Drug · FAERS side-effect profile with label screen

Pitolisant side effects: what 2,066 FDA adverse event reports show

Pitolisant Hydrochloride · 98 reaction terms · 3,042 drug–reaction co-reports · data 2026-09-14

Drug class

Histamine-3 (h3) receptor antagonist/inverse agonist

FDA label, Indications wording of the closest related product

Label matched

Pitolisant Hydrochloride (Wakix)

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

Who reports

2,066 reports · 47% serious · 9 with death outcome · 70% female

openFDA FAERS counts, all years, deduplication not applied

Used for

WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older with narcolepsy. WAKIX is a histamine-3 (H3) receptor antagonist/inverse agonist indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy patients 6 years of age and older with narcolepsy ( 1 )

FDA label, Indications and Usage

What it is

WAKIX tablets contain pitolisant hydrochloride. Pitolisant is an antagonist/inverse agonist of the histamine-3 (H3) receptor. Pitolisant hydrochloride is a white or almost white crystalline powder with a molecular formula of C 17 H 26 ClNO·HCl and a molecular weight of 332.31.

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 11Labeled (related wording) 1Reporting / coding artifact 9Not in label — unassessed 19

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. 58 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
Middle insomnia	121	66.4 55.8–79.0ROR 70.5 · χ² 7,687 / p <1e-300	65.3 EB05 56.1 · IC025 +5.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 44.9 · 93% consumer	no trial data cached
Initial insomnia	62	62.0 48.5–79.4ROR 63.9 · χ² 3,642 / p <1e-300	60.6 EB05 48.9 · IC025 +5.0 3/3 methods agree	Labeled adverse reaction exact term	serious n=19 · 87% consumer	no trial data cached
Nocturia (night-time urination)	48	40.4 30.5–53.4ROR 41.3 · χ² 1,797 / p <1e-300	39.6 EB05 31.1 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 33.3 · 73% consumer	no trial data cached
Intentional dose omission	78	29.0 23.3–36.1ROR 30.1 · χ² 2,079 / p <1e-300	28.8 EB05 23.8 · IC025 +4.2 3/3 methods agree	Reporting / coding artifact	serious PRR 58.5	no trial data cached
Brain fog	38	26.5 19.3–36.3ROR 27.0 · χ² 905 / p 4e-199	26.1 EB05 19.9 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 35.9	no trial data cached
Poor quality sleep	49	23.3 17.6–30.7ROR 23.8 · χ² 1,021 / p 2e-224	23.0 EB05 18.1 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 13.8 · 87% consumer	no trial data cached
Sleep apnoea syndrome	43	22.9 17.0–30.7ROR 23.3 · χ² 876 / p 9e-193	22.6 EB05 17.5 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 26.9	no trial data cached
Surgery	112	19.6 16.4–23.5ROR 20.7 · χ² 1,964 / p <1e-300	19.5 EB05 16.7 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious PRR 26.4	no trial data cached
Bipolar disorder	20	18.6 12.0–28.7ROR 18.7 · χ² 315 / p 1e-70	18.1 EB05 12.2 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 24.5	no trial data cached
Feeling jittery	28	14.9 10.3–21.5ROR 15.1 · χ² 349 / p 4e-78	14.5 EB05 10.3 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=16	no trial data cached
Mania	22	13.6 9.0–20.6ROR 13.7 · χ² 244 / p 2e-55	13.0 EB05 8.6 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 15.8	no trial data cached
Hunger	16	12.1 7.4–19.7ROR 12.2 · χ² 152 / p 4e-35	10.9 EB05 6.6 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious n=12	no trial data cached
Abnormal dreams	33	12.1 8.6–16.9ROR 12.2 · χ² 324 / p 1e-72	11.6 EB05 8.4 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.8 · 76% consumer	no trial data cached
Restless legs syndrome	21	11.7 7.7–17.9ROR 11.8 · χ² 195 / p 1e-44	10.9 EB05 7.1 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 19.9	no trial data cached
Panic attack	42	11.7 8.7–15.8ROR 11.9 · χ² 400 / p 2e-89	11.3 EB05 8.5 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 13.7	no trial data cached
Drug effect less than expected	15	10.8 6.5–17.9ROR 10.9 · χ² 124 / p 5e-29	9.4 EB05 5.6 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious n=7	no trial data cached
Seasonal allergy	15	10.8 6.5–17.9ROR 10.9 · χ² 124 / p 5e-29	9.4 EB05 5.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious n=7	no trial data cached
Autoimmune disorder	10	10.6 5.7–19.7ROR 10.7 · χ² 78 / p 6e-19	8.5 EB05 4.5 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 13.8	no trial data cached
Nightmare	35	10.2 7.4–14.2ROR 10.4 · χ² 282 / p 1e-63	9.7 EB05 7.1 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.7	no trial data cached
Obesity	16	10.2 6.2–16.6ROR 10.3 · χ² 123 / p 6e-29	8.9 EB05 5.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 13.5	no trial data cached
Unevaluable event	73	9.8 7.8–12.3ROR 10.1 · χ² 569 / p 4e-126	9.5 EB05 7.8 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 6.6 · 84% consumer	no trial data cached
Impaired gastric emptying	12	9.6 5.4–16.8ROR 9.6 · χ² 84 / p 3e-20	7.8 EB05 4.5 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 12.0	no trial data cached
Somnolence (drowsiness)	185	9.3 8.1–10.7ROR 10.2 · χ² 1,382 / p <1e-300	9.2 EB05 8.1 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 7.1 · 81% consumer	no trial data cached
Cholecystectomy	10	8.9 4.8–16.6ROR 9.0 · χ² 63 / p 1e-15	7.0 EB05 3.8 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 11.3	no trial data cached
Disability	17	8.7 5.4–14.0ROR 8.8 · χ² 109 / p 1e-25	7.5 EB05 4.8 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.9	no trial data cached
Sinus disorder	17	8.7 5.4–14.0ROR 8.8 · χ² 108 / p 1e-25	7.5 EB05 4.8 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.1	no trial data cached
Retching	18	8.6 5.4–13.6ROR 8.7 · χ² 113 / p 9e-27	7.5 EB05 4.8 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 12.6	no trial data cached
Intentional product use issue	74	8.5 6.8–10.7ROR 8.8 · χ² 487 / p 3e-108	8.3 EB05 6.7 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 12.0	no trial data cached
Spinal operation	10	8.4 4.5–15.6ROR 8.4 · χ² 58 / p 1e-14	6.5 EB05 3.6 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 11.1	no trial data cached
Insomnia (trouble sleeping)	217	8.3 7.3–9.4ROR 9.1 · χ² 1,394 / p <1e-300	8.2 EB05 7.3 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.8 · 81% consumer	no trial data cached
Anxiety	229	8.1 7.2–9.2ROR 9.0 · χ² 1,448 / p <1e-300	8.1 EB05 7.2 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.0	no trial data cached
Therapeutic product effect decreased	31	7.1 5.0–10.1ROR 7.2 · χ² 156 / p 4e-36	6.5 EB05 4.8 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 4.9	no trial data cached
Suicidal ideation (thoughts of suicide)	64	7.1 5.6–9.0ROR 7.3 · χ² 330 / p 5e-74	6.8 EB05 5.5 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.8	no trial data cached
Nephrolithiasis (kidney stones)	31	6.9 4.9–9.8ROR 7.0 · χ² 150 / p 8e-35	6.3 EB05 4.6 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 7.7	no trial data cached
Psychotic disorder	20	6.9 4.4–10.6ROR 6.9 · χ² 95 / p 1e-22	6.0 EB05 4.1 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 7.7	no trial data cached
Migraine	64	6.8 5.4–8.7ROR 7.0 · χ² 315 / p 9e-71	6.6 EB05 5.3 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.7	no trial data cached
Prescribed overdose	13	6.8 4.0–11.7ROR 6.9 · χ² 59 / p 8e-15	5.6 EB05 3.5 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.7	no trial data cached
Irritability	39	6.6 4.8–9.0ROR 6.7 · χ² 179 / p 4e-41	6.1 EB05 4.7 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.4 · 72% consumer	no trial data cached
Product dose omission issue	180	6.4 5.6–7.4ROR 6.9 · χ² 828 / p 2e-182	6.3 EB05 5.6 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 15.4 · 79% consumer	no trial data cached
Sciatica	10	6.4 3.4–11.9ROR 6.4 · χ² 40 / p 1e-10	5.1 EB05 2.9 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.4	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
Anxiety	229	8.1 7.2–9.2ROR 9.0 · χ² 1,448 / p <1e-300	8.1 EB05 7.2 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.0	no trial data cached
Insomnia (trouble sleeping)	217	8.3 7.3–9.4ROR 9.1 · χ² 1,394 / p <1e-300	8.2 EB05 7.3 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.8 · 81% consumer	no trial data cached
Somnolence (drowsiness)	185	9.3 8.1–10.7ROR 10.2 · χ² 1,382 / p <1e-300	9.2 EB05 8.1 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 7.1 · 81% consumer	no trial data cached
Product dose omission issue	180	6.4 5.6–7.4ROR 6.9 · χ² 828 / p 2e-182	6.3 EB05 5.6 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	serious PRR 15.4 · 79% consumer	no trial data cached
Middle insomnia	121	66.4 55.8–79.0ROR 70.5 · χ² 7,687 / p <1e-300	65.3 EB05 56.1 · IC025 +5.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 44.9 · 93% consumer	no trial data cached
Depression	112	5.0 4.2–6.0ROR 5.2 · χ² 355 / p 1e-79	4.9 EB05 4.2 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.7	no trial data cached
Surgery	112	19.6 16.4–23.5ROR 20.7 · χ² 1,964 / p <1e-300	19.5 EB05 16.7 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious PRR 26.4	no trial data cached
Feeling abnormal	100	4.2 3.5–5.1ROR 4.4 · χ² 245 / p 2e-55	4.1 EB05 3.5 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 6.4 · 75% consumer	no trial data cached
Intentional dose omission	78	29.0 23.3–36.1ROR 30.1 · χ² 2,079 / p <1e-300	28.8 EB05 23.8 · IC025 +4.2 3/3 methods agree	Reporting / coding artifact	serious PRR 58.5	no trial data cached
Intentional product use issue	74	8.5 6.8–10.7ROR 8.8 · χ² 487 / p 3e-108	8.3 EB05 6.7 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 12.0	no trial data cached
Unevaluable event	73	9.8 7.8–12.3ROR 10.1 · χ² 569 / p 4e-126	9.5 EB05 7.8 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 6.6 · 84% consumer	no trial data cached
Wrong technique in product usage process	64	3.2 2.5–4.1ROR 3.3 · χ² 96 / p 5e-23	3.2 EB05 2.6 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	serious PRR 15.5 · 71% consumer	no trial data cached
Migraine	64	6.8 5.4–8.7ROR 7.0 · χ² 315 / p 9e-71	6.6 EB05 5.3 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.7	no trial data cached
Suicidal ideation (thoughts of suicide)	64	7.1 5.6–9.0ROR 7.3 · χ² 330 / p 5e-74	6.8 EB05 5.5 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.8	no trial data cached
Initial insomnia	62	62.0 48.5–79.4ROR 63.9 · χ² 3,642 / p <1e-300	60.6 EB05 48.9 · IC025 +5.0 3/3 methods agree	Labeled adverse reaction exact term	serious n=19 · 87% 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.

Nocturia — n=48, PRR 40.4
Brain fog — n=38, PRR 26.5
Sleep apnoea syndrome — n=43, PRR 22.9
Feeling jittery — n=28, PRR 14.9
Mania — n=22, PRR 13.6
Restless legs syndrome — n=21, PRR 11.7
Panic attack — n=42, PRR 11.7
Somnolence — n=185, PRR 9.3
Nephrolithiasis — n=31, PRR 6.9
Psychotic disorder — n=20, PRR 6.9

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 Pitolisant?

In FDA FAERS, the most frequently co-reported reaction terms for Pitolisant are anxiety, insomnia, somnolence, middle insomnia, depression, feeling abnormal. 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 Pitolisant have an FDA boxed warning?

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

Do FAERS signals prove that Pitolisant 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 8daa5562-824e-476c-9652-26ceef3d4b0e, effective 20260213; matched on openfda.generic_name.exact:"PITOLISANT 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, 98 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.