Inqovi: adverse event reports filed with FDA

677

reports as suspect product

0% of all reports · about 118 a year

269

reports, 12 months to June 2026

228 in the 12 months before

81.5%

marked serious by the reporter

92.2% across the class

20.4%

record death among outcomes, as reported

138 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 Inqovi reports recording the termmedian drug in nucleoside metabolic inhibitor

1. Inappropriate schedule of product administrationthe product was taken at the wrong times17.4%118
2. Cytopenia14.9%101
3. Fatiguetiredness14.8%100
4. Product use in unapproved indicationused for a purpose not on the label13.4%91
5. Platelet count decreasedlow platelet count12.6%85
6. Deaththe patient died; cause not stated by this term11.1%75
7. White blood cell count decreasedlow white cell count9.7%66
8. Nauseafeeling sick7.4%50
9. Transfusion7.1%48
10. Astheniaweakness or lack of energy6.1%41
11. Neutropenialow neutrophils, a type of white blood cell5.8%39
12. Haemoglobin decreasedlow haemoglobin5.6%38
13. Pancytopenialow counts of all blood cells5.6%38
14. Pyrexiafever5.6%38
15. Febrile neutropeniafever with low white blood cells5%34
16. Anaemialow red blood cells4.4%30
17. Pneumonialung infection4.3%29
18. Diarrhoealoose or frequent stools4.1%28
19. Infectionan infection, type not specified4%27
20. Thrombocytopenialow platelets4%27
21. Constipationconstipation3.5%24
22. Disease progressionthe disease advanced3.1%21
23. Neutrophil count decreased3.1%21
24. Arthralgiajoint pain2.8%19
25. Off label useused for a purpose or in a way not on the label2.8%19
26. Decreased appetitereduced appetite2.5%17
27. Drug ineffectivethe medicine did not work as expected2.5%17
28. Dyspnoeashortness of breath2.4%16
29. Painpain, site not specified2.4%16
30. Falla fall2.2%15

Top 30 of 205 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 19 drugs in the nucleoside metabolic 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 313,386 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. 79.3% 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 677 reports.

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 nucleoside metabolic 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 Inqovi as a suspect or interacting product; reports listing it only as a concomitant medication (139) 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.