Short answer: In the label's trial in postmenopausal women, the most common Tymlos side effects were high urine calcium (11% vs 9% on placebo), dizziness (10% vs 6%), nausea (8% vs 3%), headache (8% vs 6%) and palpitations (5% vs 0.4%). In men, injection site redness (13% vs 5%), dizziness (9% vs 1%) and joint pain (7% vs 1%) led. There is no boxed warning.
What Tymlos is approved for: Tymlos is a PTHrP(1-34) analog approved for postmenopausal women with osteoporosis at high risk for fracture, and to increase bone density in men with osteoporosis at high risk for fracture, or for people who could not use or did not respond to other osteoporosis treatments (section 1).
Source
TYMLOS (abaloparatide) injection, for subcutaneous use, prescribing information and Medication Guide. Radius Health. DailyMed, version published August 17, 2026. DailyMed setid 712143d9-e21e-4013-bb3b-3426a21060a8
No. The current Tymlos label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Tymlos.
| Preferred term | Tymlos (N=822) (%) | Placebo (N=820) (%) |
|---|---|---|
| Hypercalciuria | 11 | 9 |
| Dizziness | 10 | 6 |
| Nausea | 8 | 3 |
| Headache | 8 | 6 |
| Palpitations | 5 | 0.4 |
| Fatigue | 3 | 2 |
| Abdominal pain upper | 3 | 2 |
| Vertigo | 2 | 2 |
* Adverse reactions reported in ≥2% of Tymlos-treated patients. Postmenopausal women aged 49 to 86 on 80 mcg once daily or placebo for 18 months. 10% on Tymlos stopped for side effects vs 6% on placebo, most often for nausea, dizziness, headache or palpitations.
| 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 |
Adverse reactions reported in ≥2% of Tymlos-treated patients. Men aged 42 to 85 on 80 mcg once daily or placebo for 12 months.
Injection site reactions in women, checked daily 1 hour after injection in the first month: redness 58% vs 28% on placebo, swelling 11% vs 3%, pain 10% vs 7%. Severe redness, swelling and pain were 2.9%, 0.4% and 0.4%.
A drop in blood pressure on standing 1 hour after the first injection: 4% vs 3% on placebo in women and 6% vs 3% in men. Fast heartbeat (tachycardia) was 2% vs 1% in women; heart rate rose within 15 minutes of a dose and settled in about 6 hours.
High blood calcium 4 hours after a dose: 3% vs 0.1% on placebo in women and 3% vs 0% in men, higher with mild or moderate kidney impairment (4%). Kidney stones: 2.1% vs 1.7% in women and 2% vs 1% in men.
Uric acid rose above normal at least once in 25% of women on Tymlos vs 6% on placebo (7% vs 6% in men), without more gout or joint pain.
Reported after approval: stomach bloating and pain, constipation, diarrhea, vomiting, weakness and tiredness, insomnia, allergic reactions including anaphylaxis, itching and rash, bone, joint, back and limb pain, raised blood pressure, leg and back muscle spasms, and injection site bruising, bleeding, itching and rash.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Allergic reactions. Anaphylaxis, angioedema and hives have been reported with parathyroid hormone analogs, including Tymlos. If signs appear, Tymlos is stopped, and it is stopped permanently after a severe reaction.
Osteosarcoma (bone cancer). Abaloparatide caused a dose-related increase in osteosarcoma in rats. It is unknown whether Tymlos causes it in people; observational studies of PTH analogs in humans have not shown a higher risk. Tymlos is avoided with open growth plates, Paget's disease or other metabolic bone disease, bone cancer or metastases, past skeletal radiation, or inherited conditions that raise the risk.
Dizziness on standing. Blood pressure can drop on standing, usually within 4 hours of the injection, with dizziness, palpitations, fast heartbeat or nausea that may ease by lying down. The first several doses are given where the person can sit or lie down.
High blood calcium. Tymlos may cause high blood calcium and is not recommended with existing high calcium or a high-calcium disorder such as primary hyperparathyroidism.
High urine calcium and kidney stones. Tymlos may raise urine calcium. It is unknown whether it worsens kidney stones; urine calcium may be measured if active stones or high urine calcium are suspected.
Who should not use it. People with a history of severe allergy to abaloparatide or any of Tymlos's inactive ingredients.
From the Medication Guide that comes with Tymlos:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.