Drug · FAERS side-effect profile with label screen
Lanreotide side effects: what 7,791 FDA adverse event reports show
Drug class
Somatostatin analog
FDA label, Indications wording of the closest related product
Label matched
Lanreotide Acetate (Lanreotide Acetate)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
7,791 reports · 59% serious · 1,422 with death outcome · 55% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Lanreotide Injection is a somatostatin analog indicated for: the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. ( 1.1 ) the treatment of adult patients with unre.
FDA label, Indications and Usage
What it is
Lanreotide Injection 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL is a prolonged-release formulation for deep subcutaneous injection. It contains the drug substance lanreotide acetate, a synt.
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 1Labeled (related wording) 5Likely indication confounding 5Reporting / coding artifact 4Lab value / disease marker 4Not in label — unassessed 21
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.
- 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.
- 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. 969 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Genitourinary tract neoplasm | 11 | 411.1 217.9–775.6ROR 411.7 · χ² 3,550 / p <1e-300 | 220.4 EB05 131.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Insulin-like growth factor abnormal | 12 | 315.3 173.4–573.4ROR 315.8 · χ² 3,085 / p <1e-300 | 194.9 EB05 118.8 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=4 | no trial data cached |
| Carcinoid crisis | 18 | 230.7 142.6–373.3ROR 231.3 · χ² 3,580 / p <1e-300 | 173.6 EB05 116.2 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious n=18 | no trial data cached |
| Growth hormone deficiency | 30 | 219.3 151.2–318.0ROR 220.2 · χ² 5,822 / p <1e-300 | 179.6 EB05 131.9 · IC025 +4.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=29 · ♀ 0% (drug 55%) · 83% consumer | no trial data cached |
| Blood growth hormone increased | 41 | 210.4 153.2–289.0ROR 211.5 · χ² 7,726 / p <1e-300 | 178.9 EB05 137.5 · IC025 +5.3 3/3 methods agree | Likely indication confounding term in indications | serious n=24 | no trial data cached |
| Insulin-like growth factor increased | 100 | 201.9 165.0–247.2ROR 204.6 · χ² 18,396 / p <1e-300 | 181.3 EB05 153.4 · IC025 +6.3 3/3 methods agree | Lab value / disease marker | serious n=33 | no trial data cached |
| Serum serotonin increased | 22 | 176.9 115.0–272.2ROR 177.4 · χ² 3,445 / p <1e-300 | 145.2 EB05 101.1 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial data cached |
| Blood chromogranin a increased | 26 | 162.7 109.6–241.6ROR 163.3 · χ² 3,787 / p <1e-300 | 138.0 EB05 99.0 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=21 | no trial data cached |
| Metastases to spinal cord | 11 | 161.3 87.8–296.3ROR 161.5 · χ² 1,504 / p <1e-300 | 120.8 EB05 72.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Carcinoid tumour pulmonary | 12 | 140.3 78.5–250.6ROR 140.5 · χ² 1,447 / p <1e-300 | 110.4 EB05 67.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Pelvic neoplasm | 15 | 121.0 72.1–202.9ROR 121.2 · χ² 1,594 / p <1e-300 | 101.2 EB05 65.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Carcinoid syndrome | 13 | 99.7 57.3–173.4ROR 99.9 · χ² 1,131 / p 3e-248 | 84.6 EB05 52.6 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=12 | no trial data cached |
| Product administered by wrong person | 13 | 98.6 56.7–171.4ROR 98.7 · χ² 1,118 / p 2e-245 | 83.8 EB05 52.1 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Product ineffective | 21 | 84.2 54.5–129.9ROR 84.4 · χ² 1,593 / p <1e-300 | 76.2 EB05 52.6 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious n=17 | no trial data cached |
| Metastases to abdominal cavity | 12 | 66.9 37.7–118.6ROR 67.0 · χ² 697 / p 7e-154 | 59.4 EB05 36.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Pituitary tumour benign | 36 | 60.3 43.4–83.9ROR 60.6 · χ² 1,996 / p <1e-300 | 57.3 EB05 43.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=36 · ♀ 0% (drug 55%) · 75% consumer | no trial data cached |
| Hepatic neoplasm | 68 | 57.3 45.1–72.7ROR 57.8 · χ² 3,626 / p <1e-300 | 55.3 EB05 45.1 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=67 · 78% consumer | no trial data cached |
| Salpingectomy | 11 | 52.7 29.0–95.7ROR 52.8 · χ² 497 / p 2e-110 | 47.7 EB05 28.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Pancreatic neuroendocrine tumour | 12 | 51.3 29.0–90.7ROR 51.4 · χ² 532 / p 5e-118 | 46.8 EB05 28.5 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=12 | no trial data cached |
| Faeces pale | 34 | 41.9 29.9–58.8ROR 42.1 · χ² 1,297 / p 2e-284 | 40.4 EB05 30.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=27 | no trial data cached |
| Tumour pain | 20 | 41.3 26.5–64.1ROR 41.4 · χ² 735 / p 4e-162 | 39.3 EB05 26.8 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious n=20 · ♀ 90% (drug 55%) | no trial data cached |
| Palliative care | 22 | 39.2 25.7–59.7ROR 39.3 · χ² 769 / p 1e-169 | 37.5 EB05 26.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial data cached |
| Oophorectomy | 12 | 36.6 20.7–64.7ROR 36.7 · χ² 376 / p 6e-84 | 34.3 EB05 20.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Neuroendocrine tumour | 19 | 36.3 23.1–57.1ROR 36.4 · χ² 610 / p 7e-135 | 34.7 EB05 23.5 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=19 | no trial data cached |
| Treatment delayed | 21 | 35.4 23.0–54.4ROR 35.5 · χ² 659 / p 1e-145 | 34.0 EB05 23.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Biliary obstruction | 13 | 28.2 16.4–48.7ROR 28.3 · χ² 311 / p 5e-70 | 26.9 EB05 16.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Injection site mass | 373 | 27.5 24.9–30.4ROR 28.8 · χ² 9,414 / p <1e-300 | 27.2 EB05 24.9 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 64.9 | no trial data cached |
| Pituitary tumour | 15 | 27.2 16.4–45.2ROR 27.3 · χ² 349 / p 3e-78 | 26.1 EB05 16.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Lack of injection site rotation | 17 | 26.8 16.6–43.2ROR 26.9 · χ² 393 / p 9e-88 | 25.9 EB05 17.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Pancreatic failure | 15 | 23.8 14.3–39.6ROR 23.9 · χ² 303 / p 4e-68 | 22.9 EB05 14.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Product supply issue | 56 | 21.5 16.6–28.0ROR 21.7 · χ² 1,067 / p 3e-234 | 21.2 EB05 16.9 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious n=50 · ♀ 76% (drug 55%) · 77% consumer | no trial data cached |
| Injection site nodule | 87 | 21.5 17.4–26.5ROR 21.7 · χ² 1,665 / p <1e-300 | 21.2 EB05 17.7 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious n=30 | no trial data cached |
| Steatorrhoea | 20 | 20.2 13.0–31.4ROR 20.3 · χ² 344 / p 4e-77 | 19.7 EB05 13.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Injection site scar | 19 | 18.3 11.6–28.6ROR 18.3 · χ² 291 / p 2e-65 | 17.7 EB05 11.7 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Vena cava thrombosis | 11 | 17.9 9.9–32.3ROR 17.9 · χ² 158 / p 2e-36 | 16.6 EB05 8.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Hepatic lesion | 27 | 16.9 11.6–24.7ROR 17.0 · χ² 386 / p 3e-86 | 16.5 EB05 11.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=27 | no trial data cached |
| Faeces soft | 45 | 16.8 12.6–22.5ROR 16.9 · χ² 650 / p 1e-143 | 16.6 EB05 12.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=32 | no trial data cached |
| Hepatic pain | 26 | 16.4 11.2–24.2ROR 16.5 · χ² 360 / p 2e-80 | 16.0 EB05 11.3 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=18 · ♀ 79% (drug 55%) | no trial data cached |
| Menopausal symptoms | 13 | 15.4 8.9–26.6ROR 15.4 · χ² 160 / p 5e-37 | 14.3 EB05 8.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Incorrect drug administration rate | 24 | 15.3 10.3–22.9ROR 15.4 · χ² 306 / p 8e-69 | 14.9 EB05 10.2 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious n=8 · 83% consumer | 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) | 1,461 | 4.5 4.3–4.7ROR 5.4 · χ² 4,188 / p <1e-300 | 4.5 EB05 4.3 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 6.3 | no trial data cached |
| Diarrhoea (diarrhea) | 1,415 | 5.9 5.7–6.2ROR 7.0 · χ² 5,963 / p <1e-300 | 5.9 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial data cached |
| Death | 1,221 | 3.8 3.6–4.0ROR 4.3 · χ² 2,641 / p <1e-300 | 3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.7 | no trial data cached |
| Fatigue (tiredness) | 972 | 3.4 3.2–3.6ROR 3.7 · χ² 1,677 / p <1e-300 | 3.4 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Nausea | 725 | 2.5 2.3–2.7ROR 2.6 · χ² 659 / p 1e-145 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Injection site pain (pain where injected) | 596 | 5.3 4.9–5.7ROR 5.6 · χ² 2,096 / p <1e-300 | 5.3 EB05 4.9 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.8 | no trial data cached |
| Abdominal pain | 568 | 6.6 6.1–7.1ROR 7.0 · χ² 2,709 / p <1e-300 | 6.5 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 | no trial data cached |
| Headache | 502 | 2.2 2.0–2.3ROR 2.2 · χ² 320 / p 7e-72 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Malaise (feeling unwell) | 435 | 2.7 2.4–2.9ROR 2.8 · χ² 460 / p 3e-102 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Dizziness | 414 | 2.2 2.0–2.5ROR 2.3 · χ² 289 / p 4e-65 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | no trial data cached |
| Asthenia (weakness) | 413 | 3.0 2.7–3.2ROR 3.1 · χ² 542 / p 4e-120 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Weight decreased (weight loss) | 398 | 3.8 3.5–4.2ROR 4.0 · χ² 844 / p 9e-186 | 3.8 EB05 3.5 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 | no trial data cached |
| Pain | 395 | 1.7 1.6–1.9ROR 1.8 · χ² 124 / p 5e-29 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Product dose omission issue | 377 | 3.6 3.2–3.9ROR 3.7 · χ² 702 / p 6e-155 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 7.9 | no trial data cached |
| Injection site mass | 373 | 27.5 24.9–30.4ROR 28.8 · χ² 9,414 / p <1e-300 | 27.2 EB05 24.9 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 64.9 | 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.
- Pituitary tumour benign — n=36, PRR 60.3
- Hepatic neoplasm — n=68, PRR 57.3
- Faeces pale — n=34, PRR 41.9
- Palliative care — n=22, PRR 39.2
- Treatment delayed — n=21, PRR 35.4
- Steatorrhoea — n=20, PRR 20.2
- Hepatic lesion — n=27, PRR 16.9
- Faeces soft — n=45, PRR 16.8
✓ A hand-written Bradford Hill causality assessment exists for this drug: Medroxyprogesterone acetate ↔ Meningioma.
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 Lanreotide?
In FDA FAERS, the most frequently co-reported reaction terms for Lanreotide are diarrhoea, fatigue, nausea, injection site pain, abdominal pain, headache. 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 Lanreotide have an FDA boxed warning?
No. The FDA label retrieved for Lanreotide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Lanreotide 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 2892b4c3-0329-4d29-97ff-3b45283bbab1, effective 20250201; matched on
openfda.generic_name.exact:"LANREOTIDE ACETATE") - 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, 1,009 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.