Protopic adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Protopic
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Product name as reported

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 1,901 adverse event reports that name Protopic. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 2,172 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 54 reports in the 12 months to June 2026 and 103 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 54 (under 0.1%) name Protopic. Reports for patients aged 18 to 44 were 23.1% of the reports that name Protopic and 12.3% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Protopic is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 13 reports that name Protopic.
In January to March 2026, FDA received 21.
In April to June 2025, FDA received 22.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 210 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for all 1,901 reports.

The site keeps a term for a year only if two or more reports of that year record it.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 210 terms.

Reaction terms in the reports that name Protopic, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,901 reports
Off label useused for a purpose or in a way not on the label	328	17.3%
Pruritusitching	174	9.2%
Drug ineffectivethe medicine did not work as expected	157	8.3%
Product use in unapproved indicationused for a purpose not on the label	125	6.6%
Erythemaskin redness	115	6%
Skin exfoliationpeeling skin	104	5.5%
Skin burning sensationburning skin	83	4.4%
Dermatitis atopic	82	4.3%
Insomniadifficulty sleeping	81	4.3%
Product use issuea problem in how the product was used	78	4.1%
Rashskin rash	76	4%
Burning sensationa burning feeling	74	3.9%
Condition aggravatedthe condition being treated got worse	66	3.5%
Application site pain	65	3.4%
Skin weeping	64	3.4%
Lymphadenopathyswollen lymph nodes	61	3.2%
Gastroenteritisstomach bug	60	3.2%
Cataractclouding of the eye lens	57	3%
Painpain, site not specified	56	2.9%
Topical steroid withdrawal reaction	56	2.9%
Fatiguetiredness	54	2.8%
Dyspepsiaindigestion	53	2.8%
Dysphagiadifficulty swallowing	53	2.8%
Eczema	49	2.6%
Steroid withdrawal syndrome	48	2.5%
Skin atrophy	42	2.2%
Pyrexiafever	39	2.1%
Hypersensitivityan allergic-type reaction	38	2%
Drug ineffective for unapproved indication	36	1.9%
Alopeciahair loss	35	1.8%
Psoriasispsoriasis, a skin condition	34	1.8%
Skin papilloma	34	1.8%
Dry skin	32	1.7%
Medication errora mistake in prescribing, dispensing or taking a medicine	29	1.5%
Neuralgia	29	1.5%
Application site pruritusitching where the product was applied	28	1.5%
Treatment failurethe treatment did not work	27	1.4%
Dyspnoeashortness of breath	26	1.4%
Pain of skin	26	1.4%
Anxiety	25	1.3%
Application site erythemaredness where the product was applied	24	1.3%
Pain in extremitypain in an arm or leg	24	1.3%
Squamous cell carcinoma	24	1.3%
Skin infection	23	1.2%
Eye irritation	22	1.2%
Peripheral swellingswelling of the arms or legs	22	1.2%
Feeling abnormalfeeling odd or not right	21	1.1%
Inappropriate schedule of product administrationthe product was taken at the wrong times	21	1.1%
Skin disorder	21	1.1%
Cellulitisa skin infection	20	1.1%

Download all 210 terms of Protopic (CSV)

The counts add to more than 1,901 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Protopic, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	20	19	1	5	11	2	0	10	1
2005	64	62	3	14	13	8	2	40	2
2006	95	87	1	13	28	7	3	58	8
2007	54	44	2	5	10	1	2	28	10
2008	69	56	8	7	17	2	1	37	13
2009	69	59	4	6	23	3	0	41	10
2010	61	60	3	4	21	4	0	38	1
2011	35	33	5	3	6	3	1	23	2
2012	48	43	1	4	16	3	0	30	5
2013	187	56	3	1	8	2	1	47	131
2014	187	76	3	4	7	4	0	68	111
2015	156	52	0	3	11	2	0	47	104
2016	58	30	0	5	11	5	0	25	28
2017	90	48	0	0	22	3	0	26	42
2018	86	60	0	4	13	4	1	44	26
2019	63	44	0	3	14	5	0	30	19
2020	75	66	1	2	9	21	0	50	9
2021	98	92	1	4	15	32	0	75	6
2022	55	45	0	0	6	12	0	38	10
2023	86	42	0	1	7	12	0	39	44
2024	126	95	1	2	2	11	0	85	31
2025	78	71	1	13	23	19	1	63	7
2026	41	38	0	1	1	11	0	35	3

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Protopic, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Protopic, by the year in which FDA received them
Year	Reports
2004	19
2005	64
2006	90
2007	52
2008	67
2009	70
2010	68
2011	38
2012	52
2013	196
2014	179
2015	152
2016	59
2017	96
2018	95
2019	68
2020	74
2021	100
2022	47
2023	86
2024	118
2025	75
2026	34

Reports that name Protopic, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Protopic
Age	Reports	Share
Under 2	38	2%
2 to 11	157	8.3%
12 to 17	80	4.2%
18 to 44	439	23.1%
45 to 64	261	13.7%
65 to 74	113	5.9%
75 and over	65	3.4%
Age not given	748	39.3%

Sex of the patient in the reports that name Protopic
Sex	Reports	Share
Female	1,062	55.9%
Male	700	36.8%
Unknown or not given	139	7.3%

Type of reporter in the reports that name Protopic
Reporter	Reports	Share
Physician	515	27.1%
Pharmacist	88	4.6%
Other health professional	276	14.5%
Lawyer	30	1.6%
Consumer or non-health professional	938	49.3%
Not given	54	2.8%

Age and sex are as the report gives them. The reporter is the primary source in the report. 44.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Protopic record
Indication as recorded (MedDRA)	Reports	Share
Dermatitis atopic	356	18.7%
Eczema	311	16.4%
Vitiligo	115	6%
Psoriasis	67	3.5%
Lichen planus	23	1.2%
Dermatitis	19	1%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,901 reports.

Drugs in the same reports

Other drugs that the reports of Protopic name, in any role, in order of name
Drug	Reports that name the two
Advair Hfa	46
Aspirin	43
Clobetasol	108
Eumovate	50
Hydrocortisone	87
Methotrexate	62
Prednisolone	76
Prednisone	120
Pulmicort Turbuhaler	55
Theophylline	54

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for ProtopicThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Protopic: adverse event reports that FDA received. https://reportedreactions.com/drug/protopic/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Protopic as a suspect or interacting product. The 2,172 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Protopic was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Protopic?

No. It is a count of what people reported to FDA: 1,901 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (49.3%), physician (27.1%) and other health professional (14.5%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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