Drug · FAERS side-effect profile with label screen

Cocaine side effects: what 373 FDA adverse event reports show

Cocaine Hydrochloride · 12 reaction terms · 487 drug–reaction co-reports · data 2026-09-14

Drug class

Ester local anesthetic

FDA label, Indications wording of the closest related product

Label matched

Cocaine Hydrochloride (Cocaine 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

373 reports · 98% serious · 245 with death outcome · 40% female

openFDA FAERS counts, all years, deduplication not applied

Used for

COCAINE HYDROCHLORIDE nasal solution is an ester local anesthetic indicated for the induction of local anesthesia of the mucous membranes when performing diagnostic procedures and surgeries on or through the nasal cavities in adults. COCAINE HYDROCHLOR.

FDA label, Indications and Usage

What it is

COCAINE HYDROCHLORIDE nasal solution for intranasal use contains a 4% solution, 160 mg/4 mL (40 mg/mL), equivalent to 142.4 mg/4 mL (35.6 mg/mL) cocaine, an ester local anesthetic.

FDA label, Description section

Boxed warning

ABUSE AND DEPENDENCE CNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence [see Warning and Precautions (5.1) .] WARNING: ABUSE AND DEPENDENCE See full prescribing information for complete boxed warning. CNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence. ( 5.1)

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 11 strongest signals

Reporting / coding artifact 2Outcome field, not a reaction 1Not in label — unassessed 8

What the badges mean

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.
Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
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. 1 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
Poisoning deliberate	38	230.5 170.4–311.8ROR 256.6 · χ² 8,424 / p <1e-300	205.9 EB05 156.6 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 134.8 · 100% clinician	no trial data cached
Respiratory arrest	86	174.4 144.8–210.0ROR 226.3 · χ² 14,625 / p <1e-300	167.4 EB05 139.8 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious PRR 102.7 · 100% clinician	no trial data cached
Completed suicide (death by suicide)	95	63.5 53.4–75.6ROR 84.9 · χ² 5,802 / p <1e-300	62.7 EB05 52.8 · IC025 +5.2 3/3 methods agree	Outcome field, not a reaction	serious PRR 37.3 · 100% clinician	no trial data cached
Cardiac arrest (heart stopping)	91	61.8 51.7–73.9ROR 81.4 · χ² 5,399 / p <1e-300	61.0 EB05 51.2 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 36.4 · 98% clinician	no trial data cached
Eating disorder	13	34.2 20.1–58.4ROR 35.4 · χ² 387 / p 2e-86	32.7 EB05 20.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 28.0	no trial data cached
Drug abuse	50	33.6 26.0–43.5ROR 38.7 · χ² 1,555 / p <1e-300	33.2 EB05 26.2 · IC025 +4.2 3/3 methods agree	Reporting / coding artifact	serious PRR 19.6	no trial data cached
Erectile dysfunction	13	28.4 16.6–48.4ROR 29.4 · χ² 317 / p 3e-71	27.3 EB05 16.9 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 24.0	no trial data cached
Blindness	14	19.3 11.6–32.3ROR 20.1 · χ² 226 / p 2e-51	18.6 EB05 11.4 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 11.7	no trial data cached
Toxicity to various agents	47	15.7 12.1–20.6ROR 17.9 · χ² 639 / p 2e-141	15.6 EB05 12.1 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 9.5	no trial data cached
Suicide attempt	17	15.7 9.9–25.0ROR 16.4 · χ² 221 / p 3e-50	15.1 EB05 9.4 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.3	no trial data cached
Drug dependence	19	6.6 4.2–10.2ROR 6.9 · χ² 85 / p 2e-20	5.8 EB05 3.9 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 3.7	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
Completed suicide (death by suicide)	95	63.5 53.4–75.6ROR 84.9 · χ² 5,802 / p <1e-300	62.7 EB05 52.8 · IC025 +5.2 3/3 methods agree	Outcome field, not a reaction	serious PRR 37.3 · 100% clinician	no trial data cached
Cardiac arrest (heart stopping)	91	61.8 51.7–73.9ROR 81.4 · χ² 5,399 / p <1e-300	61.0 EB05 51.2 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 36.4 · 98% clinician	no trial data cached
Respiratory arrest	86	174.4 144.8–210.0ROR 226.3 · χ² 14,625 / p <1e-300	167.4 EB05 139.8 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious PRR 102.7 · 100% clinician	no trial data cached
Drug abuse	50	33.6 26.0–43.5ROR 38.7 · χ² 1,555 / p <1e-300	33.2 EB05 26.2 · IC025 +4.2 3/3 methods agree	Reporting / coding artifact	serious PRR 19.6	no trial data cached
Toxicity to various agents	47	15.7 12.1–20.6ROR 17.9 · χ² 639 / p 2e-141	15.6 EB05 12.1 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 9.5	no trial data cached
Poisoning deliberate	38	230.5 170.4–311.8ROR 256.6 · χ² 8,424 / p <1e-300	205.9 EB05 156.6 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 134.8 · 100% clinician	no trial data cached
Drug dependence	19	6.6 4.2–10.2ROR 6.9 · χ² 85 / p 2e-20	5.8 EB05 3.9 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 3.7	no trial data cached
Suicide attempt	17	15.7 9.9–25.0ROR 16.4 · χ² 221 / p 3e-50	15.1 EB05 9.4 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.3	no trial data cached
Blindness	14	19.3 11.6–32.3ROR 20.1 · χ² 226 / p 2e-51	18.6 EB05 11.4 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 11.7	no trial data cached
Erectile dysfunction	13	28.4 16.6–48.4ROR 29.4 · χ² 317 / p 3e-71	27.3 EB05 16.9 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 24.0	no trial data cached
Eating disorder	13	34.2 20.1–58.4ROR 35.4 · χ² 387 / p 2e-86	32.7 EB05 20.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 28.0	no trial data cached
Respiratory depression	4	18.3 6.9–48.6ROR 18.5 · χ² 49 / p 1e-12	12.3 EB05 3.5 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 11.1	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.

Poisoning deliberate — n=38, PRR 230.5
Respiratory arrest — n=86, PRR 174.4
Cardiac arrest — n=91, PRR 61.8
Toxicity to various agents — n=47, PRR 15.7

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 Cocaine?

In FDA FAERS, the most frequently co-reported reaction terms for Cocaine are cardiac arrest, respiratory arrest, toxicity to various agents, poisoning deliberate, suicide attempt, blindness. 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 Cocaine have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: ABUSE AND DEPENDENCE CNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence [see Warning and Precautions (5.1) .] WARNING: ABUSE AND DEPENDENCE See full prescribing information for complete boxed warning. CNS stimulants, including cocaine hydrochloride, have a high potential for abuse and dependence. ( 5.1)

Do FAERS signals prove that Cocaine 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 0fb0298f-9756-26e8-e063-6294a90ae8f2, effective 20240125; matched on openfda.generic_name.exact:"COCAINE HYDROCHLORIDE")
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, 12 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.