What the label lists and what reports show
Silodosin side effects
Silodosin's FDA label: “Most common adverse reactions (incidence ≥ 2%) are retrograde ejaculation, dizziness, diarrhea, orthostatic hypotension, headache, nasopharyngitis, and nasal congestion.” FAERS holds 3,956 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (156 reports).
- Generic listed
Check it at the source: the silodosin FDA label on DailyMed (effective April 15, 2026, Amneal Pharmaceuticals NY LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 2%) are retrograde ejaculation, dizziness, diarrhea, orthostatic hypotension, headache, nasopharyngitis, and nasal congestion.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Reactions | Silodosin N = 466 n (%) | Placebo N = 457 n (%) |
|---|---|---|
| Retrograde Ejaculation | 131 (28.1) | 4 (0.9) |
| Dizziness | 15 (3.2) | 5 (1.1) |
| Diarrhea | 12 (2.6) | 6 (1.3) |
| Orthostatic Hypotension | 12 (2.6) | 7 (1.5) |
| Headache | 11 (2.4) | 4 (0.9) |
| Nasopharyngitis | 11 (2.4) | 10 (2.2) |
| Nasal Congestion | 10 (2.1) | 1 (0.2) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedMost common adverse reactions (incidence ≥ 2%) are retrograde ejaculation, dizziness, diarrhea, orthostatic hypotension, headache, nasopharyngitis, and nasal congestion. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In U.S. clinical trials, 897 patients with BPH were exposed to 8 mg silodosin daily. This includes 486 patients exposed for 6 months and 168 patients exposed for 1 year. The population was 44 to 87 years of age, and predominantly Caucasian. Of these patients, 42.8% were 65 years of age or older and 10.7% were 75 years of age or older. In double-blind, placebo controlled, 12-week clinical trials, 466 patients were administered silodosin and 457 patients were administered placebo. At least one treatment-emergent adverse reaction was reported by 55.2% of silodosin treated patients (36.8% for placebo treated). The majority (72.1%) of adverse reactions for the silodosin treated patients (59.8% for placebo treated) were qualified by the investigator as mild.
Source: FDA drug label, Amneal Pharmaceuticals NY LLC, effective April 15, 2026 (SPL set de619e27-9384-4b86-abdc-de0557cd39e8), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,956 reports list silodosin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 499 are coded as a death and 1,960 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Silodosin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions