Drug · FAERS side-effect profile with label screen
Liraglutide side effects: what 49,086 FDA adverse event reports show
Who reports
49,086 reports · 48% serious · 1,765 with death outcome · 64% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Liraglutide injection is indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: Adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity. Adults with overweight in the presence of at least one weight-related comorbid condition.
FDA label, Indications and Usage
What it is
Liraglutide injection contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. The peptide precursor of liraglutide, produced by a chemical synthesis using solid phase synthesis and is 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34.
FDA label, Description section
Boxed warning
RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether liraglut.
FDA 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 — boxed warning 1Labeled adverse reaction 3Labeled (related wording) 3Likely indication confounding 2Reporting / coding artifact 1Lab value / disease marker 6Not in label — unassessed 24
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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, 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). 1,144 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 |
|---|---|---|---|---|---|---|
| Total lung capacity abnormal | 108 | 169.4 135.5–211.7ROR 169.7 · calibrated p 2e-9 ✓ | 118.5 EB05 100.9 · IC025 +6.0 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Not in label — unassessed | serious n=108 · ♀ 0% (drug 64%) | not reported in cached trials |
| Pulmonary vasculitis | 146 | 163.2 134.8–197.5ROR 163.7 · calibrated p 3e-9 ✓ | 116.1 EB05 101.1 · IC025 +6.1 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Not in label — unassessed | serious n=146 · ♀ 0% (drug 64%) | not reported in cached trials |
| Capillaritis | 53 | 105.1 77.8–142.0ROR 105.2 · calibrated p 1e-7 ✓ | 81.9 EB05 65.0 · IC025 +5.1 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Not in label — unassessed | serious n=53 · ♀ 0% (drug 64%) | not reported in cached trials |
| Spirometry abnormal | 101 | 88.6 71.5–109.8ROR 88.8 · calibrated p 4e-7 ✓ | 72.4 EB05 61.3 · IC025 +5.4 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Lab value / disease marker | serious n=101 · ♀ 0% (drug 64%) | not reported in cached trials |
| Mite allergy | 107 | 86.0 69.9–105.8ROR 86.2 · calibrated p 4e-7 ✓ | 70.7 EB05 60.1 · IC025 +5.4 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Not in label — unassessed | serious n=107 · ♀ 0% (drug 64%) | not reported in cached trials |
| Antineutrophil cytoplasmic antibody positive | 93 | 62.4 50.2–77.6ROR 62.6 · calibrated p 4e-6 ✓ | 53.9 EB05 45.3 · IC025 +5.1 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Lab value / disease marker | serious n=93 · ♀ 0% (drug 64%) | not reported in cached trials |
| Mycotic allergy | 104 | 60.0 48.9–73.7ROR 60.2 · calibrated p 5e-6 ✓ | 52.2 EB05 44.3 · IC025 +5.1 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Not in label — unassessed | serious n=104 · ♀ 0% (drug 64%) | not reported in cached trials |
| Medullary thyroid cancer | 41 | 59.2 42.7–82.1ROR 59.3 · calibrated p 8e-6 ✓ | 50.9 EB05 39.1 · IC025 +4.5 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 3.4 (2.4–4.9) | Labeled (related wording) related wording | serious n=41 | NCT01179048: 1/4,672 (0.0%) control (serious AE) |
| Dust allergy | 106 | 52.7 43.0–64.4ROR 52.8 · calibrated p 1e-5 ✓ | 46.5 EB05 39.6 · IC025 +4.9 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Not in label — unassessed | serious n=106 · ♀ 0% (drug 64%) | not reported in cached trials |
| Weight loss poor | 472 | 49.2 44.7–54.1ROR 49.6 · calibrated p 1e-5 ✓ | 44.0 EB05 40.8 · IC025 +5.2 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 7.1 (6.3–8.0) | Likely indication confounding shares a disease stem with the indications wording | serious n=94 · 90% consumer | not reported in cached trials |
| Pancreatic carcinoma metastatic | 283 | 46.9 41.5–53.0ROR 47.1 · calibrated p 2e-5 ✓ | 42.2 EB05 38.2 · IC025 +5.1 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 5.7 (4.9–6.6) | Not in label — unassessed | serious n=283 · ♀ 41% (drug 64%) | NCT01179048: 2/4,668 (0.0%) on Liraglutide; 2/4,672 (0.0%) control (serious AE) |
| Neuritis | 152 | 46.7 39.5–55.2ROR 46.9 · calibrated p 2e-5 ✓ | 42.0 EB05 36.6 · IC025 +4.9 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Not in label — unassessed | serious n=152 · ♀ 0% (drug 64%) | NCT01179048: 1/4,672 (0.0%) control (serious AE) |
| Adenocarcinoma pancreas | 117 | 42.6 35.2–51.5ROR 42.7 · calibrated p 4e-5 ✓ | 38.6 EB05 33.0 · IC025 +4.8 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 4.8 (3.9–6.1) | Not in label — unassessed | serious n=116 | NCT01179048: 4/4,668 (0.1%) on Liraglutide; 1/4,672 (0.0%) control (serious AE) |
| Product contamination with body fluid | 16 | 36.0 21.6–59.9ROR 36.0 · calibrated p 2e-4 ✓ | 32.1 EB05 20.9 · IC025 +3.2 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Reporting / coding artifact | – | not reported in cached trials |
| Conjunctivitis allergic | 108 | 34.0 27.9–41.3ROR 34.0 · calibrated p 2e-4 ✓ | 31.4 EB05 26.7 · IC025 +4.5 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Not in label — unassessed | serious n=108 · ♀ 0% (drug 64%) | not reported in cached trials |
| Eosinophilic granulomatosis with polyangiitis | 144 | 32.7 27.6–38.8ROR 32.8 · calibrated p 2e-4 ✓ | 30.3 EB05 26.4 · IC025 +4.5 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Not in label — unassessed | serious n=144 · ♀ 0% (drug 64%) | not reported in cached trials |
| Lack of satiety | 17 | 31.5 19.2–51.5ROR 31.5 · calibrated p 4e-4 ✓ | 28.5 EB05 18.8 · IC025 +3.2 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 5.7 (3.1–10.4) | Not in label — unassessed | – | not reported in cached trials |
| Drug dose titration not performed | 97 | 25.4 20.7–31.2ROR 25.5 · calibrated p 7e-4 ✓ | 23.9 EB05 20.2 · IC025 +4.1 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 3.8 (3.0–4.9) | Not in label — unassessed | serious n=48 · 77% consumer | not reported in cached trials |
| Papillary thyroid cancer | 90 | 23.4 19.0–29.0ROR 23.5 · calibrated p 0.001 ✓ | 22.2 EB05 18.6 · IC025 +4.0 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 4.4 (3.4–5.7) | Labeled adverse reaction exact term | serious n=90 | NCT01179048: 4/4,668 (0.1%) on Liraglutide; 3/4,672 (0.1%) control (serious AE) |
| Respiratory symptom | 146 | 23.4 19.8–27.7ROR 23.5 · calibrated p 1e-3 ✓ | 22.2 EB05 19.3 · IC025 +4.1 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Not in label — unassessed | serious n=146 · ♀ 0% (drug 64%) | not reported in cached trials |
| Gastrointestinal hypomotility | 111 | 22.3 18.4–27.0ROR 22.4 · calibrated p 0.001 ✓ | 21.2 EB05 18.1 · IC025 +4.0 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.9 (0.8–1.1) | Not in label — unassessed | serious n=110 · 100% consumer | NCT01179048: 1/4,668 (0.0%) on Liraglutide (serious AE) |
| Impaired gastric emptying | 592 | 20.7 19.1–22.5ROR 21.0 · calibrated p 0.002 ✓ | 19.8 EB05 18.5 · IC025 +4.2 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.9 (0.9–1.0) | Labeled (related wording) related wording | serious PRR 24.3 · 86% consumer | NCT01179048: 5/4,668 (0.1%) on Liraglutide; 1/4,672 (0.0%) control (serious AE) |
| Cyclic vomiting syndrome | 29 | 20.7 14.3–30.1ROR 20.7 · calibrated p 0.002 ✓ | 19.5 EB05 14.2 · IC025 +3.3 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.6 (0.4–0.9) | Not in label — unassessed | serious n=28 · 100% consumer | not reported in cached trials |
| Glycosylated haemoglobin decreased | 71 | 19.9 15.7–25.2ROR 19.9 · calibrated p 0.002 ✓ | 18.9 EB05 15.5 · IC025 +3.7 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 2.0 (1.5–2.6) | Lab value / disease marker | serious n=17 | NCT01179048: 1/4,668 (0.0%) on Liraglutide; 1/4,672 (0.0%) control (serious AE) |
| Pancreatitis (pancreas inflammation) | 2,329 | 19.6 18.8–20.4ROR 20.5 · calibrated p 0.002 ✓ | 18.8 EB05 18.2 · IC025 +4.2 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 4.2 (4.0–4.4) | Labeled — boxed warning exact term | serious PRR 22.6 | NCT01179048: 1/4,672 (0.0%) control (serious AE) |
| Eructation (belching) | 766 | 17.9 16.6–19.2ROR 18.1 · calibrated p 0.003 ✓ | 17.2 EB05 16.2 · IC025 +4.0 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 2.2 (2.1–2.4) | Labeled adverse reaction exact term | serious n=149 · 83% consumer | not reported in cached trials |
| Forced expiratory volume decreased | 113 | 17.7 14.6–21.3ROR 17.7 · calibrated p 0.004 ✓ | 17.0 EB05 14.5 · IC025 +3.7 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Lab value / disease marker | serious n=113 · ♀ 0% (drug 64%) | not reported in cached trials |
| Lipase increased | 282 | 16.4 14.5–18.4ROR 16.4 · calibrated p 0.005 ✓ | 15.8 EB05 14.3 · IC025 +3.7 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 5.4 (4.7–6.3) | Lab value / disease marker | serious n=164 | NCT01179048: 11/4,668 (0.2%) on Liraglutide; 3/4,672 (0.1%) control (serious AE) |
| Normochromic normocytic anaemia | 111 | 16.4 13.5–19.8ROR 16.4 · calibrated p 0.005 ✓ | 15.7 EB05 13.4 · IC025 +3.6 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Not in label — unassessed | serious n=111 · ♀ 0% (drug 64%) | NCT01179048: 1/4,668 (0.0%) on Liraglutide (serious AE) |
| Pancreatic pseudocyst | 28 | 15.9 10.9–23.2ROR 15.9 · calibrated p 0.007 ✓ | 15.0 EB05 10.7 · IC025 +3.0 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 9.7 (5.7–16.6) | Not in label — unassessed | serious n=28 · ♀ 35% (drug 64%) · 100% clinician | NCT01179048: 1/4,668 (0.0%) on Liraglutide (serious AE) |
| Pancreatic neuroendocrine tumour | 23 | 15.8 10.5–24.0ROR 15.9 · calibrated p 0.008 ✓ | 14.9 EB05 10.1 · IC025 +2.9 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 7.4 (4.2–12.9) | Not in label — unassessed | serious n=23 | not reported in cached trials |
| Pancreatic neoplasm | 42 | 15.0 11.0–20.4ROR 15.0 · calibrated p 0.008 ✓ | 14.3 EB05 10.9 · IC025 +3.1 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 11.7 (7.4–18.7) | Not in label — unassessed | serious n=41 | NCT01179048: 2/4,668 (0.0%) on Liraglutide (serious AE) |
| Respiratory tract haemorrhage | 20 | 14.7 9.4–23.0ROR 14.8 · calibrated p 0.011 ✓ | 13.7 EB05 8.9 · IC025 +2.7 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Not in label — unassessed | serious n=20 · 100% clinician | not reported in cached trials |
| Pancreatitis acute | 740 | 14.6 13.6–15.7ROR 14.8 · calibrated p 0.007 ✓ | 14.1 EB05 13.3 · IC025 +3.7 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 4.7 (4.3–5.2) | Labeled adverse reaction exact term | serious PRR 17.0 | NCT01179048: 1/4,672 (0.0%) control (serious AE) |
| Benign neoplasm of thyroid gland | 24 | 14.4 9.6–21.6ROR 14.4 · calibrated p 0.011 ✓ | 13.5 EB05 9.2 · IC025 +2.8 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 7.4 (4.3–12.8) | Labeled (related wording) related wording | serious n=19 · ♀ 100% (drug 64%) | NCT01179048: 1/4,672 (0.0%) control (serious AE) |
| Obstructive pancreatitis | 24 | 14.4 9.6–21.6ROR 14.4 · calibrated p 0.011 ✓ | 13.4 EB05 9.2 · IC025 +2.8 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 2.3 (1.5–3.6) | Not in label — unassessed | serious n=24 | not reported in cached trials |
| Pancreatic carcinoma | 945 | 14.3 13.4–15.3ROR 14.6 · calibrated p 0.008 ✓ | 13.9 EB05 13.1 · IC025 +3.7 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 4.8 (4.4–5.2) | Not in label — unassessed | serious PRR 16.7 | NCT01179048: 4/4,668 (0.1%) on Liraglutide; 7/4,672 (0.1%) control (serious AE) |
| Diabetic metabolic decompensation | 45 | 14.3 10.6–19.3ROR 14.3 · calibrated p 0.010 ✓ | 13.7 EB05 10.5 · IC025 +3.1 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 4.8 (3.3–6.9) | Likely indication confounding shares a disease stem with the indications wording | serious n=45 · ♀ 0% (drug 64%) | not reported in cached trials |
| Pancreatic mass | 34 | 14.1 10.0–19.9ROR 14.1 · calibrated p 0.011 ✓ | 13.4 EB05 9.8 · IC025 +3.0 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 6.1 (4.0–9.5) | Not in label — unassessed | serious n=33 · 100% clinician | NCT01179048: 2/4,668 (0.0%) on Liraglutide (serious AE) |
| Pancreatic enzymes increased | 44 | 13.3 9.8–17.9ROR 13.3 · calibrated p 0.013 ✓ | 12.6 EB05 9.7 · IC025 +3.0 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 4.4 (3.1–6.3) | Lab value / disease marker | serious n=17 | NCT01179048: 1/4,668 (0.0%) on Liraglutide (serious AE) |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Liraglutide 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 (18 of 40 signal terms matched).
- NCT01179048 — Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (N=9341, PHASE3; 1560 AE terms posted; arms: Liraglutide; Placebo)
- NCT01794143 — A Comparative Effectiveness Study of Major Glycemia-lowering Medications for Treatment of Type 2 Diabetes (N=7850, PHASE3; 35 AE terms posted; arms: Glargine Insulin U-100; Glimepiride; Liraglutide; Sitagliptin)
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 |
|---|---|---|---|---|---|---|
| Nausea | 7,176 | 3.9 3.8–4.0ROR 4.4 · calibrated p 0.310 | 3.9 EB05 3.8 · IC025 +1.9 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 1.9 (1.8–1.9) | Labeled adverse reaction exact term | serious PRR 2.7 · 73% consumer | NCT01179048: 8/4,668 (0.2%) on Liraglutide; 9/4,672 (0.2%) control (serious AE) |
| Blood glucose increased | 3,907 | 9.0 8.7–9.3ROR 9.7 · calibrated p 0.036 ✓ | 8.8 EB05 8.6 · IC025 +3.1 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 1.2 (1.1–1.2) | Labeled (related wording) related wording | serious PRR 6.1 · 87% consumer | NCT01179048: 1/4,668 (0.0%) on Liraglutide; 1/4,672 (0.0%) control (serious AE) |
| Vomiting | 3,515 | 3.2 3.1–3.3ROR 3.4 · calibrated p 0.513 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 1.8 (1.7–1.8) | Labeled adverse reaction exact term | serious PRR 2.8 | NCT01179048: 17/4,668 (0.4%) on Liraglutide; 11/4,672 (0.2%) control (serious AE) |
| Diarrhoea (diarrhea) | 3,376 | 2.2 2.2–2.3ROR 2.3 · calibrated p 0.884 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 1.9 (1.8–2.0) | Labeled adverse reaction exact term | serious PRR 2.0 | NCT01179048: 14/4,668 (0.3%) on Liraglutide; 11/4,672 (0.2%) control (serious AE) |
| Pancreatitis (pancreas inflammation) | 2,329 | 19.6 18.8–20.4ROR 20.5 · calibrated p 0.002 ✓ | 18.8 EB05 18.2 · IC025 +4.2 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 4.2 (4.0–4.4) | Labeled — boxed warning exact term | serious PRR 22.6 | NCT01179048: 1/4,672 (0.0%) control (serious AE) |
| Weight decreased (weight loss) | 2,115 | 3.3 3.1–3.4ROR 3.4 · calibrated p 0.522 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.9 (0.9–1.0) | Likely indication confounding term in indications; also in warnings | serious PRR 2.3 · 70% consumer | NCT01179048: 1/4,668 (0.0%) on Liraglutide; 3/4,672 (0.1%) control (serious AE) |
| Decreased appetite (loss of appetite) | 2,108 | 3.9 3.8–4.1ROR 4.0 · calibrated p 0.370 | 3.9 EB05 3.7 · IC025 +1.9 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 1.3 (1.3–1.4) | Not in label — unassessed | serious PRR 2.0 · 80% consumer | NCT01179048: 4/4,668 (0.1%) on Liraglutide; 1/4,672 (0.0%) control (serious AE) |
| Headache | 2,019 | 1.4 1.3–1.4ROR 1.4 · calibrated p 0.571 | 1.4 EB05 1.3 · IC025 +0.4 vs other GLP-1 Receptor Agonists: PRR 2.5 (2.4–2.7) | Labeled adverse reaction exact term | serious PRR 1.1 · 76% consumer | NCT01179048: 2/4,668 (0.0%) on Liraglutide; 7/4,672 (0.1%) control (serious AE) |
| Off label use (used outside approved label) | 1,854 | 0.9 0.9–1.0ROR 0.9 · calibrated p 0.248 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other GLP-1 Receptor Agonists: PRR 1.6 (1.5–1.6) | Reporting / coding artifact | serious PRR 1.0 | not reported in cached trials |
| Fatigue (tiredness) | 1,662 | 0.9 0.9–1.0ROR 0.9 · calibrated p 0.249 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other GLP-1 Receptor Agonists: PRR 2.0 (1.9–2.1) | Labeled adverse reaction exact term | serious PRR 0.8 · 72% consumer | NCT01179048: 2/4,668 (0.0%) on Liraglutide; 1/4,672 (0.0%) control (serious AE) |
| Drug ineffective (drug did not work) | 1,597 | 0.5 0.5–0.5ROR 0.5 · calibrated p 0.049 ✓ | 0.5 EB05 0.5 · IC025 -1.0 PRR-only: not supported by EBGM or IC vs other GLP-1 Receptor Agonists: PRR 1.8 (1.7–1.9) | Reporting / coding artifact | serious PRR 0.6 · 74% consumer | not reported in cached trials |
| Constipation | 1,594 | 3.2 3.0–3.3ROR 3.2 · calibrated p 0.555 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 1.7 (1.6–1.8) | Labeled adverse reaction exact term | serious PRR 2.7 · 76% consumer | NCT01179048: 11/4,668 (0.2%) on Liraglutide; 7/4,672 (0.1%) control (serious AE) |
| Dizziness | 1,511 | 1.3 1.2–1.4ROR 1.3 · calibrated p 0.512 | 1.3 EB05 1.2 · IC025 +0.3 vs other GLP-1 Receptor Agonists: PRR 1.8 (1.7–1.9) | Labeled adverse reaction exact term | serious PRR 1.1 · 74% consumer | NCT01179048: 12/4,668 (0.3%) on Liraglutide; 6/4,672 (0.1%) control (serious AE) |
| Abdominal pain upper | 1,460 | 3.0 2.9–3.2ROR 3.1 · calibrated p 0.591 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 1.9 (1.8–2.0) | Labeled (related wording) related wording | serious PRR 2.4 · 76% consumer | NCT01179048: 20/4,668 (0.4%) on Liraglutide; 15/4,672 (0.3%) control (serious AE) |
| Malaise (feeling unwell) | 1,359 | 1.3 1.3–1.4ROR 1.3 · calibrated p 0.528 | 1.3 EB05 1.3 · IC025 +0.3 vs other GLP-1 Receptor Agonists: PRR 2.1 (2.0–2.2) | Labeled adverse reaction exact term | serious PRR 1.0 · 74% consumer | NCT01179048: 3/4,672 (0.1%) 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.
- Total lung capacity abnormal — n=108, PRR 169.4
- Pulmonary vasculitis — n=146, PRR 163.2
- Capillaritis — n=53, PRR 105.1
- Mite allergy — n=107, PRR 86.0
- Mycotic allergy — n=104, PRR 60.0
- Dust allergy — n=106, PRR 52.7
- Pancreatic carcinoma metastatic — n=283, PRR 46.9 (also seen in trial arm)
- Neuritis — n=152, PRR 46.7 (also seen in trial arm)
- Adenocarcinoma pancreas — n=117, PRR 42.6 (also seen in trial arm)
- Conjunctivitis allergic — n=108, PRR 34.0
✓ A hand-written Bradford Hill causality assessment exists for this drug: Liraglutide ↔ Impaired gastric emptying.
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 Liraglutide?
In FDA FAERS, the most frequently co-reported reaction terms for Liraglutide are nausea, blood glucose increased, vomiting, diarrhoea, pancreatitis, weight decreased. 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 Liraglutide have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: RISK OF THYROID C-CELL TUMORS Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether liraglut.
Do FAERS signals prove that Liraglutide 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 0b898330-eca1-f60a-71d2-b91716e336ed, effective 20251016; matched on
openfda.generic_name.exact:"LIRAGLUTIDE") - 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, 1,184 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
LIRAGLUTIDE, 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.