What the label lists and what reports show
Palopegteriparatide side effects
Palopegteriparatide's FDA label lists its adverse reactions in its own words. FAERS holds 368 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is hypocalcaemia (69 reports).
- No generic listed
Check it at the source: the palopegteriparatide FDA label on DailyMed (effective August 12, 2026, Ascendis Pharma, Endocrinology, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of YORVIPATH?YORVIPATH may cause serious side effects: See " What is the most important information I should know about YORVIPATH? " Decrease in blood pressure when you change positions (orthostatic hypotension). Some people may feel dizzy, get a fast heartbeat, or feel light-headed right after injecting YORVIPATH. For the first few doses, give your injection of YORVIPATH in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, contact your health care provider before you continue using YORVIPATH. Digoxin toxicity if you are using digoxin and YORVIPATH at the same time. Tell your health care provider if you experience irregular heart rhythm, heart palpitations, confusion, loss of appetite, nausea, vomiting, diarrhea, or vision problems. […]
Source: FDA drug label, Ascendis Pharma, Endocrinology, Inc., effective August 12, 2026 (SPL set a1fa23fd-c434-443e-9a17-5750578c8602), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Risk of Unintended Changes in Serum Calcium Levels Related to Number of Daily Injections [see Warnings and Precautions (5.2) ] Serious Hypercalcemia [see Warnings and Precautions (5.3) ] Serious Hypocalcemia [see Warnings and Precautions (5.4) ] Potential Risk of Osteosarcoma [see Warnings and Precautions (5.5) ] Orthostatic Hypotension [see Warnings and Precautions (5.6) ] Risk of Digoxin Toxicity with Concomitant Use of Digitalis Compounds [see Warnings and Precautions (5.7) ] Adverse reactions occurring in ≥ 5% of patients: injection site reactions, vasodilatory signs and symptoms, headache, diarrhea, back pain, hypercalcemia, and oropharyngeal pain. …
Table 3: Adverse Reactions in ≥ 5% of Subjects with Hypoparathyroidism Treated with YORVIPATH and with ≥ 2% Higher Frequency Compared to Placebo in Study 1
| Adverse Reaction | YORVIPATH N=61 n (%) | Placebo N=21 n (%) |
|---|---|---|
| Injection site reactions Injection site reactions includes the preferred terms injection… | 24 (39) | 1 (5) |
| Vasodilatory signs and symptoms Vasodilatory signs and symptoms includes the preferred… | 17 (28) | 0 |
| Headache | 13 (21) | 2 (10) |
| Diarrhea | 6 (10) | 1 (5) |
| Back pain Back pain includes the preferred terms back pain, flank pain, and spinal pain. | 5 (8) | 0 |
| Hypercalcemia | 5 (8) | 0 |
| Oropharyngeal pain | 4 (7) | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Ascendis Pharma, Endocrinology, Inc., effective August 12, 2026 (SPL set a1fa23fd-c434-443e-9a17-5750578c8602), via openFDA; the full label on DailyMed
What do FAERS reports show?
368 reports list palopegteriparatide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 90 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Palopegteriparatide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions