Iressa: adverse event reports filed with FDA

6,466

reports as suspect product

0% of all reports · about 287 a year

77

reports, 12 months to June 2026

47 in the 12 months before

94.1%

marked serious by the reporter

70.8% across the class

23%

record death among outcomes, as reported

1,487 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 Iressa reports recording the termmedian drug in kinase inhibitor

1. Malignant neoplasm progression18.5%1,199
2. Drug resistance11.8%760
3. Diarrhoealoose or frequent stools10.4%672
4. Deaththe patient died; cause not stated by this term9.2%595
5. Rashskin rash7%455
6. Interstitial lung diseasescarring or inflammation of lung tissue5.4%347
7. Disease progressionthe disease advanced4.4%283
8. Nauseafeeling sick4.1%262
9. Dyspnoeashortness of breath4%256
10. Metastases to central nervous system3.9%253
11. Vomitingbeing sick3.6%233
12. Pneumonialung infection3.4%222
13. Pyrexiafever3.4%222
14. Lung disordera lung problem, type not specified3.1%203
15. Hepatic function abnormal3.1%202
16. Drug ineffectivethe medicine did not work as expected3.1%200
17. Pleural effusionfluid around the lung2.9%185
18. Decreased appetitereduced appetite2.6%168
19. Dry skindry skin2.4%155
20. Astheniaweakness or lack of energy2.3%150
21. Liver disorder2.3%147
22. Coughcough2.3%146
23. Dehydrationdehydration2.1%138
24. Fatiguetiredness2.1%138
25. Pruritusitching2.1%137
26. Weight decreasedweight loss1.8%114
27. Metastases to bone1.7%111
28. Respiratory failurethe lungs could not supply enough oxygen1.7%111
29. Alanine aminotransferase increasedraised liver enzyme (ALT)1.5%98
30. Off label useused for a purpose or in a way not on the label1.5%98

Top 30 of 862 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 100 drugs in the kinase 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 849,161 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. 20.9% 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 6,466 reports.

Drugs most often listed in the same reports

Other products listed in reports where Iressa 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 kinase 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 Iressa as a suspect or interacting product; reports listing it only as a concomitant medication (258) 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.