Miconazole 3 Combination Pack: adverse event reports filed with FDA

901

reports as suspect product

0% of all reports · about 89 a year

141

reports, 12 months to June 2026

44 in the 12 months before

0.1%

marked serious by the reporter

57.4% across all reports

0%

record death among outcomes, as reported

0 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 Miconazole 3 Combination Pack reports recording the termall reports in the database

1. Vulvovaginal burning sensation45.5%410
2. Drug ineffectivethe medicine did not work as expected22.6%204
3. Vulvovaginal pain14.7%132
4. Condition aggravatedthe condition being treated got worse11.2%101
5. Vulvovaginal pruritus11%99
6. Vulvovaginal discomfort7.4%67
7. Vulvovaginal swelling5%45
8. Wrong technique in product usage processthe product was used in the wrong way4.1%37
9. Vaginal haemorrhagevaginal bleeding4%36
10. Off label useused for a purpose or in a way not on the label2.8%25
11. Underdoseless than the intended dose2.8%25
12. Expired product administeredthe product was used past its expiry date2.6%23
13. Hypersensitivityan allergic-type reaction2.6%23
14. Inappropriate schedule of product administrationthe product was taken at the wrong times2.2%20
15. Incorrect route of drug administrationthe medicine was given by the wrong route2.2%20
16. Vulvovaginal erythema2%18
17. Therapeutic product effect incomplete1.7%15
18. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times1.3%12
19. Incorrect route of product administrationthe product was given by the wrong route1.2%11
20. No adverse eventno adverse event was reported1.2%11
21. Product dose omission issuea dose was missed1.2%11
22. Vaginal discharge1.2%11
23. Abdominal painstomach or belly pain1.1%10
24. Drug dose omissiona dose was missed1%9
25. Accidental exposure to product0.8%7
26. Nauseafeeling sick0.8%7
27. Insomniadifficulty sleeping0.7%6
28. Abdominal pain upperupper stomach pain0.6%5
29. Adverse drug reactiona harmful or unpleasant reaction reported to a medicine0.4%4
30. Adverse reaction0.4%4

Top 30 of 71 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 share of all reports in the database; 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 20,646,523 reports. 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. 100% 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 901 reports.

Drugs most often listed in the same reports

Other products listed in reports where Miconazole 3 Combination Pack 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."

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 Miconazole 3 Combination Pack as a suspect or interacting product; reports listing it only as a concomitant medication (0) 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.