Octreotide Acetate side effects: what 30,453 FDA adverse event reports show
Drug class
Somatostatin Analog
Brand names
Mycapssa
Who reports
30,453 reports · 77% serious · 6,099 with death outcome · 55% female
Used for
MYCAPSSA is indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. MYCAPSSA is a somatostatin analog indicated for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide ( 1 ).
What it is
MYCAPSSA delayed release capsules contain octreotide acetate, a somatostatin analog. Octreotide is known chemically as L-cysteinamide, D-phenylalanyl-L-cysteinyl-L-phenylalanyl-D-tryptophyl-L-lysyl-L-threonyl-N-[2-hydroxy-1-(hydroxy-methyl) propyl]-, cyclic (2→7)-disulfide; [R-(R*,R*)].
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
What the badges mean
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,186 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| 5-hydroxyindolacetic acid increased | 44 | 1,571.2 917.5–2,690.6ROR 1,573.5 · calibrated p 2e-17 ✓ | 393.2 EB05 305.0 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 33% (drug 55%) | not reported in cached trials |
| Gastroenteropancreatic neuroendocrine tumour disease | 75 | 1,413.5 950.1–2,102.9ROR 1,417.0 · calibrated p 7e-18 ✓ | 410.8 EB05 338.5 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=75 | not reported in cached trials |
| Carcinoid crisis | 151 | 1,384.5 1,048.5–1,828.0ROR 1,391.3 · calibrated p 2e-18 ✓ | 431.0 EB05 376.3 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=151 | NCT00412061: 1/215 (0.5%) on Octreotide (serious AE) |
| 5-hydroxyindolacetic acid in urine increased | 36 | 1,285.5 737.5–2,240.8ROR 1,287.0 · calibrated p 2e-16 ✓ | 359.6 EB05 271.4 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | serious n=35 · ♀ 0% (drug 55%) | not reported in cached trials |
| Blood growth hormone increased | 310 | 848.1 717.9–1,001.8ROR 856.8 · calibrated p 2e-16 ✓ | 368.9 EB05 335.7 · IC025 +7.7 3/3 methods agree | Lab value / disease marker | serious n=302 | not reported in cached trials |
| Carcinoid heart disease | 45 | 710.0 467.5–1,078.3ROR 711.1 · calibrated p 2e-14 ✓ | 302.7 EB05 235.5 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=45 | NCT00412061: 2/215 (0.9%) on Octreotide; 2/211 (0.9%) control (serious AE) |
| Metastatic carcinoid tumour | 46 | 529.0 359.8–777.7ROR 529.8 · calibrated p 2e-13 ✓ | 264.9 EB05 206.7 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=46 | not reported in cached trials |
| Blood mercury abnormal | 41 | 496.7 332.1–743.1ROR 497.4 · calibrated p 5e-13 ✓ | 253.3 EB05 194.7 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=41 · ♀ 0% (drug 55%) | not reported in cached trials |
| Blood chromogranin a increased | 177 | 439.9 364.2–531.3ROR 442.5 · calibrated p 3e-13 ✓ | 259.8 EB05 229.2 · IC025 +7.0 3/3 methods agree | Lab value / disease marker | serious n=161 | not reported in cached trials |
| Carcinoid tumour | 276 | 400.1 345.0–464.1ROR 403.8 · calibrated p 7e-13 ✓ | 247.7 EB05 224.2 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=275 | not reported in cached trials |
| Carcinoid syndrome | 127 | 371.4 299.2–461.0ROR 373.0 · calibrated p 2e-12 ✓ | 232.0 EB05 200.1 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=124 | NCT00412061: 2/215 (0.9%) on Octreotide; 2/211 (0.9%) control (serious AE) |
| Pancreatic neuroendocrine tumour metastatic | 82 | 361.3 276.4–472.2ROR 362.2 · calibrated p 4e-12 ✓ | 223.8 EB05 186.0 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=80 | not reported in cached trials |
| Carcinoid tumour of the small bowel | 31 | 292.1 191.8–445.0ROR 292.4 · calibrated p 8e-11 ✓ | 181.8 EB05 134.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=31 · ♀ 0% (drug 55%) · 100% clinician | not reported in cached trials |
| Neuroendocrine tumour | 410 | 279.0 248.8–312.8ROR 282.8 · calibrated p 2e-11 ✓ | 196.2 EB05 180.8 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=407 | not reported in cached trials |
| Blood growth hormone abnormal | 34 | 268.2 180.4–398.9ROR 268.5 · calibrated p 1e-10 ✓ | 173.9 EB05 130.1 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious n=33 · ♀ 100% (drug 55%) | not reported in cached trials |
| Pancreatic neuroendocrine tumour | 177 | 263.4 221.5–313.2ROR 264.9 · calibrated p 4e-11 ✓ | 186.2 EB05 164.3 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=174 | not reported in cached trials |
| Serum serotonin increased | 81 | 202.8 158.3–259.9ROR 203.3 · calibrated p 6e-10 ✓ | 150.9 EB05 125.2 · IC025 +6.0 3/3 methods agree | Lab value / disease marker | serious n=63 | not reported in cached trials |
| Insulin-like growth factor increased | 293 | 177.3 156.0–201.6ROR 179.0 · calibrated p 1e-9 ✓ | 139.5 EB05 126.6 · IC025 +6.6 3/3 methods agree | Lab value / disease marker | serious n=274 | not reported in cached trials |
| Acromegaly | 61 | 163.6 123.7–216.3ROR 163.9 · calibrated p 4e-9 ✓ | 126.8 EB05 102.3 · IC025 +5.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=61 | not reported in cached trials |
| Insulin-like growth factor decreased | 86 | 132.9 105.5–167.4ROR 133.3 · calibrated p 2e-8 ✓ | 108.7 EB05 90.7 · IC025 +5.7 3/3 methods agree | Lab value / disease marker | serious n=81 · ♀ 80% (drug 55%) | not reported in cached trials |
| Transfusion-related circulatory overload | 38 | 132.2 93.4–187.1ROR 132.4 · calibrated p 3e-8 ✓ | 105.1 EB05 79.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=38 · ♀ 0% (drug 55%) | not reported in cached trials |
| Neuroendocrine carcinoma metastatic | 39 | 130.3 92.5–183.6ROR 130.5 · calibrated p 3e-8 ✓ | 104.0 EB05 79.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=39 | not reported in cached trials |
| Blood growth hormone decreased | 32 | 128.5 88.1–187.4ROR 128.6 · calibrated p 5e-8 ✓ | 101.8 EB05 75.5 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious n=30 | not reported in cached trials |
| Body temperature decreased | 1,459 | 118.7 112.4–125.3ROR 124.6 · calibrated p 2e-8 ✓ | 101.0 EB05 96.8 · IC025 +6.5 3/3 methods agree | Lab value / disease marker | serious PRR 84.5 | not reported in cached trials |
| Blood pressure systolic increased | 2,393 | 95.8 91.9–99.9ROR 103.9 · calibrated p 8e-8 ✓ | 84.0 EB05 81.2 · IC025 +6.3 3/3 methods agree | Lab value / disease marker | serious PRR 68.9 | not reported in cached trials |
| Blood pressure diastolic decreased | 882 | 93.0 86.7–99.7ROR 95.7 · calibrated p 2e-7 ✓ | 81.7 EB05 77.3 · IC025 +6.2 3/3 methods agree | Lab value / disease marker | serious PRR 65.0 | not reported in cached trials |
| Metastases to pancreas | 52 | 91.4 68.4–122.1ROR 91.6 · calibrated p 4e-7 ✓ | 78.4 EB05 62.1 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=52 | not reported in cached trials |
| Angina bullosa haemorrhagica | 26 | 85.6 57.0–128.7ROR 85.7 · calibrated p 1e-6 ✓ | 72.3 EB05 51.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=26 · 100% clinician | not reported in cached trials |
| Metastases to gastrointestinal tract | 25 | 79.3 52.4–119.9ROR 79.3 · calibrated p 2e-6 ✓ | 67.6 EB05 48.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=25 | not reported in cached trials |
| Hepatic neoplasm | 327 | 76.7 68.5–86.0ROR 77.5 · calibrated p 8e-7 ✓ | 68.8 EB05 62.7 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=325 | not reported in cached trials |
| Needle issue | 2,790 | 74.4 71.7–77.3ROR 81.8 · calibrated p 5e-7 ✓ | 67.1 EB05 65.1 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=1,474 | not reported in cached trials |
| Metastases to ovary | 27 | 64.1 43.2–95.0ROR 64.1 · calibrated p 6e-6 ✓ | 56.4 EB05 40.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 100% (drug 55%) | not reported in cached trials |
| Nephritic syndrome | 25 | 60.6 40.2–91.2ROR 60.6 · calibrated p 9e-6 ✓ | 53.5 EB05 38.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 100% (drug 55%) · 100% clinician | not reported in cached trials |
| Pituitary tumour | 121 | 60.5 50.2–72.8ROR 60.7 · calibrated p 5e-6 ✓ | 55.2 EB05 47.4 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=121 | not reported in cached trials |
| Blood pressure diastolic increased | 366 | 59.0 53.1–65.6ROR 59.7 · calibrated p 5e-6 ✓ | 54.2 EB05 49.7 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=366 | not reported in cached trials |
| Intestinal metastasis | 27 | 57.2 38.7–84.8ROR 57.3 · calibrated p 1e-5 ✓ | 51.1 EB05 36.9 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=27 | not reported in cached trials |
| Neuroendocrine carcinoma | 52 | 55.6 41.9–73.7ROR 55.7 · calibrated p 1e-5 ✓ | 50.5 EB05 40.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=51 | not reported in cached trials |
| Hepatic lesion | 314 | 53.9 48.1–60.5ROR 54.5 · calibrated p 8e-6 ✓ | 49.9 EB05 45.4 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=312 | not reported in cached trials |
| Metastases to abdominal cavity | 35 | 52.4 37.2–73.9ROR 52.5 · calibrated p 2e-5 ✓ | 47.6 EB05 35.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=35 | not reported in cached trials |
| Blood follicle stimulating hormone increased | 26 | 48.6 32.6–72.3ROR 48.6 · calibrated p 3e-5 ✓ | 44.1 EB05 31.6 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious n=26 · ♀ 0% (drug 55%) | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Octreotide as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (3 of 40 signal terms matched).
- NCT00966355 — Comparison of Terlipressin, Somatostatin, and Octreotide for Control of Variceal Bleeding (N=1034, PHASE4; 1 AE terms posted; arms: Octreotide; Somatostatin; Terlipressin)
- NCT00412061 — Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor (N=429, PHASE3; 354 AE terms posted; arms: Everolimus + Octreotide; Placebo + Octreotide; Everolimus Open Label)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Diarrhoea (diarrhea) | 4,550 | 4.9 4.8–5.0ROR 5.6 · calibrated p 0.180 | 4.9 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | NCT00966355: 3/260 (1.2%) on Octreotide |
| Death | 4,179 | 3.4 3.3–3.4ROR 3.7 · calibrated p 0.432 | 3.3 EB05 3.3 · IC025 +1.7 3/3 methods agree | Outcome field, not a reaction | serious PRR 2.5 | NCT00412061: 1/215 (0.5%) on Octreotide (serious AE) |
| Fatigue (tiredness) | 3,531 | 3.1 3.0–3.2ROR 3.4 · calibrated p 0.505 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | NCT00412061: 2/215 (0.9%) on Octreotide; 1/211 (0.5%) control (serious AE) |
| Malaise (feeling unwell) | 3,024 | 4.8 4.6–4.9ROR 5.2 · calibrated p 0.216 | 4.7 EB05 4.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | NCT00412061: 2/215 (0.9%) on Octreotide; 1/211 (0.5%) control (serious AE) |
| Blood pressure increased | 2,980 | 13.6 13.2–14.1ROR 15.0 · calibrated p 0.007 ✓ | 13.4 EB05 13.0 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.3 | not reported in cached trials |
| Nausea | 2,968 | 2.6 2.5–2.7ROR 2.8 · calibrated p 0.706 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | NCT00412061: 4/215 (1.9%) on Octreotide; 4/211 (1.9%) control (serious AE) |
| Needle issue | 2,790 | 74.4 71.7–77.3ROR 81.8 · calibrated p 5e-7 ✓ | 67.1 EB05 65.1 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=1,474 | not reported in cached trials |
| Pain | 2,595 | 2.9 2.8–3.0ROR 3.1 · calibrated p 0.598 | 2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | NCT00412061: 15/215 (7.0%) on Octreotide; 11/211 (5.2%) control (serious AE) |
| Malignant neoplasm progression | 2,478 | 17.1 16.5–17.8ROR 18.6 · calibrated p 0.003 ✓ | 16.7 EB05 16.2 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 12.8 | not reported in cached trials |
| Abdominal pain | 2,472 | 7.4 7.1–7.7ROR 8.0 · calibrated p 0.068 | 7.3 EB05 7.1 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 | NCT00412061: 15/215 (7.0%) on Octreotide; 11/211 (5.2%) control (serious AE) |
| Blood pressure systolic increased | 2,393 | 95.8 91.9–99.9ROR 103.9 · calibrated p 8e-8 ✓ | 84.0 EB05 81.2 · IC025 +6.3 3/3 methods agree | Lab value / disease marker | serious PRR 68.9 | not reported in cached trials |
| Asthenia (weakness) | 2,285 | 4.2 4.0–4.4ROR 4.5 · calibrated p 0.302 | 4.2 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | NCT00412061: 2/215 (0.9%) on Octreotide; 3/211 (1.4%) control (serious AE) |
| Weight decreased (weight loss) | 2,280 | 5.7 5.4–5.9ROR 6.0 · calibrated p 0.147 | 5.6 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.1 | NCT00412061: 1/215 (0.5%) on Octreotide; 1/211 (0.5%) control (serious AE) |
| Injection site pain (pain where injected) | 2,203 | 5.0 4.8–5.2ROR 5.3 · calibrated p 0.201 | 5.0 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 22.0 | NCT00412061: 15/215 (7.0%) on Octreotide; 11/211 (5.2%) control (serious AE) |
| Headache | 2,086 | 2.3 2.2–2.4ROR 2.4 · calibrated p 0.860 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | NCT00412061: 2/211 (0.9%) control (serious AE) |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- 5-hydroxyindolacetic acid increased — n=44, PRR 1,571.2
- Gastroenteropancreatic neuroendocrine tumour disease — n=75, PRR 1,413.5
- Carcinoid crisis — n=151, PRR 1,384.5 (also seen in trial arm)
- Carcinoid heart disease — n=45, PRR 710.0 (also seen in trial arm)
- Metastatic carcinoid tumour — n=46, PRR 529.0
- Carcinoid tumour — n=276, PRR 400.1
- Carcinoid syndrome — n=127, PRR 371.4 (also seen in trial arm)
- Pancreatic neuroendocrine tumour metastatic — n=82, PRR 361.3
- Carcinoid tumour of the small bowel — n=31, PRR 292.1
- Neuroendocrine tumour — n=410, PRR 279.0
✓ A hand-written Bradford Hill causality assessment exists for this drug: Octreotide (somatostatin analogues) ↔ Gallstones (cholelithiasis).
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Octreotide?
In FDA FAERS, the most frequently co-reported reaction terms for Octreotide are diarrhoea, fatigue, malaise, blood pressure increased, nausea, needle issue. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Octreotide have an FDA boxed warning?
No. The FDA label retrieved for Octreotide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Octreotide causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 58d80bc6-bdfb-4908-93e7-aace447c8d1a, effective 20250724; matched on
openfda.generic_name.exact:"OCTREOTIDE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,226 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
OCTREOTIDE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.