Drug · FAERS side-effect profile with label screen
Pasireotide side effects: what 2,235 FDA adverse event reports show
Drug class
Somatostatin analog
FDA label, Indications wording
Brand names
Signifor Lar
openFDA label
Who reports
2,235 reports · 71% serious · 157 with death outcome · 66% female
openFDA FAERS counts, all years, deduplication not applied
Used for
SIGNIFOR LAR is a somatostatin analog indicated for the treatment of: Patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. ( 1.1 ) Patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative.
FDA label, Indications and Usage
What it is
SIGNIFOR LAR (pasireotide) for injectable suspension is a long-acting release form of pasireotide pamoate, as powder to be suspended in the provided diluent immediately prior to intramuscular injection. SIGNIFOR LAR contains pasireotide, a somatostatin analog in the form of pasireotide pamoate (pamoic acid salt).
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 9Labeled (related wording) 4Reporting / coding artifact 1Lab value / disease marker 11Not in label — unassessed 15
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. 36 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 |
|---|---|---|---|---|---|---|
| Hyperglycaemia (high blood sugar) | 247 | 64.2 57.1–72.3ROR 72.1 · χ² 15,232 / p <1e-300 | 63.5 EB05 57.1 · IC025 +5.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 51.3 | no trial data cached |
| Adrenal insufficiency | 50 | 39.3 29.9–51.8ROR 40.2 · χ² 1,824 / p <1e-300 | 38.7 EB05 30.5 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 32.1 | no trial data cached |
| Diabetes mellitus | 244 | 30.0 26.6–33.8ROR 33.5 · χ² 6,811 / p <1e-300 | 29.8 EB05 26.8 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 26.0 | no trial data cached |
| Nocturia (night-time urination) | 37 | 28.7 20.9–39.6ROR 29.2 · χ² 961 / p 3e-211 | 28.3 EB05 21.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 39.9 · ♀ 100% (drug 66%) | no trial data cached |
| Glycosylated haemoglobin increased | 71 | 26.5 21.1–33.3ROR 27.4 · χ² 1,715 / p <1e-300 | 26.3 EB05 21.5 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 41.0 | no trial data cached |
| Faeces discoloured | 46 | 19.9 15.0–26.6ROR 20.3 · χ² 808 / p 4e-178 | 19.8 EB05 15.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 22.3 · ♀ 95% (drug 66%) | no trial data cached |
| Sleep apnoea syndrome | 40 | 19.7 14.5–26.7ROR 20.0 · χ² 689 / p 4e-152 | 19.4 EB05 14.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 18.9 · ♀ 92% (drug 66%) | no trial data cached |
| Cholelithiasis | 65 | 18.6 14.7–23.7ROR 19.2 · χ² 1,066 / p 4e-234 | 18.5 EB05 15.0 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.6 | no trial data cached |
| Diabetes mellitus inadequate control | 35 | 18.6 13.4–25.8ROR 18.9 · χ² 564 / p 6e-125 | 18.3 EB05 13.7 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.6 | no trial data cached |
| Hypoglycaemia (low blood sugar) | 81 | 15.7 12.7–19.4ROR 16.2 · χ² 1,099 / p 2e-241 | 15.6 EB05 12.9 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.7 | no trial data cached |
| Blood pressure systolic increased | 31 | 14.9 10.5–21.1ROR 15.1 · χ² 387 / p 2e-86 | 14.5 EB05 10.5 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 12.7 | no trial data cached |
| Hepatic steatosis | 29 | 14.6 10.2–21.0ROR 14.8 · χ² 355 / p 2e-79 | 14.3 EB05 10.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 | no trial data cached |
| Blood glucose fluctuation | 17 | 14.5 9.0–23.3ROR 14.6 · χ² 201 / p 8e-46 | 13.7 EB05 8.5 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious n=14 | no trial data cached |
| Nerve injury | 17 | 14.3 8.9–23.0ROR 14.4 · χ² 197 / p 4e-45 | 13.5 EB05 8.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 15.0 | no trial data cached |
| Neoplasm | 17 | 13.9 8.6–22.3ROR 14.0 · χ² 190 / p 2e-43 | 13.0 EB05 8.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | no trial data cached |
| Blood glucose increased | 259 | 12.9 11.5–14.4ROR 14.4 · χ² 2,843 / p <1e-300 | 12.8 EB05 11.5 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.3 · 71% consumer | no trial data cached |
| Blood iron decreased | 16 | 12.7 7.8–20.8ROR 12.8 · χ² 162 / p 3e-37 | 11.7 EB05 7.0 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 14.0 | no trial data cached |
| Body temperature decreased | 13 | 12.3 7.1–21.2ROR 12.4 · χ² 124 / p 5e-29 | 10.8 EB05 6.1 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 11.0 | no trial data cached |
| Blood glucose decreased | 63 | 12.3 9.6–15.7ROR 12.6 · χ² 642 / p 6e-142 | 12.1 EB05 9.7 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.6 · 78% consumer | no trial data cached |
| Brain neoplasm | 11 | 11.2 6.2–20.3ROR 11.3 · χ² 93 / p 3e-22 | 9.3 EB05 5.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Blood potassium increased | 19 | 11.0 7.0–17.2ROR 11.1 · χ² 163 / p 1e-37 | 10.0 EB05 6.3 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 11.5 | no trial data cached |
| Type 2 diabetes mellitus | 39 | 10.8 7.9–14.8ROR 11.0 · χ² 339 / p 6e-76 | 10.4 EB05 7.7 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.2 · 92% clinician | no trial data cached |
| Pulmonary mass | 17 | 10.7 6.7–17.2ROR 10.8 · χ² 140 / p 1e-32 | 9.5 EB05 5.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Neoplasm progression | 38 | 10.2 7.4–13.9ROR 10.3 · χ² 305 / p 1e-68 | 9.6 EB05 7.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 · ♀ 40% (drug 66%) | no trial data cached |
| Blood urea increased | 17 | 9.5 5.9–15.2ROR 9.5 · χ² 121 / p 2e-28 | 8.2 EB05 5.2 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 8.5 | no trial data cached |
| Haematocrit decreased | 17 | 8.0 5.0–12.8ROR 8.0 · χ² 97 / p 3e-23 | 6.9 EB05 4.4 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 7.3 | no trial data cached |
| Lymphocyte count decreased | 15 | 8.0 4.8–13.2ROR 8.0 · χ² 84 / p 2e-20 | 6.7 EB05 4.2 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 7.9 | no trial data cached |
| Blood glucose abnormal | 15 | 7.6 4.6–12.6ROR 7.6 · χ² 80 / p 2e-19 | 6.4 EB05 4.0 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 11.4 | no trial data cached |
| Inappropriate schedule of drug administration | 58 | 7.5 5.9–9.7ROR 7.7 · χ² 324 / p 1e-72 | 7.2 EB05 5.7 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 · 86% consumer | no trial data cached |
| Heart rate irregular | 18 | 7.4 4.7–11.8ROR 7.5 · χ² 94 / p 2e-22 | 6.4 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Thirst | 13 | 6.8 4.0–11.8ROR 6.9 · χ² 59 / p 7e-15 | 5.7 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Hypophagia | 18 | 6.7 4.2–10.6ROR 6.7 · χ² 81 / p 1e-19 | 5.8 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Blood pressure fluctuation | 16 | 6.2 3.8–10.2ROR 6.3 · χ² 65 / p 3e-16 | 5.4 EB05 3.5 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 6.4 | no trial data cached |
| Limb discomfort | 19 | 5.8 3.7–9.0ROR 5.8 · χ² 70 / p 3e-17 | 5.1 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Blood pressure increased | 90 | 5.5 4.5–6.8ROR 5.7 · χ² 330 / p 4e-74 | 5.4 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.8 | no trial data cached |
| Urinary incontinence | 17 | 5.4 3.4–8.7ROR 5.4 · χ² 56 / p 3e-14 | 4.7 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Red blood cell count decreased | 16 | 5.2 3.2–8.5ROR 5.3 · χ² 51 / p 5e-13 | 4.6 EB05 3.0 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious PRR 5.6 | no trial data cached |
| Osteoporosis | 23 | 5.2 3.5–7.9ROR 5.3 · χ² 75 / p 3e-18 | 4.8 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · ♀ 91% (drug 66%) | no trial data cached |
| Blood pressure decreased | 36 | 5.1 3.7–7.0ROR 5.2 · χ² 115 / p 5e-27 | 4.8 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 · ♀ 87% (drug 66%) | no trial data cached |
| Diabetic ketoacidosis | 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 | Labeled adverse reaction exact term | 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 |
|---|---|---|---|---|---|---|
| Blood glucose increased | 259 | 12.9 11.5–14.4ROR 14.4 · χ² 2,843 / p <1e-300 | 12.8 EB05 11.5 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.3 · 71% consumer | no trial data cached |
| Hyperglycaemia (high blood sugar) | 247 | 64.2 57.1–72.3ROR 72.1 · χ² 15,232 / p <1e-300 | 63.5 EB05 57.1 · IC025 +5.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 51.3 | no trial data cached |
| Diabetes mellitus | 244 | 30.0 26.6–33.8ROR 33.5 · χ² 6,811 / p <1e-300 | 29.8 EB05 26.8 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 26.0 | no trial data cached |
| Blood pressure increased | 90 | 5.5 4.5–6.8ROR 5.7 · χ² 330 / p 4e-74 | 5.4 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.8 | no trial data cached |
| Hypoglycaemia (low blood sugar) | 81 | 15.7 12.7–19.4ROR 16.2 · χ² 1,099 / p 2e-241 | 15.6 EB05 12.9 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.7 | no trial data cached |
| Inappropriate schedule of product administration | 72 | 3.8 3.0–4.8ROR 3.9 · χ² 148 / p 2e-34 | 3.7 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 7.1 | no trial data cached |
| Glycosylated haemoglobin increased | 71 | 26.5 21.1–33.3ROR 27.4 · χ² 1,715 / p <1e-300 | 26.3 EB05 21.5 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 41.0 | no trial data cached |
| Cholelithiasis | 65 | 18.6 14.7–23.7ROR 19.2 · χ² 1,066 / p 4e-234 | 18.5 EB05 15.0 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.6 | no trial data cached |
| Blood glucose decreased | 63 | 12.3 9.6–15.7ROR 12.6 · χ² 642 / p 6e-142 | 12.1 EB05 9.7 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.6 · 78% consumer | no trial data cached |
| Disease progression | 59 | 4.7 3.7–6.0ROR 4.8 · χ² 169 / p 7e-39 | 4.5 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.3 · ♀ 43% (drug 66%) | no trial data cached |
| Inappropriate schedule of drug administration | 58 | 7.5 5.9–9.7ROR 7.7 · χ² 324 / p 1e-72 | 7.2 EB05 5.7 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 · 86% consumer | no trial data cached |
| Adrenal insufficiency | 50 | 39.3 29.9–51.8ROR 40.2 · χ² 1,824 / p <1e-300 | 38.7 EB05 30.5 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 32.1 | no trial data cached |
| Faeces discoloured | 46 | 19.9 15.0–26.6ROR 20.3 · χ² 808 / p 4e-178 | 19.8 EB05 15.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 22.3 · ♀ 95% (drug 66%) | no trial data cached |
| Injection site pain (pain where injected) | 41 | 1.3 0.9–1.7ROR 1.3 · χ² 2 / p 0.074 | 1.3 EB05 1.0 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Labeled (related wording) related wording | serious PRR 3.2 | no trial data cached |
| Sleep apnoea syndrome | 40 | 19.7 14.5–26.7ROR 20.0 · χ² 689 / p 4e-152 | 19.4 EB05 14.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 18.9 · ♀ 92% (drug 66%) | 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.
- Nocturia — n=37, PRR 28.7
- Faeces discoloured — n=46, PRR 19.9
- Sleep apnoea syndrome — n=40, PRR 19.7
- Hepatic steatosis — n=29, PRR 14.6
- Neoplasm progression — n=38, PRR 10.2
- Osteoporosis — n=23, PRR 5.2
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 Pasireotide?
In FDA FAERS, the most frequently co-reported reaction terms for Pasireotide are blood glucose increased, hyperglycaemia, diabetes mellitus, blood pressure increased, hypoglycaemia, glycosylated haemoglobin increased. 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 Pasireotide have an FDA boxed warning?
No. The FDA label retrieved for Pasireotide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Pasireotide 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 a0aad470-3f38-af97-e053-2995a90a383a, effective 20240716; matched on
openfda.generic_name.exact:"PASIREOTIDE") - 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, 76 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.