Metreleptin side effects: what 1,244 FDA adverse event reports show
Drug class
Leptin Analog
Brand names
Myalept
Who reports
1,244 reports · 51% serious · 69 with death outcome · 81% female
Used for
MYALEPT is a leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. ( 1 ) Limitations of Use The safety and effectiveness of MYALEPT for the treatment of complications of partial lipodystrophy have not been established.
What it is
MYALEPT (metreleptin) for injection is a recombinant human leptin analog for injection that binds to and activates the leptin receptor. Metreleptin (recombinant methionyl-human leptin) is produced in E. coli and differs from native human leptin by the addition of a methionine residue at its amino terminus.
Boxed warning
RISK OF ANTI-METRELEPTIN ANTIBODIES WITH NEUTRALIZING ACTIVITY AND RISK OF LYMPHOMA Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with MYALEPT. The consequences of th.
Causality screen of the 33 strongest signals
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. 27 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Blood triglycerides increased | 53 | 50.5 38.8–65.8ROR 52.7 · χ² 2,519 / p <1e-300 | 49.5 EB05 39.3 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 57.4 | no trial data cached |
| Therapy cessation | 92 | 30.4 25.0–37.0ROR 32.8 · χ² 2,588 / p <1e-300 | 30.2 EB05 25.4 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 45.9 | no trial data cached |
| Glycosylated haemoglobin increased | 41 | 27.5 20.3–37.1ROR 28.4 · χ² 1,019 / p 6e-224 | 27.1 EB05 20.8 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious PRR 39.4 | no trial data cached |
| Hepatic steatosis | 25 | 22.7 15.4–33.4ROR 23.1 · χ² 496 / p 3e-110 | 22.3 EB05 15.8 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 24.5 | no trial data cached |
| Diabetes mellitus inadequate control | 21 | 20.0 13.1–30.6ROR 20.3 · χ² 360 / p 1e-80 | 19.6 EB05 13.4 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 25.2 | no trial data cached |
| Hepatomegaly | 10 | 17.1 9.2–31.7ROR 17.2 · χ² 136 / p 1e-31 | 15.6 EB05 7.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 20.9 | no trial data cached |
| Treatment noncompliance | 52 | 16.1 12.4–21.1ROR 16.8 · χ² 725 / p 6e-160 | 16.0 EB05 12.6 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 20.2 · ♀ 60% (drug 81%) | no trial data cached |
| Therapy interrupted | 66 | 16.1 12.8–20.4ROR 17.0 · χ² 924 / p 2e-203 | 16.0 EB05 13.0 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 27.7 | no trial data cached |
| Pancreatitis acute | 21 | 15.9 10.4–24.3ROR 16.1 · χ² 278 / p 1e-62 | 15.4 EB05 10.3 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.0 · 95% clinician | no trial data cached |
| Blood glucose abnormal | 17 | 15.5 9.7–24.8ROR 15.7 · χ² 216 / p 3e-49 | 14.8 EB05 9.2 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 13.2 | no trial data cached |
| Hypoglycaemia (low blood sugar) | 40 | 13.9 10.2–18.9ROR 14.3 · χ² 467 / p 8e-104 | 13.6 EB05 10.3 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.0 | no trial data cached |
| Hunger | 10 | 12.5 6.8–23.3ROR 12.6 · χ² 95 / p 1e-22 | 10.5 EB05 5.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=3 | no trial data cached |
| Hyperglycaemia (high blood sugar) | 27 | 12.5 8.6–18.2ROR 12.8 · χ² 276 / p 4e-62 | 12.0 EB05 8.3 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.2 | no trial data cached |
| Increased appetite | 13 | 11.7 6.8–20.0ROR 11.8 · χ² 116 / p 2e-27 | 10.1 EB05 5.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.1 | no trial data cached |
| Blood glucose decreased | 33 | 11.5 8.2–16.2ROR 11.8 · χ² 308 / p 3e-69 | 11.0 EB05 8.0 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.6 | no trial data cached |
| Pancreatitis (pancreas inflammation) | 33 | 10.5 7.5–14.7ROR 10.8 · χ² 275 / p 4e-62 | 9.9 EB05 7.2 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.1 | no trial data cached |
| Diabetic ketoacidosis | 14 | 9.9 5.9–16.6ROR 10.0 · χ² 103 / p 2e-24 | 8.4 EB05 5.0 · IC025 +2.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 11.1 | no trial data cached |
| Needle issue | 16 | 9.4 5.8–15.4ROR 9.5 · χ² 112 / p 1e-26 | 8.1 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Maternal exposure during pregnancy | 48 | 9.2 7.0–12.1ROR 9.5 · χ² 343 / p 8e-77 | 8.7 EB05 6.8 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 | no trial data cached |
| Diabetes mellitus | 37 | 8.1 5.9–11.2ROR 8.4 · χ² 226 / p 3e-51 | 7.6 EB05 5.7 · IC025 +2.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 9.4 | no trial data cached |
| Ill-defined disorder | 27 | 7.5 5.2–10.9ROR 7.6 · χ² 146 / p 7e-34 | 6.8 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 | no trial data cached |
| Blood glucose increased | 82 | 7.3 5.9–9.0ROR 7.8 · χ² 444 / p 7e-99 | 7.1 EB05 5.9 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.2 | no trial data cached |
| Intentional dose omission | 10 | 6.2 3.3–11.4ROR 6.2 · χ² 38 / p 3e-10 | 4.9 EB05 2.9 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 7.1 | no trial data cached |
| Injection site mass | 13 | 5.9 3.5–10.2ROR 6.0 · χ² 49 / p 1e-12 | 5.0 EB05 3.1 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.5 | no trial data cached |
| Product dose omission issue | 98 | 5.8 4.8–7.0ROR 6.2 · χ² 390 / p 4e-87 | 5.7 EB05 4.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 9.1 | no trial data cached |
| Product dose omission | 21 | 5.3 3.5–8.2ROR 5.4 · χ² 70 / p 3e-17 | 4.8 EB05 3.3 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 9.4 · 90% clinician | no trial data cached |
| Injection site pruritus | 19 | 4.8 3.1–7.5ROR 4.9 · χ² 54 / p 1e-13 | 4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.1 | no trial data cached |
| Injection site haemorrhage | 16 | 3.4 2.1–5.5ROR 3.4 · χ² 25 / p 3e-7 | 3.1 EB05 2.1 · IC025 +0.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.6 | no trial data cached |
| Injection site bruising | 14 | 3.0 1.8–5.0ROR 3.0 · χ² 17 / p 2e-5 | 2.8 EB05 1.8 · IC025 +0.6 | Labeled (related wording) related wording | serious PRR 2.9 | no trial data cached |
| Injection site reaction | 12 | 2.9 1.7–5.2ROR 3.0 · χ² 14 / p 1e-4 | 2.7 EB05 1.7 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Injection site swelling | 13 | 2.9 1.7–5.0ROR 2.9 · χ² 14 / p 8e-5 | 2.7 EB05 1.7 · IC025 +0.5 | Labeled (related wording) related wording | serious PRR 4.9 | no trial data cached |
| Injection site pain (pain where injected) | 48 | 2.7 2.0–3.5ROR 2.7 · χ² 49 / p 1e-12 | 2.6 EB05 2.1 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.2 | no trial data cached |
| Injection site erythema (redness where injected) | 19 | 2.6 1.7–4.1ROR 2.6 · χ² 17 / p 2e-5 | 2.5 EB05 1.7 · IC025 +0.5 | Labeled (related wording) related wording | serious PRR 4.7 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Product dose omission issue | 98 | 5.8 4.8–7.0ROR 6.2 · χ² 390 / p 4e-87 | 5.7 EB05 4.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 9.1 | no trial data cached |
| Therapy cessation | 92 | 30.4 25.0–37.0ROR 32.8 · χ² 2,588 / p <1e-300 | 30.2 EB05 25.4 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 45.9 | no trial data cached |
| Blood glucose increased | 82 | 7.3 5.9–9.0ROR 7.8 · χ² 444 / p 7e-99 | 7.1 EB05 5.9 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.2 | no trial data cached |
| Therapy interrupted | 66 | 16.1 12.8–20.4ROR 17.0 · χ² 924 / p 2e-203 | 16.0 EB05 13.0 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 27.7 | no trial data cached |
| Blood triglycerides increased | 53 | 50.5 38.8–65.8ROR 52.7 · χ² 2,519 / p <1e-300 | 49.5 EB05 39.3 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 57.4 | no trial data cached |
| Treatment noncompliance | 52 | 16.1 12.4–21.1ROR 16.8 · χ² 725 / p 6e-160 | 16.0 EB05 12.6 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 20.2 · ♀ 60% (drug 81%) | no trial data cached |
| Injection site pain (pain where injected) | 48 | 2.7 2.0–3.5ROR 2.7 · χ² 49 / p 1e-12 | 2.6 EB05 2.1 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.2 | no trial data cached |
| Maternal exposure during pregnancy | 48 | 9.2 7.0–12.1ROR 9.5 · χ² 343 / p 8e-77 | 8.7 EB05 6.8 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 | no trial data cached |
| Glycosylated haemoglobin increased | 41 | 27.5 20.3–37.1ROR 28.4 · χ² 1,019 / p 6e-224 | 27.1 EB05 20.8 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious PRR 39.4 | no trial data cached |
| Hypoglycaemia (low blood sugar) | 40 | 13.9 10.2–18.9ROR 14.3 · χ² 467 / p 8e-104 | 13.6 EB05 10.3 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.0 | no trial data cached |
| Diabetes mellitus | 37 | 8.1 5.9–11.2ROR 8.4 · χ² 226 / p 3e-51 | 7.6 EB05 5.7 · IC025 +2.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 9.4 | no trial data cached |
| Pancreatitis (pancreas inflammation) | 33 | 10.5 7.5–14.7ROR 10.8 · χ² 275 / p 4e-62 | 9.9 EB05 7.2 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.1 | no trial data cached |
| Blood glucose decreased | 33 | 11.5 8.2–16.2ROR 11.8 · χ² 308 / p 3e-69 | 11.0 EB05 8.0 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.6 | no trial data cached |
| Ill-defined disorder | 27 | 7.5 5.2–10.9ROR 7.6 · χ² 146 / p 7e-34 | 6.8 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 | no trial data cached |
| Hyperglycaemia (high blood sugar) | 27 | 12.5 8.6–18.2ROR 12.8 · χ² 276 / p 4e-62 | 12.0 EB05 8.3 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 14.2 | 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.
- Ill-defined disorder — n=27, PRR 7.5
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 Metreleptin?
In FDA FAERS, the most frequently co-reported reaction terms for Metreleptin are blood glucose increased, blood triglycerides increased, injection site pain, glycosylated haemoglobin increased, hypoglycaemia, diabetes mellitus. 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 Metreleptin have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: RISK OF ANTI-METRELEPTIN ANTIBODIES WITH NEUTRALIZING ACTIVITY AND RISK OF LYMPHOMA Anti-metreleptin antibodies with neutralizing activity have been identified in patients treated with MYALEPT. The consequences of th.
Do FAERS signals prove that Metreleptin 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 d3b50bbd-140b-425c-b5ec-d4682aad62bc, effective 20240325; matched on
openfda.generic_name.exact:"METRELEPTIN") - 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, 60 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.