Tykerblapatinib
According to the FDA label: TYKERB ® is indicated in combination with: capecitabine for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress human epidermal growth factor receptor 2 (HER2) and who have received prior therapy, including an anthracycline, a taxane, and trastuzumab. Limitations of Use : Patients should have disease progression on trastuzumab prior to initiation of treatment with TYKERB in combination with capecitabine.
15,404 adverse event reports submitted to the FDA (2005–2026)
Top Reported Adverse Events
The most frequently reported events in association with Tykerb 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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Diarrhoea 4,172 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 →Nausea 1,613 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Death 1,452 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 →Fatigue 1,304 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Vomiting 1,207 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Rash 1,061 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Disease Progression 999 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 →Palmar-Plantar Erythrodysaesthesia Syndrome 921 reports
A skin reaction on the palms and soles, sometimes called hand-foot syndrome, that can occur with some cancer treatments. It causes redness, swelling, and discomfort.
Full definition in the glossary →Asthenia 603 reports
Physical weakness or lack of strength.
Full definition in the glossary →Drug Ineffective 561 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 →Dyspnoea 561 reports
Shortness of breath or difficulty breathing. Also spelled dyspnea in American English.
Full definition in the glossary → See all drugs reporting this event →Malignant Neoplasm Progression 559 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 →Pyrexia 527 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Dehydration 524 reports
A condition where the body does not have enough water.
Full definition in the glossary →Decreased Appetite 519 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 | 13,679 |
| Male | 673 |
| Unknown | 68 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 34 |
| 18-34 | 333 |
| 35-49 | 2,277 |
| 50-64 | 4,195 |
| 65-74 | 1,599 |
| 75+ | 645 |
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 Tykerb. 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 | 5,561 |
| Non-Serious | 4,871 |
| Hospitalization | 4,000 |
| Death | 2,461 |
| Life-Threatening | 427 |
| Disability | 201 |
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 Tykerb. 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 |
|---|---|
| 2005 | 9 |
| 2006 | 14 |
| 2007 | 936 |
| 2008 | 743 |
| 2009 | 1,056 |
| 2010 | 1,246 |
| 2011 | 1,668 |
| 2012 | 1,539 |
| 2013 | 1,479 |
| 2014 | 1,035 |
| 2015 | 1,102 |
| 2016 | 532 |
| 2017 | 721 |
| 2018 | 635 |
| 2019 | 674 |
| 2020 | 706 |
| 2021 | 356 |
| 2022 | 240 |
| 2023 | 253 |
| 2024 | 297 |
| 2025 | 144 |
| 2026 (partial) | 19 |
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 Tykerb
In FDA adverse event reports that mention Tykerb, these medications appeared most often in the same report.
- Capecitabine (6,482 reports)
- Trastuzumab (3,880 reports)
- Paclitaxel (1,688 reports)
- Paclitaxel Aibumin-bound (1,550 reports)
- Docetaxel (1,050 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