Alecensa: adverse event reports filed with FDA

7,095

reports as suspect product

0% of all reports · about 676 a year

481

reports, 12 months to June 2026

1,168 in the 12 months before

54.3%

marked serious by the reporter

70.8% across the class

12.9%

record death among outcomes, as reported

913 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 Alecensa reports recording the termmedian drug in kinase inhibitor

1. Deaththe patient died; cause not stated by this term9.8%695
2. Fatiguetiredness7.1%507
3. No adverse eventno adverse event was reported6.6%466
4. Off label useused for a purpose or in a way not on the label6.4%457
5. Constipationconstipation6.2%438
6. Rashskin rash3.5%251
7. Dyspnoeashortness of breath3.3%233
8. Myalgiamuscle pain2.9%207
9. Disease progressionthe disease advanced2.9%205
10. Weight increasedweight gain2.9%203
11. Astheniaweakness or lack of energy2.6%187
12. Peripheral swellingswelling of the arms or legs2.5%176
13. Drug ineffectivethe medicine did not work as expected2.3%166
14. Painpain, site not specified2.2%159
15. Nauseafeeling sick2.1%148
16. Pneumonialung infection1.9%135
17. Diarrhoealoose or frequent stools1.9%134
18. Oedemaswelling from fluid1.7%118
19. Coughcough1.6%117
20. Dizzinesslight-headedness or unsteadiness1.6%116
21. Oedema peripheralswelling of the legs, ankles or hands1.6%116
22. Anaemialow red blood cells1.6%115
23. Arthralgiajoint pain1.6%110
24. Headachehead pain1.5%108
25. Covid-19COVID-19 infection1.5%104
26. Blood bilirubin increased1.4%100
27. Pyrexiafever1.4%98
28. Bradycardiaslow heart rate1.2%87
29. Pleural effusionfluid around the lung1.2%87
30. Hepatic function abnormal1.2%85

Top 30 of 615 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. 62.6% 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 7,095 reports.

Drugs most often listed in the same reports

Other products listed in reports where Alecensa 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 Alecensa as a suspect or interacting product; reports listing it only as a concomitant medication (114) 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.