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 →
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.
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.
This is a plain-language summary of hydrocortisone's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of hydrocortisone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
Apply the medicine as soon as you remember. Do not apply extra cream to make up for a missed dose.
This is a plain-language summary of hydrocortisone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature between 68-77°F (20-25°C).
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
- Feeling tired
Feeling tired
8,852 reports
- Pain
Pain
7,126 reports
- Condition got worse
Condition got worse
6,709 reports
- Feeling sick to your stomach
Feeling sick to your stomach
6,687 reports
- Joint pain
Joint pain
6,666 reports
- Headache
Headache
6,226 reports
- Skin rash
Skin rash
6,104 reports
- Diarrhea
Diarrhea
6,062 reports
- Difficulty breathing
Difficulty breathing
5,833 reports
- Fever
Fever
5,252 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.
Reports over time
Adverse-event reports filed for hydrocortisone each year to the FDA Adverse Event Reporting System (FAERS).
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.
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
Age Distribution
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
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
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,...
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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
What should I do if my skin gets more irritated after using the cream?
Can I use this cream on my face?
How long should I use this cream?
Can I use a bandage over the cream?
What should I do if I accidentally swallow some of the cream?
Can children under 2 use this?
Can I buy this over the counter?
Can I use this cream for a fungal infection?
What are the common side effects of hydrocortisone?
Does hydrocortisone interact with other medications?
What drug class is hydrocortisone?
Is there a generic version of hydrocortisone?
Is hydrocortisone safe during pregnancy?
Has hydrocortisone been recalled?
Is hydrocortisone currently in shortage?
Active Recalls
Subpotent Drug
Island Kinetics, Inc. d.b.a. CoValence Laboratories
Subpotent Drug
Island Kinetics, Inc. d.b.a. CoValence Laboratories
Subpotent Drug
Island Kinetics, Inc. d.b.a. CoValence Laboratories
CGMP Deviations
KENIL HEALTHCARE PRIVATE LIMITED
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Medication Guides
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Narrow Therapeutic Index Drugs
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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 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
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages