Drugs › 5-alpha reductase inhibitor
Brand name · Dutasteride and tamsulosin hydrochloride
Jalyn: adverse event reports filed with FDA
579 reports list it as a suspect or interacting product, 2010–2022. Class: 5-alpha reductase inhibitor.
- 579
- reports as suspect product
- 0% of all reports · about 37 a year
- 0
- reports, 12 months to June 2026
- 0 in the 12 months before
- 20.4%
- marked serious by the reporter
- 62.8% across the class
- 2.4%
- record death among outcomes, as reported
- 14 reports · not verified by FDA
Between October 2010 and September 2022, 579 adverse event reports received by FDA list the brand name Jalyn (dutasteride and tamsulosin hydrochloride) as a suspect or interacting product. Reports that mention it only as a concomitant medication (426) are left out of every figure here.
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 37 reports a year and 0% of the 20,646,523 reports in the database, and 2.3% of the reports for the 5-alpha reductase inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded drug ineffective (9.8%), dizziness (8.5%) and rash (5%). A report can list several reactions, so shares add to more than 100%; 136 different terms appear across these reports. Drug ineffective is recorded in 9.8% of these reports, a larger share than in the median 5-alpha reductase inhibitor drug (6.3%).
20.4% of the reports are marked serious by the reporter (62.8% across the class); 2.4% record death among the outcomes and 7.8% record hospitalisation, as reported. 82% of the reports came from consumers, and the largest patient age group is 75 and over (21.4%). 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
Reactions recorded in the reports
share of Jalyn reports recording the termmedian drug in 5-alpha reductase inhibitor
- Drug ineffectivethe medicine did not work as expected9.8%57
- Dizzinesslight-headedness or unsteadiness8.5%49
- Rashskin rash5%29
- Erectile dysfunctiondifficulty getting or keeping an erection4.7%27
- Pruritusitching2.8%16
- Breast tenderness2.6%15
- Dyspnoeashortness of breath2.6%15
- Blood pressure decreaseda low blood pressure reading2.2%13
- Headachehead pain2.2%13
- Hypotensionlow blood pressure2.2%13
- Pollakiuriapassing urine more often2.2%13
- Dysuriapain on passing urine1.9%11
- Fatiguetiredness1.9%11
- Gynaecomastiabreast enlargement in men1.7%10
- Libido decreasedreduced sex drive1.7%10
- Product quality issuea problem with the product itself1.7%10
- Back painback pain1.6%9
- Breast enlargement1.6%9
- Diarrhoealoose or frequent stools1.6%9
- Ejaculation disorder1.6%9
- Insomniadifficulty sleeping1.6%9
- Nocturia1.6%9
- Rhinorrhoeaa runny nose1.6%9
- Dyspepsiaindigestion1.4%8
- Somnolencedrowsiness1.4%8
- Astheniaweakness or lack of energy1.2%7
- Ill-defined disordera condition that was not clearly described1.2%7
- Testicular pain1.2%7
- Therapeutic response decreasedthe medicine worked less well1.2%7
- Dysphagiadifficulty swallowing1%6
Top 30 of 136 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 5 drugs in the 5-alpha reductase inhibitor 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 24,827 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 |
|---|---|---|
| Benign prostatic hyperplasia | 234 | 40.4% |
| Prostatomegaly | 53 | 9.2% |
| Prostatic disorder | 18 | 3.1% |
| Pollakiuria | 8 | 1.4% |
| Nocturia | 6 | 1% |
| Micturition disorder | 5 | 0.9% |
The indication field is filled in by the reporter and is often blank; shares are of all 579 reports.
In context
| Measure | Jalyn | 5-alpha reductase inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 579 | 24,827 | 20,646,523 |
| Share of that pool | — | 2.3% | 0% |
| Reports, latest 12 months | 0 | — | 1,332,454 |
| Marked serious | 20.4% | 62.8% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 24 | 48 | 91 |
| Hospitalisation recorded, per 1,000 reports | 78 | 153 | 213 |
| Consumer-filed share | 82% | 60.8% | 45.8% |
| Top term, share of reports | Drug ineffective 9.8% | median 6.3% | 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 5-alpha reductase inhibitor class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Finasteride | generic | 15,517 | 2,671 | 59.9% |
| Propecia | brand | 4,320 | 18 | 67.4% |
| Dutasteride | generic | 2,726 | 151 | 74.7% |
| Proscar | brand | 1,685 | 17 | 73.4% |
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 Jalyn reports
How many adverse event reports has FDA received for Jalyn?
579 reports list Jalyn 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 426 list it only as a concomitant medication.
What reactions are recorded in Jalyn reports?
drug ineffective (9.8%), dizziness (8.5%), rash (5%), erectile dysfunction (4.7%) and pruritus (2.8%). 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 Jalyn was responsible.
How serious are the reports?
20.4% are marked serious by the reporter. Among the outcomes recorded, 2.4% of reports include death and 7.8% 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 (82%), physician (9.7%) and other health professional (6.4%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Jalyn 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 Jalyn 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 Jalyn?
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 Jalyn as a suspect or interacting product; reports listing it only as a concomitant medication (426) 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.