Foscarnet sodium: adverse event reports filed with FDA

648

reports as suspect product

0% of all reports · about 29 a year

47

reports, 12 months to June 2026

65 in the 12 months before

97.2%

marked serious by the reporter

98% across the class

36.4%

record death among outcomes, as reported

236 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 Foscarnet sodium reports recording the termmedian drug in pyrophosphate analog dna polymerase inhibitor

1. Off label useused for a purpose or in a way not on the label39.5%256
2. Acute kidney injurysudden loss of kidney function21%136
3. Drug ineffectivethe medicine did not work as expected19.1%124
4. Pancytopenialow counts of all blood cells15.4%100
5. Nephropathy toxic13.7%89
6. Drug resistance12.8%83
7. BK virus infection11.6%75
8. Myelosuppression11.3%73
9. Cytomegalovirus infection reactivation10.6%69
10. Cystitis haemorrhagic10.3%67
11. Encephalitis cytomegalovirus9.9%64
12. Generalised oedema9.1%59
13. Respiratory distressdifficulty breathing9.1%59
14. Lung disordera lung problem, type not specified9%58
15. Cytomegalovirus infection8.5%55
16. Epstein-Barr viraemia8.5%55
17. Renal impairmentreduced kidney function6%39
18. Cytomegalovirus viraemia5.7%37
19. Pathogen resistance4.5%29
20. Renal failurekidney failure4.2%27
21. Product use in unapproved indicationused for a purpose not on the label3.9%25
22. Pyrexiafever3.7%24
23. Diarrhoealoose or frequent stools3.5%23
24. Hypokalaemialow blood potassium3.4%22
25. Condition aggravatedthe condition being treated got worse3.1%20
26. Multiple organ dysfunction syndromeseveral organs failing3.1%20
27. Neutropenialow neutrophils, a type of white blood cell3.1%20
28. Blood creatinine increasedraised creatinine, a kidney test2.9%19
29. Intentional product use issuedeliberate use not as intended2.8%18
30. Respiratory failurethe lungs could not supply enough oxygen2.8%18

Top 30 of 186 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 3 drugs in the pyrophosphate analog dna polymerase 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 2,514 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. 29.9% 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 648 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 pyrophosphate analog dna polymerase 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 Foscarnet sodium as a suspect or interacting product; reports listing it only as a concomitant medication (299) 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.