What the label lists and what reports show
Abaloparatide side effects
Abaloparatide's FDA label: “The most common adverse reactions (incidence ≥2%) are hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain, and vertigo.” FAERS holds 29,258 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is headache (5,123 reports).
- No generic listed
Check it at the source: the abaloparatide FDA label on DailyMed (effective August 11, 2026, Radius Health, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of TYMLOS?TYMLOS may cause serious side effects including: See " What is the most important information I should know about TYMLOS? " Decrease in blood pressure when you change positions. Some people may feel dizzy, have a faster heartbeat, or feel lightheaded soon after the TYMLOS injection is given. These symptoms generally go away within a few hours. Take your injections of TYMLOS in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, stop taking TYMLOS and call your healthcare provider. Increased blood calcium (hypercalcemia). TYMLOS can cause some people to have a higher blood calcium level than normal. Your healthcare provider may check your blood calcium before you start and during your treatment with TYMLOS. Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness. […]
Source: FDA drug label, Radius Health, Inc., effective August 11, 2026 (SPL set 712143d9-e21e-4013-bb3b-3426a21060a8), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence ≥2%) are hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain, and vertigo.
Table 2: Common Adverse Reactions Reported in Men with Osteoporosis Adverse reactions reported in ≥2% of TYMLOS-treated patients.
| Preferred Term | TYMLOS (N=149) (%) | Placebo (N=79) (%) |
|---|---|---|
| Injection site erythema | 13 | 5 |
| Dizziness | 9 | 1 |
| Arthralgia | 7 | 1 |
| Injection site swelling | 7 | 0 |
| Injection site pain | 6 | 0 |
| Contusion | 3 | 0 |
| Abdominal distention | 3 | 0 |
| Diarrhea | 3 | 0 |
| Nausea | 3 | 0 |
| Abdominal Pain | 2 | 0 |
| Bone Pain | 2 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are described in greater detail in other sections: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Risk of Osteosarcoma [see Warnings and Precautions (5.2) ] Orthostatic Hypotension [see Warnings and Precautions ( 5.3 )] Hypercalcemia [see Warnings and Precautions ( 5.4 )] Hypercalciuria and Urolithiasis [see Warnings and Precautions ( 5.5 )] Osteoporosis in postmenopausal women: The most common adverse reactions (incidence ≥2%) are hypercalciuria, dizziness, nausea, headache, palpitations, fatigue, upper abdominal pain, and vertigo. ( 6.1 ) Osteoporosis in men: The most common adverse reactions (incidence ≥2%) are injection site erythema, dizziness, arthralgia, injection site swelling, injection site pain, contusion, nausea, diarrhea, abdominal distension, abdominal pain, and bone pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Radius Health, Inc. at 1-855-672-3487 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Source: FDA drug label, Radius Health, Inc., effective August 11, 2026 (SPL set 712143d9-e21e-4013-bb3b-3426a21060a8), via openFDA; the full label on DailyMed
What do FAERS reports show?
29,258 reports list abaloparatide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 313 are coded as a death and 2,046 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (6,306, against a median of 2,039 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 21 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Abaloparatide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions