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Dexamethasone 1.5 side effects: what 291,204 FDA adverse event reports show

Dexamethasone 1.5 Mg · 1,259 reaction terms · 927,467 drug–reaction co-reports · data 2026-09-14
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Drug class

Corticosteroid

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Dexamethasone 1.5 Mg (Dexamethasone 1.5 Mg)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

291,204 reports · 85% serious · 47,510 with death outcome · 48% 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

Dexamethasone is a fluorinated steroid that is 9-fluoropregna-1,4-diene substituted by hydroxy groups at positions 11, 17 and 21, a methyl group at position 16 and oxo groups at positions 3 and 20.

PubChem CID 5743 (ChEBI)

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) 1Likely indication confounding 10Lab value / disease marker 2Not in label — unassessed 27
What the badges mean

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). 1,219 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Lymphoid tissue hypoplasia1411,645.9
727.1–3,725.9ROR 1,646.7 · calibrated p 2e-15 ✓
67.5 EB05 58.7 · IC025 +5.5
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=141 · ♀ 0% (drug 48%) · 100% consumerno trial arm names this drug
Thymus hypoplasia145406.2
265.7–621.0ROR 406.4 · calibrated p 4e-12 ✓
60.1 EB05 52.4 · IC025 +5.4
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=145 · ♀ 0% (drug 48%)no trial arm names this drug
Plasma cell leukaemia31982.1
69.9–96.6ROR 82.2 · calibrated p 6e-7 ✓
38.3 EB05 34.9 · IC025 +5.0
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=318 · 91% clinicianno trial arm names this drug
Plasma cell myeloma refractory64370.8
63.5–79.0ROR 71.0 · calibrated p 1e-6 ✓
35.7 EB05 33.4 · IC025 +5.0
3/3 methods agree
Not in label — unassessedserious n=640 · 91% clinicianno trial arm names this drug
Rhinocerebral mucormycosis15559.3
47.9–73.5ROR 59.4 · calibrated p 6e-6 ✓
32.5 EB05 28.4 · IC025 +4.6
3/3 methods agree
Not in label — unassessedserious n=155 · ♀ 0% (drug 48%) · 100% clinicianno trial arm names this drug
Plasma cell myeloma recurrent1,35350.6
47.2–54.2ROR 50.8 · calibrated p 1e-5 ✓
29.8 EB05 28.5 · IC025 +4.8
3/3 methods agree
Not in label — unassessedserious n=1,237no trial arm names this drug
Plasmacytoma73846.3
42.2–50.8ROR 46.4 · calibrated p 2e-5 ✓
28.3 EB05 26.6 · IC025 +4.7
3/3 methods agree
Not in label — unassessedserious n=716 · 91% clinicianno trial arm names this drug
Disseminated aspergillosis17542.6
35.3–51.4ROR 42.6 · calibrated p 4e-5 ✓
26.8 EB05 23.6 · IC025 +4.4
3/3 methods agree
Not in label — unassessedserious n=175 · ♀ 0% (drug 48%)no trial arm names this drug
Plasma cell myeloma14,16340.6
39.8–41.5ROR 42.6 · calibrated p 4e-5 ✓
26.1 EB05 25.7 · IC025 +4.7
3/3 methods agree
Not in label — unassessedage-adj. PRR 30.6 · serious PRR 18.0no trial arm names this drug
Light chain analysis increased34736.5
32.1–41.5ROR 36.5 · calibrated p 9e-5 ✓
24.3 EB05 22.2 · IC025 +4.4
3/3 methods agree
Not in label — unassessedserious n=222no trial arm names this drug
Monoclonal immunoglobulin present24032.6
28.0–38.0ROR 32.7 · calibrated p 2e-4 ✓
22.5 EB05 20.3 · IC025 +4.2
3/3 methods agree
Lab value / disease markerserious n=159no trial arm names this drug
B-cell type acute leukaemia19125.8
21.9–30.5ROR 25.8 · calibrated p 6e-4 ✓
19.1 EB05 16.9 · IC025 +4.0
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=191 · 100% clinicianno trial arm names this drug
Diffuse large b-cell lymphoma refractory24425.4
21.9–29.4ROR 25.4 · calibrated p 7e-4 ✓
18.9 EB05 17.0 · IC025 +4.0
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=240 · 100% clinicianno trial arm names this drug
Diffuse large b-cell lymphoma recurrent52923.3
21.1–25.7ROR 23.3 · calibrated p 1e-3 ✓
17.7 EB05 16.5 · IC025 +4.0
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=528no trial arm names this drug
C-reactive protein21321.8
18.7–25.5ROR 21.9 · calibrated p 0.001 ✓
16.9 EB05 15.0 · IC025 +3.8
3/3 methods agree
Lab value / disease markerserious n=213 · ♀ 100% (drug 48%) · 100% clinicianno trial arm names this drug
Pseudomonal sepsis35417.9
15.9–20.1ROR 17.9 · calibrated p 0.003 ✓
14.4 EB05 13.2 · IC025 +3.7
3/3 methods agree
Not in label — unassessedserious n=354no trial arm names this drug
Hypofibrinogenaemia19417.8
15.2–20.8ROR 17.8 · calibrated p 0.004 ✓
14.4 EB05 12.7 · IC025 +3.6
3/3 methods agree
Not in label — unassessedserious n=191 · ♀ 0% (drug 48%) · 100% clinicianno trial arm names this drug
Parainfluenzae virus infection30217.3
15.2–19.6ROR 17.3 · calibrated p 0.004 ✓
14.0 EB05 12.7 · IC025 +3.6
3/3 methods agree
Not in label — unassessedserious n=301no trial arm names this drug
Mycobacterium chelonae infection14317.2
14.3–20.6ROR 17.2 · calibrated p 0.004 ✓
13.9 EB05 12.1 · IC025 +3.5
3/3 methods agree
Not in label — unassessedserious n=143no trial arm names this drug
Osteolysis39216.8
15.1–18.8ROR 16.8 · calibrated p 0.004 ✓
13.7 EB05 12.6 · IC025 +3.6
3/3 methods agree
Not in label — unassessedserious n=388no trial arm names this drug
Cytomegalovirus chorioretinitis36016.3
14.6–18.3ROR 16.3 · calibrated p 0.005 ✓
13.4 EB05 12.3 · IC025 +3.5
3/3 methods agree
Not in label — unassessedserious n=358 · 93% clinicianno trial arm names this drug
Deep vein thrombosis postoperative35215.6
13.9–17.5ROR 15.6 · calibrated p 0.006 ✓
12.9 EB05 11.8 · IC025 +3.5
3/3 methods agree
Not in label — unassessedserious n=352 · ♀ 100% (drug 48%) · 94% clinicianno trial arm names this drug
Febrile bone marrow aplasia70814.5
13.4–15.7ROR 14.5 · calibrated p 0.008 ✓
12.2 EB05 11.4 · IC025 +3.5
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=708 · 100% clinicianno trial arm names this drug
Neutropenic infection16214.3
12.1–17.0ROR 14.3 · calibrated p 0.009 ✓
12.0 EB05 10.5 · IC025 +3.3
3/3 methods agree
Not in label — unassessedserious n=162 · ♀ 100% (drug 48%) · 100% clinicianno trial arm names this drug
Neutropenic sepsis1,19914.3
13.5–15.2ROR 14.4 · calibrated p 0.008 ✓
12.1 EB05 11.5 · IC025 +3.5
3/3 methods agree
Not in label — unassessedserious PRR 8.2 · 93% clinicianno trial arm names this drug
Acute lymphocytic leukaemia recurrent42914.2
12.8–15.7ROR 14.2 · calibrated p 0.009 ✓
11.9 EB05 11.0 · IC025 +3.4
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=425 · 91% clinicianno trial arm names this drug
Mucormycosis40913.4
12.1–14.9ROR 13.5 · calibrated p 0.011 ✓
11.4 EB05 10.5 · IC025 +3.3
3/3 methods agree
Not in label — unassessedserious n=407 · 100% clinicianno trial arm names this drug
Strongyloidiasis24512.7
11.1–14.5ROR 12.7 · calibrated p 0.014 ✓
10.8 EB05 9.7 · IC025 +3.2
3/3 methods agree
Not in label — unassessedserious n=245 · ♀ 0% (drug 48%) · 100% clinicianno trial arm names this drug
Escherichia bacteraemia34212.3
11.0–13.8ROR 12.4 · calibrated p 0.015 ✓
10.6 EB05 9.7 · IC025 +3.2
3/3 methods agree
Not in label — unassessedserious n=341 · 92% clinicianno trial arm names this drug
Cardiac amyloidosis16012.3
10.4–14.5ROR 12.3 · calibrated p 0.016 ✓
10.5 EB05 9.2 · IC025 +3.1
3/3 methods agree
Not in label — unassessedserious n=160 · 100% clinicianno trial arm names this drug
Cytopenia1,72812.0
11.4–12.7ROR 12.1 · calibrated p 0.016 ✓
10.4 EB05 10.0 · IC025 +3.3
3/3 methods agree
Likely indication confounding
term in indications
serious PRR 7.1no trial arm names this drug
Multiple myeloma67011.7
10.8–12.7ROR 11.8 · calibrated p 0.018 ✓
10.2 EB05 9.5 · IC025 +3.2
3/3 methods agree
Not in label — unassessedserious n=671 · 100% clinicianno trial arm names this drug
Autonomic neuropathy14211.6
9.7–13.8ROR 11.6 · calibrated p 0.020 ✓
9.9 EB05 8.6 · IC025 +3.0
3/3 methods agree
Not in label — unassessedserious n=142 · ♀ 0% (drug 48%) · 100% clinicianno trial arm names this drug
Febrile infection16111.6
9.8–13.6ROR 11.6 · calibrated p 0.020 ✓
9.9 EB05 8.7 · IC025 +3.0
3/3 methods agree
Not in label — unassessedserious n=157 · 100% clinicianno trial arm names this drug
Pneumonia influenzal16611.5
9.7–13.5ROR 11.5 · calibrated p 0.021 ✓
9.9 EB05 8.7 · IC025 +3.0
3/3 methods agree
Likely indication confounding
shares a disease stem with the indications wording
serious n=166 · 100% clinicianno trial arm names this drug
Amyloidosis23911.4
10.0–13.1ROR 11.4 · calibrated p 0.021 ✓
9.9 EB05 8.9 · IC025 +3.1
3/3 methods agree
Not in label — unassessedserious n=233no trial arm names this drug
Febrile neutropenia9,03611.2
11.0–11.5ROR 11.6 · calibrated p 0.019 ✓
9.8 EB05 9.7 · IC025 +3.3
3/3 methods agree
Not in label — unassessedage-adj. PRR 9.4 · serious PRR 6.7 · 94% clinicianno trial arm names this drug
Listeriosis14911.1
9.4–13.2ROR 11.1 · calibrated p 0.023 ✓
9.6 EB05 8.4 · IC025 +3.0
3/3 methods agree
Not in label — unassessedserious n=148 · ♀ 0% (drug 48%) · 100% clinicianno trial arm names this drug
Peripheral motor neuropathy18711.0
9.4–12.8ROR 11.0 · calibrated p 0.024 ✓
9.5 EB05 8.4 · IC025 +3.0
3/3 methods agree
Not in label — unassessedserious n=183 · ♀ 0% (drug 48%) · 100% clinicianno trial arm names this drug

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

ConceptReportsPRR 95% CIReading
Neutropenia / agranulocytosis22,3047.06.9–7.1signal
Thrombocytopenia16,4705.75.7–5.8signal
Anaemia12,6983.13.1–3.2signal
Venous thromboembolism8,8273.03.0–3.1signal
Serious infection29,7462.82.8–2.9signal
Opportunistic infection4,7102.52.5–2.6signal
Osteonecrosis1,9322.52.3–2.6signal
Hyponatraemia2,3352.12.0–2.2signal
Interstitial lung disease2,7492.12.0–2.2signal
Kidney injury12,3282.01.9–2.0raised
Liver injury7,3271.81.7–1.8raised
Arrhythmia / qt4,6541.71.7–1.8raised
Anaphylaxis / angioedema2,7921.61.6–1.7raised
Heart failure3,9811.61.6–1.7raised
Severe cutaneous reaction1,6211.61.5–1.7raised
Pancreatitis1,4281.31.2–1.3raised

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Dexamethasone 1.5 only as a background or rescue medication (NCT00083551, NCT03061812); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Off label use (used outside approved label)22,2721.9
1.8–1.9ROR 1.9 · calibrated p 0.912
1.8 EB05 1.8 · IC025 +0.9Reporting / coding artifactage-adj. PRR 1.8 · serious PRR 2.1no trial arm names this drug
Fatigue (tiredness)17,2201.6
1.6–1.6ROR 1.6 · calibrated p 0.737
1.6 EB05 1.6 · IC025 +0.6Not in label — unassessedage-adj. PRR 1.3 · serious PRR 1.4no trial arm names this drug
Diarrhoea (diarrhea)17,0471.9
1.9–2.0ROR 2.0 · calibrated p 0.939
1.9 EB05 1.9 · IC025 +0.9Labeled adverse reaction
exact term
age-adj. PRR 1.5 · serious PRR 1.7no trial arm names this drug
Plasma cell myeloma14,16340.6
39.8–41.5ROR 42.6 · calibrated p 4e-5 ✓
26.1 EB05 25.7 · IC025 +4.7
3/3 methods agree
Not in label — unassessedage-adj. PRR 30.6 · serious PRR 18.0no trial arm names this drug
Nausea13,9601.3
1.3–1.3ROR 1.3 · calibrated p 0.503
1.3 EB05 1.3 · IC025 +0.3Labeled adverse reaction
exact term
age-adj. PRR 1.1 · serious PRR 1.3no trial arm names this drug
Pneumonia (lung infection)13,6653.1
3.1–3.2ROR 3.2 · calibrated p 0.553
3.0 EB05 3.0 · IC025 +1.6
3/3 methods agree
Likely indication confounding
term in indications
age-adj. PRR 2.6 · serious PRR 2.1no trial arm names this drug
Death13,2301.1
1.1–1.1ROR 1.1 · calibrated p 0.381
1.1 EB05 1.1 · IC025 +0.1Outcome field, not a reactionage-adj. PRR 1.0 · serious PRR 0.8no trial arm names this drug
Drug ineffective (drug did not work)12,9140.7
0.7–0.7ROR 0.7 · calibrated p 0.125
0.7 EB05 0.7 · IC025 -0.5
PRR-only: not supported by EBGM or IC
Reporting / coding artifactage-adj. PRR 1.0 · serious PRR 1.2no trial arm names this drug
Neutropenia (low neutrophils (infection-fighting cells))11,5996.7
6.5–6.8ROR 6.9 · calibrated p 0.103
6.2 EB05 6.1 · IC025 +2.6
3/3 methods agree
Not in label — unassessedage-adj. PRR 5.2 · serious PRR 4.2 · 93% clinicianno trial arm names this drug
Pyrexia (fever)10,9682.3
2.3–2.4ROR 2.4 · calibrated p 0.868
2.3 EB05 2.2 · IC025 +1.2
3/3 methods agree
Not in label — unassessedage-adj. PRR 2.1 · serious PRR 1.9no trial arm names this drug
Thrombocytopenia (low platelets)10,6187.5
7.3–7.6ROR 7.7 · calibrated p 0.074
6.9 EB05 6.7 · IC025 +2.7
3/3 methods agree
Likely indication confounding
term in indications
age-adj. PRR 5.6 · serious PRR 4.7 · 91% clinicianno trial arm names this drug
Dyspnoea (shortness of breath)10,2241.3
1.3–1.3ROR 1.3 · calibrated p 0.520
1.3 EB05 1.3 · IC025 +0.3Not in label — unassessedage-adj. PRR 1.2 · serious PRR 1.1no trial arm names this drug
Febrile neutropenia9,03611.2
11.0–11.5ROR 11.6 · calibrated p 0.019 ✓
9.8 EB05 9.7 · IC025 +3.3
3/3 methods agree
Not in label — unassessedage-adj. PRR 9.4 · serious PRR 6.7 · 94% clinicianno trial arm names this drug
Anaemia (low red blood cells)9,0183.5
3.4–3.6ROR 3.6 · calibrated p 0.460
3.4 EB05 3.3 · IC025 +1.7
3/3 methods agree
Likely indication confounding
term in indications
age-adj. PRR 2.5 · serious PRR 2.4no trial arm names this drug
Vomiting8,7541.4
1.3–1.4ROR 1.4 · calibrated p 0.549
1.3 EB05 1.3 · IC025 +0.4Not in label — unassessedage-adj. PRR 1.2 · serious PRR 1.2no trial arm names this drug

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.

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 1.5?

In FDA FAERS, the most frequently co-reported reaction terms for Dexamethasone 1.5 are fatigue, diarrhoea, plasma cell myeloma, nausea, pneumonia, neutropenia. 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 1.5 have an FDA boxed warning?

No. The FDA label retrieved for Dexamethasone 1.5 has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Dexamethasone 1.5 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

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.