Drug · FAERS side-effect profile with label screen
Semaglutide side effects: what 72,971 FDA adverse event reports show
Brand names
Wegovy
openFDA label
Who reports
72,971 reports · 50% serious · 1,270 with death outcome · 64% female
openFDA FAERS counts, all years, deduplication not applied
Used for
WEGOVY is indicated in combination with a reduced calorie diet and increased physical activity: • to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight.
FDA label, Indications and Usage
What it is
WEGOVY (semaglutide) injection, for subcutaneous use, contains semaglutide, a human GLP-1 receptor agonist (or GLP-1 analog). The peptide backbone is produced by yeast fermentation. The main p.
FDA label, Description section
Boxed warning
RISK OF THYROID C-CELL TUMORS • In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether WEGOVY causes thyroid C-cel.
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 1Reporting / coding artifact 10Lab value / disease marker 3Not in label — unassessed 19
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). 1,151 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 |
|---|---|---|---|---|---|---|
| Cyclic vomiting syndrome | 355 | 382.7 326.3–448.9ROR 384.6 · calibrated p 1e-12 ✓ | 161.7 EB05 148.1 · IC025 +6.9 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 2.4 (1.8–3.1) | Not in label — unassessed | serious n=344 · 100% consumer | not reported in cached trials |
| Gastric hypomotility | 86 | 114.0 88.8–146.5ROR 114.2 · calibrated p 6e-8 ✓ | 80.1 EB05 66.9 · IC025 +5.4 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.4 (0.3–0.6) | Not in label — unassessed | serious n=82 · 100% consumer | not reported in cached trials |
| Impaired gastric emptying | 3,558 | 111.3 107.2–115.7ROR 117.0 · calibrated p 3e-8 ✓ | 80.1 EB05 77.9 · IC025 +6.3 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.6 (0.6–0.7) | Not in label — unassessed | serious PRR 103.5 · 93% consumer | NCT03574597: 4/8,803 (0.0%) on Semaglutide (serious AE) |
| Corrective lens user | 214 | 86.5 74.2–100.8ROR 86.7 · calibrated p 4e-7 ✓ | 66.1 EB05 59.0 · IC025 +5.6 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Not in label — unassessed | serious n=32 · 100% consumer | not reported in cached trials |
| Gastrointestinal hypomotility | 489 | 80.6 72.9–89.1ROR 81.2 · calibrated p 5e-7 ✓ | 62.8 EB05 58.3 · IC025 +5.7 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.3 (0.3–0.4) | Not in label — unassessed | serious n=485 · 100% consumer | not reported in cached trials |
| Product dose confusion | 72 | 77.3 59.6–100.3ROR 77.4 · calibrated p 1e-6 ✓ | 60.0 EB05 49.2 · IC025 +5.0 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Medullary thyroid cancer | 61 | 63.6 48.2–83.9ROR 63.6 · calibrated p 4e-6 ✓ | 51.3 EB05 41.4 · IC025 +4.8 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.3 (0.2–0.5) | Labeled (related wording) related wording | serious n=61 | NCT03574597: 2/8,801 (0.0%) control (serious AE) |
| Optic ischaemic neuropathy | 631 | 61.9 56.8–67.4ROR 62.4 · calibrated p 3e-6 ✓ | 50.9 EB05 47.6 · IC025 +5.5 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 5.5 (4.1–7.2) | Not in label — unassessed | serious n=625 · ♀ 41% (drug 64%) | NCT03574597: 2/8,803 (0.0%) on Semaglutide; 1/8,801 (0.0%) control (serious AE) |
| Metabolic dysfunction-associated steatohepatitis | 30 | 48.1 32.7–70.9ROR 48.2 · calibrated p 3e-5 ✓ | 40.3 EB05 29.6 · IC025 +4.0 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Not in label — unassessed | serious n=30 | not reported in cached trials |
| Product information content complaint | 28 | 45.2 30.3–67.3ROR 45.2 · calibrated p 5e-5 ✓ | 38.2 EB05 27.7 · IC025 +3.9 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Drug dose titration not performed | 220 | 42.0 36.4–48.4ROR 42.1 · calibrated p 4e-5 ✓ | 36.6 EB05 32.7 · IC025 +4.9 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 1.0 (0.8–1.3) | Not in label — unassessed | serious n=67 · 88% consumer | not reported in cached trials |
| Weight loss poor | 546 | 38.9 35.6–42.6ROR 39.2 · calibrated p 6e-5 ✓ | 34.3 EB05 32.0 · IC025 +4.9 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.5 (0.4–0.5) | Likely indication confounding shares a disease stem with the indications wording | serious n=47 · 95% consumer | not reported in cached trials |
| Device use confusion | 59 | 38.4 29.3–50.4ROR 38.4 · calibrated p 9e-5 ✓ | 33.6 EB05 27.0 · IC025 +4.3 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Lack of satiety | 26 | 33.7 22.4–50.6ROR 33.7 · calibrated p 2e-4 ✓ | 29.6 EB05 21.2 · IC025 +3.6 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.7 (0.4–1.3) | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Glycosylated haemoglobin decreased | 149 | 29.6 25.0–35.0ROR 29.6 · calibrated p 3e-4 ✓ | 26.8 EB05 23.4 · IC025 +4.4 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.3 (0.2–0.4) | Lab value / disease marker | serious n=49 · 85% consumer | NCT03574597: 1/8,801 (0.0%) control (serious AE) |
| Product communication issue | 752 | 27.7 25.7–29.9ROR 28.0 · calibrated p 4e-4 ✓ | 25.3 EB05 23.9 · IC025 +4.5 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 4.3 (3.4–5.4) | Reporting / coding artifact | serious n=132 · 93% consumer | not reported in cached trials |
| Skin laxity | 35 | 26.7 18.9–37.8ROR 26.7 · calibrated p 7e-4 ✓ | 24.2 EB05 18.2 · IC025 +3.6 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Not in label — unassessed | ♀ 100% (drug 64%) · 74% consumer | not reported in cached trials |
| Food craving | 417 | 26.3 23.8–29.1ROR 26.5 · calibrated p 5e-4 ✓ | 24.1 EB05 22.3 · IC025 +4.4 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.6 (0.5–0.7) | Not in label — unassessed | serious n=59 · 92% consumer | not reported in cached trials |
| Obstructive pancreatitis | 61 | 25.9 20.0–33.7ROR 26.0 · calibrated p 7e-4 ✓ | 23.7 EB05 19.1 · IC025 +3.9 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.5 (0.4–0.7) | Not in label — unassessed | serious n=61 | NCT03574597: 4/8,803 (0.0%) on Semaglutide; 7/8,801 (0.1%) control (serious AE) |
| Allodynia | 83 | 22.8 18.3–28.5ROR 22.9 · calibrated p 0.001 ✓ | 21.1 EB05 17.6 · IC025 +3.9 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Labeled adverse reaction exact term | serious n=20 | not reported in cached trials |
| Gallbladder injury | 139 | 22.1 18.6–26.3ROR 22.1 · calibrated p 0.001 ✓ | 20.5 EB05 17.8 · IC025 +4.0 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.7 (0.5–0.9) | Labeled (related wording) related wording | serious n=139 · 100% consumer | not reported in cached trials |
| Glycosylated haemoglobin abnormal | 81 | 21.0 16.8–26.4ROR 21.1 · calibrated p 0.002 ✓ | 19.6 EB05 16.2 · IC025 +3.8 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.2 (0.2–0.3) | Lab value / disease marker | serious n=39 · 77% consumer | NCT03574597: 1/8,801 (0.0%) control (serious AE) |
| Product label confusion | 395 | 20.9 18.8–23.1ROR 21.0 · calibrated p 0.002 ✓ | 19.5 EB05 17.9 · IC025 +4.1 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Reporting / coding artifact | serious n=61 · 93% consumer | not reported in cached trials |
| Food aversion | 110 | 20.2 16.7–24.5ROR 20.2 · calibrated p 0.002 ✓ | 18.9 EB05 16.1 · IC025 +3.8 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.4 (0.3–0.6) | Not in label — unassessed | serious n=49 · 76% consumer | not reported in cached trials |
| Hunger | 820 | 18.6 17.3–20.0ROR 18.8 · calibrated p 0.003 ✓ | 17.5 EB05 16.5 · IC025 +4.0 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.4 (0.3–0.4) | Not in label — unassessed | serious n=92 · 94% consumer | not reported in cached trials |
| Hearing aid user | 24 | 17.3 11.5–26.1ROR 17.3 · calibrated p 0.005 ✓ | 16.0 EB05 11.1 · IC025 +3.0 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Eructation (belching) | 1,059 | 16.9 15.9–18.0ROR 17.1 · calibrated p 0.004 ✓ | 16.0 EB05 15.2 · IC025 +3.9 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.2 (0.2–0.2) | Labeled adverse reaction exact term | serious n=311 · 86% consumer | NCT03574597: 1/8,803 (0.0%) on Semaglutide (serious AE) |
| Ileus | 632 | 15.5 14.3–16.8ROR 15.6 · calibrated p 0.006 ✓ | 14.7 EB05 13.8 · IC025 +3.7 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.8 (0.7–0.9) | Labeled adverse reaction exact term | serious PRR 17.2 · 87% consumer | NCT03574597: 3/8,803 (0.0%) on Semaglutide; 2/8,801 (0.0%) control (serious AE) |
| Product confusion | 38 | 14.7 10.6–20.4ROR 14.7 · calibrated p 0.009 ✓ | 13.8 EB05 10.3 · IC025 +3.0 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Drug titration error | 126 | 14.7 12.3–17.5ROR 14.7 · calibrated p 0.008 ✓ | 13.9 EB05 12.0 · IC025 +3.4 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 1.0 (0.8–1.4) | Reporting / coding artifact | serious n=75 · 79% consumer | not reported in cached trials |
| Diabetic retinopathy | 160 | 14.1 12.1–16.6ROR 14.2 · calibrated p 0.009 ✓ | 13.5 EB05 11.8 · IC025 +3.4 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.3 (0.2–0.4) | Labeled — boxed warning exact term | serious n=153 | NCT03914326: 29/4,825 (0.6%) on Semaglutide; 15/4,825 (0.3%) control (serious AE) |
| Thirst decreased | 29 | 14.1 9.7–20.4ROR 14.1 · calibrated p 0.011 ✓ | 13.0 EB05 9.2 · IC025 +2.9 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.2 (0.1–0.4) | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Euglycaemic diabetic ketoacidosis | 186 | 14.0 12.1–16.2ROR 14.1 · calibrated p 0.009 ✓ | 13.4 EB05 11.8 · IC025 +3.5 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.4 (0.3–0.5) | Not in label — unassessed | serious n=186 · 92% clinician | NCT03914326: 2/4,825 (0.0%) on Semaglutide; 3/4,825 (0.1%) control (serious AE) |
| Counterfeit product administered | 59 | 13.9 10.7–18.0ROR 13.9 · calibrated p 0.011 ✓ | 13.1 EB05 10.5 · IC025 +3.2 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Reporting / coding artifact | serious n=42 | not reported in cached trials |
| Glycosylated haemoglobin increased | 1,156 | 13.8 13.0–14.6ROR 14.0 · calibrated p 0.009 ✓ | 13.2 EB05 12.5 · IC025 +3.6 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.1 (0.1–0.1) | Lab value / disease marker | serious PRR 13.6 · 82% consumer | NCT03574597: 1/8,801 (0.0%) control (serious AE) |
| Increased appetite | 861 | 13.7 12.8–14.7ROR 13.9 · calibrated p 0.010 ✓ | 13.1 EB05 12.4 · IC025 +3.6 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.4 (0.3–0.4) | Not in label — unassessed | serious PRR 4.7 · 93% consumer | NCT03574597: 2/8,803 (0.0%) on Semaglutide; 1/8,801 (0.0%) control (serious AE) |
| Incorrect dose administered by product | 68 | 13.4 10.5–17.1ROR 13.4 · calibrated p 0.012 ✓ | 12.7 EB05 10.3 · IC025 +3.2 3/3 methods agree vs other GLP-1 Receptor Agonists: only this drug | Reporting / coding artifact | 100% consumer | not reported in cached trials |
| Early satiety | 85 | 13.4 10.7–16.6ROR 13.4 · calibrated p 0.012 ✓ | 12.7 EB05 10.5 · IC025 +3.2 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.1 (0.0–0.1) | Not in label — unassessed | serious n=56 · 84% consumer | not reported in cached trials |
| Injection site discharge | 213 | 12.5 10.9–14.3ROR 12.5 · calibrated p 0.015 ✓ | 11.9 EB05 10.6 · IC025 +3.3 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 2.8 (2.0–4.0) | Labeled (related wording) related wording | serious n=34 · 94% consumer | NCT03914326: 1/4,825 (0.0%) control (serious AE) |
| Cataract operation | 222 | 11.2 9.8–12.8ROR 11.2 · calibrated p 0.022 ✓ | 10.7 EB05 9.6 · IC025 +3.2 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 1.3 (1.0–1.6) | Reporting / coding artifact | serious n=219 · 92% consumer | NCT03574597: 1/8,801 (0.0%) control (serious AE) |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Semaglutide 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 (14 of 40 signal terms matched).
- NCT03574597 — Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity (N=17604, PHASE3; 1768 AE terms posted; arms: Semaglutide; Placebo)
- NCT03914326 — A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes (N=9651, PHASE3; 1622 AE terms posted; arms: Oral Semaglutide; Placebo)
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 | 10,674 | 3.9 3.9–4.0ROR 4.4 · calibrated p 0.307 | 3.9 EB05 3.8 · IC025 +1.9 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.2 (0.2–0.2) | Labeled adverse reaction exact term | serious PRR 4.0 · 79% consumer | NCT03574597: 12/8,803 (0.1%) on Semaglutide; 8/8,801 (0.1%) control (serious AE) |
| Off label use (used outside approved label) | 7,325 | 2.4 2.4–2.5ROR 2.6 · calibrated p 0.773 | 2.4 EB05 2.4 · IC025 +1.2 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.7 (0.7–0.7) | Reporting / coding artifact | serious PRR 2.7 · 83% consumer | not reported in cached trials |
| Vomiting | 6,964 | 4.3 4.2–4.4ROR 4.7 · calibrated p 0.274 | 4.3 EB05 4.2 · IC025 +2.1 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.2 (0.2–0.2) | Labeled adverse reaction exact term | serious PRR 4.6 · 74% consumer | NCT03574597: 18/8,803 (0.2%) on Semaglutide; 12/8,801 (0.1%) control (serious AE) |
| Diarrhoea (diarrhea) | 6,462 | 2.9 2.8–3.0ROR 3.1 · calibrated p 0.598 | 2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.2 (0.2–0.2) | Labeled adverse reaction exact term | serious PRR 3.2 · 79% consumer | NCT03574597: 23/8,803 (0.3%) on Semaglutide; 16/8,801 (0.2%) control (serious AE) |
| Decreased appetite (loss of appetite) | 4,905 | 6.2 6.0–6.4ROR 6.6 · calibrated p 0.118 | 6.1 EB05 5.9 · IC025 +2.6 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.2 (0.2–0.2) | Not in label — unassessed | serious PRR 4.3 · 85% consumer | NCT03574597: 2/8,803 (0.0%) on Semaglutide; 1/8,801 (0.0%) control (serious AE) |
| Constipation | 4,724 | 6.4 6.2–6.6ROR 6.8 · calibrated p 0.109 | 6.3 EB05 6.1 · IC025 +2.6 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.4 (0.4–0.4) | Labeled adverse reaction exact term | serious PRR 6.8 · 88% consumer | NCT03574597: 8/8,803 (0.1%) on Semaglutide; 6/8,801 (0.1%) control (serious AE) |
| Weight decreased (weight loss) | 4,487 | 4.7 4.5–4.8ROR 4.9 · calibrated p 0.243 | 4.6 EB05 4.5 · IC025 +2.2 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.1 (0.1–0.1) | Likely indication confounding term in indications; also in warnings | serious PRR 2.8 · 81% consumer | NCT03574597: 1/8,803 (0.0%) on Semaglutide; 1/8,801 (0.0%) control (serious AE) |
| Impaired gastric emptying | 3,558 | 111.3 107.2–115.7ROR 117.0 · calibrated p 3e-8 ✓ | 80.1 EB05 77.9 · IC025 +6.3 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.6 (0.6–0.7) | Not in label — unassessed | serious PRR 103.5 · 93% consumer | NCT03574597: 4/8,803 (0.0%) on Semaglutide (serious AE) |
| Product use in unapproved indication | 3,483 | 4.1 4.0–4.3ROR 4.3 · calibrated p 0.327 | 4.1 EB05 4.0 · IC025 +2.0 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 2.5 (2.3–2.8) | Reporting / coding artifact | serious PRR 4.8 · 79% consumer | not reported in cached trials |
| Blood glucose increased | 3,303 | 5.1 4.9–5.3ROR 5.3 · calibrated p 0.206 | 5.0 EB05 4.9 · IC025 +2.3 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.1 (0.0–0.1) | Labeled (related wording) related wording | serious PRR 5.1 · 89% consumer | NCT03914326: 1/4,825 (0.0%) on Semaglutide; 1/4,825 (0.0%) control (serious AE) |
| Headache | 3,099 | 1.4 1.4–1.5ROR 1.4 · calibrated p 0.604 | 1.4 EB05 1.4 · IC025 +0.4 vs other GLP-1 Receptor Agonists: PRR 0.2 (0.2–0.2) | Labeled adverse reaction exact term | serious PRR 1.2 · 79% consumer | NCT03574597: 7/8,803 (0.1%) on Semaglutide; 11/8,801 (0.1%) control (serious AE) |
| Fatigue (tiredness) | 3,063 | 1.1 1.1–1.2ROR 1.1 · calibrated p 0.399 | 1.1 EB05 1.1 · IC025 +0.1 vs other GLP-1 Receptor Agonists: PRR 0.2 (0.2–0.2) | Labeled adverse reaction exact term | serious PRR 1.1 · 79% consumer | NCT03574597: 2/8,803 (0.0%) on Semaglutide; 3/8,801 (0.0%) control (serious AE) |
| Abdominal pain upper | 3,039 | 4.3 4.2–4.5ROR 4.4 · calibrated p 0.305 | 4.2 EB05 4.1 · IC025 +2.0 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.3 (0.3–0.3) | Labeled adverse reaction exact term | serious PRR 4.5 · 88% consumer | NCT03574597: 9/8,803 (0.1%) on Semaglutide; 18/8,801 (0.2%) control (serious AE) |
| Wrong technique in product usage process | 3,016 | 4.3 4.2–4.5ROR 4.5 · calibrated p 0.299 | 4.3 EB05 4.2 · IC025 +2.0 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 1.2 (1.1–1.3) | Reporting / coding artifact | serious PRR 6.3 · 93% consumer | not reported in cached trials |
| Weight increased (weight gain) | 2,612 | 3.4 3.3–3.5ROR 3.5 · calibrated p 0.488 | 3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree vs other GLP-1 Receptor Agonists: PRR 0.3 (0.3–0.3) | Likely indication confounding term in indications; also in warnings | serious PRR 1.7 · 90% consumer | NCT03574597: 1/8,803 (0.0%) on Semaglutide; 1/8,801 (0.0%) 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.
- Cyclic vomiting syndrome — n=355, PRR 382.7
- Gastric hypomotility — n=86, PRR 114.0
- Impaired gastric emptying — n=3,558, PRR 111.3 (also seen in trial arm)
- Corrective lens user — n=214, PRR 86.5
- Gastrointestinal hypomotility — n=489, PRR 80.6
- Optic ischaemic neuropathy — n=631, PRR 61.9 (also seen in trial arm)
- Metabolic dysfunction-associated steatohepatitis — n=30, PRR 48.1
- Drug dose titration not performed — n=220, PRR 42.0
- Lack of satiety — n=26, PRR 33.7
- Skin laxity — n=35, PRR 26.7
✓ A hand-written Bradford Hill causality assessment exists for this drug: Semaglutide ↔ 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 Semaglutide?
In FDA FAERS, the most frequently co-reported reaction terms for Semaglutide are nausea, vomiting, diarrhoea, decreased appetite, constipation, 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 Semaglutide have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: RISK OF THYROID C-CELL TUMORS • In rodents, semaglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether WEGOVY causes thyroid C-cel.
Do FAERS signals prove that Semaglutide 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 f5e548d0-cc79-4c34-a3f5-e20a5b8b6564, effective 20240423; matched on
openfda.generic_name.exact:"SEMAGLUTIDE") - 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, 1,191 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
SEMAGLUTIDE, 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.