Drugs › Cholinergic muscarinic antagonist
Brand name · Oxybutynin
Oxytrol for Women: adverse event reports filed with FDA
6,283 reports list it as a suspect or interacting product, 2013–2026. Class: Cholinergic muscarinic antagonist.
- 6,283
- reports as suspect product
- 0% of all reports · about 490 a year
- 80
- reports, 12 months to June 2026
- 29 in the 12 months before
- 0.9%
- marked serious by the reporter
- 39.8% across the class
- 0.1%
- record death among outcomes, as reported
- 4 reports · not verified by FDA
Between September 2013 and June 2026, 6,283 adverse event reports received by FDA list the brand name Oxytrol for Women (oxybutynin) as a suspect or interacting product. Reports that mention it only as a concomitant medication (30) are left out of every figure here.
In the 12 months to June 2026, 80 reports listed it, up 176% from 29 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 490 reports a year and 0% of the 20,646,523 reports in the database, and 33.7% of the reports for the cholinergic muscarinic antagonist class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are drug ineffective (35.3%), application site erythema (12.8%) and product adhesion issue (10.7%). A report can list several reactions, so shares add to more than 100%; 325 different terms appear across these reports. Drug ineffective is recorded in 35.3% of these reports, a larger share than in the median cholinergic muscarinic antagonist drug (17.7%).
0.9% of the reports are marked serious by the reporter (39.8% across the class); 0.1% record death among the outcomes and 0.3% record hospitalisation, as reported. 97.2% of the reports came from consumers, and the largest patient age group is 75 and over (15.2%). 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 Oxytrol for Women reports recording the termmedian drug in cholinergic muscarinic antagonist
- Drug ineffectivethe medicine did not work as expected35.3%2,217
- Application site erythemaredness where the product was applied12.8%802
- Product adhesion issue10.7%675
- Drug effect decreasedthe medicine had less effect8.9%557
- Application site pruritusitching where the product was applied8.3%521
- Pruritusitching7.7%486
- Off label useused for a purpose or in a way not on the label6.4%400
- Product quality issuea problem with the product itself5.8%367
- Erythemaskin redness5.7%358
- Rashskin rash5.1%323
- Application site rash5.1%318
- Product use issuea problem in how the product was used3.6%227
- Inappropriate schedule of drug administrationthe medicine was taken at the wrong times3.1%194
- Application site pain2.9%185
- Application site irritation2.8%175
- Skin irritationirritated skin2.6%162
- Dizzinesslight-headedness or unsteadiness2.2%137
- Rash erythematousa red rash1.9%117
- Dry mouthdry mouth1.8%113
- Condition aggravatedthe condition being treated got worse1.5%93
- Painpain, site not specified1.5%93
- Application site burn1.4%88
- Wrong technique in drug usage processthe medicine was used in the wrong way1.4%88
- Drug effect incomplete1.4%86
- Product packaging issuea problem with the packaging1.3%83
- Pollakiuriapassing urine more often1.3%81
- Burning sensationa burning feeling1.2%76
- Application site discolouration1.1%71
Top 30 of 325 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 9 drugs in the cholinergic muscarinic antagonist 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 18,647 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
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. 100% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Hypertonic bladder | 1,573 | 25% |
| Urinary incontinence | 419 | 6.7% |
| Pollakiuria | 402 | 6.4% |
| Incontinence | 279 | 4.4% |
| Micturition urgency | 196 | 3.1% |
| Nocturia | 183 | 2.9% |
The indication field is filled in by the reporter and is often blank; shares are of all 6,283 reports.
In context
| Measure | Oxytrol for Women | Cholinergic muscarinic antagonist | All reports |
|---|---|---|---|
| Reports as suspect product | 6,283 | 18,647 | 20,646,523 |
| Share of that pool | — | 33.7% | 0% |
| Reports, latest 12 months | 80 | — | 1,332,454 |
| Marked serious | 0.9% | 39.8% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 1 | 42 | 91 |
| Hospitalisation recorded, per 1,000 reports | 3 | 135 | 213 |
| Consumer-filed share | 97.2% | 66.4% | 45.8% |
| Top term, share of reports | Drug ineffective 35.3% | median 17.7% | 6.3% |
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 cholinergic muscarinic antagonist class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Detrol | brand | 4,851 | 15 | 55.8% |
| Oxybutynin | generic | 2,996 | 178 | 61.8% |
| Oxybutynin chloride | generic | 1,133 | 52 | 59.9% |
| Tolterodine tartrate | generic | 942 | 7 | 63.9% |
| Oxytrol | brand | 803 | 125 | 23% |
| Solifenacin succinate | generic | 575 | 137 | 87.7% |
| Tolterodine | generic | 552 | 47 | 82.2% |
| Trospium chloride | generic | 512 | 58 | 72.7% |
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.
Questions about Oxytrol for Women reports
How many adverse event reports has FDA received for Oxytrol for Women?
6,283 reports list Oxytrol for Women as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 80 of them arrived in the latest 12 months. Another 30 list it only as a concomitant medication.
What reactions are recorded in Oxytrol for Women reports?
drug ineffective (35.3%), application site erythema (12.8%), product adhesion issue (10.7%), drug effect decreased (8.9%) and application site pruritus (8.3%). 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 Oxytrol for Women was responsible.
How serious are the reports?
0.9% are marked serious by the reporter. Among the outcomes recorded, 0.1% of reports include death and 0.3% 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 (97.2%), other health professional (2%) and physician (0.6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Oxytrol for Women rising?
80 reports in the 12 months to June 2026, up 176% from 29 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 Oxytrol for Women 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 Oxytrol for Women?
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 Oxytrol for Women as a suspect or interacting product; reports listing it only as a concomitant medication (30) 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.