Corticosteroid · Brand: Maxidex, Dextenza + 4 more

Dexamethasone Side Effects: Common, Serious & FDA Warnings

Creator: MedivaScan
Published: 2026-05-28T04:28:23.034875+00:00

Verified from FDA on May 28, 2026Refreshes every 6 hoursFDA-Sourced

FDA-Approved For

Quick answer

Based on 303,000+ FDA adverse event reports, the most-reported dexamethasone reactions include diarrhoea, fatigue, and nausea. FDA reports 2 active Class II recalls of dexamethasone, primarily for failed dissolution specifications. The FDA-approved label does not carry a boxed warning.

For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.

Common Side Effects of Dexamethasone

The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for dexamethasone. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.

Reaction	Reports	% of total
Diarrhoea	17,285	5.7%
Fatigue	17,412	5.7%
Nausea	14,427	4.8%
Plasma Cell Myeloma	14,108	4.7%
Pneumonia	13,902	4.6%
Neutropenia	11,717	3.9%
Pyrexia	11,399	3.8%
Dyspnoea	10,564	3.5%
Thrombocytopenia	10,723	3.5%
Anaemia	9,322	3.1%

Source: FDA FAERS·Updated May 28, 2026·n=303,291+·verify on FDA →·Methodology

Serious Outcomes and FDA Warnings

FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.

Outcome flag	Reports	% of total
Serious reports (any flag)	—	—
Hospitalization	—	—
Death reported as outcome FAERS outcome flag, not a reaction term. The patient was on the drug when the report was filed; causation is not established.	13,579	4.5%

Dexamethasone Recalls

FDA enforcement actions matched to dexamethasone via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.

Date	Reason	Class	Quantity	Status
2026-03-25	Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate. SOMERSET THERAPEUTICS LLC	Class II	62190 vials	Ongoing
2024-06-26	Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec. Eugia US LLC	Class II	70,125 vials	Ongoing

Source: FDA Drug Enforcement Reports·Updated May 28, 2026·Refreshes every 6 hours·verify on FDA →

Show 3 closed recalls (2017 to 2019)

Includes resolved and terminated recalls matched to dexamethasone. Most recent first.

Date	Reason	Class	Quantity	Status
2019-01-16	GMP Deviations: A silicone particulate was noted in Ozurdex. Allergan, PLC.	Class II	133,716 Cartons	Resolved
2017-11-29	Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound). West-Ward Pharmaceuticals Corp.	Class III	16,157 shelf packs	Terminated
2017-11-29	Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound). West-Ward Pharmaceuticals Corp.	Class III	1,896 shelf packs	Terminated

Dexamethasone Shortages

FDA-listed shortages of dexamethasone products. Strength and dosage-form level detail.

No active or recent shortages of dexamethasone are listed. We refresh this view daily.

Source: FDA Drug Shortages·Updated May 28, 2026

Is Dexamethasone Safe?

Dexamethasone is FDA-approved and the label does not carry a boxed warning.

As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.

Source: DailyMed (dexamethasone label)·Updated May 28, 2026

FDA-Approved Indications

Dexamethasone is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.

INDICATIONS AND USAGE A l l ergic States: Control of severe or incapacitating a llergic 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. Dermatologic Diseases: Bul l ous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis.
Show full Indications and UsageSee less
Gastrointestinal Diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), idiopathic thrombocytopenic purpura in adults, pure red cell aplasia, and selected cases of secondary thrombocytopenia. Misce l l aneous: Diagnostic testing of adrenocortical hyperfunction, trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases: For the palliative management of leukemias and lymphomas. Nervous System: Acute exacerbations of multiple sclerosis, cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury. Ophthalmic Diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases: To induce a diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory Diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute rheumatic carditis, ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.

Source: DailyMed (dexamethasone label)·Updated May 28, 2026·Section 1 (Indications and Usage)

Frequently Asked Questions

What are the most-reported side effects of dexamethasone?

Diarrhoea, fatigue, and nausea are among the most-reported reactions in FDA FAERS data for dexamethasone. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.

Is dexamethasone the same as Maxidex?

Dexamethasone is the generic name; Maxidex is a brand name for the same active ingredient. Other brand names include Dextenza, Ozurdex, Dexycu, Dexycu Kit, and Hemady. The active ingredient is identical; formulation and inactive ingredients may vary by manufacturer.

Has dexamethasone been recalled?

Yes. Dexamethasone has active and closed recalls on record in the FDA enforcement database. Reasons are dominated by contamination or foreign material and CGMP deviations. See the recalls table on this page for current counts, firm names, dates, and lot quantities.

What are dexamethasone's current ongoing recalls about?

Active dexamethasone recalls are listed in the recalls table above with their class, reason, firm, and affected lots. The dominant reason across these recalls is contamination or foreign material. For lot numbers, distribution patterns, and the FDA enforcement record for any individual recall, follow the verify-on-FDA link from each row.

What do FDA recall classes mean?

Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.

Data Sources & Methodology

How each section of this page is sourced, and how often the data is refreshed.

Source	Endpoint	Refresh
FAERS reactions	openFDA `/drug/event.json` count API. Aggregated per drug per reaction term; we do not store individual reports.	Daily
Recalls	openFDA `/drug/enforcement.json`. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here.	6 hours
Shortages	FDA Drug Shortages list.	Daily
Boxed warnings & label sections	openFDA `/drug/label.json`. Labels are stable; monthly cadence is sufficient.	Monthly
Condition categories	Synonym-mapped from drug_labels.indications. Methodology at /methodology/.	Per-drug

What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.