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hydrocortisone

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Brand names: Cortef

Corticosteroid OTC

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

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 →

What it does

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

Common side effects

Rash, Itching

Key warnings

There are no boxed warnings for this medication.

How It Works

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

How to Take It

For skin irritation, adults and children 2 years and older can use it. Apply to the affected area 3 to 4 times per day. For anal or genital itching, clean the area with mild soap and water first. Gently dry the area before applying the cream 3 to 4 times per day.

Pregnancy & Breastfeeding

Tell your doctor if you are pregnant or breastfeeding before using this medicine. It is not known if hydrocortisone can harm an unborn baby or pass into breast milk.

Missed Dose

Apply the medicine as soon as you remember. Do not apply extra cream to make up for a missed dose.

Storage

Store at room temperature between 68-77°F (20-25°C).

Side Effects (from patient reports)

Based on 76,067 FDA adverse event reports.

Using the medicine for something it's not approved for
11,314
The medicine did not work
10,321
Feeling tired
8,852
Pain
7,126
Condition got worse
6,709
Feeling sick to your stomach
6,687
Joint pain
6,666
Headache
6,226
Skin rash
6,104
Diarrhea
6,062

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

Death-Related Reports

10,868

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
1 OFF LABEL USE 11,314
2 DRUG INEFFECTIVE 10,322
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

Reactions in Death Reports

OFF LABEL USE 2,152
DEATH 1,881
GENERAL PHYSICAL HEALTH DETERIORATION 1,697
DRUG INEFFECTIVE 1,691
FATIGUE 1,673
VOMITING 1,551
CONDITION AGGRAVATED 1,525
RASH 1,510
PNEUMONIA 1,503
DIARRHOEA 1,496

Reactions in Hospitalization Reports

OFF LABEL USE 4,739
DRUG INEFFECTIVE 4,043
FATIGUE 3,951
DIARRHOEA 3,457
DYSPNOEA 3,444
NAUSEA 3,431
PYREXIA 3,393
PAIN 3,325
VOMITING 3,233
ARTHRALGIA 3,066

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

Serious Warnings

There are no boxed warnings for this medication.

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

What to do: Your healthcare provider should check your blood levels of theophylline regularly. They may need to change your dose to keep the medicine at a safe and helpful level.

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.

What to do: Your doctor may suggest taking these medicines at different times to make sure the hydrocortisone works correctly.

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.

What to do: Talk to your doctor before taking these together, as they may need to monitor your heart health.

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.

What to do: This combination is typically managed by healthcare providers during a medical emergency.

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.

What to do: Your doctor should monitor your heart health closely and may need to adjust your medication doses.

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.
What strength is this cream?
This information is not available in the source data.
Can I use this cream for a fungal infection?
No, this cream is not for fungal infections. Talk to your doctor.
What are the inactive ingredients?
This information is not available in the source data.
What are the common side effects of hydrocortisone?
The most commonly reported side effects of hydrocortisone include Rash, Itching. Based on 76,067 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does hydrocortisone interact with other medications?
Yes, hydrocortisone has 5 known drug interactions. Notable interactions include theophylline, colestipol, dexamethasone. Always inform your doctor about all medications you are taking.
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.
Is hydrocortisone safe during pregnancy?
Tell your doctor if you are pregnant or breastfeeding before using this medicine. It is not known if hydrocortisone can harm an unborn baby or pass into breast milk. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has hydrocortisone been recalled?
There is 1 recall associated with hydrocortisone products. CGMP Deviations. 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 II April 24, 2025

CGMP Deviations

KENIL HEALTHCARE PRIVATE LIMITED

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Medication Guides

Related Health & Safety Data

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 76,067 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 1 recall record 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). 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. Always consult a healthcare professional before making medication decisions.

Last updated: September 17, 2024

All federal data sources used on this page