Drug · FAERS side-effect profile with label screen
Lacosamide side effects: what 36,986 FDA adverse event reports show
Drug class
Not stated in label
Who reports
36,986 reports · 79% serious · 3,133 with death outcome · 55% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Lacosamide tablets are indicated for: • Treatment of partial-onset seizures in patients 4 years of age and older ( 1.1 ) • Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older ( 1.2 ) 1.1 Partial-Onset Seizures Lacosamide tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older.
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 2Labeled (related wording) 3Likely indication confounding 7Reporting / coding artifact 3Lab value / disease marker 2Not in label — unassessed 23
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). 1,177 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 |
|---|---|---|---|---|---|---|
| New onset refractory status epilepticus | 55 | 614.2 418.8–900.7ROR 615.1 · calibrated p 5e-14 ✓ | 265.9 EB05 212.0 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=55 · 100% clinician | not reported in cached trials |
| Epilepsia partialis continua | 21 | 558.3 305.0–1,022.2ROR 558.7 · calibrated p 2e-12 ✓ | 223.1 EB05 153.9 · IC025 +4.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=21 · 100% clinician | not reported in cached trials |
| Automatism epileptic | 18 | 558.3 290.5–1,073.0ROR 558.6 · calibrated p 3e-12 ✓ | 215.8 EB05 144.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Febrile infection-related epilepsy syndrome | 15 | 558.3 273.0–1,142.1ROR 558.6 · calibrated p 7e-12 ✓ | 206.5 EB05 132.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Mitochondrial dna mutation | 38 | 451.4 294.4–692.2ROR 451.9 · calibrated p 2e-12 ✓ | 222.2 EB05 169.0 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=38 · ♀ 100% (drug 55%) | not reported in cached trials |
| Tuberous sclerosis complex | 28 | 208.4 135.1–321.7ROR 208.6 · calibrated p 2e-9 ✓ | 137.9 EB05 100.2 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=28 | not reported in cached trials |
| Multiple-drug resistance | 816 | 203.6 188.0–220.4ROR 208.1 · calibrated p 3e-10 ✓ | 148.9 EB05 140.6 · IC025 +7.0 3/3 methods agree | Reporting / coding artifact | serious n=638 · 94% clinician | not reported in cached trials |
| Brain lobectomy | 15 | 199.4 110.6–359.5ROR 199.5 · calibrated p 7e-9 ✓ | 124.3 EB05 80.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Angiofibroma | 16 | 154.0 88.6–267.9ROR 154.1 · calibrated p 4e-8 ✓ | 106.0 EB05 69.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Csf oligoclonal band present | 26 | 152.8 99.0–235.8ROR 152.9 · calibrated p 2e-8 ✓ | 110.6 EB05 79.3 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=26 · ♀ 100% (drug 55%) · 100% clinician | not reported in cached trials |
| Sudden unexplained death in epilepsy | 104 | 135.0 109.0–167.3ROR 135.4 · calibrated p 2e-8 ✓ | 106.8 EB05 90.7 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=104 · ♀ 28% (drug 55%) | NCT00771927: 1/511 (0.2%) on Lacosamide (serious AE) |
| Focal dyscognitive seizures | 216 | 132.2 114.1–153.3ROR 133.0 · calibrated p 1e-8 ✓ | 106.1 EB05 94.8 · IC025 +6.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=205 | not reported in cached trials |
| Hippocampal sclerosis | 24 | 128.8 82.7–200.8ROR 128.9 · calibrated p 7e-8 ✓ | 97.0 EB05 68.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=24 | not reported in cached trials |
| Partial seizures with secondary generalisation | 86 | 127.4 100.8–160.9ROR 127.7 · calibrated p 3e-8 ✓ | 101.6 EB05 84.8 · IC025 +5.7 3/3 methods agree | Labeled (related wording) related wording | serious n=85 | NCT01243177: 3/442 (0.7%) control (serious AE) |
| Vagal nerve stimulator implantation | 53 | 123.3 91.6–166.0ROR 123.5 · calibrated p 4e-8 ✓ | 97.7 EB05 77.6 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=51 | NCT00771927: 1/493 (0.2%) on Lacosamide |
| Seizure cluster | 141 | 120.6 100.5–144.6ROR 121.0 · calibrated p 3e-8 ✓ | 98.0 EB05 85.2 · IC025 +5.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=127 | NCT00771927: 2/511 (0.4%) on Lacosamide (serious AE) |
| Change in seizure presentation | 115 | 120.5 98.5–147.3ROR 120.8 · calibrated p 4e-8 ✓ | 97.7 EB05 83.6 · IC025 +5.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=111 | not reported in cached trials |
| Postictal psychosis | 25 | 109.1 71.0–167.4ROR 109.1 · calibrated p 2e-7 ✓ | 85.6 EB05 61.0 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=25 · 100% clinician | NCT00771927: 1/493 (0.2%) on Lacosamide |
| Cerebral salt-wasting syndrome | 16 | 108.9 63.8–186.1ROR 109.0 · calibrated p 4e-7 ✓ | 82.6 EB05 53.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Postictal paralysis | 35 | 95.8 66.9–137.1ROR 95.9 · calibrated p 4e-7 ✓ | 78.5 EB05 59.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=35 | NCT00771927: 1/493 (0.2%) on Lacosamide (serious AE) |
| Intestinal atresia | 15 | 92.0 53.3–158.9ROR 92.1 · calibrated p 1e-6 ✓ | 72.2 EB05 46.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Partial seizures | 670 | 84.6 78.1–91.7ROR 86.2 · calibrated p 4e-7 ✓ | 73.5 EB05 68.9 · IC025 +6.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=635 | NCT00771927: 1/511 (0.2%) on Lacosamide (serious AE) |
| Atonic seizures | 101 | 82.2 66.7–101.3ROR 82.4 · calibrated p 6e-7 ✓ | 70.9 EB05 60.0 · IC025 +5.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=95 | not reported in cached trials |
| Cataract congenital | 21 | 79.8 50.5–126.0ROR 79.8 · calibrated p 2e-6 ✓ | 65.9 EB05 45.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=21 · 100% clinician | not reported in cached trials |
| Status epilepticus | 1,276 | 72.0 68.0–76.3ROR 74.6 · calibrated p 1e-6 ✓ | 63.8 EB05 61.0 · IC025 +5.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 46.7 | NCT00771927: 3/511 (0.6%) on Lacosamide (serious AE) |
| Myocardial depression | 25 | 65.8 43.5–99.6ROR 65.9 · calibrated p 5e-6 ✓ | 56.6 EB05 40.3 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious n=25 · ♀ 100% (drug 55%) · 100% clinician | not reported in cached trials |
| Umbilical haemorrhage | 15 | 62.5 36.7–106.6ROR 62.5 · calibrated p 1e-5 ✓ | 52.8 EB05 33.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Organic brain syndrome | 18 | 59.5 36.6–96.7ROR 59.5 · calibrated p 1e-5 ✓ | 51.1 EB05 34.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Aura | 169 | 56.6 48.3–66.3ROR 56.9 · calibrated p 7e-6 ✓ | 51.2 EB05 45.0 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=128 | NCT00771927: 2/511 (0.4%) on Lacosamide |
| Propofol infusion syndrome | 61 | 53.6 41.2–69.6ROR 53.6 · calibrated p 1e-5 ✓ | 48.3 EB05 38.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=61 · ♀ 88% (drug 55%) · 90% clinician | not reported in cached trials |
| Brain tumour operation | 17 | 51.9 31.6–85.2ROR 51.9 · calibrated p 3e-5 ✓ | 45.3 EB05 30.0 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious n=17 | not reported in cached trials |
| Electrocardiogram pr prolongation | 61 | 50.2 38.6–65.2ROR 50.2 · calibrated p 2e-5 ✓ | 45.5 EB05 36.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=56 · ♀ 82% (drug 55%) · 100% clinician | not reported in cached trials |
| Anticonvulsant drug level above therapeutic | 53 | 50.1 37.8–66.3ROR 50.1 · calibrated p 2e-5 ✓ | 45.3 EB05 36.0 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=52 · ♀ 29% (drug 55%) | not reported in cached trials |
| Petit mal epilepsy | 405 | 49.0 44.3–54.2ROR 49.5 · calibrated p 1e-5 ✓ | 45.0 EB05 41.5 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=389 | NCT00771927: 1/493 (0.2%) on Lacosamide |
| Myoclonic epilepsy | 117 | 48.9 40.5–59.0ROR 49.0 · calibrated p 2e-5 ✓ | 44.7 EB05 38.3 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=116 | NCT00771927: 1/493 (0.2%) on Lacosamide |
| Brain operation | 177 | 48.2 41.4–56.2ROR 48.5 · calibrated p 2e-5 ✓ | 44.3 EB05 39.1 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=173 · 84% consumer | NCT00771927: 1/511 (0.2%) on Lacosamide (serious AE) |
| Intensive care unit acquired weakness | 29 | 46.5 31.9–67.9ROR 46.6 · calibrated p 4e-5 ✓ | 41.9 EB05 30.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=29 · 100% clinician | not reported in cached trials |
| Simple partial seizures | 60 | 44.9 34.5–58.4ROR 45.0 · calibrated p 3e-5 ✓ | 41.1 EB05 33.1 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious n=55 | NCT00771927: 1/511 (0.2%) on Lacosamide |
| Generalised tonic-clonic seizure | 1,197 | 44.7 42.2–47.4ROR 46.2 · calibrated p 2e-5 ✓ | 41.4 EB05 39.5 · IC025 +5.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 30.0 | not reported in cached trials |
| Congenital aplasia | 21 | 44.2 28.4–69.0ROR 44.3 · calibrated p 6e-5 ✓ | 39.7 EB05 27.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=21 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Lacosamide 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 (13 of 40 signal terms matched).
- NCT00771927 — Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onse (N=1005, phase n/a; 457 AE terms posted; arms: Lacosamide; Other AED)
- NCT01243177 — Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Init (N=888, PHASE3; 97 AE terms posted; arms: Lacosamide; Carbamazepine-Controlled Release (CBZ-CR)
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 | 6,858 | 36.0 35.2–36.8ROR 44.0 · calibrated p 3e-5 ✓ | 33.9 EB05 33.2 · IC025 +5.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 22.7 | NCT00771927: 2/511 (0.4%) on Lacosamide (serious AE) |
| Drug ineffective (drug did not work) | 4,137 | 1.8 1.7–1.8ROR 1.9 · calibrated p 0.878 | 1.8 EB05 1.7 · IC025 +0.8 | Reporting / coding artifact | serious PRR 3.1 | NCT00771927: 1/511 (0.2%) on Lacosamide (serious AE) |
| Off label use (used outside approved label) | 3,974 | 2.6 2.5–2.7ROR 2.8 · calibrated p 0.696 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | not reported in cached trials |
| Dizziness | 1,669 | 1.9 1.8–2.0ROR 1.9 · calibrated p 0.914 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.7 | NCT00771927: 4/511 (0.8%) on Lacosamide (serious AE) |
| Somnolence (drowsiness) | 1,496 | 4.2 4.0–4.5ROR 4.4 · calibrated p 0.314 | 4.2 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | NCT00771927: 1/511 (0.2%) on Lacosamide (serious AE) |
| Fatigue (tiredness) | 1,446 | 1.1 1.0–1.1ROR 1.1 · calibrated p 0.344 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.0 | NCT00771927: 1/493 (0.2%) on Lacosamide (serious AE) |
| Epilepsy | 1,417 | 27.6 26.2–29.0ROR 28.6 · calibrated p 3e-4 ✓ | 26.3 EB05 25.2 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.9 | NCT00771927: 1/511 (0.2%) on Lacosamide (serious AE) |
| Fall | 1,395 | 2.4 2.3–2.5ROR 2.4 · calibrated p 0.840 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.9 | NCT00771927: 2/511 (0.4%) on Lacosamide (serious AE) |
| Overdose | 1,279 | 3.4 3.2–3.5ROR 3.4 · calibrated p 0.498 | 3.3 EB05 3.2 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 | not reported in cached trials |
| Status epilepticus | 1,276 | 72.0 68.0–76.3ROR 74.6 · calibrated p 1e-6 ✓ | 63.8 EB05 61.0 · IC025 +5.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 46.7 | NCT00771927: 3/511 (0.6%) on Lacosamide (serious AE) |
| Generalised tonic-clonic seizure | 1,197 | 44.7 42.2–47.4ROR 46.2 · calibrated p 2e-5 ✓ | 41.4 EB05 39.5 · IC025 +5.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 30.0 | not reported in cached trials |
| Death | 1,071 | 0.7 0.7–0.7ROR 0.7 · calibrated p 0.128 | 0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.5 | NCT00771927: 1/511 (0.2%) on Lacosamide (serious AE) |
| Headache | 1,065 | 1.0 0.9–1.0ROR 1.0 · calibrated p 0.283 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.1 | NCT00771927: 3/511 (0.6%) on Lacosamide (serious AE) |
| Drug interaction | 1,001 | 3.6 3.4–3.8ROR 3.7 · calibrated p 0.446 | 3.6 EB05 3.4 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 | not reported in cached trials |
| Nausea | 949 | 0.7 0.6–0.7ROR 0.7 · calibrated p 0.117 | 0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.7 | NCT00771927: 2/511 (0.4%) on Lacosamide (serious AE) |
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.
- New onset refractory status epilepticus — n=55, PRR 614.2
- Mitochondrial dna mutation — n=38, PRR 451.4
- Tuberous sclerosis complex — n=28, PRR 208.4
- Sudden unexplained death in epilepsy — n=104, PRR 135.0 (also seen in trial arm)
- Hippocampal sclerosis — n=24, PRR 128.8
- Vagal nerve stimulator implantation — n=53, PRR 123.3 (also seen in trial arm)
- Postictal psychosis — n=25, PRR 109.1 (also seen in trial arm)
- Postictal paralysis — n=35, PRR 95.8 (also seen in trial arm)
- Cataract congenital — n=21, PRR 79.8
- Aura — n=169, PRR 56.6 (also seen in trial arm)
✓ A hand-written Bradford Hill causality assessment exists for this drug: Lacosamide ↔ Bradycardia.
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 Lacosamide?
In FDA FAERS, the most frequently co-reported reaction terms for Lacosamide are seizure, dizziness, somnolence, fatigue, epilepsy, 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 Lacosamide have an FDA boxed warning?
No. The FDA label retrieved for Lacosamide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Lacosamide 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 035d85e5-8688-4390-bd55-74baa91c0e9d, effective 20240604; matched on
openfda.generic_name.exact:"LACOSAMIDE") - 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, 1,217 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
LACOSAMIDE, 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.