Drug · FAERS side-effect profile with label screen
Dabrafenib side effects: what 20,946 FDA adverse event reports show
Drug class
Kinase inhibitor
FDA label, Indications wording
Brand names
Tafinlar
openFDA label
Who reports
20,946 reports · 74% serious · 4,394 with death outcome · 47% female
openFDA FAERS counts, all years, deduplication not applied
Used for
TAFINLAR is a kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. ( 1.1 , 2.1 ) TAFINLAR is indicated, in combination with trametinib , for: the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
FDA label, Indications and Usage
What it is
Dabrafenib mesylate is a kinase inhibitor.
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) 12Likely indication confounding 8Lab value / disease marker 1Not in label — unassessed 17
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.
- 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. 1,022 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 |
|---|---|---|---|---|---|---|
| Braf v600e mutation positive | 27 | 888.2 528.2–1,493.6ROR 889.4 · χ² 12,131 / p <1e-300 | 351.3 EB05 253.5 · IC025 +5.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=25 · 93% clinician | not reported in cached trials |
| Anaplastic thyroid cancer | 48 | 648.9 450.9–933.8ROR 650.4 · χ² 18,345 / p <1e-300 | 338.9 EB05 265.8 · IC025 +5.8 3/3 methods agree | Likely indication confounding term in indications | serious n=48 | not reported in cached trials |
| Ganglioglioma | 14 | 406.4 218.1–757.1ROR 406.6 · χ² 3,728 / p <1e-300 | 207.1 EB05 131.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Metastatic malignant melanoma | 476 | 262.6 237.6–290.3ROR 268.7 · χ² 97,777 / p <1e-300 | 205.9 EB05 190.8 · IC025 +7.3 3/3 methods agree | Labeled (related wording) related wording | serious n=475 | NCT01597908: 1/349 (0.3%) on Dabrafenib (serious AE) |
| Malignant melanoma stage iv | 57 | 251.1 187.8–335.8ROR 251.8 · χ² 11,122 / p <1e-300 | 187.9 EB05 150.4 · IC025 +5.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=57 | not reported in cached trials |
| Braf gene mutation | 15 | 200.0 114.9–348.4ROR 200.2 · χ² 2,307 / p <1e-300 | 137.7 EB05 88.6 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | not reported in cached trials |
| Melanoma recurrent | 57 | 157.6 119.2–208.3ROR 158.0 · χ² 7,513 / p <1e-300 | 130.2 EB05 104.2 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | serious n=57 | not reported in cached trials |
| Malignant mesenteric neoplasm | 10 | 151.8 78.0–295.4ROR 151.9 · χ² 1,171 / p 6e-257 | 105.7 EB05 61.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Vogt-koyanagi-harada disease | 25 | 131.9 86.9–200.2ROR 132.1 · χ² 2,751 / p <1e-300 | 107.2 EB05 76.3 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=25 · 100% clinician | not reported in cached trials |
| Astrocytoma, low grade | 12 | 75.0 41.7–134.8ROR 75.0 · χ² 746 / p 1e-164 | 63.1 EB05 38.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Malignant melanoma stage iii | 13 | 68.2 38.9–119.7ROR 68.3 · χ² 744 / p 4e-164 | 58.7 EB05 36.5 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=13 | not reported in cached trials |
| Anaplastic astrocytoma | 10 | 63.7 33.6–120.7ROR 63.7 · χ² 522 / p 8e-116 | 54.1 EB05 31.4 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | not reported in cached trials |
| Serous retinal detachment | 46 | 61.4 45.6–82.7ROR 61.6 · χ² 2,518 / p <1e-300 | 56.6 EB05 44.2 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=45 · 100% clinician | not reported in cached trials |
| Sarcoid-like reaction | 13 | 59.4 33.9–103.9ROR 59.4 · χ² 650 / p 1e-143 | 52.1 EB05 32.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Panniculitis | 135 | 59.3 49.9–70.6ROR 59.7 · χ² 7,251 / p <1e-300 | 55.6 EB05 48.2 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=132 · ♀ 79% (drug 47%) · 93% clinician | NCT01682083: 1/435 (0.2%) on Dabrafenib (serious AE) |
| Non-small cell lung cancer recurrent | 15 | 57.2 34.0–96.2ROR 57.2 · χ² 730 / p 4e-161 | 50.8 EB05 32.7 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | not reported in cached trials |
| Intestinal metastasis | 18 | 54.0 33.6–86.8ROR 54.0 · χ² 838 / p 1e-184 | 48.8 EB05 32.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Lung adenocarcinoma stage iv | 19 | 52.7 33.2–83.5ROR 52.7 · χ² 866 / p 1e-190 | 47.8 EB05 32.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Metastases to stomach | 19 | 51.9 32.8–82.4ROR 52.0 · χ² 854 / p 5e-188 | 47.2 EB05 31.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Acute polyneuropathy | 12 | 44.7 25.1–79.7ROR 44.7 · χ² 449 / p 5e-100 | 40.3 EB05 24.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=12 | NCT01682083: 1/435 (0.2%) on Dabrafenib (serious AE) |
| Glioma | 25 | 40.6 27.2–60.5ROR 40.6 · χ² 889 / p 1e-195 | 38.0 EB05 27.1 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=25 · 92% clinician | not reported in cached trials |
| Metastases to central nervous system | 494 | 40.1 36.7–43.9ROR 41.1 · χ² 18,087 / p <1e-300 | 38.6 EB05 35.8 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 30.0 | NCT01597908: 1/350 (0.3%) on Dabrafenib (serious AE) |
| Cutaneous sarcoidosis | 16 | 39.3 23.8–64.7ROR 39.3 · χ² 538 / p 3e-119 | 36.3 EB05 23.7 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=16 | not reported in cached trials |
| Metastases to heart | 11 | 37.6 20.6–68.6ROR 37.6 · χ² 343 / p 8e-77 | 34.3 EB05 20.4 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | not reported in cached trials |
| Thyroid cancer metastatic | 10 | 36.4 19.4–68.4ROR 36.4 · χ² 299 / p 3e-67 | 33.1 EB05 19.2 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications | serious n=10 | not reported in cached trials |
| Metastases to spleen | 14 | 34.8 20.4–59.3ROR 34.8 · χ² 412 / p 7e-92 | 32.3 EB05 20.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Metastases to skin | 34 | 34.3 24.4–48.3ROR 34.4 · χ² 1,032 / p 1e-226 | 32.7 EB05 24.5 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious n=34 | not reported in cached trials |
| Astrocytoma | 13 | 34.3 19.7–59.6ROR 34.3 · χ² 375 / p 9e-84 | 31.8 EB05 19.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=13 | NCT01597908: 1/349 (0.3%) on Dabrafenib (serious AE) |
| Malignant melanoma | 438 | 33.8 30.7–37.1ROR 34.5 · χ² 13,442 / p <1e-300 | 32.6 EB05 30.2 · IC025 +4.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 25.3 | NCT01682083: 1/435 (0.2%) on Dabrafenib; 3/432 (0.7%) control (serious AE) |
| Small cell carcinoma | 11 | 33.1 18.2–60.3ROR 33.1 · χ² 301 / p 1e-67 | 30.5 EB05 18.1 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | not reported in cached trials |
| Non-small cell lung cancer stage iv | 11 | 31.5 17.3–57.3ROR 31.5 · χ² 286 / p 2e-64 | 29.1 EB05 17.2 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | not reported in cached trials |
| Procalcitonin increased | 35 | 31.3 22.4–43.8ROR 31.3 · χ² 966 / p 3e-212 | 29.9 EB05 22.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=35 · 100% clinician | not reported in cached trials |
| Keratoacanthoma | 20 | 30.3 19.4–47.3ROR 30.3 · χ² 522 / p 8e-116 | 28.7 EB05 19.6 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=18 · 90% clinician | NCT01682083: 1/435 (0.2%) on Dabrafenib; 1/432 (0.2%) control (serious AE) |
| Chorioretinopathy | 41 | 29.3 21.5–40.0ROR 29.4 · χ² 1,061 / p 5e-233 | 28.2 EB05 21.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=40 · 92% clinician | NCT01682083: 4/435 (0.9%) on Dabrafenib (serious AE) |
| Creatine kinase increased | 12 | 28.5 16.1–50.7ROR 28.6 · χ² 284 / p 6e-64 | 26.7 EB05 16.1 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious n=12 | not reported in cached trials |
| Metastases to meninges | 60 | 27.5 21.3–35.5ROR 27.6 · χ² 1,465 / p <1e-300 | 26.6 EB05 21.4 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=60 | not reported in cached trials |
| Ureteral disorder | 11 | 27.3 15.0–49.6ROR 27.3 · χ² 246 / p 1e-55 | 25.4 EB05 14.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Detachment of retinal pigment epithelium | 23 | 27.1 17.9–41.0ROR 27.1 · χ² 538 / p 3e-119 | 25.9 EB05 18.2 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=23 · 100% clinician | not reported in cached trials |
| Metastases to adrenals | 23 | 25.7 17.0–38.8ROR 25.7 · χ² 508 / p 9e-113 | 24.6 EB05 17.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=23 | not reported in cached trials |
| Autoimmune colitis | 16 | 25.5 15.5–41.9ROR 25.5 · χ² 344 / p 5e-77 | 24.2 EB05 15.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=16 | 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 Dabrafenib 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 (8 of 40 signal terms matched).
- NCT01682083 — Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI- (N=870, PHASE3; 183 AE terms posted; arms: Dabrafenib + Trametinib Combination Ther; Dabrafenib and Trametinib Placebos; Dabrafenib + Trametinib Combination Ther; Dabrafenib and Trametinib Placebos (Post)
- NCT01597908 — Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma (N=704, PHASE3; 338 AE terms posted; arms: Dabrafenib Plus Trametinib; Vemurafenib; Crossover Dabrafenib Plus Trametinib; All Patients)
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 |
|---|---|---|---|---|---|---|
| Pyrexia (fever) | 4,104 | 12.0 11.7–12.3ROR 14.7 · χ² 41,557 / p <1e-300 | 11.9 EB05 11.6 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.4 | NCT01682083: 67/435 (15.4%) on Dabrafenib; 4/432 (0.9%) control (serious AE) |
| Death | 2,879 | 3.4 3.2–3.5ROR 3.7 · χ² 4,943 / p <1e-300 | 3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree | Outcome field, not a reaction | serious PRR 2.6 | not reported in cached trials |
| Malignant neoplasm progression | 1,756 | 17.5 16.8–18.4ROR 19.1 · χ² 27,036 / p <1e-300 | 17.3 EB05 16.6 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 13.6 | not reported in cached trials |
| Fatigue (tiredness) | 1,428 | 1.8 1.8–1.9ROR 1.9 · χ² 569 / p 5e-126 | 1.8 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.6 | NCT01682083: 2/435 (0.5%) on Dabrafenib (serious AE) |
| Nausea | 1,403 | 1.8 1.7–1.9ROR 1.8 · χ² 498 / p 1e-110 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.7 | NCT01682083: 173/435 (39.8%) on Dabrafenib; 88/432 (20.4%) control |
| Chills | 1,332 | 11.5 10.9–12.1ROR 12.2 · χ² 12,653 / p <1e-300 | 11.3 EB05 10.8 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.4 | NCT01682083: 13/435 (3.0%) on Dabrafenib (serious AE) |
| Rash | 1,174 | 2.7 2.6–2.9ROR 2.8 · χ² 1,294 / p 1e-283 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | NCT01682083: 1/435 (0.2%) on Dabrafenib (serious AE) |
| Vomiting | 986 | 2.1 2.0–2.2ROR 2.2 · χ² 585 / p 2e-129 | 2.1 EB05 2.0 · IC025 +1.0 | Labeled adverse reaction exact term | serious PRR 1.9 | NCT01682083: 4/435 (0.9%) on Dabrafenib (serious AE) |
| Diarrhoea (diarrhea) | 974 | 1.5 1.4–1.6ROR 1.5 · χ² 176 / p 2e-40 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.5 | NCT01682083: 1/435 (0.2%) on Dabrafenib (serious AE) |
| Headache | 742 | 1.2 1.1–1.3ROR 1.2 · χ² 22 / p 1e-6 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.3 | NCT01682083: 4/435 (0.9%) on Dabrafenib (serious AE) |
| Asthenia (weakness) | 727 | 1.9 1.8–2.1ROR 2.0 · χ² 334 / p 6e-75 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.8 | NCT01682083: 1/435 (0.2%) on Dabrafenib (serious AE) |
| Malaise (feeling unwell) | 623 | 1.4 1.3–1.5ROR 1.4 · χ² 78 / p 4e-19 | 1.4 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.3 | NCT01597908: 1/350 (0.3%) on Dabrafenib (serious AE) |
| Decreased appetite (loss of appetite) | 585 | 2.5 2.3–2.7ROR 2.6 · χ² 546 / p 6e-121 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | NCT01682083: 1/435 (0.2%) on Dabrafenib (serious AE) |
| Arthralgia (joint pain) | 579 | 1.4 1.3–1.5ROR 1.4 · χ² 67 / p 1e-16 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.3 | NCT01682083: 1/435 (0.2%) on Dabrafenib (serious AE) |
| Visual impairment | 536 | 4.4 4.0–4.8ROR 4.5 · χ² 1,395 / p <1e-300 | 4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | NCT01682083: 1/435 (0.2%) on Dabrafenib (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.
- Vogt-koyanagi-harada disease — n=25, PRR 131.9
- Procalcitonin increased — n=35, PRR 31.3
- Chorioretinopathy — n=41, PRR 29.3 (also seen in trial arm)
- Metastases to meninges — n=60, PRR 27.5
- Metastases to adrenals — n=23, PRR 25.7
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 Dabrafenib?
In FDA FAERS, the most frequently co-reported reaction terms for Dabrafenib are pyrexia, fatigue, nausea, chills, rash, vomiting. 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 Dabrafenib have an FDA boxed warning?
No. The FDA label retrieved for Dabrafenib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dabrafenib 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 fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea, effective 20260520; matched on
openfda.generic_name.exact:"DABRAFENIB") - 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, 1,062 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
DABRAFENIB, 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.