Prednisolone is a corticosteroid sold in the U.S. under 15 brand and generic names, for adrenal insufficiency, hemolytic anemia and asthma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Orapred ODT (application NDA021959). Other prednisolone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Individualize dosing based on disease severity and patient response: Initial Dose: 10 mg to 60 mg of prednisolone (as 13.4 mg to 80.6 mg of prednisolone sodium phosphate) ( 2 ) Maintenance Dose: Use lowest dosage that will maintain an adequate clinical response ( 2 ) Discontinuation: Withdraw gradually if discontinuing long-term or high-dose therapy ( 2 ) Take with food to avoid gastrointestinal (GI) irritation ( 2 ) DO NOT BREAK OR USE PARTIAL ORAPRED ODT TABLETS. USE AN APPROPRIATE FORMULATION OF PREDNISOLONE IF INDICATED DOSE CANNOT BE OBTAINED USING ORAPRED ODT. ( 2 ) 2.1 Recommended Dosing Dosage of Orapred ODT should be individualized according to the severity of the disease and the response of the patient. For pediatric patients, the recommended dosage should be governed by the same considerations rather than strict adherence to the ratio indicated by age or body weight. Do not break or use partial Orapred ODT tablets. Use an appropriate formulation of prednisolone if indicated dose cannot be obtained using Orapred ODT. This may become important in the treatment of conditions that require tapering doses that cannot be adequately accommodated by Orapred ODT, e.g., tapering the dose below 10 mg. The initial dose of Orapred ODT may vary from 10 to 60 mg (prednisolone base) per day, depending on the specific disease entity being treated. In situations of less severity,…
Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain. Allergic Reactions: Anaphylactoid reaction, anaphylaxis, angioedema Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis Dermatologic: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scalp, edema, facial erythema, hyper or hypo-pigmentation, impaired wound healing, increased sweating, petechiae and ecchymoses, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria Endocrine: Abnormal fat deposits, decreased carbohydrate tolerance, development of Cushingoid state, hirsutism, manifestations of latent diabetes mellitus and increased requirements for insulin or oral hypoglycemic agents in diabetics, menstrual irregularities, moon facies, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery or illness), suppression of growth in children Fluid and…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Topical | Generic | $1 | View → | |
| 2 | 70/100 | Prescription | Drops | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| T100 | 5 mg / 2 mg | gray | round | — |
| 42;16;V;4 | 4 mg | white | oval | — |
| MP | 4 mg | white | oval | — |
| MEDROL;4 | 4 mg | white | oval | — |
| MEDROL;8 | 8 mg | white | oval | — |
| MEDROL;16 | 16 mg | white |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Steril…
Failed Stability Specifications
AbbVie Inc. · May 18, 2026
methylprednisolone tablets
Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
Greenstone Llc · Jan 15, 2026
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension
Lack of Assurance of Sterility
Imprimis NJOF, LLC · May 14, 2024
MethylPREDNISolone Acetate Injectable Suspension
Presence of Particulate Matter: Potential for black particulates in the drug product.
Sagent Pharmaceuticals · Apr 25, 2024
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution…
Subpotent Drug
Imprimis NJOF, LLC · Apr 10, 2024
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Orapred ODT is contraindicated in patients who are hypersensitive to corticosteroids such as prednisolone or any components of this product. Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy. Hypersensitivity to prednisolone or any components of this product. ( 4 )
Aminoglutethimide: Aminoglutethimide may lead to loss of corticosteroid-induced adrenal suppression. Amphotericin B: There have been cases reported in which concomitant use of Amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see also Potassium depleting agents). Anticholinesterase agents: Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. Anticoagulant agents: Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetic Agents: Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. Antitubercular drugs: Serum concentrations of isoniazid may be decreased. CYP 3A4 inducers (e.g. barbiturates, phenytoin, carbamazepine, and rifampin): Drugs such as barbiturates, phenytoin, ephedrine, and rifampin, which induce hepatic microsomal drug metabolizing enzyme activity may enhance metabolism of prednisolone and require that the dosage of Orapred be increased. CYP…
| $1 |
| View → |
| 3 | 70/100 | Prescription | Drops | Generic | $1 | View → |
| 4 | 70/100 | Prescription | Solution | Generic | $1 | View → |
| 5 | 64/100 | Prescription | Drops | Generic | $1 | View → |
| 6 | 56/100 | Prescription | Drops | Generic | $1 | View → |
| 7 | 56/100 | Prescription | Tablet | Generic | $1 | View → |
| 8 | Not yet rated | Prescription | Tablet | Generic | $1 | View → |
| 9 | Not yet rated | Prescription | Drops | Generic | $1 | View → |
| 10 | Not yet rated | Prescription | Suspension | Generic | $1 | View → |
| oval |
| — |
| MEDROL;32 | 32 mg | white | oval | — |
|---|
| MP | 4 mg | white | oval | — |
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