ozurdex
Pharmaranks rates Ozurdex 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Ozurdex (Dexamethasone) is a corticosteroid used to treat Addison Disease, Brain Edema, Bursitis, Ulcerative Colitis.
Dexamethasone · by Abbvie
Available as a generic: Dexamethasone
⚠ FDA reports a current shortage of the injection form — availability differs between suppliers — see drug shortages →Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Dexamethasone
- Drug class
- Corticosteroid
- Form
- Implant
- Strength
- Dexamethasone 0.7MG
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- addison disease, brain edema, bursitis
- Manufacturer
- Abbvie
- Half-life
- about 4 hours (how long it stays in your system)
- What the pharmacy pays
- ~$0.24 per ml — not your price
- FDA application
- NDA022315
What is Ozurdex?
From the FDA label:OZURDEX is a sterile intravitreal implant containing 0.7 mg (700 mcg) dexamethasone in the NOVADUR solid polymer sustained-release drug delivery system which does not contain an antimicrobial preservative. OZURDEX is preloaded into a single-use, DDS applicator to facilitate injection of the rodshaped implant directly into the vitreous. The NOVADUR system contains two poly D,L-lactide-co-glycolide (PLGA) polymer excipients. Both of these polymer materials have the same PLGA backbone, but the terminal end groups differ between them. One polymer, DL-Lactide and Glycolide (50:50) Copolymer 12000 Ethyl Ester, is ester terminated, and the other DL-Lactide and Glycolide (50:50) Copolymer 12000 Acid is acid terminated. The chemical name for dexamethasone is Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11β, 16α)-. Its structural formula is: MW 392.47; molecular formula: C 22 H 29 FO 5 Dexamethasone occurs as a white to cream-colored crystalline powder having not more than a slight odor, and is practically insoluble in water and very soluble in alcohol. The PLGA matrix slowly degrades to lactic acid and glycolic acid. The structural formula for OZURDEX® is an intravitreal implant containing 0.7 mg (700 mcg) dexamethasone in the NOVADUR® solid polymer sustained-release drug delivery system. OZURDEX® is preloaded into a single-use, DDS® applicator to facilitate…
How to use
For ophthalmic intravitreal injection. ( 2.1 ) The intravitreal injection procedure should be carried out under controlled aseptic conditions. ( 2.2 ) Following the intravitreal injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. ( 2.2 ) 2.1 General Dosing Information For ophthalmic intravitreal injection. 2.2 Administration The intravitreal injection procedure should be carried out under controlled aseptic conditions which include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide applied to the periocular skin, eyelid and ocular surface are recommended to be given prior to the injection. Remove the foil pouch from the carton and examine for damage. Then, open the foil pouch over a sterile field and gently drop the applicator on a sterile tray. Perform a detailed visual inspection of the applicator, including ensuring that the actuator button has not been depressed, and the safety tab is in place. Carefully remove the plastic safety cap taking care to avoid contacting the needle tip. Inspect the needle tip for damage prior to use; the implant retention plug may be visible in the bevel and should not be removed. Hold the applicator in one hand and pull the safety tab straight off the applicator. Do not twist or flex the tab. The long…
Side effects
In controlled studies, the most common adverse reactions reported by 20–70% of patients were cataract, increased intraocular pressure and conjunctival hemorrhage. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Figure 1: Mean IOP during the study 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse reactions associated with ophthalmic steroids including OZURDEX include elevated intraocular pressure, which may be associated with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera. Retinal Vein Occlusion and Posterior Segment Uveitis The following information is based on the combined clinical trial results from 3 initial, randomized, 6-month, sham-controlled studies (2 for retinal vein occlusion and 1 for posterior segment uveitis): Table 1: Adverse Reactions Reported by Greater than 2% of Patients MedDRA Term OZURDEX N=497 (%) Sham N=498 (%) Intraocular pressure…
Warnings
Important safety information
Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored following the injection. ( 5.1 ) Use of corticosteroids may produce posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. ( 5.2 ) 5.1 Intravitreal Injection-related Effects Intravitreal injections, including those with OZURDEX, have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored regularly following the injection [see Patient Counseling Information ( 17 )] . 5.2 Steroid-related Effects Use of corticosteroids including OZURDEX may produce posterior subcapsular cataracts, increased intraocular pressure, and glaucoma. Use of corticosteroids may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses [see Adverse Reactions ( 6.1 )] . Corticosteroids are not recommended to be used in patients with a history of ocular herpes simplex because of the potential for reactivation of the viral infection.
Who should not take Ozurdex
Ocular or periocular infections ( 4.1 ) Glaucoma ( 4.2 ) Torn or ruptured posterior lens capsule ( 4.3 ) Hypersensitivity ( 4.4 ) 4.1 Ocular or Periocular Infections OZURDEX (dexamethasone intravitreal implant) is contraindicated in patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases. 4.2 Glaucoma OZURDEX is contraindicated in patients with glaucoma, who have cup to disc ratios of greater than 0.8. 4.3 Torn or Ruptured Posterior Lens Capsule OZURDEX is contraindicated in patients whose posterior lens capsule is torn or ruptured because of the risk of migration into the anterior chamber. Laser posterior capsulotomy in pseudophakic patients is not a contraindication for OZURDEX use. 4. 4 Hypersensitivity OZURDEX is contraindicated in patients with known hypersensitivity to any components of this product [see Adverse Reactions ( 6 )] .
How long does Dexamethasone stay in your body?
The elimination half-life of dexamethasone is about 4 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the plasma (terminal) elimination half-life — the label states the mean terminal half-life is 4 hours. Dexamethasone's anti-inflammatory/biologic effect lasts far longer than its blood levels (commonly cited biologic half-life ~36-54 hours), which is why it is dosed less often than the short plasma half-life implies; the drug is largely cleared from the blood within about a day (roughly 4-5 half-lives, ~1 day), but this clearance window is not the same as a drug-test detection window. Dexamethasone is ~77% protein-bound and metabolized by CYP3A4 (renal excretion is less than 10% of clearance), so strong CYP3A4 inhibitors/inducers can lengthen or shorten exposure. The manufacturer notes the effect of renal or hepatic impairment on its pharmacokinetics has not been formally studied.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: HEMADY (dexamethasone) tablets — FDA label, Clinical Pharmacology (DailyMed).
Drug class
How this class works, per Corticosteroids - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Ozurdex ranks — best-rated corticosteroid for:
Dosage forms
Implant
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Ozurdex treat?
- Ozurdex (Dexamethasone) may be used to treat addison disease, brain edema, bursitis, ulcerative colitis, collagen diseases, dermatitis herpetiformis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Ozurdex work?
- Ozurdex is a corticosteroid. Corticosteroids mimic the body's natural stress hormone cortisol: they enter cells and bind a glucocorticoid receptor that switches off genes for inflammatory chemicals, calming swelling, redness, and an overactive immune response.
- How is Ozurdex rated?
- pharmaranks gives Ozurdex a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Ozurdex cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.24 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Ozurdex?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Ozurdex. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Ozurdex?
- Ozurdex is marketed by Abbvie. You can see Abbvie's full profile, rating, and other products on pharmaranks.
- Is Ozurdex a brand-name or generic drug?
- Ozurdex is a brand-name product with the active ingredient Dexamethasone. Lower-cost generic equivalents containing Dexamethasone are available — ask your pharmacist.
- Is Ozurdex available over the counter?
- No. Ozurdex is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Ozurdex come in?
- Ozurdex is currently marketed as implant, per the FDA's National Drug Code Directory.
- What class of drug is Ozurdex?
- Ozurdex is classified as corticosteroid, per the FDA's Established Pharmacologic Class.
- Is Ozurdex FDA-registered?
- Ozurdex is on record with the U.S. FDA under application number NDA022315. You can verify this on its official FDA label.
- Has Ozurdex been recalled by the FDA?
- Yes. Ozurdex has 1 recorded FDA recall event in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
- Is Ozurdex safe?
- There's no single safe-or-not verdict. pharmaranks gives Ozurdex a recall-safety score of 70/100, based on its FDA recall history (1 recorded recall event) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Ozurdex?
- Ozurdex's side effects are taken directly from its FDA label. From the label: In controlled studies, the most common adverse reactions reported by 20–70% of patients were cataract, increased intraocular pressure and conjunctival hemorrhage. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
What people report to the FDA about DEXAMETHASONE
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 323,104 reports naming DEXAMETHASONE — the active ingredient in Ozurdex, and the FDA flagged 85% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- fatigue18,623 reports
- diarrhoea18,509 reports
- nausea15,468 reports
- pneumonia15,192 reports
- plasma cell myeloma14,665 reports
- neutropenia12,723 reports
- pyrexia12,475 reports
- thrombocytopenia11,609 reports
Read these as a signal, not a rate. A report does not mean DEXAMETHASONE caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 25, 2026.
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ozurdex
70/100