CombiPatch (estradiol/norethindrone acetate transdermal system): adverse event reports filed with FDA

3,608

reports as suspect product

0% of all reports · about 161 a year

384

reports, 12 months to June 2026

575 in the 12 months before

19.5%

marked serious by the reporter

57.2% across the class

0.3%

record death among outcomes, as reported

11 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 CombiPatch (estradiol/norethindrone acetate transdermal system) reports recording the termmedian drug in estrogen

1. Product adhesion issue21.5%774
2. Product storage errorthe product was stored wrongly20%722
3. Application site erythemaredness where the product was applied15.6%562
4. Off label useused for a purpose or in a way not on the label15.2%548
5. Application site pruritusitching where the product was applied14%506
6. No adverse eventno adverse event was reported13.7%493
7. Application site irritation10.5%380
8. Wrong technique in product usage processthe product was used in the wrong way10.5%379
9. Hot flusha hot flush6.5%233
10. Device issuea problem with the device6.2%223
11. Product quality issuea problem with the product itself6.2%223
12. Vaginal haemorrhagevaginal bleeding6%216
13. Drug dose omissiona dose was missed5.4%196
14. Product administered at inappropriate site5.3%193
15. Application site pain4.9%175
16. Application site rash4.8%173
17. Drug ineffectivethe medicine did not work as expected4.1%149
18. Breast cancerbreast cancer3.6%130
19. Therapeutic product ineffective3.5%128
20. Product residue present3.5%127
21. Headachehead pain3%110
22. Therapy cessation3%110
23. Product administration errora mistake in giving the product3%107
24. Application site swelling2.9%106
25. Adhesive tape use2.8%101
26. Postmenopausal haemorrhage2.7%98
27. Product ineffective2.7%98
28. Therapeutic response unexpected2.3%83
29. Product dose omission issuea dose was missed2.3%82
30. Insomniadifficulty sleeping2.1%75

Top 30 of 496 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. 97.7% 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 3,608 reports.

Drugs most often listed in the same reports

Other products listed in reports where CombiPatch (estradiol/norethindrone acetate transdermal system) 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 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 CombiPatch (estradiol/norethindrone acetate transdermal system) as a suspect or interacting product; reports listing it only as a concomitant medication (376) 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.