Prednisone Side Effects are documented on the FDA prescribing label, and reported separately by patients and doctors to the FDA’s adverse event system. This page sets out what the official record actually says about Prednisone: what it is approved to treat, what the label warns about, its recall history, and what the reported side effects are — along with what those figures do and do not mean.
- What Prednisone Is Prescribed For, and Where Prednisone Side Effects Come From
- Warnings on the Prednisone Label
- Warnings Beyond the Common Prednisone Side Effects
- Prednisone Side Effects Listed on the FDA Label
- Reported Prednisone Side Effects in the FDA Database
- Who the Label Says Should Take Extra Care
- Prednisone Recall History
- Is Prednisone the Subject of Litigation?
- If You Are Worried About Prednisone Side Effects
- Frequently Asked Questions
- Official Sources
- Related Guides
Before you read on. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first.
What Prednisone Is Prescribed For, and Where Prednisone Side Effects Come From
According to the FDA label, rednisone delayed-release tablets are indicated in the treatment of the following diseases or conditions: Prednisone delayed-release tablets are a corticosteroid indicated as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and organ transplantation ( 1 ) for the treatment of certain endocrine conditions ( 1 ) for palliation of certain neoplastic conditions ( 1 ) 1.1 Allergic Conditions Control of severe or incapacitatin […]
Two separate official sources describe prednisone side effects. The prescribing label records what was observed in clinical trials, where the drug was compared against a control group. The FDA’s adverse event database records what patients and clinicians have reported since approval, which is a much larger but far less controlled picture. Both appear below, and they answer different questions.
| Active ingredient | Prednisone |
| Brand names on this label | Prednisone delayed release |
| How it is given | oral |
| Boxed warning | See the label for this product |
| Recall records | 4 |
| Label last updated | 2025-12-15 |
The FDA has revised this label recently. The label’s own record of recent major changes reads: Warnings and Precautions, Immunosuppressionand Increased Risk of Infection ( 5.2 ) 03/2024 A recent revision usually means new safety information was added.
Warnings on the Prednisone Label
The FDA prescribing label carries the full set of warnings and precautions for Prednisone. Because a medicine can have several approved labels from different manufacturers and formulations, the safest way to see the warnings that apply to the exact product you have is to read the label for that product.
You can look up any product’s current FDA label on DailyMed, the National Library of Medicine’s official label database, using the name on your bottle or box.
Warnings Beyond the Common Prednisone Side Effects
The label’s warnings and precautions section describes risks the FDA requires prescribers to weigh. For Prednisone it covers: ypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and hyperglycemia: Monitor patients for these conditions with chronic use. Taper doses gradually for withdrawal after chronic use. ( 5.1 ) Immunosuppression and Increased Risk of Infection: Increased susceptibility to new infection and increased risk of exacerbation, dissemination, or reactivation of latent infection.
Signs and symptoms of infection may be masked. ( 5.2 ) Elevated blood pressure, salt and water retention, and hypokalemia: Monitor blood pressure and sodium, potassium serum levels ( 5.3 ) GI perforation: increased risk in patients with certain GI disorders.
Signs and symptoms may be masked. ( 5.4 ) Behavioral and mood disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis. Existing conditions may be aggravated. ( 5.5 ) Decreases in bone density: Monitor bone density in patients receiving long term corticosteroid therapy. ( 5.6 ) Ophthalmic effects: May include cataracts, infections, and glaucoma. […]
These are the risks the FDA has judged significant enough to state formally, and they sit apart from the routine prednisone side effects most people ask about. They apply to different patients to very different degrees, which is why the same medicine can be routine for one person and unsuitable for another.
Prednisone Side Effects Listed on the FDA Label
The label’s adverse reactions section records what was observed in clinical trials: ommon 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: 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 hypopigmentation, impaired wound healing, increased sweating, petechiae and ecchymoses, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning […]
Trial data is the most reliable source for how common prednisone side effects are, because the people taking the drug were compared against people who were not. A symptom that appeared just as often in the control group is not caused by the medicine.
Reported Prednisone Side Effects in the FDA Database
Reported prednisone side effects — and what these numbers do not mean
The FDA’s adverse event database holds 491,135 reports mentioning Prednisone, of which 385,671 were classified as serious.
Read those numbers carefully. An adverse event report means somebody told the FDA that something happened to a person taking this medicine. It is not a finding that the medicine caused it. Reports are submitted voluntarily by patients, families, doctors and manufacturers; nobody verifies them; and the same event can be reported more than once.
Report volume tracks how many people take a drug, how new it is, and how much attention it is getting. A widely prescribed medicine will always show more reports than a rarely used one, and reports rise sharply when a drug is in the news or in litigation. A large number here does not mean a drug is dangerous, and a small number does not mean it is safe.
| Most frequently reported | Reports |
|---|---|
| Fatigue | 40,186 |
| Pain | 37,389 |
| Dyspnoea | 34,346 |
| Arthralgia | 32,789 |
| Condition Aggravated | 28,168 |
| Nausea | 28,098 |
| Diarrhoea | 27,963 |
| Headache | 26,177 |
Source: FDA Adverse Event Reporting System (FAERS), retrieved July 2026. Non-clinical reporting categories such as “off label use” have been excluded from the list above because they describe how a drug was used, not something that happened to a patient.
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Who the Label Says Should Take Extra Care
Contraindications. The label states that Prednisone should not be used in certain situations: rednisone delayed-release tablets are contraindicated in patients who have known hypersensitivity to prednisone or to any of the excipients. Rare instances of anaphylaxis have occurred in patients receiving corticosteroid therapy [ see Adverse Reactions (6) ]. Known hypersensitivity to prednisone or any excipients in the formulation ( 4 , 6 )
Interactions with other medicines. nticoagulant agents: May enhance or diminish anticoagulant effects. ( 7.4 ) Antidiabetic agents: May increase blood glucose concentrations. Dose adjustments of antidiabetic agents may be required. ( 7.5 ) CYP 3A4 inducers and inhibitors: May, respectively, increase or decrease clearance of corticosteroids, necessitating dose adjustment. ( 7.7 , 7.8 ) Cyclosporine: Increase in activity of both, cyclosporine and corticosteroid when administered concurrently. […]
Older adults. 8.5 Geriatric Use No overall differences in safety or effectiveness were observed between elderly subjects and younger subjects, and other reported clinical experience with prednisone has not identified differences in responses between the elderly and younger patients. However, the incidence of corticosteroid-induced side effects may be increased in geriatric patients and are dose-related. […]
Your pharmacist can check your full medicine list against this in a couple of minutes, including anything bought over the counter, and that check is free.
Prednisone Recall History
The FDA enforcement database records 4 recall entries involving Prednisone products (2 Class II, 2 Class III). A recall almost always concerns specific manufactured batches rather than the medicine itself, and different manufacturers of the same generic drug have separate recall records.
The FDA classifies recalls by how serious the potential consequence is. Class I means a reasonable probability of serious harm or death; Class II means temporary or reversible harm is possible; Class III means the product breaks a regulation but is unlikely to cause harm.
| Date | Class | Recalling firm | Reason |
|---|---|---|---|
| 2022-08-17 | Class II | Strides Pharma Inc. | Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets |
| 2020-03-25 | Class III | Par Pharmaceutical Inc. | Labeling: Incorrect or Missing Exp Date – An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg |
| 2016-10-12 | Class II | West-Ward Pharmaceutical | Failed Tablet/Capsule Specifications: Discovery of an underweight tablet. |
| 2013-08-21 | Class III | Boehringer Ingelheim Roxane Inc | Labeling: Missing Label; missing label on blister card |
If a batch you have was recalled, the pharmacy that dispensed it is the fastest way to find out and to get a replacement. Do not simply stop taking a prescribed medicine because a recall notice exists — the recall may not affect your batch, and stopping can carry its own risk.
Is Prednisone the Subject of Litigation?
We are not tracking consolidated federal litigation over Prednisone. It is a widely prescribed medicine, and the information on this page is drawn from the FDA label and public safety data rather than from any legal claim.
If You Are Worried About Prednisone Side Effects
Concern about prednisone side effects is a good reason to have a conversation, and not a reason to act alone. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first. Stopping some medicines abruptly carries risks of its own, and your prescriber can tell you whether that applies to yours.
Write down what you have noticed and when it started before the appointment. Not everything that happens while taking a medicine is one of its prednisone side effects, and a specific account — what changed, when, and how often — is what lets a clinician tell the difference.
You can also report a side effect directly to the FDA through MedWatch. Reports from patients are part of how safety signals are detected, and filing one takes a few minutes.
Frequently Asked Questions
What are the most commonly reported prednisone side effects?
In FDA reports, the most frequently mentioned are fatigue, pain, dyspnoea. The label’s own adverse reactions section, drawn from clinical trials, is the better guide to how common a side effect actually is, because reports to the FDA are not collected in a way that supports rates.
Has Prednisone been recalled?
There are 4 recall records for Prednisone products, the most recent dated 2022-08-17. Recalls generally affect specific manufactured batches rather than the medicine as a whole. Your pharmacy can tell you whether a batch you have was affected.
Does Prednisone have a boxed warning?
A medicine can have several approved labels from different manufacturers, so the reliable answer for the exact product you have is on that product’s label. You can look it up on DailyMed using the name on your packaging.
Do the FDA report numbers tell me how common these prednisone side effects are?
No. Reports are unverified, anyone can file one, and the total mostly reflects how many people take the medicine and how much attention it is getting. A high count is not evidence of danger, and a low one is not evidence of safety. Clinical trial data on the label is the source that supports rates.
Where can I check prednisone side effects for the exact product I have?
DailyMed holds the current FDA label for every marketed product, searchable by the name on your packaging. Different manufacturers and formulations of the same medicine can have slightly different labels, so checking the one you actually have is worth the two minutes.
Official Sources
- DailyMed (National Library of Medicine) — the current FDA prescribing label for every product
- FDA Adverse Event Reporting System dashboard — the public report data summarised above
- FDA recalls and safety alerts — current recall notices
- FDA MedWatch — how to report a side effect yourself
Related Guides
Medical and legal disclaimer. This page summarises publicly available FDA data about Prednisone and is general information, not medical advice, and not legal advice. It is not a substitute for the judgement of a clinician who knows your medical history. Nothing here states that Prednisone caused any illness or injury in any individual. Adverse event reports are unverified and do not establish causation.
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FDA labels are revised regularly; confirm current information on DailyMed or with your pharmacist. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first.