Abaloparatide: Side Effects
Known side effects, contraindications, and interactions
📌TL;DR
- •4 known side effects documented
- •4 mild, 0 moderate, 0 severe
- •4 contraindications listed
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Side Effects Severity Chart
Most common adverse event (16% vs 7% placebo in ACTIVE). Includes erythema, edema, pain, and pruritus at the injection site. Usually mild and transient. Rotating injection sites within the periumbilical area may reduce incidence.
Elevated serum calcium above ULN reported in 3.4% of patients (vs 6.4% teriparatide). Usually transient and asymptomatic, occurring 4-6 hours post-injection. Generally resolves by 16-24 hours post-dose.
Reported in approximately 6% of patients. May be related to transient hypotension following injection. Patients should sit or lie down if dizziness occurs.
Reported in approximately 8% of patients vs 2% placebo. Usually mild and does not require treatment discontinuation.
⛔Contraindications
- •Patients at increased risk for osteosarcoma (Paget disease of bone, unexplained elevations of alkaline phosphatase, open epiphyses, prior external beam or implant radiation therapy involving the skeleton)
- •Pre-existing hypercalcemia
- •Pregnancy (embryo-fetal toxicity observed in animal studies)
- •Known hypersensitivity to abaloparatide or excipients
⚠️Drug Interactions
- •Digoxin: Hypercalcemia from abaloparatide may predispose to digitalis toxicity. Monitor serum calcium and digoxin levels if co-administered.
- •Thiazide diuretics: May increase serum calcium when combined with abaloparatide due to reduced renal calcium excretion.
- •Calcium supplements: High-dose calcium supplementation may exacerbate abaloparatide-induced hypercalcemia. Monitor serum calcium levels.
Community-Reported Side Effects
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Based on 35+ community reports
View community protocolsSafety Overview#
Abaloparatide (Tymlos) has been evaluated in the ACTIVE phase 3 trial (n=2,463 postmenopausal women, 18 months), the ACTIVExtend extension study, and the male osteoporosis trial. The safety profile is well characterized through these programs and post-marketing surveillance since the April 2017 FDA approval. The overall safety profile is favorable for an osteoanabolic agent, with notably lower hypercalcemia rates than the comparator teriparatide.
Injection Site Reactions#
Injection site reactions are the most frequently reported adverse event with abaloparatide, occurring in approximately 16% of patients versus 7% with placebo and 7% with teriparatide in the ACTIVE trial. Reactions include erythema, edema, pain, and pruritus at the injection site.
The higher rate compared to both placebo and teriparatide may be related to formulation-specific factors. Reactions are generally mild (grade 1), transient, and do not require treatment discontinuation. Rotating injection sites within the periumbilical region is recommended.
Hypercalcemia#
Abaloparatide transiently increases serum calcium through PTH1R-mediated calcium mobilization from bone and enhanced renal and intestinal calcium absorption. In the ACTIVE trial, hypercalcemia (albumin-corrected serum calcium above ULN) was reported in 3.4% of abaloparatide patients versus 6.4% of teriparatide patients and 0.4% of placebo patients.
The lower hypercalcemia rate compared to teriparatide is attributed to abaloparatide's preferential RG conformation binding, which produces more transient cAMP signaling and less sustained calcium mobilization. Peak calcium elevation typically occurs 4-6 hours post-injection and resolves within 16-24 hours.
Orthostatic Hypotension and Dizziness#
Dizziness was reported in approximately 6% of abaloparatide patients. Some cases may be related to transient orthostatic hypotension following injection, a known effect of PTH1R agonists. Patients who experience dizziness should sit or lie down during and after the injection. Tachycardia was reported in approximately 2% of patients.
Nausea#
Nausea was reported in approximately 8% of abaloparatide patients versus 2% with placebo. It is generally mild, does not require dose adjustment, and rarely leads to treatment discontinuation.
Other Reported Adverse Events#
| Adverse Event | Abaloparatide | Teriparatide | Placebo |
|---|---|---|---|
| Injection site reaction | 16% | 7% | 7% |
| Nausea | 8% | 5% | 2% |
| Dizziness | 6% | 4% | 2% |
| Headache | 5% | 5% | 4% |
| Palpitations | 2% | 1% | 1% |
| Hypercalcemia | 3.4% | 6.4% | 0.4% |
| Upper abdominal pain | 3% | 2% | 1% |
Osteosarcoma Considerations#
Like teriparatide, abaloparatide carries labeling regarding the risk of osteosarcoma based on findings in rat carcinogenicity studies. In Fischer 344 rats treated with high doses of PTH1R agonists for near-lifetime durations, dose-dependent increases in osteosarcoma were observed.
Human relevance of this finding is considered low because:
- Rats have continuous skeletal growth and lack osteonal bone remodeling
- Human thyroid C-cells and osteoblasts respond differently to sustained PTH1R activation
- Over 20 years of post-marketing surveillance of teriparatide have not identified increased osteosarcoma risk in humans
- The teriparatide osteosarcoma boxed warning was removed by the FDA in 2020
Nonetheless, abaloparatide is contraindicated in patients at increased baseline risk for osteosarcoma, including those with Paget disease of bone, unexplained alkaline phosphatase elevations, open epiphyses, or prior skeletal radiation therapy.
Contraindications#
- Increased osteosarcoma risk: Paget disease, unexplained elevated alkaline phosphatase, open epiphyses, prior skeletal radiation
- Pre-existing hypercalcemia: Abaloparatide may worsen hypercalcemia
- Pregnancy: Animal studies showed embryo-fetal toxicity. Women of childbearing potential should use effective contraception
- Known hypersensitivity: Prior allergic reaction to abaloparatide or pen components
Drug Interactions#
Digoxin: Abaloparatide-induced hypercalcemia may increase the risk of digitalis toxicity. Monitor serum calcium and digoxin levels during concomitant use.
Thiazide diuretics: Thiazides reduce renal calcium excretion and may compound abaloparatide-induced calcium elevations. Monitor serum calcium more frequently if co-administered.
CYP interactions: Abaloparatide is not metabolized by CYP enzymes and does not inhibit or induce CYP isoforms. CYP-mediated pharmacokinetic interactions are not expected.
Special Populations#
- Renal impairment: No dose adjustment needed for mild to moderate impairment. Not studied in severe renal impairment.
- Hepatic impairment: No dose adjustment required.
- Elderly (>65): No dose adjustment required. ACTIVE trial enrolled patients up to age 86.
- Pediatric: Not indicated for pediatric use. Contraindicated in patients with open epiphyses.
Related Reading#
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