Sold as Cortef, Cortifoam, Ala-Cort, Ala-Scalp, Texacort and 38 more.
Class: Corticosteroids for local oral treatment; Corticosteroids acting locally; Corticosteroids; Corticosteroids, weak (group I); Glucocorticoids; Corticosteroids, plain; Corticosteroids.
First FDA approval 12/21/1951: 75 years on the US market.
This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
B
Score breakdown (84/100)
Safety ×35%
A
Evidence ×25%
D
Regulatory ×15%
B
Money & lawsuits ×15%
A
Options ×10%
A
Safety: 88
6,325 FDA reports naming it as the suspect drug per million Medicare fills, 2.3x the median drug on this site (-7)
Death appears in 1.6x the FAERS average share of reports (within the margin this measure deserves)
Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)
Evidence: 60
460 randomized trials and 37 systematic reviews/meta-analyses indexed in PubMed
On the WHO Model List of Essential Medicines (shown for context; no score effect)
No Cochrane review found (-5)
Only 25% of completed registered trials posted results (-15)
Regulatory history: 86
Recalls since 2016: 0 Class I, 6 Class II, 0 Class III across 87 generic makers (-6)
9 label changes approved since 2021: the safety story is still moving (-8)
Money & lawsuits: 100
Pharma paid doctors $79,864 tied to this drug last year: negligible
Not named in any pending federal MDL
Options: 100
Generic versions approved (87 applications)
29 same-class alternatives exist
Independent reviews and post-approval warnings
WHO Essential Medicine
Listed on the WHO Model List of Essential Medicines: a global expert panel judged it among the medicines a health system should always have, on evidence of value, not marketing.
What the FDA label says
Approved uses
INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Contraindications
CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Warnings and precautions
Not available.
Adverse reactions (label)
ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.
Source: FDA SPL label for Hydrocortisone (Preferred Pharmaceuticals Inc.), effective 20260511.
Full label on DailyMed.
Side-effect reports sent to the FDA
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
79,088reports that mention this drug
78,880of those blame this drug, not another one the person was taking
82%of reports describe a serious outcome, such as a hospital stay (average for all drugs: 57%)
14.7%of reports include a death, from any cause (average for all drugs: 9.1%)
6,325 reports blaming this drug for every million Medicare prescriptions filled, which is 2.3× the typical drug on this site. (19,001 reports in 2024–2026, against 3,004,258 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
Recalls and regulatory record
6recall actions on file
22 / 87brand / generic applications
9label changes since 2021
NoREMS program
Date
Class
Firm
Reason
10/2026
Class II
Zydus Pharmaceuticals (USA) Inc
Failed Impurities/Degradation Specifications.
04/2025
Class II
KENIL HEALTHCARE PRIVATE LIMITED
CGMP Deviations
04/2022
Class II
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
03/2021
Class II
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
07/2019
Class II
US Pharmaceuticals Inc.
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
05/2018
Class II
Perrigo New York
Failed Stability Specifications
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Evidence base
460randomized trials (PubMed)
37systematic reviews
1,585registered trials
25%of completed trials posted results
9%terminated or withdrawn
15%industry-funded
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
Money and lawsuits
In 2024, drug companies reported $79,864 in payments to US physicians and hospitals tied to this drug across 124 transactions (Alkindi $79,864).
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
Who takes it and what it costs
1,581,642Medicare Part D patients (2024)
3,004,258prescriptions filled
$20average cost per fill
$59Mtotal Medicare spend
Product
Fills
$/fill
Hydrocortisone
2,634,143
$17
Procto-Med HC
257,304
$16
Proctozone-HC
53,297
$17
Hydrocortisone Valerate
24,734
$55
Hydrocortisone Butyrate
16,202
$350
Proctosol-HC
13,760
$22
Cortef
2,648
$231
Cortifoam
821
$618
Same-class alternatives
1 drug in the same class grades a letter or more higher than hydrocortisone on this site. Worth asking whether one of them would do the same job for you.
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.
Questions to ask your prescriber
The most-reported problems in FDA's adverse event data are fatigue, condition aggravated. How would we recognize and handle those?
Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?
Why this one over alclometasone, beclomethasone, betamethasone? What would make you pick one of those instead?
What result are we expecting, by when, and what is the plan if it does not happen?
If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)