What the label lists and what reports show
Pasireotide side effects
Pasireotide's FDA label lists its adverse reactions in its own words. FAERS holds 2,235 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 blood glucose increased (259 reports).
- No generic listed
Check it at the source: the pasireotide FDA label on DailyMed (effective July 16, 2024, Recordati Rare Diseases, 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 SIGNIFOR LAR?SIGNIFOR LAR may cause serious side effects, including: high blood sugar (hyperglycemia), diabetes, and increased ketones in your urine or blood (ketoacidosis). High blood sugar and diabetes are serious but common side effects of SIGNIFOR LAR. Ketoacidosis is a serious condition that should be evaluated and treated promptly.Your healthcare provider should check your blood sugar level before you start receiving SIGNIFOR LAR and while you receive it. Tell your healthcare provider right away if you have any of these symptoms: o feel very thirsty o urinate more than usual o nausea o vomiting o abdominal pain o increased appetite with weight loss o tiredness o fruity scented breath o trouble breathing o confusion If you get hyperglycemia while receiving SIGNIFOR LAR, your healthcare provider may give you another medicine to lower your blood sugar. […]
Source: FDA drug label, Recordati Rare Diseases, Inc., effective July 16, 2024 (SPL set a0aad470-3f38-af97-e053-2995a90a383a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsClinically significant adverse reactions that appear in other sections of the labeling include: Hyperglycemia, Diabetes, and Ketoacidosis [see Warnings and Precautions (5.1)] Bradycardia and QT Prolongation [see Warnings and Precautions (5.2)] Liver Test Elevations [see Warnings and Precautions (5.3)] Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions (5.4)] Pituitary Hormone Deficiency(ies) [see Warnings and Precautions (5.5)] Steatorrhea and Malabsorption of Dietary Fats [see Warnings and Precautions (5.6) ] Adverse drug reactions associated with SIGNIFOR LAR and occurring in ≥ 20% of patients were diarrhea, cholelithiasis, hyperglycemia, and diabetes mellitus. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Table 1 – Adverse Reactions Occurring in Greater Than or Equal to 5% of Patients Exposed to SIGNIFOR LAR in Patients With Acromegaly Naïve to Drug Therapy
| Adverse Reaction Type | SIGNIFOR LAR (40-60 mg) % N = 178 | Active Comparator % N = 180 |
|---|---|---|
| Hyperglycemia | 29 | 8 |
| Diabetes mellitus a | 26 | 4 |
| Blood glucose increased | 8 | 2 |
| Glycosylated hemoglobin increased | 6 | 2 |
| Hypoglycemia | 5 | 7 |
| Diarrhea | 39 | 45 |
| Abdominal pain | 18 | 22 |
| Nausea | 14 | 22 |
| Abdominal distension | 12 | 12 |
| Vomiting | 8 | 7 |
| Abdominal pain upper | 6 | 8 |
| Cholelithiasis | 26 | 36 |
| Sinus bradycardia b | 10 | 7 |
| Hypertension | 8 | 7 |
| Headache | 19 | 26 |
| Dizziness | 10 | 11 |
| Alopecia | 18 | 19 |
| Nasopharyngitis | 16 | 16 |
| Influenza | 8 | 4 |
| Upper respiratory tract infection | 7 | 3 |
| Cough | 5 | 8 |
| Blood creatine phosphokinase increased | 13 | 12 |
| Alanine aminotransferase increased | 8 | 4 |
| Aspartate aminotransferase increased | 6 | 4 |
| Lipase increased | 6 | 7 |
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, Recordati Rare Diseases, Inc., effective July 16, 2024 (SPL set a0aad470-3f38-af97-e053-2995a90a383a), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,235 reports list pasireotide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 157 are coded as a death and 641 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, 17 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.
Reports received each year
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?
- Pasireotide: 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