Minivelle: adverse event reports filed with FDA

2,823

reports as suspect product

0% of all reports · about 211 a year

33

reports, 12 months to June 2026

41 in the 12 months before

4%

marked serious by the reporter

57.2% across the class

0.1%

record death among outcomes, as reported

2 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

Reactions recorded in the reports

share of Minivelle reports recording the termmedian drug in estrogen

1. No adverse eventno adverse event was reported29.5%833
2. Product quality issuea problem with the product itself26%735
3. Off label useused for a purpose or in a way not on the label17.4%492
4. Hot flusha hot flush16.6%468
5. Product adhesion issue15.5%437
6. Drug ineffectivethe medicine did not work as expected14.3%404
7. Wrong technique in product usage processthe product was used in the wrong way10.8%306
8. Wrong technique in drug usage processthe medicine was used in the wrong way9.9%279
9. Drug dose omissiona dose was missed7.7%217
10. Drug prescribing errora prescribing mistake7%199
11. Application site erythemaredness where the product was applied5.3%149
12. Incorrect drug administration duration4.8%136
13. Oestradiol decreased4.7%132
14. Headachehead pain4.6%131
15. Application site pruritusitching where the product was applied4.5%127
16. Therapy cessation4.3%122
17. Insomniadifficulty sleeping3.4%96
18. Night sweatssweating at night3.3%93
19. Application site rash2.9%82
20. Nauseafeeling sick2.7%75
21. Application site irritation2.6%74
22. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times2.6%74
23. Vaginal haemorrhagevaginal bleeding2.6%73
24. Feeling abnormalfeeling odd or not right2.5%70
25. Metrorrhagia2.5%70
26. Weight increasedweight gain2%56
27. Drug administered at inappropriate site1.9%53
28. Migrainemigraine1.8%52
29. Application site pain1.7%49
30. Drug administration errora mistake in giving the medicine1.7%49

Top 30 of 273 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 25 drugs in the estrogen 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 127,523 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. 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 2,823 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 estrogen 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 Minivelle as a suspect or interacting product; reports listing it only as a concomitant medication (381) 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.