Abaloparatide Injection
Abaloparatide is a bone-building injection used to treat osteoporosis in postmenopausal women and men who are at high risk for fracture.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Abaloparatide Injection: Patient Information Guide
A plain-language walkthrough of Abaloparatide Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Abaloparatide (brand name Tymlos) is a prescription subcutaneous injection approved for two main uses in adults with osteoporosis:
- Tymlos for postmenopausal women with osteoporosis: Treats osteoporosis in women who are at high risk for fracture (history of osteoporotic fracture or multiple fracture risk factors), or who have not responded to or cannot tolerate other osteoporosis treatments. Tymlos reduces the risk of both spinal (vertebral) and non-spinal (nonvertebral) fractures in this group.
- Tymlos for men with osteoporosis: Increases bone density in men with osteoporosis at high risk for fracture, or who have failed or are intolerant to other osteoporosis therapies.
⚙️How it works▾
Abaloparatide is a synthetic analog (engineered copy) of a naturally occurring hormone called parathyroid hormone-related peptide, or PTHrP. It binds to and activates a receptor on bone cells called PTH1R, which triggers a signaling cascade inside the cell. This stimulates osteoblasts — the cells responsible for building new bone — to lay down fresh bone tissue on both the spongy inner structure (trabecular bone) and the dense outer shell (cortical bone).
The net effect is measurably stronger, denser bone over the course of treatment. Bone formation markers rise significantly within the first month of use, and bone density increases continue throughout the treatment period.
💊How it's taken▾
Tymlos is injected subcutaneously (just under the skin) into the belly area around the navel, once daily. Try to inject at approximately the same time each day and rotate the injection site with each dose. For the first several doses, stay seated or lying down for a short time afterward in case of lightheadedness.
- Tymlos should not be injected into a vein or muscle — subcutaneous only.
- Supplemental calcium and vitamin D are recommended if your diet does not provide enough.
- Treatment with Tymlos should not exceed 2 years over a patient's lifetime.
- Always follow your prescriber's guidance and the instructions provided with the Tymlos pen.
🤒Side effects — in detail▾
The most common side effects vary slightly depending on whether Tymlos is used in women or men with osteoporosis:
- In postmenopausal women: high calcium in the urine (hypercalciuria), dizziness, nausea, headache, palpitations (racing heartbeat), fatigue, upper abdominal pain, and vertigo
- In men: injection site redness, dizziness, joint pain (arthralgia), injection site swelling or pain, bruising (contusion), nausea, diarrhea, abdominal bloating or pain, and bone pain
- Injection site redness, swelling, and pain are common in the first month of use in both groups.
- Tymlos can temporarily raise heart rate within 15 minutes of injection and may cause a short-lived drop in blood pressure when standing (orthostatic hypotension).
Seek immediate medical help for signs of a serious allergic reaction (trouble breathing, swelling of the face or throat, hives) or for severe dizziness, fainting, or symptoms of high blood calcium such as confusion, weakness, or excessive thirst.
⚠️Warnings & precautions▾
- Osteosarcoma risk: Animal studies showed a dose-related increase in a rare bone cancer (osteosarcoma) with abaloparatide. While this has not been clearly shown in human studies, Tymlos should be avoided in people at elevated baseline risk — including those with Paget's disease of the bone, bone metastases, a history of bone or skeletal cancer, prior radiation to the skeleton, or hereditary conditions linked to osteosarcoma. Use is limited to 2 years over a lifetime for this reason.
- Orthostatic hypotension (blood pressure drop when standing): Can occur within 4 hours of injection, causing dizziness, palpitations, rapid heartbeat, or nausea. Sit or lie down for the first several doses.
- Hypercalcemia (high blood calcium): Tymlos can raise blood calcium levels. It should not be used by people who already have high calcium or conditions such as primary hyperparathyroidism.
- Hypercalciuria and urolithiasis (excess calcium in urine and kidney stones): Tymlos increases urine calcium. Patients with a history of kidney stones or high urine calcium should be monitored.
- Hypersensitivity reactions: Serious allergic reactions including anaphylaxis have been reported. Tymlos is contraindicated in anyone with a history of severe allergy to abaloparatide or its ingredients.
🔀What it interacts with▾
No specific drug-drug interaction studies have been conducted with Tymlos. Laboratory studies show that abaloparatide does not inhibit or trigger the liver enzymes (Cytochrome P450) that process many common medications, and it does not interact with key kidney transport proteins. Your pharmacist and prescriber should still be aware of all medications you take.
- No specific food, alcohol, or drug interactions are identified in the Tymlos label at this time.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Do not use Tymlos if you have had a severe allergic reaction (anaphylaxis, angioedema) to abaloparatide or any inactive ingredient in Tymlos.
- Tell your doctor if you have pre-existing high blood calcium (hypercalcemia) or a condition that causes it, such as primary hyperparathyroidism.
- Tell your doctor if you have Paget's disease of the bone, any history of bone cancer, bone metastases, or prior radiation therapy involving bones.
- Tell your doctor if you have a hereditary condition associated with increased osteosarcoma risk.
- Tell your doctor if you have kidney disease — drug exposure is higher with severe kidney impairment, and monitoring for side effects is advised. No dose adjustment is required, but caution is needed.
- Tymlos is not approved for use in children or adolescents with open growth plates (epiphyses still developing).
- Tymlos is not intended for use in pregnancy or while breastfeeding, as it is not indicated in females of reproductive potential and safety data are lacking.
- Older adults (65 and over) have been well represented in clinical trials and no overall differences in safety or effectiveness were found compared to younger patients, though some individual sensitivity cannot be ruled out.
🚑If you take too much▾
In one reported case, a patient accidentally received five times the recommended daily dose of Tymlos in a single day and experienced weakness, headache, nausea, and dizziness. There is no specific antidote for Tymlos overdose. If an overdose is suspected, Tymlos should be stopped, blood calcium and phosphorus levels should be monitored, and supportive care such as hydration should be provided as needed.
📡Pharmacodynamics — effects in the body▾
Tymlos stimulates bone formation by activating osteoblasts — the cells that build new bone. In clinical studies of postmenopausal women, a key bone formation marker (sPINP) rose approximately 93% above baseline within the first month and remained elevated throughout 18 months of treatment. In men, the same marker rose even more sharply — about 133% above baseline in the first month. A bone breakdown marker (sCTX) also increased early in treatment but returned toward baseline levels over time, reflecting a net bone-building effect. Tymlos also causes a temporary, dose-related increase in heart rate (typically within 15 minutes of injection) that resolves within about 6 hours, without meaningful effects on heart rhythm.
🔬Pharmacokinetics — how your body processes it▾
After a subcutaneous injection, Tymlos is absorbed quickly, with peak blood levels reached in about 30 minutes. Its absolute bioavailability is approximately 36%, and it has a short half-life of about 1 hour, meaning it clears from the body fairly quickly each day. Abaloparatide is broken down by natural protein-degrading enzymes in the body and the resulting fragments are cleared primarily through the kidneys. People with severe kidney disease have higher drug exposure (up to about twice as much as those with normal kidney function), so they should be monitored more closely for side effects.
📦How to store it▾
store TYMLOS under refrigeration between 2°C to 8°C (36°F to 46°F). store for up to 30 days at 20°C to 25°C (68°F to 77°F). Do not freeze or subject to heat.
📄 Written from Abaloparatide Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Abaloparatide Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Tymlos supposed to do for my bones? ▾
How do I take it, and does it have to be at a specific time of day? ▾
What side effects should I expect, and which ones should make me call my doctor? ▾
I've heard there's a concern about bone cancer with this type of medication — should I be worried? ▾
How long will I need to take it, and what happens when I stop? ▾
Can I use Tymlos if I have kidney disease? ▾
Is Abaloparatide Injection available over the counter? ▾
When was Abaloparatide Injection first available? ▾
💬 Answers drafted from Abaloparatide Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Abaloparatide Injection comes
Abaloparatide Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Tymlos is used to treat osteoporosis in postmenopausal women at high risk for fracture, reducing the risk of spinal and non-spinal fractures
- Tymlos is used to increase bone density in men with osteoporosis at high risk for fracture
- Tymlos is an option for patients who have not responded to or cannot tolerate other osteoporosis therapies
- Tymlos is injected subcutaneously (just under the skin) into the belly area around the navel once daily
- Tymlos injection sites should be rotated each day; inject at approximately the same time each day
- For the first several doses of Tymlos, sit or lie down nearby in case lightheadedness or low blood pressure occurs
- Inspect Tymlos solution before use — do not use if it appears cloudy, colored, or contains particles
📊 Abaloparatide Injection across the U.S. market
How Abaloparatide Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
📈 How widely Abaloparatide Injection is used
A general measure of how commonly Abaloparatide Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Abaloparatide Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Abaloparatide Injection prescribed? Of the 1,596 medications we measure, Abaloparatide Injection ranks #1,016 by Medicaid prescriptions — more than 36% of them.
Utilization by Abaloparatide Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
1.56 ML abaloparatide 2 MG/ML Pen Injector
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1921075
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Abaloparatide Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 4 listed Abaloparatide Injection NDCs with Medicaid activity.
🔍 Compare Abaloparatide Injection products
A representative set of FDA-listed product records for Abaloparatide Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 2000 mcg/mL | Subcutaneous | Radius Health, Inc. | NDA | View NDC → |
| 3.12 mg/1.56 mL | Subcutaneous | Radius Health, Inc. × 3 listings | NDA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Abaloparatide Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Abaloparatide Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Abaloparatide Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Abaloparatide Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1921069 1 dose form · 1 strength
-
Dose form (SCDF) Pen Injector RxCUI 1921074In current FDA listingsClinical drug / strength (SCD) 1.56 ML abaloparatide 2 MG/MLRxCUI 1921075
Look up RxCUI 1921069 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Abaloparatide Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Abaloparatide Injection belongs to the Parathyroid Hormone-Related Peptide Analog class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Radius Health, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.