What the label lists and what reports show
Octreotide side effects
Octreotide's FDA label: “Most common adverse reactions (incidence > 10%) in patients with acromegaly are gallbladder abnormalities, sinus bradycardia, diarrhea, loose stools, nausea, abdominal discomfort, hyperglycemia, and hypothyroidism.” FAERS holds 30,742 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 (4,580 reports).
- Generic listed
Check it at the source: the octreotide FDA label on DailyMed (effective July 22, 2026, Novartis Pharmaceuticals Corporation); 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 MYCAPSSA?gallbladder problems. MYCAPSSA may cause problems with the gallbladder. Tell your healthcare provider if you have sudden pain in your upper right stomach (abdomen), sudden pain in your right shoulder or between your shoulder blades, yellowing of your skin or the whites of your eyes, fever with chills, nausea blood sugar problems. MYCAPSSA may cause you to have 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 MYCAPSSA or when your dose is changed. thyroid problems. MYCAPSSA may keep your thyroid from releasing thyroid hormones leading to hypothyroidism. Your thyroid function will be checked regularly during your treatment with MYCAPSSA. heart rhythm problems. […]
Source: FDA drug label (Mycapssa), Chiesi USA, Inc., effective July 24, 2025 (SPL set 58d80bc6-bdfb-4908-93e7-aace447c8d1a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence > 10%) in patients with acromegaly are gallbladder abnormalities, sinus bradycardia, diarrhea, loose stools, nausea, abdominal discomfort, hyperglycemia, and hypothyroidism.
Table 4. Adverse Events Occurring in ≥ 15% of Carcinoid Tumor and VIPoma Patients in Study 1
This table is printed in the Sandostatin LAR Depot label published by Novartis Pharmaceuticals Corporation of December 22, 2025; the label quoted above does not print one.
| WHO Preferred Term | S.C. N = 26 | 10 mg N = 22 | 20 mg N = 20 | 30 mg N = 25 |
|---|---|---|---|---|
| Abdominal Pain | 8 (30.8) | 8 (35.4) | 2 (10.0) | 5 (20.0) |
| Arthropathy | 5 (19.2) | 2 (9.1) | 3 (15.0) | 2 (8.0) |
| Back Pain | 7 (26.9) | 6 (27.3) | 2 (10.0) | 2 (8.0) |
| Dizziness | 4 (15.4) | 4 (18.2) | 4 (20.0) | 5 (20.0) |
| Fatigue | 3 (11.5) | 7 (31.8) | 2 (10.0) | 2 (8.0) |
| Flatulence | 3 (11.5) | 2 (9.1) | 2 (10.0) | 4 (16.0) |
| Generalized Pain | 4 (15.4) | 2 (9.1) | 3 (15.0) | 1 (4.0) |
| Headache | 5 (19.2) | 4 (18.2) | 6 (30.0) | 4 (16.0) |
| Musculoskeletal Pain | 4 (15.4) | 0 | 1 (5.0) | 0 |
| Myalgia | 0 | 4 (18.2) | 1 (5.0) | 1 (4.0) |
| Nausea | 8 (30.8) | 9 (40.9) | 6 (30.0) | 6 (24.0) |
| Pruritus | 0 | 4 (18.2) | 0 | 0 |
| Rash | 1 (3.8) | 0 | 3 (15.0) | 0 |
| Sinusitis | 4 (15.4) | 0 | 1 (5.0) | 3 (12.0) |
| URTI | 6 (23.1) | 4 (18.2) | 2 (10.0) | 3 (12.0) |
| Vomiting | 3 (11.5) | 0 | 0 | 4 (16.0) |
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.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Complete Atrioventricular Block [see Warnings and Precautions (5.1)] Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions (5.2)] Hyperglycemia and Hypoglycemia [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 B12 Levels [see Warnings and Precautions (5.6)] Most common adverse reactions (incidence > 10%) in patients with acromegaly are gallbladder abnormalities, sinus bradycardia, diarrhea, loose stools, nausea, abdominal discomfort, hyperglycemia, and hypothyroidism. In other patients, most common adverse reactions (incidence > 10%) are gallbladder abnormalities. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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. …
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective July 22, 2026 (SPL set 4e2c9856-1836-49f0-9472-4dbeeb408f39), via openFDA; the full label on DailyMed
What do FAERS reports show?
30,742 reports list octreotide among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6,112 are coded as a death and 10,420 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, 7 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?
- Octreotide: 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