Drug · FAERS side-effect profile with label screen
Naloxone Nasal side effects: what 3,839 FDA adverse event reports show
Drug class
Opioid antagonist
FDA label, Indications wording of the closest related product
Label matched
Naloxone Hydrochloride Nasal (Naloxone Hydrochloride)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
3,839 reports · 69% serious · 593 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Naloxone HCl Nasal Spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. Naloxone HCl Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. Naloxone HCl Nasal Spray is not a substitute for emergency medical care.
FDA label, Indications and Usage
What it is
Naloxone Hydrochloride Nasal Spray is a pre-filled, single dose intranasal spray.
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 2Labeled (related wording) 2Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 34
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. 299 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 |
|---|---|---|---|---|---|---|
| Hospice care | 27 | 15.0 10.3–21.8ROR 15.1 · χ² 338 / p 9e-76 | 14.6 EB05 10.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Acute respiratory failure | 48 | 13.7 10.3–18.2ROR 13.9 · χ² 552 / p 2e-122 | 13.5 EB05 10.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 | no trial data cached |
| Dental caries | 26 | 12.9 8.8–18.9ROR 12.9 · χ² 272 / p 2e-61 | 12.3 EB05 8.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 14.0 | no trial data cached |
| Malnutrition | 26 | 12.8 8.7–18.8ROR 12.9 · χ² 271 / p 4e-61 | 12.2 EB05 8.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Atelectasis | 21 | 11.8 7.7–18.1ROR 11.9 · χ² 197 / p 4e-45 | 11.0 EB05 7.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Premature delivery | 32 | 10.9 7.7–15.4ROR 11.0 · χ² 279 / p 8e-63 | 10.3 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · ♀ 100% (drug 58%) | no trial data cached |
| Sickle cell anaemia with crisis | 31 | 10.7 7.6–15.2ROR 10.8 · χ² 263 / p 2e-59 | 10.1 EB05 7.2 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Intervertebral disc degeneration | 18 | 10.6 6.7–16.8ROR 10.6 · χ² 146 / p 5e-34 | 9.4 EB05 5.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 | no trial data cached |
| Impaired gastric emptying | 22 | 9.4 6.2–14.3ROR 9.5 · χ² 157 / p 2e-36 | 8.5 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · ♀ 81% (drug 58%) | no trial data cached |
| End stage renal disease | 31 | 9.2 6.5–13.1ROR 9.3 · χ² 218 / p 1e-49 | 8.5 EB05 6.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Chronic kidney disease | 112 | 8.0 6.7–9.6ROR 8.2 · χ² 679 / p 7e-150 | 7.8 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Insurance issue | 21 | 7.7 5.0–11.8ROR 7.8 · χ² 116 / p 2e-27 | 6.8 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 | no trial data cached |
| Anhedonia | 37 | 7.6 5.5–10.5ROR 7.7 · χ² 207 / p 4e-47 | 7.1 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Osteopenia | 21 | 7.5 4.9–11.5ROR 7.6 · χ² 112 / p 2e-26 | 6.6 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Tooth abscess | 14 | 7.5 4.4–12.6ROR 7.5 · χ² 72 / p 1e-17 | 6.2 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Vitamin d deficiency | 13 | 7.3 4.2–12.5ROR 7.3 · χ² 64 / p 5e-16 | 6.0 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Unresponsive to stimuli | 34 | 7.2 5.2–10.1ROR 7.3 · χ² 176 / p 2e-40 | 6.7 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Mental status changes | 35 | 6.9 4.9–9.6ROR 6.9 · χ² 170 / p 4e-39 | 6.4 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Blood calcium decreased | 14 | 6.8 4.0–11.4ROR 6.8 · χ² 63 / p 9e-16 | 5.7 EB05 3.6 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 7.0 | no trial data cached |
| Spinal operation | 15 | 6.8 4.1–11.2ROR 6.8 · χ² 68 / p 8e-17 | 5.7 EB05 3.7 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 | no trial data cached |
| Iron deficiency anaemia | 11 | 6.5 3.6–11.8ROR 6.6 · χ² 46 / p 5e-12 | 5.3 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Drug withdrawal syndrome | 105 | 6.5 5.4–7.8ROR 6.6 · χ² 481 / p 6e-107 | 6.3 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.0 · 70% consumer | no trial data cached |
| Tooth fracture | 13 | 6.4 3.7–11.1ROR 6.5 · χ² 54 / p 8e-14 | 5.4 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Bursitis | 14 | 6.3 3.8–10.7ROR 6.4 · χ² 58 / p 2e-14 | 5.3 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Generalised oedema | 14 | 6.2 3.7–10.5ROR 6.2 · χ² 56 / p 4e-14 | 5.2 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Disability | 22 | 6.1 4.0–9.2ROR 6.1 · χ² 88 / p 3e-21 | 5.4 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Leukocytosis | 20 | 6.0 3.9–9.4ROR 6.1 · χ² 79 / p 3e-19 | 5.4 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Withdrawal syndrome | 46 | 5.9 4.5–7.9ROR 6.0 · χ² 185 / p 2e-42 | 5.6 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 · 89% consumer | no trial data cached |
| Transfusion | 11 | 5.7 3.2–10.3ROR 5.7 · χ² 38 / p 3e-10 | 4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Dizziness postural | 10 | 5.7 3.1–10.6ROR 5.7 · χ² 34 / p 3e-9 | 4.6 EB05 2.7 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Neuralgia | 25 | 5.6 3.8–8.3ROR 5.7 · χ² 91 / p 9e-22 | 5.1 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Renal tubular necrosis | 10 | 5.6 3.0–10.3ROR 5.6 · χ² 33 / p 5e-9 | 4.5 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Hypoxia (low oxygen) | 35 | 5.4 3.9–7.6ROR 5.5 · χ² 123 / p 8e-29 | 5.1 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Sinus tachycardia | 14 | 5.4 3.2–9.1ROR 5.4 · χ² 46 / p 7e-12 | 4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Dyspnoea exertional | 37 | 5.4 3.9–7.4ROR 5.4 · χ² 128 / p 6e-30 | 5.1 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Respiratory depression | 12 | 5.3 3.0–9.4ROR 5.4 · χ² 38 / p 3e-10 | 4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Rib fracture | 20 | 5.3 3.4–8.2ROR 5.3 · χ² 66 / p 2e-16 | 4.8 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Pulmonary hypertension | 20 | 5.2 3.4–8.1ROR 5.2 · χ² 64 / p 6e-16 | 4.7 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.4 | no trial data cached |
| Immunodeficiency | 14 | 5.2 3.1–8.8ROR 5.2 · χ² 43 / p 2e-11 | 4.5 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Incontinence | 10 | 5.2 2.8–9.6ROR 5.2 · χ² 29 / p 3e-8 | 4.3 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | 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 |
|---|---|---|---|---|---|---|
| Pain | 305 | 2.7 2.4–3.0ROR 2.9 · χ² 336 / p 2e-75 | 2.7 EB05 2.5 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Death | 265 | 1.7 1.5–1.9ROR 1.7 · χ² 75 / p 2e-18 | 1.7 EB05 1.5 · IC025 +0.5 | Outcome field, not a reaction | serious PRR 1.4 | no trial data cached |
| Fall | 174 | 2.9 2.5–3.3ROR 2.9 · χ² 211 / p 3e-48 | 2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Overdose | 166 | 4.2 3.6–4.9ROR 4.3 · χ² 403 / p 7e-90 | 4.1 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.6 · 73% consumer | no trial data cached |
| Anxiety | 155 | 3.0 2.5–3.5ROR 3.0 · χ² 203 / p 3e-46 | 2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Toxicity to various agents | 143 | 4.7 4.0–5.5ROR 4.8 · χ² 409 / p 3e-91 | 4.6 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Product dose omission issue | 126 | 2.4 2.0–2.9ROR 2.5 · χ² 104 / p 8e-25 | 2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 · 72% consumer | no trial data cached |
| Urinary tract infection (bladder infection) | 122 | 3.9 3.3–4.7ROR 4.0 · χ² 264 / p 1e-59 | 3.9 EB05 3.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · ♀ 79% (drug 58%) | no trial data cached |
| Drug dependence | 120 | 4.0 3.4–4.8ROR 4.1 · χ² 272 / p 2e-61 | 4.0 EB05 3.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 · 91% consumer | no trial data cached |
| Back pain | 119 | 2.8 2.3–3.3ROR 2.9 · χ² 137 / p 7e-32 | 2.8 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.0 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 116 | 4.2 3.5–5.0ROR 4.3 · χ² 277 / p 2e-62 | 4.1 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Chronic kidney disease | 112 | 8.0 6.7–9.6ROR 8.2 · χ² 679 / p 7e-150 | 7.8 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Drug withdrawal syndrome | 105 | 6.5 5.4–7.8ROR 6.6 · χ² 481 / p 6e-107 | 6.3 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.0 · 70% consumer | no trial data cached |
| Somnolence (drowsiness) | 102 | 2.8 2.3–3.4ROR 2.8 · χ² 115 / p 5e-27 | 2.7 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Depression | 100 | 2.4 2.0–2.9ROR 2.4 · χ² 80 / p 2e-19 | 2.4 EB05 2.0 · IC025 +0.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 2.6 | 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.
- Hospice care — n=27, PRR 15.0
- Acute respiratory failure — n=48, PRR 13.7
- Dental caries — n=26, PRR 12.9
- Malnutrition — n=26, PRR 12.8
- Atelectasis — n=21, PRR 11.8
- Premature delivery — n=32, PRR 10.9
- Sickle cell anaemia with crisis — n=31, PRR 10.7
- Impaired gastric emptying — n=22, PRR 9.4
- End stage renal disease — n=31, PRR 9.2
- Chronic kidney disease — n=112, PRR 8.0
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 Naloxone Nasal?
In FDA FAERS, the most frequently co-reported reaction terms for Naloxone Nasal are pain, fall, anxiety, toxicity to various agents, urinary tract infection, back pain. 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 Naloxone Nasal have an FDA boxed warning?
No. The FDA label retrieved for Naloxone Nasal has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Naloxone Nasal 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 4517afa1-4b17-4a15-b91b-65b18bd0558f, effective 20231124; matched on
openfda.generic_name.exact:"NALOXONE HYDROCHLORIDE NASAL") - 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, 339 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.