Yorvipath Side Effects: FDA Label Numbers vs Placebo
[Side effects · Yorvipath]

Yorvipath side effects

palopegteriparatide injection · once-daily subcutaneous injection, 14-dose prefilled pen · Label checked

Short answer: In the Yorvipath label's 26-week placebo-controlled trial, the most common side effects were injection site reactions (39% vs 5% on placebo), dizziness or blood pressure drops on standing (28% vs 0%), headache (21% vs 10%), diarrhea (10% vs 5%), back pain and high blood calcium (8% each vs 0%). There is no boxed warning; the label warns about serious high and low calcium and allergic reactions.

What Yorvipath is approved for: Yorvipath is a parathyroid hormone analog (PTH(1-34)) approved to treat hypoparathyroidism (low parathyroid hormone) in adults. It was not studied for sudden low parathyroid hormone right after surgery, and its dose-adjustment plan was only tested in adults whose albumin-corrected blood calcium was first brought to at least 7.8 mg/dL with calcium and active vitamin D (section 1).

Source
YORVIPATH (palopegteriparatide) injection, for subcutaneous use, prescribing information, Medication Guide and Instructions for Use. Ascendis Pharma. DailyMed, version published October 26, 2026. DailyMed setid a1fa23fd-c434-443e-9a17-5750578c8602

Does Yorvipath have a boxed warning?

No. The current Yorvipath label has no boxed warning.

What are the most common Yorvipath side effects?

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 Yorvipath.

Table 3: Adverse Reactions in ≥ 5% of Subjects with Hypoparathyroidism Treated with YORVIPATH and with ≥ 2% Higher Frequency Compared to Placebo in Study 1 [Section 6.1]
Adverse ReactionYORVIPATH N=61 n (%)Placebo N=21 n (%)
Injection site reactions24 (39)1 (5)
Vasodilatory signs and symptoms17 (28)0
Headache13 (21)2 (10)
Diarrhea6 (10)1 (5)
Back pain5 (8)0
Hypercalcemia5 (8)0
Oropharyngeal pain4 (7)0

82 adults with hypoparathyroidism, 26-week blinded period. "Vasodilatory signs and symptoms" groups dizziness, dizziness on standing, blood pressure drops on standing, palpitations, fast heart rate on standing, near-fainting, fainting and vertigo.

Table 4: Incidence of Elevated Albumin-Corrected Serum Calcium (> 10.6 mg/dL or > 12 mg/dL) Post-Baseline in Subjects with Hypoparathyroidism Treated with YORVIPATH or Placebo in Study 1 [Section 6.1]
MeasureYORVIPATH N=61Placebo N=21
Albumin-Corrected Serum Calcium >10.6 mg/dL, n (%)33 (54.1)2 (9.5)
Albumin-Corrected Serum Calcium >12 mg/dL, n (%)8 (13.1)0 (0)

People with at least one calcium reading above the limit after starting. The above 10.6 mg/dL row includes those above 12 mg/dL.

Other numbers in the Adverse Reactions section

  • Section 6.1

    High blood calcium with symptoms was reported in 8% of people on Yorvipath, all within the first 3 months after starting.

  • Section 6.2

    Reported after approval: allergic reactions, including anaphylaxis, angioedema (swelling under the skin), drug hypersensitivity and hives.

What serious risks does the Yorvipath label warn about?

The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.

  • Section 5.1

    Allergic reactions. Anaphylaxis, angioedema and hives have been reported with parathyroid hormone analogs, including Yorvipath. Yorvipath is stopped if signs appear, and stopped permanently after a severe reaction.

  • Section 5.2

    Calcium swings from using two injections. The daily dose is given as one injection. Using two injections to reach the daily dose makes the total delivered dose less predictable, which can push calcium too high or too low.

  • Section 5.3

    Serious high blood calcium. High calcium needing a hospital stay has been reported. The risk is highest when starting or raising the dose. Calcium is checked 7 to 10 days after any dose change and at least every 4 to 6 weeks on a steady dose. Above 12 mg/dL, Yorvipath is held for at least 2 to 3 days.

  • Section 5.4

    Serious low blood calcium. Serious low calcium has been seen with parathyroid hormone products. The risk is highest when Yorvipath is stopped suddenly but can happen at any time, even on a steady dose.

  • Section 5.5

    Possible risk of osteosarcoma (bone cancer). Parathyroid hormone analogs caused osteosarcoma in rats, and cases have been reported in people taking teriparatide, though observational studies in humans have not shown a higher risk. Yorvipath is not recommended for people at higher risk, such as those with open growth plates, Paget's disease or other bone disease, unexplained high alkaline phosphatase, bone cancer or metastases, or past radiation to the skeleton.

  • Section 5.6

    Low blood pressure on standing. Dizziness, fast heartbeat, palpitations, near-fainting or fainting can happen. The label says symptoms can be managed by dosing at bedtime while reclining, and the first doses are given where the person can sit or lie down.

  • Section 5.7

    Digoxin. Because Yorvipath raises calcium, people on digoxin may be more prone to digoxin toxicity if calcium gets high, so calcium and digoxin levels are checked.

  • Section 4

    Who should not use it. People with a history of severe allergy to palopegteriparatide or any of Yorvipath's inactive ingredients.

When does the label say to call your doctor?

From the Medication Guide that comes with Yorvipath:

  • Swelling of the face, lips, mouth or tongue, breathing problems, fainting, dizziness or light-headedness, fast heartbeat, itching, rash or hives: stop Yorvipath and get medical help right away.
  • Nausea, vomiting, dizziness, feeling thirsty, confusion, muscle weakness or irregular heartbeat, which may be signs of high blood calcium.
  • Tingling in the fingertips, toes, lips or tongue, muscle spasms or cramps, mouth numbness, depression, trouble thinking or remembering, abnormal heart rhythms or seizures, which may be signs of low blood calcium.
  • Pain anywhere that does not go away, or new or unusual tender lumps or swelling under the skin: tell your health care provider right away.
  • Dizziness, fast heartbeat or light-headedness after a dose that gets worse or does not go away: contact your health care provider before continuing.

How do I keep track of side effects in Dose Track?

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.

Side effects for similar medicines

Frequently asked questions

What is the most common side effect of Yorvipath?+
Injection site reactions, in 39% of people on Yorvipath vs 5% on placebo. Dizziness and blood pressure drops on standing were 28% vs 0%, and headache 21% vs 10% (section 6.1, Table 3).
Does Yorvipath have a boxed warning?+
No. The Yorvipath label has no boxed warning. Its warnings cover allergic reactions, calcium swings from using two injections, serious high and low calcium, possible osteosarcoma risk, low blood pressure on standing and digoxin (section 5).
Can Yorvipath cause high calcium?+
Yes. 54.1% of people on Yorvipath had at least one calcium reading above 10.6 mg/dL vs 9.5% on placebo, and 13.1% above 12 mg/dL. Symptomatic high calcium (8%) happened in the first 3 months (section 6.1).
Why does Yorvipath make me dizzy?+
Yorvipath can lower blood pressure when standing. The label says the first doses are given where you can sit or lie down, and symptoms can be managed by dosing at bedtime while reclining (sections 2.6 and 5.6).
What happens if Yorvipath is stopped suddenly?+
The label says the risk of serious low blood calcium is highest when Yorvipath is stopped abruptly (section 5.4).