What the label lists and what reports show
Paltusotine side effects
Paltusotine's FDA label: “Most common adverse reactions (≥5%) are diarrhea, abdominal pain, nausea, decreased appetite, sinus bradycardia, hyperglycemia, palpitations, and gastroenteritis ( 6.1 ).” FAERS holds 223 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 diarrhoea (50 reports).
- No generic listed
Check it at the source: the paltusotine FDA label on DailyMed (effective September 16, 2025, Crinetics Pharmaceuticals, 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 PALSONIFY?PALSONIFY may cause serious side effects including: gallbladder problems. PALSONIFY may cause problems with the gallbladder. Tell your healthcare provider if you have sudden pain in the upper right area of your stomach (abdomen), sudden pain in your right shoulder or between your shoulder blades, yellowing of your skin or the whites of your eyes, or pale stools. blood sugar problems. PALSONIFY may change hormone levels that can lead to high blood sugar (hyperglycemia), low blood sugar (hypoglycemia), or diabetes. Tell your healthcare provider if you have problems with high or low blood sugar. Your healthcare provider will check your blood sugar when you start taking PALSONIFY or when your dose is changed. heart rate problems. Tell your healthcare provider if your heart is not beating normally. thyroid problems. […]
Source: FDA drug label, Crinetics Pharmaceuticals, Inc., effective September 16, 2025 (SPL set 8a6d2ce0-a621-4ee7-983c-977cd948ff4d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥5%) are diarrhea, abdominal pain, nausea, decreased appetite, sinus bradycardia, hyperglycemia, palpitations, and gastroenteritis ( 6.1 ).
Table 1. Adverse Reactions Occurring in ≥5% of PALSONIFY-Treated Participants and 5% Greater Incidence than Placebo-Treated Participants During the Randomized Controlled Period of Study 1
| Adverse Reaction | PALSONIFY N=54 n (%) | Placebo N=57 n (%) |
|---|---|---|
| Diarrhea | 18 (33) | 8 (14) |
| Abdominal pain a | 10 (19) | 3 (5) |
| Nausea | 5 (9) | 1 (2) |
| Sinus bradycardia | 4 (7) | 0 |
| Hyperglycemia b | 4 (7) | 1 (2) |
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.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions ( 5.1 )] Hyperglycemia and Hypoglycemia [see Warnings and Precautions ( 5.2 )] Cardiovascular Abnormalities [see Warnings and Precautions ( 5.3 )] Thyroid Function Abnormalities [see Warnings and Precautions ( 5.4 )] Steatorrhea and Malabsorption of Dietary Fats [see Warnings and Precautions ( 5.5 )] Changes in Vitamin B 12 Levels [see Warnings and Precautions ( 5.6 )] Most common adverse reactions (≥5%) are diarrhea, abdominal pain, nausea, decreased appetite, sinus bradycardia, hyperglycemia, palpitations, and gastroenteritis ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Crinetics Pharmaceuticals, Inc. at toll-free phone 1-833-CRN-INFO or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of PALSONIFY was evaluated in adults with acromegaly in two randomized, double-blind, placebo-controlled Phase 3 studies. …
Source: FDA drug label, Crinetics Pharmaceuticals, Inc., effective September 16, 2025 (SPL set 8a6d2ce0-a621-4ee7-983c-977cd948ff4d), via openFDA; the full label on DailyMed
What do FAERS reports show?
223 reports list paltusotine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 13 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 20 reactions below, 4 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?
- Paltusotine: 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