Reported Reactions

Drugs › Corticosteroid

Brand name · Budesonide

Tarpeyo: adverse event reports filed with FDA

5,365 reports list it as a suspect or interacting product, 2022–2026. Class: Corticosteroid.

5,365
reports as suspect product
0% of all reports · about 1,239 a year
1,383
reports, 12 months to June 2026
894 in the 12 months before
19.3%
marked serious by the reporter
77.7% across the class
1.1%
record death among outcomes, as reported
59 reports · not verified by FDA

Between March 2022 and June 2026, 5,365 adverse event reports received by FDA list the brand name Tarpeyo (budesonide) as a suspect or interacting product. Reports that mention it only as a concomitant medication (192) are left out of every figure here.

In the 12 months to June 2026, 1,383 reports listed it, up 55% from 894 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 1,239 reports a year and 0% of the 20,646,523 reports in the database, and 0.7% of the reports for the corticosteroid class. How many people take it is not in the data, so a count is not a rate of occurrence.

The reactions recorded most often are product dose omission issue (11%), weight increased (10.4%) and fatigue (10.4%). A report can list several reactions, so shares add to more than 100%; 600 different terms appear across these reports. Product dose omission issue is recorded in 11% of these reports, a larger share than in the median corticosteroid drug (0.6%).

19.3% of the reports are marked serious by the reporter (77.7% across the class); 1.1% record death among the outcomes and 8.7% record hospitalisation, as reported. 91.3% of the reports came from consumers, and the largest patient age group is 45 to 64 (34.4%). 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

0448896Jul 2021: 0Aug 2021: 0Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 19Apr 2022: 28May 2022: 31Jun 2022: 54Jul 2022: 83Aug 2022: 52Sep 2022: 75Oct 2022: 47Nov 2022: 105Dec 2022: 872023Jan 2023: 109Feb 2023: 88Mar 2023: 127Apr 2023: 94May 2023: 96Jun 2023: 76Jul 2023: 95Aug 2023: 144Sep 2023: 184Oct 2023: 106Nov 2023: 133Dec 2023: 1582024Jan 2024: 136Feb 2024: 174Mar 2024: 186Apr 2024: 151May 2024: 191Jun 2024: 259Jul 2024: 33Aug 2024: 59Sep 2024: 59Oct 2024: 62Nov 2024: 79Dec 2024: 622025Jan 2025: 67Feb 2025: 86Mar 2025: 79Apr 2025: 104May 2025: 86Jun 2025: 118Jul 2025: 100Aug 2025: 80Sep 2025: 99Oct 2025: 58Nov 2025: 42Dec 2025: 242026Jan 2026: 18Feb 2026: 896Mar 2026: 20Apr 2026: 10May 2026: 19Jun 2026: 17

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

07261,4512022: 58120222023: 1,41020232024: 1,45120242025: 94320252026: 9802026

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Tarpeyo reports recording the termmedian drug in corticosteroid

  1. Product dose omission issuea dose was missed11%590
  2. Weight increasedweight gain10.4%559
  3. Fatiguetiredness10.4%558
  4. Peripheral swellingswelling of the arms or legs9.3%501
  5. Blood pressure increaseda raised blood pressure reading8.7%468
  6. Muscle spasmsmuscle cramps8%428
  7. Headachehead pain7.3%391
  8. Off label useused for a purpose or in a way not on the label6.9%372
  9. Hypertensionhigh blood pressure6.4%345
  10. Swelling facea swollen face5.7%305
  11. Acneacne5.3%287
  12. Dizzinesslight-headedness or unsteadiness5%270
  13. Nauseafeeling sick5%267
  14. Drug ineffectivethe medicine did not work as expected4.6%248
  15. Joint swellinga swollen joint4.1%221
  16. Insomniadifficulty sleeping3.7%197
  17. Vomitingbeing sick3.4%185
  18. Diarrhoealoose or frequent stools3.4%180
  19. Contusiona bruise3.2%173
  20. Swellingswelling3.2%170
  21. Abdominal discomfortstomach discomfort3.1%165
  22. Abdominal distensiona bloated abdomen3.1%164
  23. Astheniaweakness or lack of energy3%163
  24. Rashskin rash2.9%155
  25. Cushingoid2.9%153
  26. Blood glucose increasedraised blood sugar reading2.7%147
  27. Dyspnoeashortness of breath2.7%144

Top 30 of 600 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 74 drugs in the corticosteroid class; it describes the reports, not the patients. 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."

Outcomes recorded

Death1.1%59
Life-threatening0.2%12
Hospitalisation (initial or prolonged)8.7%467
Disability0.1%3
Congenital anomaly0%0
Other serious12.3%662
Not serious80.7%4,331

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 808,789 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Patient age

Under 20%1
2 to 110%2
12 to 170.4%20
18 to 4432.1%1,720
45 to 6434.4%1,845
65 to 7410.6%570
75 and over4.2%223
Age not given18.3%984

Patient sex

Female40.7%2,183
Male52%2,792
Not given7.3%390

Who reported

Physician4.9%261
Pharmacist0.1%8
Other health professional3.6%194
Lawyer0%0
Consumer or non-health professional91.3%4,899
Not given0.1%3

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 100% of reports give the United States as the country of the event or reporter.

Reason for use recorded

Indication as recorded (MedDRA)ReportsShare
Iga nephropathy4,28579.9%
Haematuria70613.2%
Chronic kidney disease541%
Proteinuria380.7%
Nephritic syndrome300.6%
Selective iga immunodeficiency130.2%

The indication field is filled in by the reporter and is often blank; shares are of all 5,365 reports.

In context

MeasureTarpeyoCorticosteroidAll reports
Reports as suspect product5,365808,78920,646,523
Share of that pool—0.7%0%
Reports, latest 12 months1,383—1,332,454
Marked serious19.3%77.7%57.4%
Death recorded among outcomes, per 1,000 reports1114691
Hospitalisation recorded, per 1,000 reports87336213
Consumer-filed share91.3%29.1%45.8%
Top term, share of reportsProduct dose omission issue 11%median 0.6%1.4%

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."

Other drugs in the corticosteroid class

DrugName typeReportsLatest 12 monthsMarked serious
Prednisonegeneric183,86715,61491.4%
Dexamethasonegeneric129,6779,21695.1%
Prednisolonegeneric87,8066,62497.6%
Methylprednisolonegeneric49,5374,43095.2%
Symbicortbrand39,1191,17750.6%
Breo Elliptabrand22,22062831.7%
Hydrocortisonegeneric21,2632,38689.5%
Advair Diskusbrand20,51812029%
Advair Hfabrand19,62258954.9%
Budesonidegeneric14,7141,08382.2%
Desoximetasonegeneric12,2091,52599.2%
Floventbrand10,77217142.1%
Methylprednisolone sodium succinategeneric10,7721,63097.8%
Solu-medrolgeneric10,28843288.8%
Ciprobrand9,79110857.3%

Ordered by report count for navigation only. 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." A brand and its generic are separate rows because reporters name them separately.

Questions about Tarpeyo reports

How many adverse event reports has FDA received for Tarpeyo?

5,365 reports list Tarpeyo as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 1,383 of them arrived in the latest 12 months. Another 192 list it only as a concomitant medication.

What reactions are recorded in Tarpeyo reports?

product dose omission issue (11%), weight increased (10.4%), fatigue (10.4%), peripheral swelling (9.3%) and blood pressure increased (8.7%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Tarpeyo was responsible.

How serious are the reports?

19.3% are marked serious by the reporter. Among the outcomes recorded, 1.1% of reports include death and 8.7% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.

Who files these reports?

consumer or non-health professional (91.3%), physician (4.9%) and other health professional (3.6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.

Are reports for Tarpeyo rising?

1,383 reports in the 12 months to June 2026, up 55% from 894 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.

Do these reports show that Tarpeyo was responsible for these reactions?

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." The reaction may relate to the condition being treated, to other medicines, or to something else.

Is this a list of the side effects of Tarpeyo?

No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.

How do I report an adverse event?

Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.

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. A report counts here when it lists Tarpeyo as a suspect or interacting product; reports listing it only as a concomitant medication (192) are excluded. 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.