Iressagefitinib
According to the FDA label: IRESSA is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies (14) ] .
8,949 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Iressa in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Malignant Neoplasm Progression 1,817 reports
A report that a cancer grew or spread. This describes the course of the illness, not necessarily an effect of the drug. Malignant neoplasm is the medical term for a cancerous growth.
Full definition in the glossary →Drug Resistance 1,249 reports
A situation where a medication becomes less effective against the condition it was meant to treat, such as an infection no longer responding to an antibiotic.
Full definition in the glossary →Diarrhoea 900 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Death 755 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Rash 639 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Disease Progression 458 reports
A report that the underlying condition being treated got worse over time. This describes the course of the illness, not necessarily an effect of the drug.
Full definition in the glossary →Interstitial Lung Disease 420 reports
A group of conditions that cause scarring or inflammation of the lung tissue, which can make breathing harder.
Full definition in the glossary →Nausea 378 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →- Metastases To Central Nervous System 376 reports
Dyspnoea 331 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Vomiting 325 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Drug Ineffective 298 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Pyrexia 270 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Pneumonia 269 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →- Acquired Gene Mutation 258 reports
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 4,805 |
| Male | 3,241 |
| Unknown | 13 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 35 |
| 18-34 | 58 |
| 35-49 | 432 |
| 50-64 | 1,749 |
| 65-74 | 1,594 |
| 75+ | 1,322 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Iressa. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 5,165 |
| Hospitalization | 2,570 |
| Death | 1,949 |
| Non-Serious | 468 |
| Life-Threatening | 461 |
| Disability | 270 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Iressa. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 801 |
| 2005 | 514 |
| 2006 | 1,182 |
| 2007 | 235 |
| 2008 | 214 |
| 2009 | 194 |
| 2010 | 240 |
| 2011 | 333 |
| 2012 | 87 |
| 2013 | 37 |
| 2014 | 48 |
| 2015 | 239 |
| 2016 | 503 |
| 2017 | 557 |
| 2018 | 614 |
| 2019 | 990 |
| 2020 | 713 |
| 2021 | 430 |
| 2022 | 278 |
| 2023 | 283 |
| 2024 | 249 |
| 2025 | 181 |
| 2026 (partial) | 27 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Iressa
In FDA adverse event reports that mention Iressa, these medications appeared most often in the same report.
- Osimertinib (974 reports)
- Carboplatin (608 reports)
- Pemetrexed Disodium (494 reports)
- Pemetrexed (407 reports)
- Cisplatin (359 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026