Drug · FAERS side-effect profile with label screen

Diphenhydramine and Zinc side effects: what 798 FDA adverse event reports show

Diphenhydramine Hydrochloride, Zinc Acetate · 25 reaction terms · 278 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Diphenhydramine (Nightime Sleep Aid)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

798 reports · 59% serious · 56 with death outcome · 69% female

openFDA FAERS counts, all years, deduplication not applied

Used for

For relief of occasional sleeplessness.

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 21 strongest signals

Reporting / coding artifact 1Lab value / disease marker 1No label text to screen 19

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.
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. 4 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
Infusion site pain	17	35.0 21.8–56.0ROR 35.7 · χ² 527 / p 6e-117	33.7 EB05 22.3 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=12	no trial data cached
Anhedonia	23	22.8 15.2–34.1ROR 23.5 · χ² 458 / p 6e-102	22.4 EB05 15.7 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 21.5 · ♀ 48% (drug 69%)	no trial data cached
Economic problem	12	20.4 11.7–35.9ROR 20.7 · χ² 203 / p 2e-46	19.6 EB05 11.4 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 21.9	no trial data cached
End stage renal disease	14	20.0 11.9–33.6ROR 20.3 · χ² 234 / p 5e-53	19.3 EB05 11.8 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 19.5	no trial data cached
Insurance issue	11	19.4 10.8–35.0ROR 19.7 · χ² 174 / p 4e-40	18.4 EB05 10.2 · IC025 +2.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 39.4	no trial data cached
Impaired gastric emptying	9	18.5 9.7–35.5ROR 18.7 · χ² 132 / p 7e-31	16.9 EB05 8.2 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 20.5	no trial data cached
Ear infection	18	17.8 11.3–28.1ROR 18.2 · χ² 269 / p 9e-61	17.3 EB05 11.2 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 23.0	no trial data cached
Seasonal allergy	9	16.7 8.7–32.1ROR 16.9 · χ² 118 / p 9e-28	15.0 EB05 7.1 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=5	no trial data cached
Osteopenia	9	15.5 8.1–29.7ROR 15.7 · χ² 108 / p 1e-25	13.6 EB05 6.4 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.9	no trial data cached
Hereditary angioedema	6	15.0 6.8–33.3ROR 15.1 · χ² 65 / p 4e-16	11.4 EB05 4.4 · IC025 +1.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 17.5	no trial data cached
Respiratory depression	7	15.0 7.2–31.3ROR 15.1 · χ² 78 / p 5e-19	12.1 EB05 5.0 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 15.1	no trial data cached
Dermatitis contact	6	13.9 6.2–30.8ROR 14.0 · χ² 59 / p 7e-15	10.3 EB05 4.0 · IC025 +1.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=5	no trial data cached
Chronic kidney disease	40	13.7 10.1–18.5ROR 14.4 · χ² 460 / p 3e-102	13.4 EB05 10.1 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.6	no trial data cached
Pharyngitis streptococcal	5	12.1 5.1–29.1ROR 12.2 · χ² 41 / p 1e-10	7.9 EB05 3.1 · IC025 +1.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=5	no trial data cached
Bone density decreased	14	11.6 6.9–19.5ROR 11.8 · χ² 125 / p 2e-29	10.2 EB05 5.9 · IC025 +2.2 3/3 methods agree	Lab value / disease marker	serious PRR 12.2	no trial data cached
Sleep disorder due to a general medical condition	6	9.7 4.4–21.6ROR 9.8 · χ² 39 / p 2e-10	6.6 EB05 3.0 · IC025 +1.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Multiple fractures	5	7.9 3.3–19.0ROR 8.0 · χ² 24 / p 6e-7	5.1 EB05 2.3 · IC025 +0.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 8.3	no trial data cached
Emotional distress	28	6.0 4.2–8.7ROR 6.2 · χ² 114 / p 8e-27	5.5 EB05 4.0 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 6.0 · ♀ 46% (drug 69%)	no trial data cached
Dermatitis atopic	10	5.3 2.8–9.7ROR 5.3 · χ² 30 / p 2e-8	4.3 EB05 2.5 · IC025 +1.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=2	no trial data cached
Injection site rash	5	4.3 1.8–10.4ROR 4.3 · χ² 10 / p 9e-4	3.3 EB05 1.6 · IC025 +0.2	No label text to screen label has no adverse-reaction text	–	no trial data cached
Injection site pruritus	9	3.5 1.9–6.8ROR 3.6 · χ² 14 / p 9e-5	3.1 EB05 1.8 · IC025 +0.5	No label text to screen label has no adverse-reaction text	serious PRR 10.9	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
Chronic kidney disease	40	13.7 10.1–18.5ROR 14.4 · χ² 460 / p 3e-102	13.4 EB05 10.1 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.6	no trial data cached
Emotional distress	28	6.0 4.2–8.7ROR 6.2 · χ² 114 / p 8e-27	5.5 EB05 4.0 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 6.0 · ♀ 46% (drug 69%)	no trial data cached
Anhedonia	23	22.8 15.2–34.1ROR 23.5 · χ² 458 / p 6e-102	22.4 EB05 15.7 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 21.5 · ♀ 48% (drug 69%)	no trial data cached
Ear infection	18	17.8 11.3–28.1ROR 18.2 · χ² 269 / p 9e-61	17.3 EB05 11.2 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 23.0	no trial data cached
Infusion site pain	17	35.0 21.8–56.0ROR 35.7 · χ² 527 / p 6e-117	33.7 EB05 22.3 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=12	no trial data cached
Bone density decreased	14	11.6 6.9–19.5ROR 11.8 · χ² 125 / p 2e-29	10.2 EB05 5.9 · IC025 +2.2 3/3 methods agree	Lab value / disease marker	serious PRR 12.2	no trial data cached
End stage renal disease	14	20.0 11.9–33.6ROR 20.3 · χ² 234 / p 5e-53	19.3 EB05 11.8 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 19.5	no trial data cached
Economic problem	12	20.4 11.7–35.9ROR 20.7 · χ² 203 / p 2e-46	19.6 EB05 11.4 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 21.9	no trial data cached
Insurance issue	11	19.4 10.8–35.0ROR 19.7 · χ² 174 / p 4e-40	18.4 EB05 10.2 · IC025 +2.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 39.4	no trial data cached
Dermatitis atopic	10	5.3 2.8–9.7ROR 5.3 · χ² 30 / p 2e-8	4.3 EB05 2.5 · IC025 +1.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=2	no trial data cached
Injection site pruritus	9	3.5 1.9–6.8ROR 3.6 · χ² 14 / p 9e-5	3.1 EB05 1.8 · IC025 +0.5	No label text to screen label has no adverse-reaction text	serious PRR 10.9	no trial data cached
Osteopenia	9	15.5 8.1–29.7ROR 15.7 · χ² 108 / p 1e-25	13.6 EB05 6.4 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.9	no trial data cached
Seasonal allergy	9	16.7 8.7–32.1ROR 16.9 · χ² 118 / p 9e-28	15.0 EB05 7.1 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=5	no trial data cached
Impaired gastric emptying	9	18.5 9.7–35.5ROR 18.7 · χ² 132 / p 7e-31	16.9 EB05 8.2 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 20.5	no trial data cached
Respiratory depression	7	15.0 7.2–31.3ROR 15.1 · χ² 78 / p 5e-19	12.1 EB05 5.0 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 15.1	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.

✓ A hand-written Bradford Hill causality assessment exists for this drug: Medroxyprogesterone acetate ↔ Meningioma.

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 Diphenhydramine and Zinc?

In FDA FAERS, the most frequently co-reported reaction terms for Diphenhydramine and Zinc are chronic kidney disease, emotional distress, anhedonia, ear infection, infusion site pain, bone density decreased. 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 Diphenhydramine and Zinc have an FDA boxed warning?

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

Do FAERS signals prove that Diphenhydramine and Zinc 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 9c44e54f-d8bc-4451-8382-40d2e8e03b42, effective 20180521; matched on openfda.generic_name.exact:"DIPHENHYDRAMINE")
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.