% of reports
Top Indication
Osteoporosis Postmenopausal
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 266 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 206 |
| PNEUMONIA | 11 |
| OFF LABEL USE | 8 |
| CARDIAC FAILURE CONGESTIVE | 7 |
| RESPIRATORY FAILURE | 5 |
| SEPSIS | 5 |
| CEREBROVASCULAR ACCIDENT | 4 |
| FALL | 4 |
| MYOCARDIAL INFARCTION | 4 |
| COVID-19 | 3 |
| ENCEPHALOPATHY | 3 |
| HIP FRACTURE | 3 |
| LIVER DISORDER | 3 |
| RESPIRATORY DISTRESS | 3 |
| THROMBOSIS | 3 |
| URINARY TRACT INFECTION | 3 |
| ACUTE KIDNEY INJURY | 2 |
| AORTIC DISSECTION | 2 |
| ATRIAL FIBRILLATION | 2 |
| CARDIAC ARREST | 2 |
Reactions in Hospitalization Reports
Top reactions in 1,677 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| FALL | 201 |
| HOSPITALISATION | 126 |
| DIZZINESS | 119 |
| INTENTIONAL DOSE OMISSION | 110 |
| HEADACHE | 106 |
| NAUSEA | 103 |
| PRODUCT DOSE OMISSION ISSUE | 99 |
| PNEUMONIA | 98 |
| FATIGUE | 86 |
| THERAPY INTERRUPTED | 81 |
| PRODUCT DOSE OMISSION | 65 |
| PAIN | 64 |
| ARTHRALGIA | 57 |
| HIP FRACTURE | 57 |
| PALPITATIONS | 56 |
| URINARY TRACT INFECTION | 54 |
| ATRIAL FIBRILLATION | 53 |
| CEREBROVASCULAR ACCIDENT | 51 |
| BACK PAIN | 49 |
| VOMITING | 47 |
Nearby — Related Medications
What the FAERS Data Reveals About abaloparatide Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 24,667 voluntary reports linked to abaloparatide and its brand equivalents (Tymlos), spanning 2015 through 2025. Of those, 266 (1.1%) listed death as an outcome and 1,677 (6.8%) involved hospitalization. The most common indication reported alongside adverse events was Osteoporosis Postmenopausal.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 95% were female and 5% male; age distribution skews toward 45-64, with 4,118 reports in that bracket. The single most reported reaction is headache with 4,180 submissions, followed by nausea and dizziness.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.