What the label lists and what reports show
Dexamethasone side effects
Dexamethasone's FDA label lists its adverse reactions in its own words. FAERS holds 304,163 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (17,599 reports).
- Generic listed
- In shortage
Check it at the source: the dexamethasone FDA label on DailyMed (effective June 6, 2025, Hikma Pharmaceuticals USA, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactions(Listed alphabetically, under each subsection) The following adverse reactions have been reported with dexamethasone or other corticosteroids: Allergic Reactions Anaphylactoid reaction, anaphylaxis, angioedema. Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal ), edema, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. Dermatologic Acne, allergic dermatitis, dry scaly skin, ecchymoses and petechiae, erythema, impaired wound healing, increased sweating, rash, striae, suppression of reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria. …
Table 2: Ocular Adverse Reactions Reported by ≥ 1% of Patients and Non-ocular Adverse Reactions Reported by ≥ 5% of Patients
This table is printed in the OZURDEX label published by Allergan, Inc. of March 11, 2026; the label quoted above does not print one.
| MedDRA Term Cataract 1 | OZURDEX N=324 (%) 166/243 2 (68%) | Sham N=328 (%) 49/230 (21%) |
|---|---|---|
| Conjunctival hemorrhage | 73 (23%) | 44 (13%) |
| Visual acuity reduced | 28 (9%) | 13 (4%) |
| Conjunctivitis | 19 (6%) | 8 (2%) |
| Vitreous floaters | 16 (5%) | 6 (2%) |
| Conjunctival edema | 15 (5%) | 4 (1%) |
| Dry eye | 15 (5%) | 7 (2%) |
| Vitreous detachment | 14 (4%) | 8 (2%) |
| Vitreous opacities | 11 (3%) | 3 (1%) |
| Retinal aneurysm | 10 (3%) | 5 (2%) |
| Foreign body sensation | 7 (2%) | 4 (1%) |
| Corneal erosion | 7 (2%) | 3 (1%) |
| Keratitis | 6 (2%) | 3 (1%) |
| Anterior Chamber Inflammation | 6 (2%) | 0 (0%) |
| Retinal tear | 5 (2%) | 2 (1%) |
| Eyelid ptosis | 5 (2%) | 2 (1%) |
| Hypertension | 41 (13%) | 21 (6%) |
| Bronchitis | 15 (5%) | 8 (2%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Hikma Pharmaceuticals USA, Inc., effective June 6, 2025 (SPL set b15200fb-1826-472b-a907-e677a272513b), via openFDA; the full label on DailyMed
What do FAERS reports show?
304,163 reports list dexamethasone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 49,353 are coded as a death and 117,148 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 1 is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Dexamethasone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions