Daliresp: adverse event reports filed with FDA

2,443

reports as suspect product

0% of all reports · about 151 a year

14

reports, 12 months to June 2026

53 in the 12 months before

58.4%

marked serious by the reporter

23% across the class

23.8%

record death among outcomes, as reported

582 reports · not verified by FDA

Reports by month, five years

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

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Daliresp reports recording the termmedian drug in phosphodiesterase 4 inhibitor

1. Deaththe patient died; cause not stated by this term21.6%527
2. Diarrhoealoose or frequent stools14.2%347
3. Dyspnoeashortness of breath12.4%302
4. Weight decreasedweight loss11.7%285
5. Nauseafeeling sick10.7%261
6. Insomniadifficulty sleeping9.3%228
7. Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease8.7%212
8. Decreased appetitereduced appetite7.2%177
9. Headachehead pain7.1%173
10. Dizzinesslight-headedness or unsteadiness6.6%161
11. Off label useused for a purpose or in a way not on the label5.9%143
12. Back painback pain5%123
13. Tremorshaking4.7%116
14. Malaisegeneral feeling of being unwell4.7%115
15. Anxietyanxiety4.4%108
16. Suicidal ideationthoughts of suicide3.6%88
17. Intentional product misusedeliberate use not as intended3.6%87
18. Drug dose omissiona dose was missed3.5%85
19. Pneumonialung infection3.3%81
20. Feeling abnormalfeeling odd or not right3.2%78
21. Coughcough3.2%77
22. Astheniaweakness or lack of energy2.7%66
23. Fatiguetiredness2.7%66
24. Depressionlow mood2.7%65
25. Influenza like illnessflu-like symptoms2.7%65
26. Drug ineffectivethe medicine did not work as expected2.5%61
27. Vomitingbeing sick2.2%54
28. Abdominal pain upperupper stomach pain1.9%47
29. Product use issuea problem in how the product was used1.9%46
30. Condition aggravatedthe condition being treated got worse1.8%45

Top 30 of 319 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 5 drugs in the phosphodiesterase 4 inhibitor 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

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 152,432 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 99.3% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 2,443 reports.

Drugs most often listed in the same reports

Other products listed in reports where Daliresp is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

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 phosphodiesterase 4 inhibitor class

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.

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 Daliresp as a suspect or interacting product; reports listing it only as a concomitant medication (1,846) 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.