Drug · FAERS side-effect profile with label screen
Dexamethasone Sodium Phosphate side effects: what 10,095 FDA adverse event reports show
Who reports
10,095 reports · 93% serious · 1,763 with death outcome · 50% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness.
FDA label, Indications and Usage
What it is
DESCRIPTION Dexamethasone Tablets, USP for oral administration, are supplied in the following potencies, 0.5mg, 0.75mg, 1.5 mg, 2 mg, 4 mg and 6 mg. Inactive ingredients are Microcrystalline C.
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 (related wording) 3Likely indication confounding 7Reporting / coding artifact 1Lab value / disease marker 5Not in label — unassessed 24
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. 1,007 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 |
|---|---|---|---|---|---|---|
| Malignant cranial nerve neoplasm | 16 | 3,277.1 1,487.5–7,219.7ROR 3,282.3 · χ² 18,914 / p <1e-300 | 501.3 EB05 327.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Retro-orbital neoplasm | 16 | 885.7 492.9–1,591.6ROR 887.1 · χ² 9,263 / p <1e-300 | 355.3 EB05 231.9 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Choroiditis | 67 | 451.4 346.7–587.7ROR 454.4 · χ² 24,305 / p <1e-300 | 334.7 EB05 272.6 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=67 · ♀ 0% (drug 50%) | no trial data cached |
| Neuroblastoma recurrent | 15 | 167.0 98.7–282.5ROR 167.2 · χ² 2,137 / p <1e-300 | 129.4 EB05 83.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Coombs positive haemolytic anaemia | 19 | 88.6 56.0–140.3ROR 88.8 · χ² 1,495 / p <1e-300 | 78.5 EB05 53.1 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=19 | no trial data cached |
| Anaplastic large cell lymphoma t- and null-cell types | 10 | 77.0 41.0–144.7ROR 77.1 · χ² 652 / p 5e-144 | 65.4 EB05 38.0 · IC025 +3.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | no trial data cached |
| Central hypothyroidism | 10 | 69.4 37.0–130.4ROR 69.5 · χ² 588 / p 4e-130 | 59.9 EB05 34.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Globulins decreased | 11 | 65.3 35.8–119.0ROR 65.4 · χ² 614 / p 7e-136 | 57.4 EB05 34.2 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=11 | no trial data cached |
| Allergy test positive | 12 | 57.8 32.6–102.6ROR 57.9 · χ² 598 / p 3e-132 | 51.9 EB05 31.6 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious n=12 | no trial data cached |
| Splenic abscess | 10 | 52.9 28.3–99.1ROR 53.0 · χ² 447 / p 1e-99 | 47.3 EB05 27.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Triple negative breast cancer | 15 | 50.7 30.4–84.6ROR 50.8 · χ² 665 / p 5e-147 | 46.8 EB05 30.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Monoclonal gammopathy | 14 | 47.3 27.9–80.3ROR 47.4 · χ² 576 / p 1e-127 | 43.7 EB05 27.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Cerebral venous sinus thrombosis | 18 | 46.6 29.2–74.3ROR 46.7 · χ² 742 / p 1e-163 | 43.6 EB05 29.2 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=18 | no trial data cached |
| Radiation necrosis | 12 | 44.7 25.2–79.1ROR 44.7 · χ² 460 / p 3e-102 | 41.1 EB05 25.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Hypoproteinaemia | 39 | 44.7 32.5–61.3ROR 44.8 · χ² 1,587 / p <1e-300 | 42.9 EB05 32.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=39 | no trial data cached |
| Renal vein thrombosis | 14 | 44.7 26.3–75.8ROR 44.7 · χ² 543 / p 2e-120 | 41.5 EB05 26.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Hypochloraemia | 22 | 39.9 26.2–60.8ROR 40.0 · χ² 781 / p 4e-172 | 38.0 EB05 26.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=21 · 100% clinician | no trial data cached |
| Mycobacterium chelonae infection | 12 | 34.4 19.4–60.8ROR 34.4 · χ² 350 / p 2e-78 | 32.2 EB05 19.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Eastern cooperative oncology group performance status worsened | 20 | 33.9 21.8–52.8ROR 34.0 · χ² 597 / p 4e-132 | 32.5 EB05 22.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=20 · 95% clinician | no trial data cached |
| Arteritis | 10 | 33.1 17.7–61.9ROR 33.2 · χ² 276 / p 3e-62 | 30.8 EB05 17.8 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications | serious n=10 | no trial data cached |
| Granulocyte count decreased | 28 | 33.1 22.8–48.1ROR 33.2 · χ² 827 / p 3e-182 | 32.0 EB05 23.2 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious n=29 · 93% clinician | no trial data cached |
| Aortitis | 10 | 30.9 16.5–57.7ROR 30.9 · χ² 256 / p 6e-58 | 28.9 EB05 16.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Hypoalbuminaemia | 107 | 29.5 24.4–35.6ROR 29.8 · χ² 2,872 / p <1e-300 | 28.9 EB05 24.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 17.8 · 97% clinician | no trial data cached |
| Plasma cell myeloma refractory | 18 | 29.2 18.4–46.5ROR 29.3 · χ² 457 / p 1e-101 | 28.1 EB05 18.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Blood fibrinogen decreased | 15 | 28.2 16.9–46.9ROR 28.2 · χ² 361 / p 7e-81 | 26.9 EB05 17.3 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious n=15 | no trial data cached |
| Endophthalmitis | 79 | 27.7 22.2–34.6ROR 27.9 · χ² 1,981 / p <1e-300 | 27.2 EB05 22.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=79 · ♀ 5% (drug 50%) | no trial data cached |
| Myelosuppression | 440 | 27.2 24.8–29.8ROR 28.4 · χ² 10,950 / p <1e-300 | 26.8 EB05 24.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.7 · 92% clinician | no trial data cached |
| Diffuse large b-cell lymphoma refractory | 12 | 27.1 15.4–47.9ROR 27.2 · χ² 273 / p 1e-61 | 25.7 EB05 15.5 · IC025 +2.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=12 | no trial data cached |
| Product ineffective for unapproved use | 18 | 27.1 17.0–43.1ROR 27.1 · χ² 421 / p 9e-94 | 26.1 EB05 17.4 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious n=18 | no trial data cached |
| Secondary immunodeficiency | 14 | 24.6 14.5–41.7ROR 24.6 · χ² 290 / p 2e-65 | 23.6 EB05 14.8 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious n=14 | no trial data cached |
| Steroid diabetes | 17 | 24.5 15.2–39.5ROR 24.5 · χ² 355 / p 1e-79 | 23.6 EB05 15.5 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=17 | no trial data cached |
| Hyperuricaemia | 47 | 24.1 18.1–32.1ROR 24.2 · χ² 1,004 / p 1e-220 | 23.6 EB05 18.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=43 · 100% clinician | no trial data cached |
| Systemic candida | 28 | 23.8 16.4–34.5ROR 23.9 · χ² 583 / p 5e-129 | 23.2 EB05 16.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 20% (drug 50%) | no trial data cached |
| Febrile infection | 13 | 23.7 13.7–40.9ROR 23.7 · χ² 257 / p 3e-58 | 22.6 EB05 13.8 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Arteriovenous malformation | 10 | 22.9 12.3–42.7ROR 22.9 · χ² 186 / p 1e-42 | 21.5 EB05 11.9 · IC025 +2.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | no trial data cached |
| Neutrophil count decreased | 439 | 22.7 20.7–24.9ROR 23.7 · χ² 9,020 / p <1e-300 | 22.5 EB05 20.8 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious PRR 15.4 · 92% clinician | no trial data cached |
| Deep vein thrombosis postoperative | 21 | 22.5 14.6–34.5ROR 22.5 · χ² 405 / p 2e-90 | 21.8 EB05 15.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=21 · 95% clinician | no trial data cached |
| Jc virus infection | 17 | 22.3 13.8–36.0ROR 22.4 · χ² 322 / p 3e-72 | 21.6 EB05 14.1 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=17 | no trial data cached |
| Central nervous system infection | 12 | 22.0 12.5–38.9ROR 22.0 · χ² 218 / p 1e-49 | 20.9 EB05 12.4 · IC025 +2.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=12 | no trial data cached |
| Keratopathy | 16 | 21.3 13.0–34.8ROR 21.3 · χ² 287 / p 1e-64 | 20.5 EB05 13.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 943 | 2.3 2.1–2.4ROR 2.4 · χ² 687 / p 9e-152 | 2.3 EB05 2.1 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.5 | no trial data cached |
| Nausea | 604 | 1.6 1.5–1.7ROR 1.6 · χ² 137 / p 7e-32 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Pyrexia (fever) | 604 | 3.6 3.4–3.9ROR 3.8 · χ² 1,164 / p 2e-255 | 3.6 EB05 3.4 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 · 90% clinician | no trial data cached |
| Anaemia (low red blood cells) | 496 | 5.4 5.0–5.9ROR 5.6 · χ² 1,789 / p <1e-300 | 5.4 EB05 5.0 · IC025 +2.3 3/3 methods agree | Likely indication confounding term in indications | serious PRR 3.6 · 91% clinician | no trial data cached |
| Drug ineffective (drug did not work) | 475 | 0.7 0.7–0.8ROR 0.7 · χ² 42 / p 4e-11 | 0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.2 | no trial data cached |
| Diarrhoea (diarrhea) | 470 | 1.5 1.4–1.7ROR 1.5 · χ² 85 / p 1e-20 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Platelet count decreased | 448 | 8.8 8.0–9.6ROR 9.1 · χ² 3,077 / p <1e-300 | 8.7 EB05 8.0 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 6.6 · 90% clinician | no trial data cached |
| Myelosuppression | 440 | 27.2 24.8–29.8ROR 28.4 · χ² 10,950 / p <1e-300 | 26.8 EB05 24.8 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.7 · 92% clinician | no trial data cached |
| Neutrophil count decreased | 439 | 22.7 20.7–24.9ROR 23.7 · χ² 9,020 / p <1e-300 | 22.5 EB05 20.8 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious PRR 15.4 · 92% clinician | no trial data cached |
| White blood cell count decreased | 437 | 8.4 7.7–9.2ROR 8.7 · χ² 2,842 / p <1e-300 | 8.3 EB05 7.7 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 7.0 | no trial data cached |
| Vomiting | 408 | 1.8 1.6–2.0ROR 1.8 · χ² 150 / p 1e-34 | 1.8 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.6 · 91% clinician | no trial data cached |
| Fatigue (tiredness) | 396 | 1.1 1.0–1.2ROR 1.1 · χ² 1 / p 0.130 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.1 | no trial data cached |
| Pneumonia (lung infection) | 392 | 2.5 2.3–2.8ROR 2.6 · χ² 363 / p 3e-81 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 1.6 · 91% clinician | no trial data cached |
| Dyspnoea (shortness of breath) | 391 | 1.4 1.3–1.6ROR 1.5 · χ² 53 / p 2e-13 | 1.4 EB05 1.3 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.2 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 365 | 5.6 5.1–6.2ROR 5.8 · χ² 1,382 / p <1e-300 | 5.6 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 94% clinician | no trial data cached |
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.
- Choroiditis — n=67, PRR 451.4
- Hypoproteinaemia — n=39, PRR 44.7
- Hypochloraemia — n=22, PRR 39.9
- Eastern cooperative oncology group performance status worsened — n=20, PRR 33.9
- Hypoalbuminaemia — n=107, PRR 29.5
- Endophthalmitis — n=79, PRR 27.7
- Myelosuppression — n=440, PRR 27.2
- Hyperuricaemia — n=47, PRR 24.1
- Systemic candida — n=28, PRR 23.8
- Deep vein thrombosis postoperative — n=21, PRR 22.5
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 Dexamethasone?
In FDA FAERS, the most frequently co-reported reaction terms for Dexamethasone are nausea, pyrexia, anaemia, diarrhoea, platelet count decreased, myelosuppression. 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 Dexamethasone have an FDA boxed warning?
No. The FDA label retrieved for Dexamethasone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dexamethasone 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 05c77a4c-c508-babd-e063-6294a90a450a, effective 20240308; matched on
openfda.generic_name.exact:"DEXAMETHASONE") - 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, 1,047 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
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.