Advil Pm side effects: what 4,435 FDA adverse event reports show

Advil Pm · 97 reaction terms · 4,902 drug–reaction co-reports · data 2026-09-14

Drug class

Nonsteroidal Anti-inflammatory Drug

FDA label (Established Pharmacologic Class) · compare the class

Who reports

4,435 reports · 17% serious · 27 with death outcome · 69% female

openFDA FAERS counts, all years, deduplication not applied

Used for

for relief of occasional sleeplessness when associated with minor aches and pains helps you fall asleep and stay asleep

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

Labeled adverse reaction 1Labeled (related wording) 1Reporting / coding artifact 16Not in label — unassessed 22

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. 57 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
Drug effective for unapproved indication	283	46.2 41.3–51.8ROR 49.3 · χ² 12,372 / p <1e-300	45.7 EB05 41.4 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious n=1 · ♀ 90% (drug 69%) · 100% consumer	no trial data cached
Restless legs syndrome	59	15.4 11.9–19.8ROR 15.6 · χ² 776 / p 4e-171	15.2 EB05 12.2 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.3 · 93% consumer	no trial data cached
Drug effect incomplete	99	12.7 10.5–15.5ROR 13.0 · χ² 1,058 / p 3e-232	12.6 EB05 10.6 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 3.5 · 97% consumer	no trial data cached
Feeling jittery	49	12.2 9.2–16.1ROR 12.3 · χ² 490 / p 8e-109	11.9 EB05 9.2 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=14 · 97% consumer	no trial data cached
Poor quality sleep	54	12.0 9.2–15.6ROR 12.1 · χ² 530 / p 1e-117	11.7 EB05 9.2 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious PRR 8.4 · 91% consumer	no trial data cached
Middle insomnia	45	11.5 8.6–15.3ROR 11.6 · χ² 419 / p 2e-93	11.1 EB05 8.5 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 3.8 · 91% consumer	no trial data cached
Somnolence (drowsiness)	424	10.0 9.1–10.9ROR 10.9 · χ² 3,446 / p <1e-300	9.9 EB05 9.2 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.8 · 97% consumer	no trial data cached
Restlessness	75	9.7 7.7–12.1ROR 9.8 · χ² 576 / p 2e-127	9.4 EB05 7.7 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 15.3 · 95% consumer	no trial data cached
Psychomotor hyperactivity	31	8.8 6.2–12.5ROR 8.9 · χ² 206 / p 4e-47	8.1 EB05 5.9 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 12.9 · ♀ 90% (drug 69%) · 92% consumer	no trial data cached
Product physical issue	37	8.8 6.4–12.1ROR 8.9 · χ² 247 / p 5e-56	8.2 EB05 6.1 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious n=4 · 97% consumer	no trial data cached
Choking	33	8.0 5.7–11.3ROR 8.1 · χ² 196 / p 6e-45	7.4 EB05 5.5 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 30.5 · 97% consumer	no trial data cached
Product use complaint	26	7.9 5.4–11.7ROR 8.0 · χ² 151 / p 6e-35	7.2 EB05 5.1 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious n=8 · 92% consumer	no trial data cached
Intentional product misuse	145	7.9 6.7–9.3ROR 8.1 · χ² 869 / p 2e-191	7.7 EB05 6.7 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 8.5 · 95% consumer	no trial data cached
Drug effect decreased	84	7.3 5.9–9.0ROR 7.4 · χ² 449 / p 6e-100	7.0 EB05 5.8 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 30.6 · 98% consumer	no trial data cached
Nightmare	53	7.2 5.5–9.4ROR 7.3 · χ² 278 / p 1e-62	6.8 EB05 5.4 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 4.8 · 98% consumer	no trial data cached
Drug effect less than expected	21	7.0 4.6–10.8ROR 7.1 · χ² 103 / p 2e-24	6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	100% consumer	no trial data cached
Product use in unapproved indication	346	6.7 6.1–7.4ROR 7.2 · χ² 1,691 / p <1e-300	6.6 EB05 6.1 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 0.7 · 99% consumer	no trial data cached
Abnormal dreams	36	6.1 4.4–8.5ROR 6.2 · χ² 149 / p 1e-34	5.7 EB05 4.3 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 2.8 · 97% consumer	no trial data cached
Expired product administered	42	6.0 4.4–8.1ROR 6.0 · χ² 170 / p 4e-39	5.6 EB05 4.3 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious n=3 · 93% consumer	no trial data cached
Product taste abnormal	16	5.6 3.5–9.2ROR 5.6 · χ² 56 / p 3e-14	4.9 EB05 3.2 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Coeliac disease	11	5.3 2.9–9.6ROR 5.3 · χ² 34 / p 3e-9	4.4 EB05 2.7 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 14.4	no trial data cached
Gastric haemorrhage	12	4.9 2.8–8.6ROR 4.9 · χ² 33 / p 4e-9	4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 14.5	no trial data cached
Therapeutic response unexpected	43	4.5 3.4–6.1ROR 4.6 · χ² 114 / p 5e-27	4.3 EB05 3.3 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 2.8 · 98% consumer	no trial data cached
Dysphagia (difficulty swallowing)	87	4.3 3.5–5.4ROR 4.4 · χ² 222 / p 2e-50	4.3 EB05 3.6 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 5.8 · 94% consumer	no trial data cached
Feeling abnormal	219	4.3 3.8–4.9ROR 4.5 · χ² 559 / p 9e-124	4.3 EB05 3.8 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.0 · 96% consumer	no trial data cached
Insomnia (trouble sleeping)	240	4.3 3.8–4.8ROR 4.4 · χ² 602 / p 4e-133	4.2 EB05 3.8 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.0 · 92% consumer	no trial data cached
Drug ineffective (drug did not work)	1,175	4.2 4.0–4.4ROR 5.4 · χ² 3,076 / p <1e-300	4.2 EB05 4.0 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 3.5 · 98% consumer	no trial data cached
Nervousness	45	4.1 3.0–5.4ROR 4.1 · χ² 101 / p 6e-24	3.9 EB05 3.0 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 5.1 · 92% consumer	no trial data cached
Head discomfort	15	4.0 2.4–6.7ROR 4.0 · χ² 31 / p 1e-8	3.6 EB05 2.4 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Hypersomnia	24	4.0 2.7–5.9ROR 4.0 · χ² 50 / p 7e-13	3.7 EB05 2.6 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 3.1 · 96% consumer	no trial data cached
Product complaint	20	3.8 2.4–5.9ROR 3.8 · χ² 38 / p 3e-10	3.5 EB05 2.4 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious n=2 · 100% consumer	no trial data cached
Oral discomfort	11	3.7 2.1–6.7ROR 3.7 · χ² 19 / p 5e-6	3.3 EB05 2.0 · IC025 +0.7 3/3 methods agree	Not in label — unassessed	serious n=2	no trial data cached
Throat irritation	34	3.6 2.6–5.0ROR 3.6 · χ² 61 / p 3e-15	3.4 EB05 2.6 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 10.1 · 100% consumer	no trial data cached
Drug ineffective for unapproved indication	41	3.5 2.6–4.7ROR 3.5 · χ² 70 / p 3e-17	3.4 EB05 2.6 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	98% consumer	no trial data cached
Retching	15	3.3 2.0–5.5ROR 3.3 · χ² 22 / p 1e-6	3.1 EB05 2.0 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 6.0	no trial data cached
Fear	19	3.3 2.1–5.2ROR 3.3 · χ² 28 / p 5e-8	3.1 EB05 2.1 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 4.9	no trial data cached
Therapeutic product effect incomplete	47	3.1 2.4–4.2ROR 3.2 · χ² 67 / p 2e-16	3.1 EB05 2.4 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 0.9 · 98% consumer	no trial data cached
Sedation	17	3.1 1.9–5.0ROR 3.1 · χ² 22 / p 1e-6	2.9 EB05 1.9 · IC025 +0.7	Not in label — unassessed	serious PRR 5.1	no trial data cached
Muscle twitching	14	2.9 1.7–4.8ROR 2.9 · χ² 15 / p 5e-5	2.7 EB05 1.7 · IC025 +0.5	Not in label — unassessed	serious PRR 6.6	no trial data cached
Intentional product use issue	53	2.8 2.2–3.7ROR 2.9 · χ² 62 / p 2e-15	2.8 EB05 2.2 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 1.9 · 94% consumer	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
Drug ineffective (drug did not work)	1,175	4.2 4.0–4.4ROR 5.4 · χ² 3,076 / p <1e-300	4.2 EB05 4.0 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 3.5 · 98% consumer	no trial data cached
Somnolence (drowsiness)	424	10.0 9.1–10.9ROR 10.9 · χ² 3,446 / p <1e-300	9.9 EB05 9.2 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 3.8 · 97% consumer	no trial data cached
Product use in unapproved indication	346	6.7 6.1–7.4ROR 7.2 · χ² 1,691 / p <1e-300	6.6 EB05 6.1 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 0.7 · 99% consumer	no trial data cached
Drug effective for unapproved indication	283	46.2 41.3–51.8ROR 49.3 · χ² 12,372 / p <1e-300	45.7 EB05 41.4 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious n=1 · ♀ 90% (drug 69%) · 100% consumer	no trial data cached
Insomnia (trouble sleeping)	240	4.3 3.8–4.8ROR 4.4 · χ² 602 / p 4e-133	4.2 EB05 3.8 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.0 · 92% consumer	no trial data cached
Feeling abnormal	219	4.3 3.8–4.9ROR 4.5 · χ² 559 / p 9e-124	4.3 EB05 3.8 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.0 · 96% consumer	no trial data cached
Intentional product misuse	145	7.9 6.7–9.3ROR 8.1 · χ² 869 / p 2e-191	7.7 EB05 6.7 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 8.5 · 95% consumer	no trial data cached
Overdose	115	2.5 2.1–3.0ROR 2.6 · χ² 104 / p 1e-24	2.5 EB05 2.1 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	serious PRR 2.2 · 98% consumer	no trial data cached
Drug effect incomplete	99	12.7 10.5–15.5ROR 13.0 · χ² 1,058 / p 3e-232	12.6 EB05 10.6 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 3.5 · 97% consumer	no trial data cached
Dysphagia (difficulty swallowing)	87	4.3 3.5–5.4ROR 4.4 · χ² 222 / p 2e-50	4.3 EB05 3.6 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 5.8 · 94% consumer	no trial data cached
Drug effect decreased	84	7.3 5.9–9.0ROR 7.4 · χ² 449 / p 6e-100	7.0 EB05 5.8 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 30.6 · 98% consumer	no trial data cached
Incorrect dose administered	79	1.7 1.3–2.1ROR 1.7 · χ² 20 / p 3e-6	1.7 EB05 1.4 · IC025 +0.4	Reporting / coding artifact	serious PRR 1.9 · 94% consumer	no trial data cached
Restlessness	75	9.7 7.7–12.1ROR 9.8 · χ² 576 / p 2e-127	9.4 EB05 7.7 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 15.3 · 95% consumer	no trial data cached
Restless legs syndrome	59	15.4 11.9–19.8ROR 15.6 · χ² 776 / p 4e-171	15.2 EB05 12.2 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 7.3 · 93% consumer	no trial data cached
Poor quality sleep	54	12.0 9.2–15.6ROR 12.1 · χ² 530 / p 1e-117	11.7 EB05 9.2 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious PRR 8.4 · 91% consumer	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.

Drug effective for unapproved indication — n=283, PRR 46.2
Restless legs syndrome — n=59, PRR 15.4
Feeling jittery — n=49, PRR 12.2
Middle insomnia — n=45, PRR 11.5
Restlessness — n=75, PRR 9.7
Psychomotor hyperactivity — n=31, PRR 8.8
Choking — n=33, PRR 8.0
Nightmare — n=53, PRR 7.2
Abnormal dreams — n=36, PRR 6.1
Dysphagia — n=87, PRR 4.3

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 Advil Pm?

In FDA FAERS, the most frequently co-reported reaction terms for Advil Pm are somnolence, drug effective for unapproved indication, insomnia, feeling abnormal, dysphagia, restlessness. 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 Advil Pm have an FDA boxed warning?

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

Do FAERS signals prove that Advil Pm 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 d1138e15-8ae4-7b49-e053-2995a90a9607, effective 20241230; matched on openfda.generic_name.exact:"ADVIL PM")
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, 97 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.