Carbamazepine side effects: what 66,609 FDA adverse event reports show
Drug class
Mood Stabilizer
Who reports
66,609 reports · 86% serious · 5,605 with death outcome · 58% female
Used for
Epilepsy Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: 1. Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. 2.
What it is
DESCRIPTION Carbamazepine Tablets, carbamazepine USP, is an anticonvulsant and specific analgesic for trigeminal neuralgia, available for oral administration as tablets of 100 mg and 200 mg.
Boxed warning
SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 ALLELE SERIOUS AND SOMETIMES FATAL DERMATOLOGIC REACTIONS, INCLUDING TOXIC EPIDERMAL NECROLYSIS (TEN) AND STEVENS-JOHNSON SYNDROME (SJS), HAVE BEEN REPORTED DURING TREATMENT WITH CARBAMAZEPINE.
Causality screen of the 40 strongest signals
What the badges mean
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,216 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Amyloid arthropathy | 59 | 3,653.8 1,466.5–9,103.5ROR 3,657.1 · χ² 16,548 / p <1e-300 | 262.1 EB05 210.6 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=59 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Total lung capacity increased | 101 | 185.1 144.6–236.8ROR 185.3 · χ² 11,458 / p <1e-300 | 113.8 EB05 96.3 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=101 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Human herpes virus 6 serology positive | 80 | 178.2 135.4–234.6ROR 178.4 · χ² 8,835 / p <1e-300 | 110.5 EB05 91.7 · IC025 +5.7 3/3 methods agree | Lab value / disease marker | serious n=80 · 100% clinician | not reported in cached trials |
| Sedation complication | 586 | 96.4 87.9–105.7ROR 97.3 · χ² 42,127 / p <1e-300 | 73.6 EB05 68.7 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | serious n=580 · ♀ 95% (drug 58%) | not reported in cached trials |
| Anticonvulsant drug level above therapeutic | 145 | 90.0 74.8–108.2ROR 90.2 · χ² 9,817 / p <1e-300 | 69.3 EB05 60.4 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=137 | not reported in cached trials |
| Anticonvulsant drug level increased | 339 | 82.8 73.5–93.4ROR 83.3 · χ² 21,563 / p <1e-300 | 65.3 EB05 59.7 · IC025 +5.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=326 | not reported in cached trials |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 101 | 75.7 60.9–94.1ROR 75.8 · χ² 5,924 / p <1e-300 | 60.4 EB05 51.1 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=101 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Capillaritis | 47 | 66.8 48.7–91.5ROR 66.8 · χ² 2,450 / p <1e-300 | 54.0 EB05 42.2 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=46 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Sudden unexplained death in epilepsy | 78 | 53.0 41.7–67.3ROR 53.0 · χ² 3,352 / p <1e-300 | 44.9 EB05 37.2 · IC025 +4.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=78 · ♀ 33% (drug 58%) · 100% clinician | not reported in cached trials |
| Complex partial seizures | 160 | 52.0 44.0–61.5ROR 52.1 · χ² 6,807 / p <1e-300 | 44.4 EB05 39.0 · IC025 +5.0 3/3 methods agree | Likely indication confounding term in indications | serious n=157 | NCT01243177: 2/444 (0.5%) on Carbamazepine; 1/442 (0.2%) control (serious AE) |
| Creatinine renal clearance decreased | 559 | 50.6 46.3–55.4ROR 51.1 · χ² 23,340 / p <1e-300 | 43.6 EB05 40.7 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious n=559 · ♀ 100% (drug 58%) | not reported in cached trials |
| Temporal lobe epilepsy | 61 | 50.5 38.5–66.2ROR 50.5 · χ² 2,502 / p <1e-300 | 43.0 EB05 34.7 · IC025 +4.6 3/3 methods agree | Likely indication confounding term in indications | serious n=61 · 100% clinician | not reported in cached trials |
| Drug rash with eosinophilia and systemic symptoms | 446 | 49.3 44.6–54.5ROR 49.6 · χ² 18,163 / p <1e-300 | 42.6 EB05 39.4 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=443 · 100% clinician | not reported in cached trials |
| Trigeminal neuralgia | 531 | 47.8 43.6–52.3ROR 48.1 · χ² 21,028 / p <1e-300 | 41.5 EB05 38.6 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications | serious n=441 | not reported in cached trials |
| Lymphocyte morphology abnormal | 74 | 45.6 35.8–58.3ROR 45.7 · χ² 2,777 / p <1e-300 | 39.5 EB05 32.5 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=74 · 100% clinician | not reported in cached trials |
| Lymphocyte stimulation test positive | 102 | 45.2 36.7–55.6ROR 45.3 · χ² 3,807 / p <1e-300 | 39.3 EB05 33.3 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=102 · 100% clinician | not reported in cached trials |
| Multiple drug therapy | 87 | 44.7 35.7–56.0ROR 44.8 · χ² 3,213 / p <1e-300 | 38.9 EB05 32.5 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious n=86 · ♀ 100% (drug 58%) | not reported in cached trials |
| Total lung capacity abnormal | 47 | 44.2 32.6–60.0ROR 44.3 · χ² 1,700 / p <1e-300 | 38.3 EB05 29.9 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=47 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Multiple-drug resistance | 361 | 41.5 37.2–46.3ROR 41.7 · χ² 12,550 / p <1e-300 | 36.7 EB05 33.6 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious n=312 · 92% clinician | not reported in cached trials |
| Anticonvulsant drug level below therapeutic | 85 | 39.5 31.5–49.4ROR 39.5 · χ² 2,792 / p <1e-300 | 34.9 EB05 29.1 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious n=77 | not reported in cached trials |
| Partial seizures with secondary generalisation | 46 | 34.2 25.2–46.3ROR 34.2 · χ² 1,304 / p 9e-286 | 30.5 EB05 23.8 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=46 · 100% clinician | NCT01243177: 3/442 (0.7%) control (serious AE) |
| Psychogenic seizure | 87 | 32.7 26.2–40.8ROR 32.7 · χ² 2,389 / p <1e-300 | 29.5 EB05 24.7 · IC025 +4.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=84 · 100% clinician | not reported in cached trials |
| Pulmonary vasculitis | 49 | 32.1 23.9–43.0ROR 32.1 · χ² 1,309 / p 7e-287 | 28.9 EB05 22.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=49 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Anticonvulsant drug level decreased | 128 | 30.9 25.8–37.1ROR 31.0 · χ² 3,345 / p <1e-300 | 28.1 EB05 24.3 · IC025 +4.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=121 | not reported in cached trials |
| Focal dyscognitive seizures | 102 | 30.8 25.1–37.7ROR 30.8 · χ² 2,646 / p <1e-300 | 28.0 EB05 23.7 · IC025 +4.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=101 | not reported in cached trials |
| Lip erosion | 64 | 29.9 23.1–38.6ROR 29.9 · χ² 1,604 / p <1e-300 | 27.2 EB05 22.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=64 | not reported in cached trials |
| Myoclonic epilepsy | 125 | 29.1 24.2–35.0ROR 29.2 · χ² 3,077 / p <1e-300 | 26.6 EB05 22.9 · IC025 +4.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=125 | not reported in cached trials |
| Petit mal epilepsy | 431 | 29.1 26.4–32.1ROR 29.3 · χ² 10,663 / p <1e-300 | 26.6 EB05 24.6 · IC025 +4.5 3/3 methods agree | Likely indication confounding term in indications | serious n=422 | not reported in cached trials |
| Meningomyelocele | 50 | 28.2 21.1–37.7ROR 28.2 · χ² 1,177 / p 2e-258 | 25.7 EB05 20.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=49 · 100% clinician | not reported in cached trials |
| Spirometry abnormal | 48 | 27.9 20.8–37.5ROR 28.0 · χ² 1,119 / p 1e-245 | 25.5 EB05 20.0 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=48 · ♀ 0% (drug 58%) · 100% clinician | not reported in cached trials |
| Simple partial seizures | 65 | 27.2 21.1–35.0ROR 27.2 · χ² 1,482 / p <1e-300 | 24.9 EB05 20.2 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications | serious n=65 | not reported in cached trials |
| Partial seizures | 390 | 25.7 23.2–28.5ROR 25.8 · χ² 8,524 / p <1e-300 | 23.8 EB05 21.9 · IC025 +4.4 3/3 methods agree | Likely indication confounding term in indications | serious n=377 | NCT01243177: 2/444 (0.5%) on Carbamazepine; 1/442 (0.2%) control (serious AE) |
| Creatinine renal clearance increased | 55 | 24.8 18.8–32.6ROR 24.8 · χ² 1,141 / p 2e-250 | 22.9 EB05 18.2 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious n=55 · ♀ 100% (drug 58%) · 100% clinician | not reported in cached trials |
| Atonic seizures | 58 | 24.6 18.9–32.2ROR 24.7 · χ² 1,196 / p 2e-262 | 22.7 EB05 18.2 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=52 | not reported in cached trials |
| Aura | 135 | 24.6 20.6–29.3ROR 24.6 · χ² 2,807 / p <1e-300 | 22.8 EB05 19.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=115 | not reported in cached trials |
| Change in seizure presentation | 47 | 24.2 18.0–32.6ROR 24.2 · χ² 949 / p 1e-208 | 22.4 EB05 17.5 · IC025 +3.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=46 · ♀ 100% (drug 58%) | not reported in cached trials |
| Electroencephalogram abnormal | 220 | 23.5 20.5–27.0ROR 23.6 · χ² 4,391 / p <1e-300 | 21.9 EB05 19.6 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious n=215 | not reported in cached trials |
| Dysmorphism | 161 | 22.8 19.4–26.7ROR 22.8 · χ² 3,102 / p <1e-300 | 21.2 EB05 18.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=161 | not reported in cached trials |
| Tonic convulsion | 93 | 22.3 18.1–27.5ROR 22.3 · χ² 1,746 / p <1e-300 | 20.8 EB05 17.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=92 | not reported in cached trials |
| Epilepsy | 2,022 | 22.3 21.3–23.3ROR 23.0 · χ² 38,385 / p <1e-300 | 20.9 EB05 20.1 · IC025 +4.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 14.0 | NCT01243177: 2/444 (0.5%) on Carbamazepine (serious AE) |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Carbamazepine 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 (4 of 40 signal terms matched).
- 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)
- NCT00477295 — A Double-blind Study to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in New (N=583, PHASE3; 46 AE terms posted; arms: Zonisamide; Carbamazepine)
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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 5,029 | 1.2 1.2–1.2ROR 1.2 · χ² 183 / p 5e-42 | 1.2 EB05 1.2 · IC025 +0.2 | Reporting / coding artifact | serious PRR 1.8 | not reported in cached trials |
| Seizure | 3,714 | 10.5 10.2–10.8ROR 11.1 · χ² 31,031 / p <1e-300 | 10.2 EB05 9.9 · IC025 +3.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.9 | NCT01243177: 2/444 (0.5%) on Carbamazepine; 1/442 (0.2%) control (serious AE) |
| Drug interaction | 3,462 | 7.0 6.8–7.2ROR 7.3 · χ² 17,541 / p <1e-300 | 6.9 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 | not reported in cached trials |
| Fall | 3,073 | 2.9 2.8–3.0ROR 3.0 · χ² 3,924 / p <1e-300 | 2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | NCT01243177: 1/444 (0.2%) on Carbamazepine; 1/442 (0.2%) control (serious AE) |
| Dizziness | 2,910 | 1.8 1.8–1.9ROR 1.9 · χ² 1,146 / p 2e-251 | 1.8 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.8 | NCT01243177: 53/444 (11.9%) on Carbamazepine; 41/442 (9.3%) control |
| Off label use (used outside approved label) | 2,752 | 1.0 1.0–1.0ROR 1.0 · χ² 0 / p 0.467 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.1 | not reported in cached trials |
| Pyrexia (fever) | 2,726 | 2.5 2.4–2.6ROR 2.6 · χ² 2,451 / p <1e-300 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.0 | NCT01243177: 1/444 (0.2%) on Carbamazepine (serious AE) |
| Nausea | 2,693 | 1.1 1.0–1.1ROR 1.1 · χ² 14 / p 7e-5 | 1.1 EB05 1.0 · IC025 +0.0 | Labeled adverse reaction exact term | serious PRR 1.2 | NCT01243177: 26/444 (5.9%) on Carbamazepine; 23/442 (5.2%) control |
| Toxicity to various agents | 2,689 | 5.1 4.9–5.3ROR 5.3 · χ² 8,812 / p <1e-300 | 5.0 EB05 4.9 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 · 90% clinician | not reported in cached trials |
| Vomiting | 2,569 | 1.7 1.7–1.8ROR 1.8 · χ² 802 / p 8e-177 | 1.7 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.6 | not reported in cached trials |
| Fatigue (tiredness) | 2,523 | 1.0 1.0–1.1ROR 1.0 · χ² 1 / p 0.130 | 1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.0 | NCT01243177: 1/444 (0.2%) on Carbamazepine (serious AE) |
| Convulsion (seizure) | 2,498 | 14.1 13.6–14.7ROR 14.6 · χ² 29,216 / p <1e-300 | 13.6 EB05 13.1 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.9 | NCT01243177: 4/444 (0.9%) on Carbamazepine; 2/442 (0.5%) control (serious AE) |
| Somnolence (drowsiness) | 2,389 | 3.8 3.6–3.9ROR 3.9 · χ² 4,857 / p <1e-300 | 3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.8 | NCT01243177: 27/444 (6.1%) on Carbamazepine; 41/442 (9.3%) control |
| Rash | 2,359 | 1.7 1.6–1.8ROR 1.7 · χ² 716 / p 5e-158 | 1.7 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.2 | NCT01243177: 1/444 (0.2%) on Carbamazepine (serious AE) |
| Pain | 2,332 | 1.2 1.1–1.2ROR 1.2 · χ² 75 / p 2e-18 | 1.2 EB05 1.2 · IC025 +0.2 | Likely indication confounding term in indications; also in warnings | serious PRR 1.1 | NCT00477295: 1/281 (0.4%) on Carbamazepine (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.
- Amyloid arthropathy — n=59, PRR 3,653.8
- Total lung capacity increased — n=101, PRR 185.1
- Capillaritis — n=47, PRR 66.8
- Total lung capacity abnormal — n=47, PRR 44.2
- Pulmonary vasculitis — n=49, PRR 32.1
- Lip erosion — n=64, PRR 29.9
- Meningomyelocele — n=50, PRR 28.2
- Aura — n=135, PRR 24.6
- Dysmorphism — n=161, PRR 22.8
- Tonic convulsion — n=93, PRR 22.3
✓ A hand-written Bradford Hill causality assessment exists for this drug: Carbamazepine ↔ Hyponatraemia.
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 Carbamazepine?
In FDA FAERS, the most frequently co-reported reaction terms for Carbamazepine are seizure, fall, dizziness, pyrexia, nausea, toxicity to various agents. 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 Carbamazepine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 ALLELE SERIOUS AND SOMETIMES FATAL DERMATOLOGIC REACTIONS, INCLUDING TOXIC EPIDERMAL NECROLYSIS (TEN) AND STEVENS-JOHNSON SYNDROME (SJS), HAVE BEEN REPORTED DURING TREATMENT WITH CARBAMAZEPINE.
Do FAERS signals prove that Carbamazepine 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 047bc284-060a-4db9-bf37-75d10f95a0a6, effective 20250218; matched on
openfda.generic_name.exact:"CARBAMAZEPINE") - 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, 1,256 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
CARBAMAZEPINE, results-bearing studies sorted by enrollment)
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.