This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
is indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma (MM). HEMADY is a corticosteroid indicated in combination with other anti-myeloma products for the treatment of adults with multiple myeloma. ( 1 )
is contraindicated in patients with: Hypersensitivity to dexamethasone, or any of the excipients. Rare instances of anaphylactic reactions have been reported [see Adverse Reactions ( 6 ), Description ( 11 )] . Systemic fungal infections. Corticosteroids may exacerbate systemic fungal infections [see Warnings and Precautions ( 5.2 )] . • Patients with hypersensitivity to dexamethasone ( 4 ) • Patients with systemic fungal infections ( 4 )
• Alterations in Endocrine Function: Hypothalamic-pituitary adrenal (HPA) axis suppression, Cushing’s syndrome, and hyperglycemia can occur. Monitor patients for these conditions with chronic use. ( 5.1 ) • Immunosuppression and Increased Risk of Infections: Increased risk of new, exacerbation, dissemination, or reactivation of latent infections. ( 5.2 ) • Alteration in Cardiovascular/Renal Function: Monitor for elevated blood pressure and sodium, and for decreased potassium levels. ( 5.3 ) • Venous and Arterial Thromboembolism: Risk increased; consider anticoagulant prophylaxis and monitor for evidence of thromboembolism. ( 5.4 ) • Vaccination: Avoid the administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids. ( 5.5 ) • Ophthalmic Effects: May include cataracts, infections, and glaucoma. ( 5.6 ) • Gastrointestinal Perforation: Avoid use in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation. ( 5.7 ) • Osteoporosis: Increased risk; monitor for changes in bone density with chronic use. ( 5.8 ) • Behavioral...
The following clinically significant adverse reactions are described in detail in other labeling sections: Hypersensitivity [see Contraindications ( 4 )] Alterations in Endocrine Function [see Warnings and Precautions ( 5.1 )] Immunosuppression and Increased Risk of Infections [see Warnings and Precautions ( 5.2 ) ] Alterations in Cardiovascular/Renal Function [see Warnings and Precautions ( 5.3 )] Venous and Arterial Thromboembolism [see Warnings and Precautions ( 5.4 )] Vaccination [see Warnings and Precautions ( 5.5 )] Ophthalmic Effects [see Warnings and Precautions ( 5.6 )] Gastrointestinal Perforation [see Warnings and Precautions ( 5.7 )] Osteoporosis [see Warnings and Precautions ( 5.8 )] Myopathy [see Warnings and Precautions ( 5.9 )] Behavioral and Mood Disturbances [see Warnings and Precautions ( 5.10 )] Kaposi's Sarcoma [see Warnings and Precautions ( 5.11 )] HEMADY in Combination with Anti-Myeloma Products [see Warnings and Precautions ( 5.12 )] Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.13 )] The following adverse reactions associated with the use of HEMADY or other corticosteroids were identified in clinical trials or postmarketing reports....
Warnings and Precautions, Immunosuppression and Increased Risk of Infection ( 5.2 ) 6/2024 Warnings and Precautions, Kaposi’s Sarcoma ( 5.11 ) 6/2024
Source: FDA SPL label for Hemady (Edenbridge Pharmaceuticals LLC.), effective 20260109. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 28,340 | 30,039 | 33,007 | 29,974 | 26,204 | 23,222 | 20,998 | 9,894 |
34,271 reports blaming this drug for every million Medicare prescriptions filled, which is 12.4× the typical drug on this site. (53,914 reports in 2024–2026, against 1,573,189 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 02/2026 | Class II | SOMERSET THERAPEUTICS LLC | 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 |
| 05/2024 | Class II | Eugia US LLC | Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec. |
| 12/2018 | Class II | Allergan, PLC. | GMP Deviations: A silicone particulate was noted in Ozurdex. |
| 11/2017 | Class III | West-Ward Pharmaceuticals Corp. | Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound). |
| 11/2017 | Class III | West-Ward Pharmaceuticals Corp. | Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound). |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $801,109 in payments to US physicians and hospitals tied to this drug across 9,700 transactions (Ozurdex $537,581, Dextenza $263,528).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Dexamethasone | 1,472,228 | $13 |
| Dexamethasone Sodium Phosphate | 96,184 | $34 |
| Dexamethasone Intensol | 1,977 | $56 |
| Ozurdex | 1,126 | $1,664 |
| Maxidex | 1,040 | $95 |
| Hemady | 634 | $190 |
1 drug in the same class grades a letter or more higher than dexamethasone on this site. Worth asking whether one of them would do the same job for you.
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.