Product name as reported
Provella-14: adverse event reports filed with FDA
475 reports list it as a suspect or interacting product, 2004–2011.
- 475
- reports as suspect product
- 0% of all reports · about 22 a year
- 0
- reports, 12 months to June 2026
- 0 in the 12 months before
- 99.8%
- marked serious by the reporter
- 57.4% across all reports
- 1.1%
- record death among outcomes, as reported
- 5 reports · not verified by FDA
475 adverse event reports received by FDA list the product name "Provella-14" as reporters wrote it as a suspect or interacting product, from June 2004 to October 2011. A further 130 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, 0 reports listed it, and none 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 22 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 breast cancer female (69.7%), breast cancer (17.3%) and oestrogen receptor assay positive (6.1%). A report can list several reactions, so shares add to more than 100%; 31 different terms appear across these reports. Breast cancer female is recorded in 69.7% of these reports, against 0.1% of all reports in the database.
99.8% of the reports are marked serious by the reporter; 1.1% record death among the outcomes and 8.6% record hospitalisation, as reported. 8.8% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (10.7%). 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
No report listing Provella-14 was received in the five years to June 2026; the latest was received in October 2011.
By year received
Reactions recorded in the reports
share of Provella-14 reports recording the termall reports in the database
- Breast cancer female69.7%331
- Breast cancerbreast cancer17.3%82
- Oestrogen receptor assay positive6.1%29
- Progesterone receptor assay positive5.9%28
- Ovarian cancer5.5%26
- Breast cancer in situ2.3%11
- Cerebrovascular accidentstroke1.3%6
- Myocardial infarctionheart attack1.3%6
- Pulmonary embolisma blood clot in the lung1.3%6
- Deep vein thrombosisa blood clot in a deep vein1.1%5
- Lymphoedema0.6%3
- Painpain, site not specified0.6%3
- Thrombosis0.6%3
- Arthritis0.4%2
- Condition aggravatedthe condition being treated got worse0.4%2
- Gallbladder cancer0.4%2
- Gallbladder disorder0.4%2
- Hypertensionhigh blood pressure0.4%2
- Aneurysm0.2%1
- Anorectal operation0.2%1
- Astheniaweakness or lack of energy0.2%1
- Cervix carcinoma0.2%1
- Dizzinesslight-headedness or unsteadiness0.2%1
- Drug interactionan interaction between medicines0.2%1
- Endometrial cancer stage I0.2%1
- Falla fall0.2%1
- Feeling abnormalfeeling odd or not right0.2%1
- Influenzaflu0.2%1
- Injurya physical injury0.2%1
Top 30 of 31 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. 5.1% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Hormone replacement therapy | 445 | 93.7% |
The indication field is filled in by the reporter and is often blank; shares are of all 475 reports.
In context
| Measure | Provella-14 | All reports |
|---|---|---|
| Reports as suspect product | 475 | 20,646,523 |
| Share of that pool | — | 0% |
| Reports, latest 12 months | 0 | 1,332,454 |
| Marked serious | 99.8% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 11 | 91 |
| Hospitalisation recorded, per 1,000 reports | 86 | 213 |
| Consumer-filed share | 1.7% | 45.8% |
| Top term, share of reports | Breast cancer female 69.7% | 0.1% |
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 Provella-14 reports
How many adverse event reports has FDA received for Provella-14?
475 reports list Provella-14 as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 0 of them arrived in the latest 12 months. Another 130 list it only as a concomitant medication.
What reactions are recorded in Provella-14 reports?
breast cancer female (69.7%), breast cancer (17.3%), oestrogen receptor assay positive (6.1%), progesterone receptor assay positive (5.9%) and ovarian cancer (5.5%). 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 Provella-14 was responsible.
How serious are the reports?
99.8% are marked serious by the reporter. Among the outcomes recorded, 1.1% of reports include death and 8.6% 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?
not given (88.8%), lawyer (8.8%) and consumer or non-health professional (1.7%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Provella-14 rising?
0 reports in the 12 months to June 2026, and none 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 Provella-14 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 Provella-14?
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 Provella-14 as a suspect or interacting product; reports listing it only as a concomitant medication (130) 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.