Reported Reactions

Reactions

MedDRA preferred term

Rash papular: adverse event reports recording this term

22,096 reports to FDA record it, 2004–2026; 0.1% of the database.

22,096
reports recording the term
0.1% of all reports
984
reports, 12 months to June 2026
850 in the 12 months before
39.7%
marked serious by the reporter
57.4% across all reports
1.3%
record death among outcomes, as reported
9.1% across all reports

22,096 reports in FDA's adverse event database record the MedDRA term "Rash papular": 0.1% of all reports received between January 2004 and June 2026. Coders pick the term that best matches the reporter's description.

984 reports recorded it in the 12 months to June 2026, up 16% from 850 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 39.7% are marked serious, 1.3% include death among the outcomes and 16% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Humira, Enbrel and Dupixent. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

0105209Jul 2021: 76Aug 2021: 75Sep 2021: 67Oct 2021: 57Nov 2021: 48Dec 2021: 852022Jan 2022: 64Feb 2022: 68Mar 2022: 65Apr 2022: 80May 2022: 82Jun 2022: 65Jul 2022: 78Aug 2022: 79Sep 2022: 100Oct 2022: 99Nov 2022: 144Dec 2022: 1142023Jan 2023: 125Feb 2023: 79Mar 2023: 68Apr 2023: 209May 2023: 168Jun 2023: 89Jul 2023: 74Aug 2023: 73Sep 2023: 73Oct 2023: 68Nov 2023: 66Dec 2023: 812024Jan 2024: 75Feb 2024: 97Mar 2024: 82Apr 2024: 87May 2024: 89Jun 2024: 66Jul 2024: 76Aug 2024: 69Sep 2024: 69Oct 2024: 85Nov 2024: 63Dec 2024: 512025Jan 2025: 51Feb 2025: 63Mar 2025: 80Apr 2025: 71May 2025: 79Jun 2025: 93Jul 2025: 105Aug 2025: 92Sep 2025: 83Oct 2025: 94Nov 2025: 68Dec 2025: 882026Jan 2026: 74Feb 2026: 62Mar 2026: 68Apr 2026: 74May 2026: 104Jun 2026: 72

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Drugs listed as suspect products in these reports

DrugClassReports with this termShare of the drug's own reports
Humira—2,1550.3%
EnbrelTumor necrosis factor blocker9620.2%
DupixentInterleukin-4 receptor alpha antagonist7320.2%
Proactiv Solution Daily Protection Plus Sunscreen Spf 30—4514.2%
NaproxenNonsteroidal anti-inflammatory drug3371.4%
LansoprazoleProton pump inhibitor3191.2%
PegasysInterferon alpha3020.7%
HydrochlorothiazideThiazide diuretic2941.3%
DapagliflozinSodium-Glucose cotransporter 2 inhibitor2881.3%
SimvastatinHMG-CoA reductase inhibitor2870.8%
ApixabanFactor Xa inhibitor2850.6%
DigoxinCardiac glycoside2851.8%
FelodipineDihydropyridine calcium channel blocker27813.6%
Isosorbide mononitrateNitrate vasodilator2748.6%
LinagliptinDipeptidyl peptidase 4 inhibitor2699.7%
RibavirinNucleoside analog antiviral2650.5%
Isosorbide dinitrateNitrate vasodilator26019.7%
Imdur—25630%
Astrazeneca Covid-19 Vaccine—24225.4%
EsomeprazoleProton pump inhibitor2381.4%
Levothyroxine sodiuml-Thyroxine2361.6%
Incivek—2281.6%
SkyriziInterleukin-23 antagonist2250.3%
RevlimidThalidomide analog2220.1%
Bisoprolol fumaratebeta-Adrenergic blocker2192.6%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0.1% across the whole database. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

By pharmacologic class

ClassReports with this termShare of class reportsMedian drug in class
Tumor necrosis factor blocker1,2730.1%0%
Nonsteroidal anti-inflammatory drug8630.2%0%
Proton pump inhibitor8290.2%0%
Interleukin-4 receptor alpha antagonist7840.2%0.3%
Kinase inhibitor7020.1%0%
Nitrate vasodilator5344.5%0%
Anti-epileptic agent4700.2%0%
HMG-CoA reductase inhibitor4490.2%0%
Angiotensin 2 receptor blocker4150.2%0%
Corticosteroid4090.1%0%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20.6%126
2 to 112.1%453
12 to 176%1,324
18 to 4420.8%4,598
45 to 6423.4%5,161
65 to 749.9%2,198
75 and over6.8%1,507
Age not given30.5%6,729

Patient sex

Female63.4%14,016
Male29.4%6,486
Not given7.2%1,594

Grey bar: all 20,646,523 reports in the database. 73.2% of these reports give the United States as the country.

Questions about "Rash papular"

What does "Rash papular" mean in an adverse event report?

It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record rash papular?

22,096 reports through June 2026 (0.1% of all reports), 984 of them in the latest 12 months.

Which drugs appear most often in these reports?

Humira (2,155), Enbrel (962), Dupixent (732), Proactiv Solution Daily Protection Plus Sunscreen Spf 30 (451) and Naproxen (337). Drugs with many reports overall lead almost every term's list. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.