Abaloparatide
Reviewed
Short answer
An approved osteoporosis medicine with fracture evidence in defined groups and product-specific safety limits. An FDA-approved product exists for defined osteoporosis populations.
The Peptide Field explains research. Its pages are not independently medically reviewed, and they do not diagnose, prescribe, or recommend treatment.
Read the study findingsAlso known as Tymlos · BA058 · PTHrP analogue
Part of Bone peptide medicines
Compared with Teriparatide
Legal status Is Abaloparatide legal? See the status table
Study and product details
What it is
Abaloparatide is a man-made version of a parathyroid hormone-related peptide. It acts at the PTH1 receptor and is used as a medicine to help build bone.
Type of peptide: Parathyroid hormone-related peptide analogue. This describes what the substance is or how it works. It does not show that it is safe, effective, or approved.
What has been studied?
- Strong: Several reliable sources describe this clearly.
The ACTIVE phase 3 trial supports fracture-risk reduction in postmenopausal women with osteoporosis.
Approved labeling characterizes PTH1-receptor activity, exposure, and bone-turnover effects.
Known risks and monitoring are described in the current product label.
High for authentic Tymlos used within the approved label.
Products with the same ingredient can differ.
The ingredient name does not tell you everything about a product. Check its other ingredients, its form, how it enters the body, and the use and people covered by the research or approval.
Tymlos
2025 label- Ingredients and form
- Injection pen
- How it enters the body
- Under the skin (subcutaneous)
- Use and people covered
- Osteoporosis uses in the high-fracture-risk populations defined in the product label.
- Tymlos
- Osteoporosis treatment or bone-density increase in labeled high-risk populations
What studies found
The ACTIVE study compared abaloparatide with placebo or open-label teriparatide in postmenopausal women with osteoporosis. Abaloparatide reduced new spine and non-spine fractures versus placebo over 18 months.
The result does not establish that it is better than every osteoporosis medicine, improves healthy people, or heals every new injury better.
Which products do these findings apply to?
The study result belongs to the named prescription product, not every similar product or use. Tymlos is a product-specific prescription medicine. Trial findings do not validate unapproved PTHrP analogues or general performance use.
Side effects in the Tymlos label
Tymlos is the brand name of abaloparatide. Its FDA label lists the side effects seen in two placebo-controlled trials, one in women and one in men.
In women after menopause, the most common included high calcium in the urine, dizziness, nausea, and headache. In men, the most common included redness where the shot was given, dizziness, and joint pain.
In the women's trial, 10% of women on Tymlos stopped the medicine because of side effects. On placebo, 6% stopped. Serious problems were about as common on Tymlos (10%) as on placebo (11%).
Each number is the share of people in a group who reported the problem during the trial. The label lists problems reported by at least 2% of people on Tymlos. Placebo means a shot with no medicine in it.
Trials in the FDA label
Women after menopause with osteoporosis 18 months
Women aged 49 to 86. The label counts 822 women on Tymlos and 820 on placebo.
| Reported problem | Tymlos | Placebo |
|---|---|---|
| High calcium in the urine (hypercalciuria) | 11% | 9% |
| Dizziness | 10% | 6% |
| Nausea | 8% | 3% |
| Headache | 8% | 6% |
| Pounding or fast heartbeat (palpitations) | 5% | 0.4% |
| Tiredness (fatigue) | 3% | 2% |
| Upper belly pain | 3% | 2% |
| Spinning feeling (vertigo) | 2% | 2% |
Source for Women after menopause with osteoporosis: Tymlos prescribing information on DailyMed , label revised .
Men with osteoporosis 12 months
Men aged 42 to 85. 149 men got Tymlos and 79 got placebo.
| Reported problem | Tymlos | Placebo |
|---|---|---|
| Redness where the shot was given | 13% | 5% |
| Dizziness | 9% | 1% |
| Joint pain (arthralgia) | 7% | 1% |
| Swelling where the shot was given | 7% | 0% |
| Pain where the shot was given | 6% | 0% |
| Bruising | 3% | 0% |
| Bloated belly | 3% | 0% |
| Diarrhea | 3% | 0% |
| Nausea | 3% | 0% |
| Belly pain | 2% | 0% |
| Bone pain | 2% | 0% |
Source for Men with osteoporosis: Tymlos prescribing information on DailyMed , label revised .
Heart rate and dizziness
The label says Tymlos can raise heart rate. The rise starts within 15 minutes of a shot and goes away in about 6 hours. A fast heart rate was reported in 2% of women on Tymlos and 1% on placebo.
Blood pressure can drop when a person stands up, which can cause dizziness. One hour after the first shot, this drop was seen in 4% of women on Tymlos and 3% on placebo.
Calcium and uric acid in the blood
Tymlos can raise blood calcium for a few hours after a shot. A high reading 4 hours after a shot was found at least once in 3% of women on Tymlos and 0.1% on placebo.
Among women whose uric acid started normal, it rose above the normal range at least once in 25% on Tymlos and 6% on placebo. The label says this did not lead to more gout or joint pain than placebo.
Reactions where the shot was given
In the first month of the women's trial, shot sites were checked one hour after each shot. Redness was seen in 58% of women on Tymlos and 28% on placebo. Swelling was seen in 11% and 3%, and pain in 10% and 7%.
What these numbers do not show
- The label also lists warnings, including a bone cancer called osteosarcoma that was seen in rats. The label says it is not known whether Tymlos causes it in people. Cases have been reported in people after approval of medicines of this type, but observational studies have not shown a higher risk. Read the full label for all warnings.
- The label says side-effect rates from one medicine's trials cannot be directly compared with rates from another medicine's trials.
- Trials can miss rare harms and harms that take years to appear.
- The product details above may cite an older Tymlos label. These tables use the current label on DailyMed.
- These numbers describe Tymlos in its trials. They do not describe other products sold under the name abaloparatide.
Report a side effect
You can report a suspected side effect to the FDA at 1-800-FDA-1088 or through FDA MedWatch . If a reaction feels serious, get medical care first.
Label checked .
Compare two labels
- Forteo vs Tymlos: side effects in the osteoporosis labels
Fact checks
3 statements checked. Read what the results mean.
“Abaloparatide reduced fractures in a randomized phase 3 trial.”
ACTIVE found fewer new vertebral and nonvertebral fractures versus placebo in postmenopausal women with osteoporosis.
- What this answer is based on
- Health results from a study with randomly assigned groups
- Limits of this answer
- Postmenopausal women with osteoporosis at fracture risk over 18 months.
Sources for this fact check (1)
“Abaloparatide is proven to improve bone outcomes in every population.”
Approved indications and trial populations define the evidence boundary.
- What this answer is based on
- Health results from a study with randomly assigned groups
- Limits of this answer
- Populations outside the current label and pivotal trial.
Sources for this fact check (1)
“An anabolic bone effect means abaloparatide is a safe performance enhancer.”
A prescription osteoporosis benefit-risk assessment does not establish safe enhancement in healthy people.
- What this answer is based on
- Official record or product label
- Limits of this answer
- Healthy or athletic performance use.
Sources for this fact check (1)
Questions people ask about Abaloparatide
The Tymlos label lists high calcium in the urine, dizziness, nausea, and headache as the most common side effects in women after menopause. For example, dizziness was reported by 10% of women on Tymlos and 6% on placebo. In men, redness where the shot was given and dizziness were most common. The label also says Tymlos can raise heart rate and blood calcium for a few hours after a shot.
Risks and safety limits
This prescription osteoporosis medicine has product-specific warnings and limits on use. No dose, injection, or performance guidance is provided.
This editorial review did not determine sport eligibility. Athletes must check the current prohibited list, Global DRO, and their governing body.
Reviewed .Check the rules for athletes ↗Terms used in the studies
- analog
- a changed version made to act like another substance
- placebo
- an inactive treatment used for comparison
- open-label
- a study in which people and researchers know which treatment was given
- receptor
- a protein in a cell that receives a body signal
- randomized
- assigned to study groups by chance
- outcome
- what the study measured
- indication
- the approved or studied use and patient group
- benefit-risk
- a comparison of possible benefits with possible harms for a defined use and group
Read the sources
Review history
Initial brief based on the 2025 Tymlos label and ACTIVE phase 3 trial.
Not independently medically reviewed. This page is not a dosing, sourcing, or treatment guide.
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