prednisolone acetate
Pharmaranks rates Prednisolone Acetate 2.9/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Prednisolone Acetate is a corticosteroid used to treat Adrenal Insufficiency, Hemolytic Anemia, Asthma, Berylliosis.
Corticosteroid · by Lupin
Generic of Pred Forte
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
- Prednisolone Acetate
- Drug class
- Corticosteroid
- Form
- Drops
- Strength
- Prednisolone Acetate 1%
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- adrenal insufficiency, hemolytic anemia, asthma
- Manufacturer
- Lupin
- Half-life
- 2 to 4 hours (how long it stays in your system)
- What the pharmacy pays
- ~$0.60 per ml — not your price
- FDA application
- ANDA216935
What is Prednisolone Acetate?
From the FDA label:Prednisolone acetate ophthalmic suspension USP, 1% is a sterile, topical anti-inflammatory agent for ophthalmic use. Its chemical name is 11ß,17, 21-Trihydroxypregna-1,4-diene-3, 20-dione 21-acetate and it has the following structure: Each mL of prednisolone acetate ophthalmic suspension USP contains: Active: prednisolone acetate (micronized) 1% Inactive: benzalkonium chloride as preservative, boric acid, edetate disodium, hypromellose, polysorbate 80, sodium bisulfite, sodium chloride, sodium citrate and water for injection. The pH during its shelf life ranges from 5.0 to 6.0. Structure
How to use
Shake well before using. Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated ( see PRECAUTIONS ).
Side effects
The following adverse reactions have been identified during use of Prednisolone acetate ophthalmic suspension. Because reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions include elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing. The development of secondary ocular infection (bacterial, fungal, and viral) has occurred. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used ( see PRECAUTIONS ). Other adverse reactions reported with the use of prednisolone acetate ophthalmic suspension include: allergic reactions; dysgeusia; eye pain; foreign body sensation; headache; pruritus; rash; transient burning and stinging upon instillation and other minor symptoms of ocular irritation; urticaria; and visual disturbance (blurry vision). Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of…
Warnings
Important safety information
Prolonged use of corticosteroids may result in posterior subcapsular cataract formation and may increase intraocular pressure in susceptible individuals, resulting in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently. Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended. Prednisolone acetate ophthalmic suspension contains sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
Who should not take Prednisolone Acetate
Prednisolone acetate ophthalmic suspension is contraindicated in acute untreated purulent ocular infections, in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Prednisolone acetate ophthalmic suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
Overdose — what happens if you take too much
Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
How long does Prednisolone Acetate stay in your body?
The elimination half-life of prednisolone acetate is 2 to 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 (elimination) half-life; the label states prednisolone "is eliminated from the plasma with a half-life of 2 to 4 hours" and is 70-90% protein bound. Prednisolone is itself the active corticosteroid (prednisone is the prodrug that is converted to prednisolone in the liver), so no active metabolite outlasts it. Its biological/anti-inflammatory effect lasts much longer than the plasma half-life — prednisolone is an intermediate-acting glucocorticoid with a tissue effect of roughly 18-36 hours, which is why once-daily dosing works. It is metabolized mainly in the liver, so clearance can be slowed and the half-life prolonged in significant liver impairment. Note that the plasma half-life is not the same as a drug-test detection window.
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: PediaPred (prednisolone sodium phosphate) oral solution — FDA label via DailyMed.
Drug class
How this class works, per Corticosteroids - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Prednisolone Acetate ranks — best-rated corticosteroid for:
Dosage forms
Drops
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 Prednisolone Acetate treat?
- Prednisolone Acetate (Prednisolone Acetate) may be used to treat adrenal insufficiency, hemolytic anemia, asthma, berylliosis, brain neoplasms, ulcerative colitis, 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 Prednisolone Acetate work?
- Prednisolone Acetate 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 Prednisolone Acetate rated?
- pharmaranks gives Prednisolone Acetate a composite score of 2.9 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 Prednisolone Acetate 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 $0.60 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 Prednisolone Acetate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Prednisolone Acetate. To pay less, Prednisolone Acetate is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Prednisolone Acetate?
- Prednisolone Acetate is marketed by Lupin. You can see Lupin's full profile, rating, and other products on pharmaranks.
- Is Prednisolone Acetate a brand-name or generic drug?
- Prednisolone Acetate is a generic medication; its active ingredient is Prednisolone Acetate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Prednisolone Acetate available over the counter?
- No. Prednisolone Acetate 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 Prednisolone Acetate come in?
- Prednisolone Acetate is currently marketed as drops, per the FDA's National Drug Code Directory.
- What class of drug is Prednisolone Acetate?
- Prednisolone Acetate is classified as corticosteroid, per the FDA's Established Pharmacologic Class.
- Is Prednisolone Acetate FDA-registered?
- Prednisolone Acetate is on record with the U.S. FDA under application number ANDA216935. You can verify this on its official FDA label.
- Has Prednisolone Acetate been recalled by the FDA?
- Yes. Prednisolone Acetate 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 Prednisolone Acetate safe?
- There's no single safe-or-not verdict. pharmaranks gives Prednisolone Acetate a recall-safety score of 58/100, 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 Prednisolone Acetate?
- Prednisolone Acetate's side effects are taken directly from its FDA label. From the label: The following adverse reactions have been identified during use of Prednisolone acetate ophthalmic suspension. Because reactions are reported voluntarily from a population of uncertain size,… 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 Prednisolone Acetate
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 197,022 reports naming Prednisolone Acetate, and the FDA flagged 93% 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:
- pyrexia9,124 reports
- dyspnoea7,608 reports
- pneumonia7,481 reports
- diarrhoea7,330 reports
- nausea6,101 reports
- fatigue5,708 reports
- vomiting5,646 reports
- headache5,236 reports
Read these as a signal, not a rate. A report does not mean Prednisolone Acetate 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 26, 2026.
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prednisolone acetate
58/100