Product name as reported
Fortesta: adverse event reports filed with FDA
1,475 reports list it as a suspect or interacting product, 2011–2025.
- 1,475
- reports as suspect product
- 0% of all reports · about 98 a year
- 0
- reports, 12 months to June 2026
- 4 in the 12 months before
- 69.9%
- marked serious by the reporter
- 57.4% across all reports
- 12.2%
- record death among outcomes, as reported
- 180 reports · not verified by FDA
Between July 2011 and February 2025, 1,475 adverse event reports received by FDA list the product name "Fortesta" as reporters wrote it as a suspect or interacting product. Reports that mention it only as a concomitant medication (124) are left out of every figure here.
In the 12 months to June 2026, 0 reports listed it, against 4 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 98 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 MedDRA terms listed most often are cerebrovascular accident (18.4%), pulmonary embolism (18.1%) and deep vein thrombosis (18%). A report can list several reactions, so shares add to more than 100%; 267 different terms appear across these reports. Cerebrovascular accident is recorded in 18.4% of these reports, against 0.8% of all reports in the database.
69.9% of the reports are marked serious by the reporter; 12.2% record death among the outcomes and 33.7% record hospitalisation, as reported. 53.6% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (26.3%). 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
Reactions recorded in the reports
share of Fortesta reports recording the termall reports in the database
- Cerebrovascular accidentstroke18.4%272
- Pulmonary embolisma blood clot in the lung18.1%267
- Deep vein thrombosisa blood clot in a deep vein18%265
- Myocardial infarctionheart attack16.1%238
- Painpain, site not specified13.8%203
- Thrombosis11.8%174
- Cardiovascular disorder11.1%164
- Anxietyanxiety9.9%146
- Cardiac failure congestivecongestive heart failure9.4%138
- Deaththe patient died; cause not stated by this term9.2%135
- Quality of life decreasedreduced quality of life8.3%123
- Infarction8.3%122
- Ischaemia8.3%122
- Drug ineffectivethe medicine did not work as expected6.4%95
- Application site erythemaredness where the product was applied3.5%52
- Application site rash3.4%50
- Application site pain2.9%43
- Application site exfoliation2.6%39
- Application site pruritusitching where the product was applied2.6%38
- Emotional distressemotional distress2.5%37
- Atrial fibrillationan irregular heart rhythm1.6%24
- Depressionlow mood1.6%23
- Application site dryness1.5%22
- Astheniaweakness or lack of energy1.5%22
Top 30 of 267 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. 95.9% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Androgen replacement therapy | 609 | 41.3% |
| Blood testosterone decreased | 262 | 17.8% |
| Hormone replacement therapy | 84 | 5.7% |
| Hypogonadism | 39 | 2.6% |
| Androgen deficiency | 16 | 1.1% |
| Libido decreased | 4 | 0.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,475 reports.
In context
| Measure | Fortesta | All reports |
|---|---|---|
| Reports as suspect product | 1,475 | 20,646,523 |
| Share of that pool | — | 0% |
| Reports, latest 12 months | 0 | 1,332,454 |
| Marked serious | 69.9% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 122 | 91 |
| Hospitalisation recorded, per 1,000 reports | 337 | 213 |
| Consumer-filed share | 32.7% | 45.8% |
| Top term, share of reports | Cerebrovascular accident 18.4% | 0.8% |
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 Fortesta reports
How many adverse event reports has FDA received for Fortesta?
1,475 reports list Fortesta 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 124 list it only as a concomitant medication.
What reactions are recorded in Fortesta reports?
cerebrovascular accident (18.4%), pulmonary embolism (18.1%), deep vein thrombosis (18%), myocardial infarction (16.1%) and pain (13.8%). 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 Fortesta was responsible.
How serious are the reports?
69.9% are marked serious by the reporter. Among the outcomes recorded, 12.2% of reports include death and 33.7% 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?
lawyer (53.6%), consumer or non-health professional (32.7%) and physician (7.9%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Fortesta rising?
0 reports in the 12 months to June 2026, against 4 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 Fortesta 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 Fortesta?
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 Fortesta as a suspect or interacting product; reports listing it only as a concomitant medication (124) 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.