Drug · FAERS side-effect profile with label screen

Diluent side effects: what 1,033 FDA adverse event reports show

Diluent · Humalog, Humalog Kwikpen, Humalog Tempo Pen, Sterile Diluent · 25 reaction terms · 1,591 drug–reaction co-reports · data 2026-09-14

Drug class

Insulin Analog

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Humalog, Humalog Kwikpen, Humalog Tempo Pen, Sterile Diluent

openFDA label

Who reports

1,033 reports · 6% serious · 7 with death outcome · 63% female

openFDA FAERS counts, all years, deduplication not applied

Used for

HUMALOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. HUMALOG is a rapid acting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 )

FDA label, Indications and Usage

What it is

Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli . Insulin lispro differs from huma.

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 19 strongest signals

Labeled adverse reaction 1Labeled (related wording) 7Reporting / coding artifact 10Not in label — unassessed 1

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.
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. 6 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Incorrect product storage	182	281.0 246.0–321.0ROR 340.9 · χ² 49,838 / p <1e-300	269.3 EB05 238.0 · IC025 +7.1 3/3 methods agree	Reporting / coding artifact	93% clinician	no trial data cached
No adverse event	666	76.5 73.1–80.1ROR 213.5 · χ² 49,790 / p <1e-300	76.1 EB05 71.3 · IC025 +6.0 3/3 methods agree	Reporting / coding artifact	91% clinician	no trial data cached
Expired product administered	108	66.3 55.4–79.3ROR 73.9 · χ² 6,868 / p <1e-300	65.3 EB05 55.6 · IC025 +5.3 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product storage error	189	44.4 39.1–50.6ROR 54.2 · χ² 7,996 / p <1e-300	44.2 EB05 39.1 · IC025 +5.1 3/3 methods agree	Reporting / coding artifact	91% clinician	no trial data cached
Product preparation error	35	34.4 24.8–47.6ROR 35.5 · χ² 1,100 / p 2e-241	33.7 EB05 25.4 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Injection site warmth	26	25.7 17.5–37.5ROR 26.3 · χ² 591 / p 6e-131	25.2 EB05 18.1 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious n=1 · ♀ 95% (drug 63%)	no trial data cached
Herpes zoster (shingles)	59	20.8 16.3–26.7ROR 22.0 · χ² 1,096 / p 1e-240	20.7 EB05 16.6 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 55.7	no trial data cached
Incorrect route of drug administration	33	18.5 13.2–25.9ROR 19.1 · χ² 529 / p 2e-117	18.3 EB05 13.5 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Inappropriate schedule of drug administration	39	11.0 8.1–14.9ROR 11.4 · χ² 345 / p 3e-77	10.5 EB05 7.8 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Injection site erythema (redness where injected)	63	10.4 8.2–13.2ROR 11.0 · χ² 527 / p 8e-117	10.1 EB05 8.1 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 19.9 · ♀ 94% (drug 63%)	no trial data cached
Injection site rash	15	10.0 6.1–16.6ROR 10.2 · χ² 113 / p 9e-27	8.6 EB05 5.2 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Injection site mass	18	9.9 6.3–15.7ROR 10.1 · χ² 136 / p 1e-31	8.8 EB05 5.6 · IC025 +2.2 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Exposure via skin contact	10	9.0 4.8–16.6ROR 9.1 · χ² 63 / p 9e-16	7.0 EB05 3.9 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Injection site pruritus	29	8.8 6.2–12.7ROR 9.1 · χ² 195 / p 2e-44	8.1 EB05 5.8 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 42.6 · ♀ 92% (drug 63%)	no trial data cached
Injection site swelling	25	6.7 4.5–9.9ROR 6.8 · χ² 116 / p 2e-27	6.0 EB05 4.3 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 17.2	no trial data cached
Exposure during pregnancy	19	6.2 4.0–9.7ROR 6.3 · χ² 78 / p 5e-19	5.5 EB05 3.7 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 9.7	no trial data cached
Extra dose administered	11	5.6 3.1–10.1ROR 5.6 · χ² 37 / p 6e-10	4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Accidental exposure to product	18	3.7 2.3–5.8ROR 3.7 · χ² 32 / p 7e-9	3.4 EB05 2.3 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Injection site reaction	10	3.0 1.6–5.5ROR 3.0 · χ² 11 / p 4e-4	2.7 EB05 1.6 · IC025 +0.4	Labeled adverse reaction exact term	–	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
No adverse event	666	76.5 73.1–80.1ROR 213.5 · χ² 49,790 / p <1e-300	76.1 EB05 71.3 · IC025 +6.0 3/3 methods agree	Reporting / coding artifact	91% clinician	no trial data cached
Product storage error	189	44.4 39.1–50.6ROR 54.2 · χ² 7,996 / p <1e-300	44.2 EB05 39.1 · IC025 +5.1 3/3 methods agree	Reporting / coding artifact	91% clinician	no trial data cached
Incorrect product storage	182	281.0 246.0–321.0ROR 340.9 · χ² 49,838 / p <1e-300	269.3 EB05 238.0 · IC025 +7.1 3/3 methods agree	Reporting / coding artifact	93% clinician	no trial data cached
Expired product administered	108	66.3 55.4–79.3ROR 73.9 · χ² 6,868 / p <1e-300	65.3 EB05 55.6 · IC025 +5.3 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Injection site erythema (redness where injected)	63	10.4 8.2–13.2ROR 11.0 · χ² 527 / p 8e-117	10.1 EB05 8.1 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 19.9 · ♀ 94% (drug 63%)	no trial data cached
Herpes zoster (shingles)	59	20.8 16.3–26.7ROR 22.0 · χ² 1,096 / p 1e-240	20.7 EB05 16.6 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 55.7	no trial data cached
Inappropriate schedule of drug administration	39	11.0 8.1–14.9ROR 11.4 · χ² 345 / p 3e-77	10.5 EB05 7.8 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product preparation error	35	34.4 24.8–47.6ROR 35.5 · χ² 1,100 / p 2e-241	33.7 EB05 25.4 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Incorrect route of drug administration	33	18.5 13.2–25.9ROR 19.1 · χ² 529 / p 2e-117	18.3 EB05 13.5 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Injection site pruritus	29	8.8 6.2–12.7ROR 9.1 · χ² 195 / p 2e-44	8.1 EB05 5.8 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 42.6 · ♀ 92% (drug 63%)	no trial data cached
Injection site warmth	26	25.7 17.5–37.5ROR 26.3 · χ² 591 / p 6e-131	25.2 EB05 18.1 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious n=1 · ♀ 95% (drug 63%)	no trial data cached
Injection site swelling	25	6.7 4.5–9.9ROR 6.8 · χ² 116 / p 2e-27	6.0 EB05 4.3 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 17.2	no trial data cached
Exposure during pregnancy	19	6.2 4.0–9.7ROR 6.3 · χ² 78 / p 5e-19	5.5 EB05 3.7 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 9.7	no trial data cached
Accidental exposure to product	18	3.7 2.3–5.8ROR 3.7 · χ² 32 / p 7e-9	3.4 EB05 2.3 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Injection site mass	18	9.9 6.3–15.7ROR 10.1 · χ² 136 / p 1e-31	8.8 EB05 5.6 · IC025 +2.2 3/3 methods agree	Labeled (related wording) related wording	–	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.

Herpes zoster — n=59, PRR 20.8

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 Diluent?

In FDA FAERS, the most frequently co-reported reaction terms for Diluent are injection site erythema, herpes zoster, injection site pruritus, injection site warmth, injection site swelling, injection site mass. 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 Diluent have an FDA boxed warning?

No. The FDA label retrieved for Diluent has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Diluent 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 c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f, effective 20260616; matched on openfda.generic_name.exact:"DILUENT")
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, field patient.drug.openfda.generic_name.exact, 25 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.