Over-the-counter medication · Corticosteroid

hydrocortisone

Also sold as Cortef. This medicine can help with itching, skin irritation, inflammation, and rashes.

Data updated 2026-05-15

84,725
FDA reportsOften reported
5
InteractionsFew interactions
97% less
Generic vs brandHuge savings
In shortage
FDA status

What the data shows

hydrocortisone (Cortef) is an over-the-counter Corticosteroid, more reported than most tracked drugs (84,725 FDA reports), whose generic costs a fraction of the brand (about 97% less).

Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.

hydrocortisone (Cortef) is an over-the-counter Corticosteroid. This medicine can help with itching, skin irritation, inflammation, and rashes.

Hydrocortisone cream helps relieve itching and skin problems. It belongs to a class of drugs called corticosteroids.

Verify with FDA → · CMS NADAC pricing →

Drug Shortage Alert

hydrocortisone is currently listed as to be discontinued by the FDA. Affected manufacturer: Teva Pharmaceuticals USA, Inc..

View all drug shortages →

Drug Pricing (NADAC)

Brand Price

$1.62/unit

Generic Price

$0.05/unit

Generic Savings

97%

Generic Available

Yes (41 manufacturers)

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

View Alternatives → Compare with Another Drug → Full Side Effects Report →

What it does

This medicine can help with itching, skin irritation, inflammation, and rashes.

Common side effects

Rash, Itching

Key warnings

No specific warnings noted. Always follow your prescriber's instructions.

The sections below are summarized in plain English from hydrocortisone's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.

How It Works

Hydrocortisone reduces inflammation, itching, and redness. It works by reducing the activity of the immune system. This helps to relieve discomfort.

Side Effects (from patient reports)

Based on 84,725 FDA adverse event reports.

Most-reported reactions

Adverse reactions in FAERS for hydrocortisone, by number of reports

reports

What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.

Source FDA Adverse Event Reporting System (FAERS) As of 2025

Reports over time

Adverse-event reports filed for hydrocortisone each year to the FDA Adverse Event Reporting System (FAERS).

02,0004,0006,0008,00010,000 200120052008201120142017202020232025 7,345

Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.

Where hydrocortisone sits

hydrocortisone has more FDA adverse-event reports than 83% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.

fewest reports most reports

Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is hydrocortisone; the line is the median (50th percentile).

FDA Adverse Event Report Analysis

Detailed analysis of 84,725 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2001–2025.

Total Reports

84,725

Reports Mentioning Death

10,868

12.8% of reports — not proof of cause

Hospitalization Reports

34,415

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 45,401 (61%)
Male 29,484 (39%)

Age Distribution

0–17 8,045
18–44 15,347
45–64 17,968
65–74 10,187
75+ 7,174

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
3 FATIGUE 8,851
4 PAIN 7,127
5 CONDITION AGGRAVATED 6,709
6 NAUSEA 6,688
7 ARTHRALGIA 6,664
8 HEADACHE 6,225
9 RASH 6,105
10 DIARRHOEA 6,063
11 DYSPNOEA 5,831
12 PYREXIA 5,252
13 VOMITING 5,023
14 MALAISE 4,848
15 PRURITUS 4,772
16 INFUSION RELATED REACTION 4,174
17 WEIGHT INCREASED 4,162

Reactions in Death Reports

DEATH 1,881
GENERAL PHYSICAL HEALTH DETERIORATION 1,697
FATIGUE 1,673
VOMITING 1,551
CONDITION AGGRAVATED 1,525
RASH 1,510
PNEUMONIA 1,503
DIARRHOEA 1,496
HYPERTENSION 1,493
SYSTEMIC LUPUS ERYTHEMATOSUS 1,490

Reactions in Hospitalization Reports

FATIGUE 3,951
DIARRHOEA 3,457
DYSPNOEA 3,444
NAUSEA 3,431
PYREXIA 3,393
PAIN 3,325
VOMITING 3,233
ARTHRALGIA 3,066
HEADACHE 2,967
CONDITION AGGRAVATED 2,933

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

Known Drug Interactions

major theophylline

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,...

Mechanism: Hydrocortisone can interfere with how your body handles theophylline. This can result in theophylline levels becoming too high or too low to work properly.

minor colestipol

Bile acid binding resins may also interfere with the absorption of oral phosphate supplements and hydrocortisone.

Mechanism: Colestipol can bind to hydrocortisone in the digestive tract, which prevents the medicine from being absorbed into your body.

minor dexamethasone

In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.

Mechanism: Using two different steroid medications together increases the total amount of medicine in your system. This can put extra stress on your heart and increase the risk of heart failure.

minor meperidine

Intravenous hydrocortisone or prednisolone have been used to treat severe reactions, with the addition of intravenous chlorpromazine in those cases exhibiting hypertension and hyperpyrexia.

Mechanism: Hydrocortisone is a steroid used to treat life-threatening reactions that can occur when meperidine is used with certain other medications.

minor methylprednisolone

There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.

Mechanism: Using these two steroid medications together can increase the risk of heart failure and an enlarged heart. These medications can cause the body to hold onto fluid, which puts extra stress on the heart.

This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.

Common Questions

What should I do if my skin gets more irritated after using the cream?
Stop using the cream and talk to your doctor.
Can I use this cream on my face?
Ask your doctor before using this cream on your face.
How long should I use this cream?
Use this cream for as long as your doctor tells you to.
Can I use a bandage over the cream?
You can, but it is not necessary. Ask your doctor for specific instructions.
What should I do if I accidentally swallow some of the cream?
Call a doctor or poison control center right away.
Can children under 2 use this?
No, children under 2 should not use this. Ask a doctor for advice.
Can I buy this over the counter?
Yes, you can buy this over the counter.
Can I use this cream for a fungal infection?
No, this cream is not for fungal infections. Talk to your doctor.
What are the common side effects of hydrocortisone?
The registry lists Rash, Itching among the most-reported FAERS reaction terms for hydrocortisone. The compiled record contains 84,725 FDA adverse-event reports. These counts are not an individual symptom assessment.
Does hydrocortisone interact with other medications?
The registry has 5 documented interaction rows for hydrocortisone. Notable source-record pairings include theophylline, colestipol, dexamethasone. These rows are not a complete medication review.
What drug class is hydrocortisone?
hydrocortisone belongs to the Corticosteroid drug class. It is available over the counter (OTC). This medicine can help with itching, skin irritation, inflammation, and rashes.
Is there a generic version of hydrocortisone?
Yes, generic hydrocortisone is available from 41 manufacturers. The generic costs $0.05 per unit compared to $1.62 for the brand version, saving approximately 97%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.
What pregnancy or breastfeeding source fields are listed for hydrocortisone?
The FDA label for hydrocortisone contains product-specific pregnancy or breastfeeding language. PlainMeds does not apply that source text to an individual.
Has hydrocortisone been recalled?
There are 4 recalls associated with hydrocortisone products. Subpotent Drug. Check the recalls section below for full details and affected products.
Is hydrocortisone currently in shortage?
Yes, hydrocortisone is currently listed as to be discontinued by the FDA. Affected manufacturer: Teva Pharmaceuticals USA, Inc.. Visit the FDA Drug Shortages database for the latest updates.

Active Recalls

Class III March 18, 2026

Subpotent Drug

Island Kinetics, Inc. d.b.a. CoValence Laboratories

Class III March 18, 2026

Subpotent Drug

Island Kinetics, Inc. d.b.a. CoValence Laboratories

Class III March 18, 2026

Subpotent Drug

Island Kinetics, Inc. d.b.a. CoValence Laboratories

Class II April 24, 2025

CGMP Deviations

KENIL HEALTHCARE PRIVATE LIMITED

Related Medications in Corticosteroid

Other drugs grouped near hydrocortisone - same-class peers and common alternatives.

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apremilast

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azelaic acid

Finacea, Azelex

Azelaic acid gel is a topical medicine that helps treat rosacea.

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benzoyl peroxide

Benzac, PanOxyl

Benzoyl peroxide is a topical medicine that fights germs on your skin.

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betamethasone

Diprosone, Luxiq

Betamethasone dipropionate cream is a strong steroid medicine used on the skin.

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Compare hydrocortisone vs adapalene side-by-side →

Compare beyond drug class

Nationwide peers by FAERS volume & death-report share

Two PlainMeds-derived comparison paths for hydrocortisone: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.

Similar FAERS report volume

Nearest drugs by total FAERS reports. This record: 84,725.

4 peers

Similar death-report share

Nearest drugs by FAERS death-report share. This record: 12.83%.

4 peers

Medication Guides

Understanding Drug Interactions

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Generic vs Brand Name Drugs

FDA requirements, cost savings, and when the difference matters

Pain Relievers Compared

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Narrow Therapeutic Index Drugs

FDA bioequivalence and label-record context for narrow therapeutic index medicines

Common Drug Interactions

Dangerous medication combinations and how to protect yourself

What the FDA Data Shows for hydrocortisone

The FDA label for hydrocortisone (sold under brand names such as Cortef) classifies it as an over-the-counter product in the Corticosteroid class. This medicine can help with itching, skin irritation, inflammation, and rashes. Official labeling lists 2 commonly reported side effects, including Rash, Itching.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 84,725 voluntary reports. The database also lists 5 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 $0.05 versus $1.62 for the brand - a 97% generic savings.

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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.

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). Shortage status: FDA Drug Shortages Database.

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.

Last updated: September 17, 2024

PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.

Read our methodology - how this data is sourced, computed, and verified.

Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.

All federal data sources used on this page