Levetiracetam side effects: what 132,782 FDA adverse event reports show

Levetiracetam · 1,244 reaction terms · 420,462 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

132,782 reports · 83% serious · 11,940 with death outcome · 55% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) Levetiracetam is indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with ju.

FDA label, Indications and Usage

What it is

Levetiracetam is an antiepileptic drug available as 500 mg (white), 750 mg (white) and 1000 mg (white) tablets for oral administration.

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 2Labeled (related wording) 4Likely indication confounding 13Reporting / coding artifact 2Lab value / disease marker 5Not in label — unassessed 14

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.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
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.

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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,204 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
Multiple-drug resistance	1,482	145.9 136.0–156.6ROR 147.6 · calibrated p 5e-9 ✓	75.5 EB05 72.4 · IC025 +6.1 3/3 methods agree	Reporting / coding artifact	serious n=1,131 · 94% clinician	not reported in cached trials
Postictal psychosis	73	141.3 102.9–194.0ROR 141.3 · calibrated p 2e-8 ✓	73.0 EB05 60.0 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious n=73 · ♀ 0% (drug 55%) · 100% clinician	not reported in cached trials
Epileptic encephalopathy	94	117.4 89.8–153.4ROR 117.4 · calibrated p 6e-8 ✓	66.3 EB05 55.8 · IC025 +5.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=93 · ♀ 0% (drug 55%) · 100% clinician	not reported in cached trials
Change in seizure presentation	233	86.9 74.0–102.0ROR 87.1 · calibrated p 4e-7 ✓	55.8 EB05 50.0 · IC025 +5.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=227	not reported in cached trials
Sudden unexplained death in epilepsy	185	82.1 68.7–98.1ROR 82.2 · calibrated p 6e-7 ✓	53.7 EB05 47.5 · IC025 +5.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=185 · 100% clinician	not reported in cached trials
Focal dyscognitive seizures	388	81.2 71.8–91.8ROR 81.4 · calibrated p 6e-7 ✓	53.5 EB05 49.1 · IC025 +5.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=377	not reported in cached trials
Partial seizures with secondary generalisation	148	72.7 59.8–88.4ROR 72.8 · calibrated p 1e-6 ✓	49.5 EB05 43.2 · IC025 +5.1 3/3 methods agree	Labeled (related wording) related wording	serious n=147 · 100% clinician	not reported in cached trials
Psychogenic seizure	283	69.8 60.6–80.3ROR 69.9 · calibrated p 2e-6 ✓	48.3 EB05 43.7 · IC025 +5.3 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=272 · 100% clinician	not reported in cached trials
Vagal nerve stimulator implantation	87	65.4 50.9–84.0ROR 65.4 · calibrated p 3e-6 ✓	45.8 EB05 38.3 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=79 · ♀ 0% (drug 55%) · 100% consumer	not reported in cached trials
Seizure cluster	235	65.1 55.9–75.8ROR 65.2 · calibrated p 3e-6 ✓	46.0 EB05 41.2 · IC025 +5.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=224	not reported in cached trials
Myoclonic epilepsy	422	63.3 56.5–70.9ROR 63.5 · calibrated p 3e-6 ✓	45.1 EB05 41.6 · IC025 +5.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=419	not reported in cached trials
Partial seizures	1,437	60.9 57.3–64.7ROR 61.5 · calibrated p 4e-6 ✓	44.0 EB05 42.1 · IC025 +5.4 3/3 methods agree	Labeled adverse reaction exact term	serious n=1,391	NCT00537238: 1/255 (0.4%) on Levetiracetam (serious AE)
Postictal paralysis	65	57.8 43.5–76.9ROR 57.9 · calibrated p 8e-6 ✓	41.9 EB05 34.0 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=63 · ♀ 0% (drug 55%) · 100% clinician	NCT01960075: 1/150 (0.7%) on Levetiracetam
Status epilepticus	2,923	54.9 52.6–57.2ROR 56.1 · calibrated p 6e-6 ✓	40.8 EB05 39.5 · IC025 +5.3 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 34.7 · serious PRR 28.3	NCT00537238: 2/255 (0.8%) on Levetiracetam (serious AE)
Epileptic aura	66	54.1 40.9–71.5ROR 54.1 · calibrated p 1e-5 ✓	39.9 EB05 32.5 · IC025 +4.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=58 · ♀ 100% (drug 55%) · 100% consumer	not reported in cached trials
Atonic seizures	191	49.6 42.2–58.4ROR 49.7 · calibrated p 2e-5 ✓	37.7 EB05 33.4 · IC025 +4.9 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=184	not reported in cached trials
Infantile spasms	164	46.8 39.3–55.8ROR 46.9 · calibrated p 2e-5 ✓	36.1 EB05 31.7 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious n=163	not reported in cached trials
Complex partial seizures	249	44.6 38.8–51.4ROR 44.7 · calibrated p 3e-5 ✓	34.8 EB05 31.3 · IC025 +4.8 3/3 methods agree	Labeled (related wording) related wording	serious n=242	NCT00537238: 1/255 (0.4%) on Levetiracetam (serious AE)
Simple partial seizures	178	43.9 37.2–51.8ROR 43.9 · calibrated p 3e-5 ✓	34.3 EB05 30.3 · IC025 +4.7 3/3 methods agree	Labeled (related wording) related wording	serious n=170	not reported in cached trials
Anticonvulsant drug level above therapeutic	135	41.1 34.0–49.6ROR 41.1 · calibrated p 5e-5 ✓	32.5 EB05 28.2 · IC025 +4.6 3/3 methods agree	Lab value / disease marker	serious n=133 · 100% clinician	not reported in cached trials
Petit mal epilepsy	1,047	40.8 38.1–43.7ROR 41.1 · calibrated p 4e-5 ✓	32.5 EB05 30.9 · IC025 +4.9 3/3 methods agree	Labeled (related wording) related wording	serious n=1,005	not reported in cached trials
Aura	369	38.9 34.7–43.6ROR 39.0 · calibrated p 6e-5 ✓	31.3 EB05 28.7 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=281	not reported in cached trials
Temporal lobe epilepsy	86	38.1 30.1–48.3ROR 38.2 · calibrated p 8e-5 ✓	30.6 EB05 25.6 · IC025 +4.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=85	not reported in cached trials
Anticonvulsant drug level decreased	261	35.2 30.8–40.3ROR 35.3 · calibrated p 1e-4 ✓	28.8 EB05 26.0 · IC025 +4.6 3/3 methods agree	Lab value / disease marker	serious n=244	not reported in cached trials
Generalised tonic-clonic seizure	2,968	34.9 33.5–36.3ROR 35.6 · calibrated p 1e-4 ✓	28.6 EB05 27.8 · IC025 +4.8 3/3 methods agree	Likely indication confounding term in indications; also in warnings	age-adj. PRR 18.7 · serious PRR 19.7	not reported in cached trials
Tonic convulsion	247	33.6 29.3–38.6ROR 33.7 · calibrated p 1e-4 ✓	27.8 EB05 25.0 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=243	not reported in cached trials
Anticonvulsant drug level increased	279	32.5 28.6–37.0ROR 32.6 · calibrated p 2e-4 ✓	27.0 EB05 24.5 · IC025 +4.5 3/3 methods agree	Lab value / disease marker	serious n=262	not reported in cached trials
Drug withdrawal convulsions	298	31.5 27.8–35.7ROR 31.6 · calibrated p 2e-4 ✓	26.3 EB05 23.9 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=293	NCT00537238: 1/255 (0.4%) on Levetiracetam (serious AE)
Anticonvulsant drug level below therapeutic	126	31.2 25.7–37.7ROR 31.2 · calibrated p 2e-4 ✓	26.0 EB05 22.4 · IC025 +4.3 3/3 methods agree	Lab value / disease marker	serious n=120 · 100% clinician	not reported in cached trials
Propofol infusion syndrome	102	26.5 21.5–32.7ROR 26.6 · calibrated p 6e-4 ✓	22.7 EB05 19.3 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=102 · 100% clinician	not reported in cached trials
Seizure	15,976	25.4 25.0–25.8ROR 28.8 · calibrated p 3e-4 ✓	22.0 EB05 21.7 · IC025 +4.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	age-adj. PRR 17.2 · serious PRR 14.7	NCT00537238: 1/255 (0.4%) on Levetiracetam (serious AE)
Epilepsy	4,134	24.6 23.8–25.4ROR 25.4 · calibrated p 6e-4 ✓	21.4 EB05 20.8 · IC025 +4.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	age-adj. PRR 18.7 · serious PRR 14.8	NCT00537238: 2/255 (0.8%) on Levetiracetam (serious AE)
Glioblastoma multiforme	114	24.4 20.0–29.7ROR 24.4 · calibrated p 8e-4 ✓	21.2 EB05 18.1 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=112	not reported in cached trials
Developmental hip dysplasia	100	21.4 17.4–26.4ROR 21.4 · calibrated p 0.002 ✓	18.9 EB05 16.0 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=100 · 100% clinician	not reported in cached trials
Behaviour disorder	595	19.8 18.2–21.6ROR 19.9 · calibrated p 0.002 ✓	17.7 EB05 16.5 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=479	not reported in cached trials
Breast feeding	86	19.2 15.3–24.0ROR 19.2 · calibrated p 0.003 ✓	17.1 EB05 14.3 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=74 · ♀ 100% (drug 55%)	not reported in cached trials
Encephalitis autoimmune	140	19.1 16.0–22.7ROR 19.1 · calibrated p 0.003 ✓	17.1 EB05 14.8 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=140 · 100% clinician	not reported in cached trials
Brain operation	242	18.9 16.5–21.6ROR 18.9 · calibrated p 0.003 ✓	16.9 EB05 15.2 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious n=235 · 77% consumer	not reported in cached trials
Foetal malformation	113	18.1 14.9–22.0ROR 18.1 · calibrated p 0.003 ✓	16.2 EB05 13.9 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=113 · 100% clinician	not reported in cached trials
Electroencephalogram abnormal	317	17.5 15.6–19.7ROR 17.6 · calibrated p 0.004 ✓	15.8 EB05 14.4 · IC025 +3.8 3/3 methods agree	Lab value / disease marker	serious n=300	not reported in cached trials

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Seizure	24,512	22.422.1–22.7	signal
Severe cutaneous reaction	2,607	5.75.5–5.9	signal
Rhabdomyolysis / myopathy	1,813	3.63.4–3.8	signal
Hyponatraemia	1,543	3.12.9–3.2	signal
Thrombocytopenia	3,137	2.32.2–2.3	signal
Extrapyramidal	1,294	2.01.8–2.1	raised
Suicidality	2,908	1.91.8–1.9	raised
Depression	3,109	1.81.7–1.8	raised
Liver injury	3,331	1.81.7–1.8	raised
Fall / fracture	3,937	1.61.6–1.7	raised
Neutropenia / agranulocytosis	2,337	1.51.4–1.6	raised
Stroke	2,267	1.41.4–1.5	raised
Pancreatitis	659	1.31.2–1.4	raised
Arrhythmia / qt	1,509	1.21.2–1.3	raised
Anaemia	2,334	1.21.2–1.3	raised
Kidney injury	3,509	1.21.2–1.3	raised

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Levetiracetam as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (7 of 40 signal terms matched).

NCT00537238 — Pregabalin Versus Levetiracetam In Partial Seizures (N=509, PHASE3; 62 AE terms posted; arms: Pregabalin; Levetiracetam)
NCT01960075 — Established Status Epilepticus Treatment Trial (N=478, PHASE3; 96 AE terms posted; arms: Fosphenytoin (FOS); Valproic Acid; Levetiracetam)

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

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
Seizure	15,976	25.4 25.0–25.8ROR 28.8 · calibrated p 3e-4 ✓	22.0 EB05 21.7 · IC025 +4.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	age-adj. PRR 17.2 · serious PRR 14.7	NCT00537238: 1/255 (0.4%) on Levetiracetam (serious AE)
Drug ineffective (drug did not work)	12,302	1.5 1.5–1.5ROR 1.5 · calibrated p 0.660	1.5 EB05 1.5 · IC025 +0.5	Reporting / coding artifact	age-adj. PRR 1.7 · serious PRR 2.3	not reported in cached trials
Off label use (used outside approved label)	9,498	1.7 1.7–1.8ROR 1.8 · calibrated p 0.826	1.7 EB05 1.7 · IC025 +0.8	Reporting / coding artifact	age-adj. PRR 1.5 · serious PRR 1.9	not reported in cached trials
Fatigue (tiredness)	5,588	1.1 1.1–1.2ROR 1.1 · calibrated p 0.401	1.1 EB05 1.1 · IC025 +0.1	Labeled adverse reaction exact term	age-adj. PRR 1.0 · serious PRR 1.1	not reported in cached trials
Somnolence (drowsiness)	4,175	3.3 3.2–3.4ROR 3.4 · calibrated p 0.509	3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.8 · serious PRR 3.1	NCT00537238: 76/255 (29.8%) on Levetiracetam
Epilepsy	4,134	24.6 23.8–25.4ROR 25.4 · calibrated p 6e-4 ✓	21.4 EB05 20.8 · IC025 +4.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	age-adj. PRR 18.7 · serious PRR 14.8	NCT00537238: 2/255 (0.8%) on Levetiracetam (serious AE)
Convulsion (seizure)	4,083	11.9 11.5–12.3ROR 12.2 · calibrated p 0.016 ✓	11.1 EB05 10.8 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 8.0 · serious PRR 7.6	NCT00537238: 1/255 (0.4%) on Levetiracetam (serious AE)
Fall	3,758	1.8 1.7–1.9ROR 1.8 · calibrated p 0.840	1.8 EB05 1.7 · IC025 +0.8	Labeled adverse reaction exact term	age-adj. PRR 1.9 · serious PRR 1.4	NCT00537238: 1/255 (0.4%) on Levetiracetam (serious AE)
Headache	3,731	0.9 0.9–1.0ROR 0.9 · calibrated p 0.267	0.9 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	age-adj. PRR 0.8 · serious PRR 1.1	NCT00537238: 30/255 (11.8%) on Levetiracetam
Maternal exposure during pregnancy	3,727	6.9 6.7–7.2ROR 7.1 · calibrated p 0.095	6.7 EB05 6.5 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 5.7 · ♀ 92% (drug 55%)	not reported in cached trials
Nausea	3,611	0.7 0.7–0.7ROR 0.7 · calibrated p 0.137	0.7 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC	Not in label — unassessed	age-adj. PRR 0.7 · serious PRR 0.7	NCT00537238: 15/255 (5.9%) on Levetiracetam
Dizziness	3,584	1.1 1.1–1.2ROR 1.1 · calibrated p 0.400	1.1 EB05 1.1 · IC025 +0.1	Labeled adverse reaction exact term	age-adj. PRR 1.1 · serious PRR 1.1	NCT00537238: 1/254 (0.4%) on Levetiracetam (serious AE)
Drug interaction	3,448	3.5 3.4–3.6ROR 3.6 · calibrated p 0.472	3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 3.3 · serious PRR 2.5	not reported in cached trials
Diarrhoea (diarrhea)	3,242	0.8 0.8–0.8ROR 0.8 · calibrated p 0.178	0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	age-adj. PRR 0.8 · serious PRR 0.7	not reported in cached trials
Death	3,236	0.6 0.6–0.6ROR 0.6 · calibrated p 0.077	0.6 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC	Outcome field, not a reaction	age-adj. PRR 0.8 · serious PRR 0.4	not reported in cached trials

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.

Postictal psychosis — n=73, PRR 141.3
Vagal nerve stimulator implantation — n=87, PRR 65.4
Postictal paralysis — n=65, PRR 57.8 (also seen in trial arm)
Infantile spasms — n=164, PRR 46.8
Aura — n=369, PRR 38.9
Tonic convulsion — n=247, PRR 33.6
Drug withdrawal convulsions — n=298, PRR 31.5 (also seen in trial arm)
Propofol infusion syndrome — n=102, PRR 26.5
Glioblastoma multiforme — n=114, PRR 24.4
Developmental hip dysplasia — n=100, PRR 21.4

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 Levetiracetam?

In FDA FAERS, the most frequently co-reported reaction terms for Levetiracetam are seizure, fatigue, somnolence, epilepsy, convulsion, fall. 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 Levetiracetam have an FDA boxed warning?

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

Do FAERS signals prove that Levetiracetam 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 08e1bfea-7f3f-42d9-823d-f75080e664ff, effective 20251112; matched on openfda.generic_name.exact:"LEVETIRACETAM" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG")
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, 1,244 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
ClinicalTrials.gov API v2 (query LEVETIRACETAM, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. 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.