Brand name · Miconazole nitrate
Monistat 1 Combination Pack: adverse event reports filed with FDA
814 reports list it as a suspect or interacting product, 2004–2026.
- 814
- reports as suspect product
- 0% of all reports · about 37 a year
- 87
- reports, 12 months to June 2026
- 78 in the 12 months before
- 15%
- marked serious by the reporter
- 57.4% across all reports
- 0%
- record death among outcomes, as reported
- 0 reports · not verified by FDA
814 adverse event reports received by FDA list the brand name Monistat 1 Combination Pack (miconazole nitrate) as a suspect or interacting product, from August 2004 to June 2026. A further 10 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 87 reports listed it, up 12% from 78 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 37 reports a year and 0% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are vulvovaginal burning sensation (38.2%), vulvovaginal pain (33%) and vulvovaginal pruritus (14.1%). A report can list several reactions, so shares add to more than 100%; 81 different terms appear across these reports. Vulvovaginal burning sensation is recorded in 38.2% of these reports, against 0% of all reports in the database.
15% of the reports are marked serious by the reporter; 0% record death among the outcomes and 1.6% record hospitalisation, as reported. 83.3% of the reports came from consumers, and the largest patient age group is 18 to 44 (19.4%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 Monistat 1 Combination Pack reports recording the termall reports in the database
- Vulvovaginal burning sensation38.2%311
- Vulvovaginal pain33%269
- Vulvovaginal pruritus14.1%115
- Vaginal haemorrhagevaginal bleeding13.9%113
- Vulvovaginal swelling12.8%104
- Drug ineffectivethe medicine did not work as expected11.5%94
- Vulvovaginal discomfort10%81
- Condition aggravatedthe condition being treated got worse8.4%68
- Painpain, site not specified5%41
- Product used for unknown indicationthe reason for taking the medicine was not stated4.3%35
- Burning sensationa burning feeling4.2%34
- Chemical burn of genitalia4.1%33
- Pruritusitching3.2%26
- Vaginal discharge3.2%26
- Vulvovaginal erythema2.7%22
- Application site pain2.6%21
- Dysuriapain on passing urine2.2%18
- Abdominal painstomach or belly pain2.1%17
- Chemical burn2%16
- Chemical burn of skin1.8%15
- Hypersensitivityan allergic-type reaction1.8%15
- Vaginal erosion1.8%15
- Vulvovaginal inflammation1.7%14
- Swellingswelling1.6%13
- Sleep disordera sleep problem1.5%12
- Vulvovaginal injury1.5%12
- Nauseafeeling sick1.4%11
- Product use in unapproved indicationused for a purpose not on the label1.1%9
- Unevaluable eventthe event could not be assessed1.1%9
- Application site burn1%8
Top 30 of 81 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 99.3% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Fungal infection | 374 | 45.9% |
| Vulvovaginal mycotic infection | 76 | 9.3% |
| Vulvovaginal pruritus | 4 | 0.5% |
| Accidental exposure to product | 2 | 0.2% |
The indication field is filled in by the reporter and is often blank; shares are of all 814 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Monistat 1 Combination Pack reports |
|---|---|---|
| Vitamin d | 8 | 1% |
Other products listed in reports where Monistat 1 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
| Measure | Monistat 1 Combination Pack | All reports |
|---|---|---|
| Reports as suspect product | 814 | 20,646,523 |
| Share of that pool | — | 0% |
| Reports, latest 12 months | 87 | 1,332,454 |
| Marked serious | 15% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 0 | 91 |
| Hospitalisation recorded, per 1,000 reports | 16 | 213 |
| Consumer-filed share | 83.3% | 45.8% |
| Top term, share of reports | Vulvovaginal burning sensation 38.2% | 0% |
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."
Questions about Monistat 1 Combination Pack reports
How many adverse event reports has FDA received for Monistat 1 Combination Pack?
814 reports list Monistat 1 Combination Pack as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 87 of them arrived in the latest 12 months. Another 10 list it only as a concomitant medication.
What reactions are recorded in Monistat 1 Combination Pack reports?
vulvovaginal burning sensation (38.2%), vulvovaginal pain (33%), vulvovaginal pruritus (14.1%), vaginal haemorrhage (13.9%) and vulvovaginal swelling (12.8%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Monistat 1 Combination Pack was responsible.
How serious are the reports?
15% are marked serious by the reporter. Among the outcomes recorded, 0% of reports include death and 1.6% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (83.3%), not given (14.9%) and physician (0.9%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Monistat 1 Combination Pack rising?
87 reports in the 12 months to June 2026, up 12% from 78 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Monistat 1 Combination Pack was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Monistat 1 Combination Pack?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
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 Monistat 1 Combination Pack as a suspect or interacting product; reports listing it only as a concomitant medication (10) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.