Octreotide side effects: what 5,536 FDA adverse event reports show

Octreotide · Mycapssa · 324 reaction terms · 11,699 drug–reaction co-reports · data 2026-09-14

Drug class

Somatostatin Analog

FDA label (Established Pharmacologic Class)

Brand names

Mycapssa

openFDA label

Who reports

5,536 reports · 87% serious · 902 with death outcome · 53% female

openFDA FAERS counts, all years, deduplication not applied

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 ).

FDA label, Indications and Usage

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*)].

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 6Labeled (related wording) 3Reporting / coding artifact 5Lab value / disease marker 3Not in label — unassessed 23

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 284 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Metastases to liver	101	21.7 17.9–26.3ROR 22.1 · χ² 1,962 / p <1e-300	21.5 EB05 18.2 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 14.6	no trial data cached
Blood pressure systolic increased	87	16.7 13.5–20.6ROR 16.9 · χ² 1,263 / p 6e-277	16.6 EB05 13.8 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious PRR 12.0	no trial data cached
Body temperature decreased	38	14.4 10.5–19.7ROR 14.5 · χ² 458 / p 6e-102	14.1 EB05 10.5 · IC025 +3.1 3/3 methods agree	Lab value / disease marker	serious PRR 10.7	no trial data cached
Hypoglycaemia (low blood sugar)	164	12.7 10.9–14.8ROR 13.0 · χ² 1,752 / p <1e-300	12.6 EB05 11.0 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.3	no trial data cached
Drug ineffective for unapproved indication	185	12.5 10.8–14.4ROR 12.9 · χ² 1,937 / p <1e-300	12.4 EB05 10.9 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 17.4 · 98% clinician	no trial data cached
Small intestinal obstruction	33	10.1 7.2–14.2ROR 10.1 · χ² 261 / p 6e-59	9.5 EB05 6.9 · IC025 +2.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.8 · ♀ 73% (drug 53%)	no trial data cached
Metastases to bone	42	9.6 7.1–13.0ROR 9.7 · χ² 316 / p 6e-71	9.1 EB05 6.9 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 6.4	no trial data cached
Hepatic encephalopathy	23	9.2 6.1–13.9ROR 9.3 · χ² 160 / p 4e-37	8.3 EB05 5.6 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 6.2 · ♀ 27% (drug 53%) · 91% clinician	no trial data cached
Malignant neoplasm progression	248	9.1 8.1–10.3ROR 9.5 · χ² 1,792 / p <1e-300	9.0 EB05 8.1 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious PRR 6.2	no trial data cached
Therapy non-responder	103	8.7 7.2–10.5ROR 8.8 · χ² 691 / p 2e-152	8.4 EB05 7.1 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 8.9 · 92% clinician	no trial data cached
Malnutrition	25	8.4 5.7–12.5ROR 8.5 · χ² 156 / p 4e-36	7.6 EB05 5.3 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 5.9 · 92% clinician	no trial data cached
Neoplasm progression	77	8.2 6.6–10.3ROR 8.3 · χ² 481 / p 6e-107	7.9 EB05 6.5 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 7.2	no trial data cached
Neoplasm	25	8.1 5.5–12.0ROR 8.2 · χ² 149 / p 1e-34	7.3 EB05 5.1 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 5.5 · 72% consumer	no trial data cached
Ascites	62	7.9 6.2–10.1ROR 8.0 · χ² 367 / p 5e-82	7.6 EB05 6.1 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 5.4	no trial data cached
Cholelithiasis	68	7.8 6.1–9.8ROR 7.9 · χ² 394 / p 5e-88	7.5 EB05 6.1 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.3	no trial data cached
Sinus bradycardia	20	7.7 5.0–12.0ROR 7.8 · χ² 111 / p 4e-26	6.8 EB05 4.6 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.8 · ♀ 25% (drug 53%) · 90% clinician	no trial data cached
Cardiomyopathy	27	6.8 4.7–10.0ROR 6.9 · χ² 129 / p 4e-30	6.2 EB05 4.4 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 4.6 · 96% clinician	no trial data cached
Generalised oedema	22	6.7 4.4–10.2ROR 6.7 · χ² 101 / p 5e-24	6.0 EB05 4.1 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.0	no trial data cached
Upper gastrointestinal haemorrhage	30	6.7 4.7–9.5ROR 6.7 · χ² 139 / p 3e-32	6.1 EB05 4.5 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.5	no trial data cached
Needle issue	49	6.4 4.9–8.5ROR 6.5 · χ² 219 / p 8e-50	6.1 EB05 4.8 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious n=47	no trial data cached
Intestinal obstruction	63	6.3 4.9–8.1ROR 6.4 · χ² 276 / p 3e-62	6.0 EB05 4.9 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.3	no trial data cached
Hypocalcaemia (low calcium)	29	5.8 4.0–8.3ROR 5.8 · χ² 109 / p 7e-26	5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 4.1 · ♀ 32% (drug 53%) · 100% clinician	no trial data cached
Flatulence (gas)	86	5.7 4.6–7.0ROR 5.8 · χ² 329 / p 1e-73	5.5 EB05 4.6 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.4	no trial data cached
Electrolyte imbalance	17	5.5 3.4–8.9ROR 5.6 · χ² 59 / p 9e-15	4.9 EB05 3.2 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 3.9	no trial data cached
Therapy partial responder	22	5.5 3.6–8.3ROR 5.5 · χ² 76 / p 1e-18	4.9 EB05 3.4 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 4.5 · 100% clinician	no trial data cached
Hyperglycaemia (high blood sugar)	53	5.5 4.2–7.1ROR 5.5 · χ² 189 / p 3e-43	5.2 EB05 4.1 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.0 · 92% clinician	no trial data cached
Ventricular tachycardia	24	5.4 3.6–8.1ROR 5.4 · χ² 82 / p 6e-20	4.9 EB05 3.5 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 3.7 · 91% clinician	no trial data cached
Nephropathy toxic	16	5.4 3.3–8.8ROR 5.4 · χ² 53 / p 2e-13	4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 3.5	no trial data cached
Hepatomegaly	14	5.3 3.1–9.0ROR 5.3 · χ² 45 / p 1e-11	4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 3.6	no trial data cached
Clostridium difficile colitis	15	5.3 3.2–8.8ROR 5.3 · χ² 48 / p 2e-12	4.6 EB05 3.0 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 3.6	no trial data cached
Multiple organ dysfunction syndrome	39	5.2 3.8–7.2ROR 5.3 · χ² 129 / p 3e-30	4.9 EB05 3.8 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 3.5	no trial data cached
Flank pain	13	5.2 3.0–9.0ROR 5.2 · χ² 40 / p 1e-10	4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 4.6	no trial data cached
Hypercholesterolaemia	13	5.1 3.0–8.8ROR 5.1 · χ² 39 / p 2e-10	4.4 EB05 2.7 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 3.6	no trial data cached
Disease progression	160	5.1 4.4–5.9ROR 5.2 · χ² 523 / p 5e-116	5.0 EB05 4.4 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 3.8	no trial data cached
Blood calcium decreased	15	5.0 3.0–8.3ROR 5.0 · χ² 44 / p 2e-11	4.4 EB05 2.8 · IC025 +1.3 3/3 methods agree	Lab value / disease marker	serious PRR 3.1	no trial data cached
Acute hepatic failure	18	5.0 3.1–7.9ROR 5.0 · χ² 53 / p 2e-13	4.4 EB05 3.0 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 3.3	no trial data cached
Cytomegalovirus infection	22	5.0 3.3–7.5ROR 5.0 · χ² 66 / p 3e-16	4.5 EB05 3.2 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 3.4 · 91% clinician	no trial data cached
Flushing	135	5.0 4.2–5.9ROR 5.1 · χ² 424 / p 2e-94	4.9 EB05 4.2 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 7.2	no trial data cached
Hepatic failure	39	4.8 3.5–6.6ROR 4.9 · χ² 115 / p 4e-27	4.6 EB05 3.5 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 3.2	no trial data cached
Motor dysfunction	13	4.8 2.8–8.3ROR 4.8 · χ² 36 / p 1e-9	4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 4.1	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Off label use (used outside approved label)	727	3.1 2.9–3.4ROR 3.5 · χ² 1,101 / p 9e-242	3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 3.2	no trial data cached
Drug ineffective (drug did not work)	693	2.0 1.8–2.1ROR 2.1 · χ² 352 / p 7e-79	2.0 EB05 1.8 · IC025 +0.9	Reporting / coding artifact	serious PRR 3.3	no trial data cached
Diarrhoea (diarrhea)	547	3.2 2.9–3.4ROR 3.4 · χ² 843 / p 1e-185	3.2 EB05 3.0 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.0	no trial data cached
Death	388	1.7 1.5–1.9ROR 1.7 · χ² 112 / p 2e-26	1.7 EB05 1.5 · IC025 +0.6	Outcome field, not a reaction	serious PRR 1.1	no trial data cached
Malignant neoplasm progression	248	9.1 8.1–10.3ROR 9.5 · χ² 1,792 / p <1e-300	9.0 EB05 8.1 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious PRR 6.2	no trial data cached
Abdominal pain	231	3.7 3.3–4.2ROR 3.8 · χ² 462 / p 1e-102	3.7 EB05 3.3 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.8	no trial data cached
Weight decreased (weight loss)	187	2.5 2.2–2.9ROR 2.6 · χ² 170 / p 3e-39	2.5 EB05 2.2 · IC025 +1.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.3	no trial data cached
Drug ineffective for unapproved indication	185	12.5 10.8–14.4ROR 12.9 · χ² 1,937 / p <1e-300	12.4 EB05 10.9 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 17.4 · 98% clinician	no trial data cached
Product use in unapproved indication	179	2.7 2.4–3.2ROR 2.8 · χ² 199 / p 2e-45	2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 3.3	no trial data cached
Hypoglycaemia (low blood sugar)	164	12.7 10.9–14.8ROR 13.0 · χ² 1,752 / p <1e-300	12.6 EB05 11.0 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.3	no trial data cached
Disease progression	160	5.1 4.4–5.9ROR 5.2 · χ² 523 / p 5e-116	5.0 EB05 4.4 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 3.8	no trial data cached
Decreased appetite (loss of appetite)	158	2.6 2.2–3.0ROR 2.6 · χ² 149 / p 1e-34	2.5 EB05 2.2 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 2.3	no trial data cached
Acute kidney injury (sudden kidney damage)	141	3.5 2.9–4.1ROR 3.5 · χ² 247 / p 7e-56	3.4 EB05 3.0 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.3	no trial data cached
Flushing	135	5.0 4.2–5.9ROR 5.1 · χ² 424 / p 2e-94	4.9 EB05 4.2 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 7.2	no trial data cached
Blood pressure increased	132	3.2 2.7–3.8ROR 3.3 · χ² 202 / p 4e-46	3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.9	no trial data cached

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.

Metastases to liver — n=101, PRR 21.7
Metastases to bone — n=42, PRR 9.6
Hepatic encephalopathy — n=23, PRR 9.2
Malnutrition — n=25, PRR 8.4
Neoplasm progression — n=77, PRR 8.2
Neoplasm — n=25, PRR 8.1
Ascites — n=62, PRR 7.9
Cardiomyopathy — n=27, PRR 6.8
Needle issue — n=49, PRR 6.4
Hypocalcaemia — n=29, PRR 5.8

✓ 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, abdominal pain, weight decreased, hypoglycaemia, decreased appetite, acute kidney injury. 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, field patient.drug.openfda.generic_name.exact, 324 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

Page generated 2026-10-08. 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.