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prednisolone

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Brand names: Orapred, Pediapred

Corticosteroid Rx

Prednisolone eye drops reduce inflammation in your eye. It is a type of steroid medicine.

Drug Pricing (NADAC)

Generic Price

$1.96/unit

Generic Available

Yes (16 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

This medicine treats swelling and redness in your eye.

Common side effects

Eye pain, Feeling like something is in your eye, Headache

Key warnings

Using steroid eye drops for a long time may cause glaucoma (increased pressure in the eye) or cataracts.

How It Works

Prednisolone is a corticosteroid. It works by reducing inflammation in the eye. This helps to relieve redness, swelling, and pain.

How to Take It

Shake the bottle well before using. Put 1 or 2 drops into your eye. Do this 2 to 4 times each day. You may need to use it more often during the first 1 or 2 days. Do not stop using the drops too soon.

Pregnancy & Breastfeeding

Tell your doctor if you are pregnant or breastfeeding. It is not known if prednisolone eye drops will harm an unborn baby. Talk to your doctor about the risks and benefits.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store at room temperature up to 77°F (25°C). Do not freeze. Store the bottle upright.

Side Effects (from patient reports)

Based on 75,940 FDA adverse event reports.

Using the medicine for a condition it is not approved for
14,440
The medicine is not working
12,313
Fever
8,198
Difficulty breathing
6,809
Lung infection
6,760
Loose or watery stools
6,510
Condition is getting worse
5,689
Feeling sick to your stomach
5,362
Throwing up
4,965
Using the product for a purpose that is not approved
4,894

FDA Adverse Event Report Analysis

Detailed analysis of 173,227 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1999–2025.

Total Reports

173,227

Death-Related Reports

27,831

Hospitalization Reports

79,445

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 82,144 (53%)
Male 71,840 (46%)

Age Distribution

0–17 13,687
18–44 27,176
45–64 41,274
65–74 26,893
75+ 21,626

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 OFF LABEL USE 14,440
2 DRUG INEFFECTIVE 12,312
3 PYREXIA 8,197
4 DYSPNOEA 6,807
5 PNEUMONIA 6,760
6 DIARRHOEA 6,510
7 CONDITION AGGRAVATED 5,688
8 NAUSEA 5,363
9 VOMITING 4,963
10 FATIGUE 4,894
11 PRODUCT USE IN UNAPPROVED INDICATION 4,894
12 SEPSIS 4,479
13 HEADACHE 4,466
14 RASH 4,216
15 ARTHRALGIA 4,123

Reactions in Death Reports

DEATH 3,645
PNEUMONIA 2,553
OFF LABEL USE 2,489
DRUG INEFFECTIVE 2,446
SEPSIS 2,411
PYREXIA 1,690
RESPIRATORY FAILURE 1,648
DYSPNOEA 1,397
DIARRHOEA 1,343
CONDITION AGGRAVATED 1,340

Reactions in Hospitalization Reports

OFF LABEL USE 5,888
PYREXIA 5,881
DRUG INEFFECTIVE 4,977
PNEUMONIA 4,766
DYSPNOEA 4,366
DIARRHOEA 4,024
VOMITING 3,319
NAUSEA 3,020
CONDITION AGGRAVATED 2,934
SEPSIS 2,723

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Using steroid eye drops for a long time may cause glaucoma (increased pressure in the eye) or cataracts. It can also make it harder for your eye to heal if you have an injury. Tell your doctor if your symptoms do not improve after 2 days.

Known Drug Interactions

albuterol, systemic and inhaled mebendazole amoxicillin medroxyprogesterone ampicillin, with or without sulbactam methylprednisolone atenolol metronidazole azithromycin metoprolol caffeine, dietary ingestion nadolol cefaclor nifedipine co-trimoxazole (trimethoprim and sulfamethoxazole) nizatidine diltiazem norfloxacin dirithromycin ofloxacin enflurane omeprazole famotidine prednisone, prednisolone felodipine ranitidine finasteride rifabutin hydrocortisone roxithromycin isoflurane Sorbitol (purgative doses do not inhibit theophylline absorption) isoniazid sucralfate isradipine terbutaline, s...

Mechanism: Taking these two drugs together can change how quickly your body gets rid of theophylline. This may cause the amount of medicine in your blood to go up or down.

What to do: Your doctor may need to adjust your theophylline dose when you start or stop this steroid. Report any new or worsening side effects to your healthcare provider.

moderate darunavir

betamethasone budesonide ciclesonide fluticasone methylprednisolone mometasone triamcinolone ↑ corticosteroids Co-administration with corticosteroids (all routes of administration) of which exposures are significantly increased by strong CYP3A inhibitors can increase the risk for Cushing's syndrome and adrenal suppression. Alternative corticosteroids including beclomethasone, prednisone and prednisolone (for which PK and/or PD are less affected by strong CYP3A inhibitors relative to other steroids) should be considered, particularly for long term use.

Mechanism: Darunavir has a smaller effect on prednisolone than on other steroids, so the levels do not rise as much. This makes it a safer choice when a steroid is needed.

What to do: This combination is often preferred over other steroids, but your doctor should still check for any side effects during treatment.

Corticosteroids primarily metabolized by CYP3A betamethasone, budesonide, ciclesonide, dexamethasone, fluticasone, methylprednisolone, mometasone, triamcinolone ↑ corticosteroid Co-administration with corticosteroids (all routes of administration) of which exposures are significantly increased by strong CYP3A inhibitors can increase the risk for Cushing’s syndrome and adrenal suppression. Alternative corticosteroids including beclomethasone, prednisone, and prednisolone should be considered.

Mechanism: This specific steroid is considered a safer alternative because it is less affected by the antiviral than other steroids. It is less likely to build up to dangerous levels in your system.

What to do: This is a preferred steroid to use if you are taking this antiviral. Your doctor will determine if this is the right choice for your treatment.

In addition, carbamazepine causes, or would be expected to cause, decreased levels of the following drugs, for which monitoring of concentrations or dosage adjustment may be necessary: acetaminophen, albendazole, alprazolam, aprepitant, buprenorphone, bupropion, citalopram, clonazepam, clozapine, corticosteroids (e.g., prednisolone, dexamethasone), cyclosporine, dicumarol, dihydropyridine calcium channel blockers (e.g., felodipine), doxycycline, ethosuximide, everolimus, haloperidol, imatinib, itraconazole, lamotrigine, levothyroxine, methadone, methsuximide, mianserin, midazolam, olanzapin...

Mechanism: Carbamazepine makes your body break down prednisolone faster, which lowers the amount of medicine in your blood.

What to do: Your doctor may need to increase your dose of prednisolone or monitor your condition more closely.

Concomitant use with ethinyl estradiol-containing COCs may increase systemic exposure of other drugs (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole).

Mechanism: Estradiol can slow down how your body processes prednisolone, which causes the steroid to build up in your system.

What to do: Your doctor may need to lower your prednisolone dose or monitor you more closely for steroid side effects.

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Common Questions

Can I use this medicine if I have an eye infection?
You should not use this medicine if you have certain types of eye infections, especially those caused by viruses or fungus.
What should I do if my vision gets worse while using these drops?
Tell your doctor right away if your vision gets worse or if you have any new eye problems.
Can I wear contact lenses while using these drops?
Talk to your doctor about wearing contact lenses while using this medicine.
How long should I use these eye drops?
Use these eye drops for as long as your doctor tells you to. Do not stop using them too soon.
Can these drops cause any other side effects?
Yes, some people may have allergic reactions, changes in taste, or other eye problems. Tell your doctor if you have any side effects that bother you.
What if I accidentally swallow some of the eye drops?
If you accidentally swallow the eye drops, call your doctor or poison control center right away.
Can I use these drops with other eye medicines?
Tell your doctor about all the other medicines you are using, including other eye drops.
What does 'shake well before using' mean?
It means to mix the medicine by shaking the bottle gently before each use.
How do I put the drops in my eye?
Tilt your head back, pull down your lower eyelid, and gently squeeze the bottle to put the drops in your eye. Try not to touch your eye with the dropper.
Can I drive after using these eye drops?
Your vision may be blurry after using these drops. Do not drive or operate machinery until your vision is clear.
What are the common side effects of prednisolone?
The most commonly reported side effects of prednisolone include Eye pain, Feeling like something is in your eye, Headache, Itching, Rash. Based on 75,940 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does prednisolone interact with other medications?
Yes, prednisolone has 14 known drug interactions. Notable interactions include theophylline, darunavir, nirmatrelvir/ritonavir. Always inform your doctor about all medications you are taking.
What drug class is prednisolone?
prednisolone belongs to the Corticosteroid drug class. It requires a prescription (Rx). This medicine treats swelling and redness in your eye.
Is prednisolone safe during pregnancy?
Tell your doctor if you are pregnant or breastfeeding. It is not known if prednisolone eye drops will harm an unborn baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has prednisolone been recalled?
There are 4 recalls associated with prednisolone products. Lack of Assurance of Sterility. Check the recalls section below for full details and affected products.

Active Recalls

Class II May 14, 2024

Lack of Assurance of Sterility

Imprimis NJOF, LLC

Class II April 10, 2024

Subpotent Drug

Imprimis NJOF, LLC

Class II April 26, 2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc.

Class II August 1, 2022

Defective Container: Product has incomplete induction seals.

Akorn, Inc

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Medication Guides

Related Health & Safety Data

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What the FDA Data Shows for prednisolone

The FDA label for prednisolone (sold under brand names such as Orapred, Pediapred) classifies it as a prescription-only medication in the Corticosteroid class. This medicine treats swelling and redness in your eye. Official labeling lists 7 commonly reported side effects, including Eye pain, Feeling like something is in your eye, Headache.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 75,940 voluntary reports. The database also lists 14 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $1.96.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 4 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: February 2, 2024

All federal data sources used on this page