Drug · FAERS side-effect profile with label screen
Capsicum Annuum side effects: what 1,025 FDA adverse event reports show
Drug class
Non-Standardized Plant Allergenic Extract, Non-Standardized Food Allergenic Extract
FDA label (Established Pharmacologic Class) · compare the class
Who reports
1,025 reports · 88% serious · 173 with death outcome · 47% female
openFDA FAERS counts, all years, deduplication not applied
Used for
• All-natural nasal cleanser • Reduces pathogen adhesion • Safe to use daily or anytime • Washes away pollen and allergens
FDA label, Indications and Usage
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
Lab value / disease marker 1No label text to screen 39
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 68 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 |
|---|---|---|---|---|---|---|
| Oesophagitis | 37 | 69.5 50.6–95.4ROR 72.1 · χ² 2,423 / p <1e-300 | 67.0 EB05 50.7 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 50.0 | no trial data cached |
| Metastases to bone | 28 | 35.1 24.4–50.6ROR 36.1 · χ² 893 / p 2e-196 | 34.3 EB05 24.9 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.0 · ♀ 82% (drug 47%) | no trial data cached |
| Atelectasis | 16 | 33.8 20.8–55.0ROR 34.4 · χ² 477 / p 5e-106 | 32.6 EB05 21.3 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.2 | no trial data cached |
| Osteonecrosis of jaw (jawbone death) | 41 | 33.7 25.0–45.6ROR 35.1 · χ² 1,269 / p 3e-278 | 33.2 EB05 25.5 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.0 · ♀ 76% (drug 47%) | no trial data cached |
| Bone disorder | 30 | 33.5 23.5–47.7ROR 34.5 · χ² 912 / p 1e-200 | 32.8 EB05 24.1 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.5 · ♀ 77% (drug 47%) | no trial data cached |
| Metastases to liver | 27 | 31.6 21.8–45.8ROR 32.4 · χ² 769 / p 2e-169 | 30.9 EB05 22.3 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.6 | no trial data cached |
| Metastases to central nervous system | 18 | 28.8 18.2–45.6ROR 29.3 · χ² 455 / p 2e-101 | 28.0 EB05 18.7 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.9 | no trial data cached |
| Osteomyelitis | 24 | 27.2 18.3–40.4ROR 27.8 · χ² 579 / p 3e-128 | 26.7 EB05 18.8 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.0 · ♀ 75% (drug 47%) | no trial data cached |
| Metastases to lung | 15 | 26.6 16.1–44.0ROR 27.0 · χ² 345 / p 3e-77 | 25.8 EB05 16.5 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.4 | no trial data cached |
| Intervertebral disc degeneration | 12 | 26.4 15.1–46.4ROR 26.7 · χ² 269 / p 1e-60 | 25.4 EB05 15.3 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.7 | no trial data cached |
| Tooth abscess | 13 | 26.1 15.2–44.8ROR 26.4 · χ² 289 / p 5e-65 | 25.1 EB05 15.5 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.2 | no trial data cached |
| Anorexia | 16 | 25.1 15.4–40.8ROR 25.5 · χ² 346 / p 1e-77 | 24.4 EB05 15.8 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.4 | no trial data cached |
| Fistula | 13 | 23.7 13.8–40.6ROR 23.9 · χ² 260 / p 1e-58 | 22.8 EB05 14.0 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.5 | no trial data cached |
| Emphysema | 11 | 22.3 12.4–40.1ROR 22.5 · χ² 203 / p 3e-46 | 21.2 EB05 12.2 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.4 | no trial data cached |
| Mucosal inflammation | 28 | 22.0 15.3–31.7ROR 22.6 · χ² 541 / p 5e-120 | 21.7 EB05 15.7 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.6 · ♀ 25% (drug 47%) | no trial data cached |
| Grand mal convulsion | 10 | 21.9 11.8–40.6ROR 22.1 · χ² 179 / p 4e-41 | 20.7 EB05 11.3 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.5 | no trial data cached |
| Osteopenia | 16 | 21.5 13.2–35.0ROR 21.8 · χ² 292 / p 7e-66 | 20.9 EB05 13.5 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.5 | no trial data cached |
| Aspiration | 11 | 20.8 11.6–37.5ROR 21.0 · χ² 188 / p 4e-43 | 19.8 EB05 11.2 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.9 | no trial data cached |
| Hiatus hernia | 13 | 20.5 12.0–35.3ROR 20.8 · χ² 222 / p 1e-50 | 19.7 EB05 11.9 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.1 | no trial data cached |
| Drug toxicity | 13 | 19.3 11.2–33.1ROR 19.5 · χ² 207 / p 3e-47 | 18.5 EB05 11.0 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.0 | no trial data cached |
| Pneumonitis | 25 | 18.9 12.9–27.9ROR 19.4 · χ² 407 / p 7e-91 | 18.6 EB05 13.2 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.8 | no trial data cached |
| Lymphopenia | 13 | 18.9 11.0–32.5ROR 19.2 · χ² 203 / p 2e-46 | 18.1 EB05 10.7 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.3 | no trial data cached |
| Dental caries | 10 | 18.5 10.0–34.4ROR 18.7 · χ² 149 / p 2e-34 | 17.2 EB05 8.9 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.6 | no trial data cached |
| Oral pain | 20 | 18.2 11.8–28.2ROR 18.6 · χ² 309 / p 2e-69 | 17.8 EB05 11.9 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.7 | no trial data cached |
| Sinus tachycardia | 12 | 17.4 9.9–30.5ROR 17.5 · χ² 169 / p 6e-39 | 16.3 EB05 9.1 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.5 | no trial data cached |
| Pain in jaw | 22 | 15.9 10.5–24.0ROR 16.2 · χ² 293 / p 7e-66 | 15.5 EB05 10.4 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.8 · ♀ 73% (drug 47%) | no trial data cached |
| Tooth infection | 10 | 15.5 8.4–28.8ROR 15.7 · χ² 122 / p 1e-28 | 13.9 EB05 6.9 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.7 | no trial data cached |
| Dehydration | 99 | 15.2 12.6–18.3ROR 16.7 · χ² 1,307 / p 1e-286 | 15.1 EB05 12.8 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.4 | no trial data cached |
| Pulmonary mass | 11 | 15.2 8.4–27.3ROR 15.3 · χ² 132 / p 9e-31 | 13.7 EB05 7.1 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.7 | no trial data cached |
| Gingival bleeding | 10 | 15.0 8.1–27.8ROR 15.1 · χ² 117 / p 2e-27 | 13.3 EB05 6.6 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.6 | no trial data cached |
| Pneumonia aspiration | 18 | 14.8 9.4–23.4ROR 15.0 · χ² 218 / p 1e-49 | 14.1 EB05 8.9 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.1 | no trial data cached |
| Mental status changes | 20 | 14.7 9.6–22.8ROR 15.0 · χ² 243 / p 5e-55 | 14.2 EB05 9.2 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.1 | no trial data cached |
| Hypoxia (low oxygen) | 24 | 14.0 9.4–20.8ROR 14.3 · χ² 278 / p 1e-62 | 13.5 EB05 9.2 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.3 | no trial data cached |
| Dysphagia (difficulty swallowing) | 62 | 13.4 10.5–17.1ROR 14.2 · χ² 703 / p 3e-155 | 13.3 EB05 10.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.8 | no trial data cached |
| Anhedonia | 17 | 13.1 8.2–21.1ROR 13.4 · χ² 179 / p 4e-41 | 12.2 EB05 7.5 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.4 | no trial data cached |
| Intervertebral disc protrusion | 14 | 13.1 7.8–22.0ROR 13.3 · χ² 144 / p 1e-33 | 11.8 EB05 6.8 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 | no trial data cached |
| Febrile neutropenia | 41 | 12.7 9.4–17.1ROR 13.2 · χ² 431 / p 5e-96 | 12.4 EB05 9.3 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 | no trial data cached |
| Pleural effusion | 37 | 12.4 9.1–17.1ROR 12.9 · χ² 379 / p 1e-84 | 12.1 EB05 8.9 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.4 | no trial data cached |
| Disability | 12 | 12.4 7.1–21.8ROR 12.6 · χ² 115 / p 4e-27 | 10.8 EB05 5.9 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.3 | no trial data cached |
| Blood urea increased | 10 | 12.2 6.6–22.6ROR 12.3 · χ² 92 / p 5e-22 | 10.1 EB05 5.1 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 7.9 | 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 |
|---|---|---|---|---|---|---|
| Dehydration | 99 | 15.2 12.6–18.3ROR 16.7 · χ² 1,307 / p 1e-286 | 15.1 EB05 12.8 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.4 | no trial data cached |
| Dysphagia (difficulty swallowing) | 62 | 13.4 10.5–17.1ROR 14.2 · χ² 703 / p 3e-155 | 13.3 EB05 10.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.8 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 44 | 6.7 5.0–8.9ROR 6.9 · χ² 207 / p 3e-47 | 6.3 EB05 4.8 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.4 | no trial data cached |
| Febrile neutropenia | 41 | 12.7 9.4–17.1ROR 13.2 · χ² 431 / p 5e-96 | 12.4 EB05 9.3 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 | no trial data cached |
| Osteonecrosis of jaw (jawbone death) | 41 | 33.7 25.0–45.6ROR 35.1 · χ² 1,269 / p 3e-278 | 33.2 EB05 25.5 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.0 · ♀ 76% (drug 47%) | no trial data cached |
| Pleural effusion | 37 | 12.4 9.1–17.1ROR 12.9 · χ² 379 / p 1e-84 | 12.1 EB05 8.9 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.4 | no trial data cached |
| Oesophagitis | 37 | 69.5 50.6–95.4ROR 72.1 · χ² 2,423 / p <1e-300 | 67.0 EB05 50.7 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 50.0 | no trial data cached |
| Deep vein thrombosis (leg blood clot) | 35 | 11.0 7.9–15.2ROR 11.3 · χ² 308 / p 3e-69 | 10.5 EB05 7.7 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.6 | no trial data cached |
| Bone disorder | 30 | 33.5 23.5–47.7ROR 34.5 · χ² 912 / p 1e-200 | 32.8 EB05 24.1 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.5 · ♀ 77% (drug 47%) | no trial data cached |
| Mucosal inflammation | 28 | 22.0 15.3–31.7ROR 22.6 · χ² 541 / p 5e-120 | 21.7 EB05 15.7 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.6 · ♀ 25% (drug 47%) | no trial data cached |
| Metastases to bone | 28 | 35.1 24.4–50.6ROR 36.1 · χ² 893 / p 2e-196 | 34.3 EB05 24.9 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.0 · ♀ 82% (drug 47%) | no trial data cached |
| Metastases to liver | 27 | 31.6 21.8–45.8ROR 32.4 · χ² 769 / p 2e-169 | 30.9 EB05 22.3 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.6 | no trial data cached |
| Injury | 25 | 7.2 4.9–10.7ROR 7.4 · χ² 129 / p 4e-30 | 6.5 EB05 4.6 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 · ♀ 68% (drug 47%) · 80% consumer | no trial data cached |
| Pneumonitis | 25 | 18.9 12.9–27.9ROR 19.4 · χ² 407 / p 7e-91 | 18.6 EB05 13.2 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.8 | no trial data cached |
| Malignant neoplasm progression | 24 | 4.8 3.2–7.2ROR 4.9 · χ² 69 / p 4e-17 | 4.4 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Capsicum Annuum?
In FDA FAERS, the most frequently co-reported reaction terms for Capsicum Annuum are dehydration, dysphagia, neutropenia, febrile neutropenia, osteonecrosis of jaw, pleural effusion. 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 Capsicum Annuum have an FDA boxed warning?
No. The FDA label retrieved for Capsicum Annuum has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Capsicum Annuum 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 76219cec-5392-43fc-b58e-f28ef1597869, effective 20260604; matched on
openfda.generic_name.exact:"CAPSICUM ANNUUM") - 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, 108 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.