Drug · FAERS side-effect profile with label screen
Trametinib side effects: what 24,023 FDA adverse event reports show
Drug class
Kinase inhibitor
FDA label, Indications wording
Brand names
Mekinist
openFDA label
Who reports
24,023 reports · 73% serious · 5,130 with death outcome · 49% female
openFDA FAERS counts, all years, deduplication not applied
Used for
MEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. ( 1.1 , 2.1 ) MEKIN.
FDA label, Indications and Usage
What it is
Trametinib dimethyl sulfoxide 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 1Labeled (related wording) 13Likely indication confounding 6Lab value / disease marker 1Not 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.
- 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. 1,026 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 | 26 | 721.6 428.5–1,215.1ROR 722.4 · χ² 9,787 / p <1e-300 | 304.8 EB05 218.6 · IC025 +4.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=25 · 92% clinician | not reported in cached trials |
| Anaplastic thyroid cancer | 44 | 491.6 339.5–711.9ROR 492.5 · χ² 13,399 / p <1e-300 | 275.7 EB05 213.9 · IC025 +5.6 3/3 methods agree | Likely indication confounding term in indications | serious n=44 | not reported in cached trials |
| Ganglioglioma | 12 | 286.8 149.2–551.1ROR 286.9 · χ² 2,353 / p <1e-300 | 160.8 EB05 98.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Metastatic malignant melanoma | 486 | 235.0 212.8–259.6ROR 239.9 · χ² 88,784 / p <1e-300 | 183.5 EB05 170.2 · IC025 +7.1 3/3 methods agree | Labeled (related wording) related wording | serious n=485 | NCT01597908: 1/349 (0.3%) on Trametinib (serious AE) |
| Malignant melanoma stage iv | 56 | 214.1 159.8–286.9ROR 214.6 · χ² 9,342 / p <1e-300 | 162.2 EB05 129.6 · IC025 +5.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=56 | not reported in cached trials |
| Braf gene mutation | 16 | 188.6 109.8–323.9ROR 188.7 · χ² 2,297 / p <1e-300 | 131.0 EB05 85.5 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious n=16 | not reported in cached trials |
| Malignant mesenteric neoplasm | 10 | 132.4 68.0–257.6ROR 132.4 · χ² 1,019 / p 7e-224 | 94.7 EB05 55.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Optic glioma | 13 | 130.1 72.6–233.0ROR 130.1 · χ² 1,336 / p 8e-293 | 97.4 EB05 60.5 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | not reported in cached trials |
| Melanoma recurrent | 54 | 129.1 97.0–171.7ROR 129.3 · χ² 5,856 / p <1e-300 | 108.1 EB05 86.0 · IC025 +5.3 3/3 methods agree | Labeled (related wording) related wording | serious n=54 | not reported in cached trials |
| Astrocytoma, low grade | 22 | 127.9 81.7–200.1ROR 128.0 · χ² 2,302 / p <1e-300 | 101.8 EB05 70.9 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=22 | not reported in cached trials |
| Vogt-koyanagi-harada disease | 25 | 115.0 75.8–174.6ROR 115.1 · χ² 2,393 / p <1e-300 | 94.4 EB05 67.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=25 · 100% clinician | not reported in cached trials |
| Serous retinopathy | 12 | 113.5 62.2–207.1ROR 113.5 · χ² 1,084 / p 4e-238 | 86.9 EB05 53.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Neurofibrosarcoma | 11 | 105.2 56.2–196.6ROR 105.2 · χ² 920 / p 2e-202 | 81.1 EB05 48.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Glioma | 49 | 72.2 53.9–96.6ROR 72.3 · χ² 3,108 / p <1e-300 | 65.1 EB05 51.2 · IC025 +4.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=49 · 94% clinician | not reported in cached trials |
| Brain stem glioma | 10 | 61.9 32.6–117.6ROR 61.9 · χ² 503 / p 8e-112 | 52.4 EB05 30.4 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | not reported in cached trials |
| Astrocytoma | 25 | 59.4 39.6–89.1ROR 59.5 · χ² 1,289 / p 1e-282 | 53.5 EB05 38.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=25 | NCT01597908: 1/349 (0.3%) on Trametinib (serious AE) |
| Serous retinal detachment | 49 | 57.3 42.9–76.5ROR 57.4 · χ² 2,488 / p <1e-300 | 52.7 EB05 41.5 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=48 · 100% clinician | not reported in cached trials |
| Intestinal metastasis | 21 | 55.4 35.7–86.1ROR 55.5 · χ² 1,004 / p 1e-220 | 49.9 EB05 34.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Malignant melanoma stage iii | 12 | 54.6 30.5–97.9ROR 54.7 · χ² 545 / p 9e-121 | 47.8 EB05 29.1 · IC025 +3.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=12 | not reported in cached trials |
| Lung adenocarcinoma stage iv | 21 | 51.0 32.9–79.3ROR 51.1 · χ² 926 / p 1e-203 | 46.3 EB05 32.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Panniculitis | 129 | 49.3 41.3–58.9ROR 49.6 · χ² 5,729 / p <1e-300 | 46.4 EB05 40.0 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=126 · ♀ 81% (drug 49%) · 91% clinician | NCT01682083: 1/435 (0.2%) on Trametinib (serious AE) |
| Sarcoid-like reaction | 12 | 47.6 26.6–85.1ROR 47.6 · χ² 475 / p 1e-105 | 42.3 EB05 25.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Haemangioma of bone | 10 | 47.5 25.2–89.8ROR 47.6 · χ² 389 / p 8e-87 | 41.8 EB05 24.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Acute polyneuropathy | 14 | 45.8 26.8–78.4ROR 45.8 · χ² 541 / p 7e-120 | 41.3 EB05 26.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=14 | NCT01682083: 1/435 (0.2%) on Trametinib (serious AE) |
| Metastases to stomach | 19 | 45.3 28.6–71.8ROR 45.3 · χ² 740 / p 3e-163 | 41.4 EB05 28.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Non-small cell lung cancer recurrent | 13 | 42.9 24.6–74.8ROR 42.9 · χ² 467 / p 7e-104 | 38.7 EB05 24.1 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | not reported in cached trials |
| Detachment of retinal pigment epithelium | 35 | 36.5 26.0–51.2ROR 36.6 · χ² 1,125 / p 5e-247 | 34.5 EB05 25.9 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=35 · 100% clinician | not reported in cached trials |
| Metastases to heart | 12 | 35.8 20.1–63.9ROR 35.9 · χ² 357 / p 5e-80 | 32.8 EB05 20.0 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | not reported in cached trials |
| Creatine kinase increased | 17 | 35.7 22.0–57.9ROR 35.7 · χ² 517 / p 8e-115 | 33.1 EB05 21.9 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=16 | not reported in cached trials |
| Metastases to spleen | 16 | 34.9 21.1–57.4ROR 34.9 · χ² 474 / p 3e-105 | 32.4 EB05 21.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Metastases to central nervous system | 487 | 34.5 31.5–37.7ROR 35.2 · χ² 15,195 / p <1e-300 | 33.1 EB05 30.7 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 26.4 | NCT01597908: 1/350 (0.3%) on Trametinib (serious AE) |
| Chorioretinopathy | 51 | 32.0 24.2–42.3ROR 32.1 · χ² 1,447 / p <1e-300 | 30.6 EB05 24.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=50 · 90% clinician | NCT01682083: 4/435 (0.9%) on Trametinib (serious AE) |
| Malignant melanoma | 434 | 29.2 26.5–32.1ROR 29.7 · χ² 11,395 / p <1e-300 | 28.2 EB05 26.0 · IC025 +4.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 22.3 | NCT01682083: 1/435 (0.2%) on Trametinib; 3/432 (0.7%) control (serious AE) |
| Procalcitonin increased | 37 | 28.9 20.8–40.1ROR 28.9 · χ² 937 / p 4e-206 | 27.6 EB05 20.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=37 · 100% clinician | not reported in cached trials |
| Small cell carcinoma | 11 | 28.9 15.8–52.6ROR 28.9 · χ² 260 / p 9e-59 | 26.7 EB05 15.8 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | not reported in cached trials |
| Metastases to the mediastinum | 13 | 28.2 16.2–48.9ROR 28.2 · χ² 304 / p 2e-68 | 26.3 EB05 16.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Dermatitis acneiform | 182 | 27.0 23.3–31.3ROR 27.2 · χ² 4,402 / p <1e-300 | 26.2 EB05 23.1 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=141 | NCT01682083: 54/435 (12.4%) on Trametinib; 10/432 (2.3%) control |
| Metastases to skin | 30 | 26.3 18.3–37.8ROR 26.3 · χ² 684 / p 4e-151 | 25.2 EB05 18.5 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious n=30 | not reported in cached trials |
| Metastases to meninges | 63 | 25.2 19.6–32.4ROR 25.3 · χ² 1,400 / p <1e-300 | 24.4 EB05 19.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=63 | not reported in cached trials |
| Non-small cell lung cancer stage iv | 10 | 24.9 13.3–46.6ROR 24.9 · χ² 200 / p 1e-45 | 23.0 EB05 12.9 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | 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 Trametinib 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) | 4,068 | 10.4 10.1–10.7ROR 12.3 · χ² 34,584 / p <1e-300 | 10.3 EB05 10.0 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 | NCT01682083: 67/435 (15.4%) on Trametinib; 4/432 (0.9%) control (serious AE) |
| Death | 3,392 | 3.4 3.3–3.6ROR 3.9 · χ² 6,120 / p <1e-300 | 3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree | Outcome field, not a reaction | serious PRR 2.7 | not reported in cached trials |
| Malignant neoplasm progression | 2,040 | 17.8 17.1–18.6ROR 19.4 · χ² 31,872 / p <1e-300 | 17.5 EB05 16.9 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 14.1 | not reported in cached trials |
| Rash | 1,736 | 3.5 3.3–3.7ROR 3.7 · χ² 3,158 / p <1e-300 | 3.5 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | NCT01682083: 1/435 (0.2%) on Trametinib (serious AE) |
| Fatigue (tiredness) | 1,516 | 1.7 1.6–1.8ROR 1.8 · χ² 457 / p 1e-101 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.5 | NCT01682083: 2/435 (0.5%) on Trametinib (serious AE) |
| Nausea | 1,496 | 1.7 1.6–1.7ROR 1.7 · χ² 403 / p 6e-90 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.6 | NCT01682083: 173/435 (39.8%) on Trametinib; 88/432 (20.4%) control |
| Chills | 1,293 | 9.7 9.2–10.2ROR 10.2 · χ² 10,036 / p <1e-300 | 9.6 EB05 9.2 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | NCT01682083: 13/435 (3.0%) on Trametinib (serious AE) |
| Diarrhoea (diarrhea) | 1,288 | 1.7 1.7–1.8ROR 1.8 · χ² 425 / p 1e-94 | 1.7 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.6 | NCT01682083: 1/435 (0.2%) on Trametinib (serious AE) |
| Product use in unapproved indication | 1,088 | 3.9 3.7–4.1ROR 4.0 · χ² 2,361 / p <1e-300 | 3.9 EB05 3.7 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 | not reported in cached trials |
| Vomiting | 1,071 | 2.0 1.9–2.1ROR 2.0 · χ² 542 / p 3e-120 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.8 | NCT01682083: 4/435 (0.9%) on Trametinib (serious AE) |
| Off label use (used outside approved label) | 831 | 0.8 0.8–0.9ROR 0.8 · χ² 28 / p 7e-8 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | not reported in cached trials |
| Headache | 761 | 1.1 1.0–1.1ROR 1.1 · χ² 3 / p 0.051 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.2 | NCT01682083: 4/435 (0.9%) on Trametinib (serious AE) |
| Asthenia (weakness) | 737 | 1.7 1.6–1.8ROR 1.7 · χ² 221 / p 3e-50 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.6 | NCT01682083: 1/435 (0.2%) on Trametinib (serious AE) |
| Drug ineffective (drug did not work) | 672 | 0.4 0.4–0.5ROR 0.4 · χ² 495 / p 6e-110 | 0.4 EB05 0.4 · IC025 -1.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.7 | not reported in cached trials |
| Malaise (feeling unwell) | 653 | 1.3 1.2–1.4ROR 1.3 · χ² 45 / p 1e-11 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.2 | NCT01597908: 1/350 (0.3%) on Trametinib (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.
- Astrocytoma, low grade — n=22, PRR 127.9
- Vogt-koyanagi-harada disease — n=25, PRR 115.0
- Astrocytoma — n=25, PRR 59.4 (also seen in trial arm)
- Intestinal metastasis — n=21, PRR 55.4
- Lung adenocarcinoma stage iv — n=21, PRR 51.0
- Panniculitis — n=129, PRR 49.3 (also seen in trial arm)
- Chorioretinopathy — n=51, PRR 32.0 (also seen in trial arm)
- Procalcitonin increased — n=37, PRR 28.9
- Metastases to meninges — n=63, PRR 25.2
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 Trametinib?
In FDA FAERS, the most frequently co-reported reaction terms for Trametinib are pyrexia, rash, fatigue, nausea, chills, diarrhoea. 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 Trametinib have an FDA boxed warning?
No. The FDA label retrieved for Trametinib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Trametinib 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 0002ad27-779d-42ab-83b5-bc65453412a1, effective 20260507; matched on
openfda.generic_name.exact:"TRAMETINIB") - 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, 1,066 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
TRAMETINIB, 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.