This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
Tamsulosin Hydrochloride Capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) [ see Clinical Studies (14) ]. Tamsulosin Hydrochloride Capsules are not indicated for the treatment of hypertension. • Tamsulosin Hydrochloride Capsules is an alpha 1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (1) • Tamsulosin Hydrochloride Capsules are not indicated for the treatment of hypertension (1)
Tamsulosin Hydrochloride Capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of Tamsulosin Hydrochloride Capsules. Reactions have included skin rash, urticaria, pruritus,angioedema, and respiratory symptoms [ see Adverse Reactions (6.2) ]. • Contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of Tamsulosin Hydrochloride Capsules ( 4 , 6.2)
· Advise patients about the possibility of symptoms related to postural hypotension and to avoid situations where injury could result should syncope occur (5.1) · Should not be used in combination with strong inhibitors of CYP3A4.Use with caution in combination with moderate inhibitors of CYP3A4,with strong or moderate inhibitors of CYP2D6, in patients known to be CYP2D6 poor metabolizers, or in combination with other cytochrome P450 inhibitors. ( 5.2 , 7.1, 12.3 ) · Should not be used in combination with other alpha adrenergic blocking agents ( 5.2 , 7.2, 12.3 ) · Exercise caution with concomitant administration of warfarin ( 5.2 , 7.4 , 12.3 ) · Advise patients about the possibility and seriousness of priapism (5.3) · Intraoperative Floppy Iris Syndrome has been observed during cataract and glaucoma surgery in some patients. Advise patients considering cataract or glaucoma surgery to tell their ophthalmologist that they have taken Tamsulosin Hydrochloride Capsules. (5.5) · Advise patients to be screened for the presence of prostate cancer prior to treatment and at regular intervals afterwards (5.4) 5.1 Orthostasis The signs and symptoms of orthostasis (postural hypotension, dizzi...
• The most common adverse events (³2% of patients and at a higher incidence than placebo) with the 0.4 mg dose or 0.8 mg dose were headache, dizziness, rhinitis, infection, abnormal ejaculation, asthenia,back pain, diarrhea, pharyngitis, chest pain, cough increased, somnolence,nausea, sinusitis, insomnia, libido decreased, tooth disorder, and blurred vision (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) or FDA at 1-800-332-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The incidence of treatment-emergent adverse events has been ascertained from six short-term U.S. and European placebo-controlled clinical trials in which daily doses of 0.1 to 0.8 mg Tamsulosin Hydrochloride Capsules were used. These studies evaluated safety in 1783 patients treated with Tamsulosin Hydrochloride Capsules and 798 patients administered placebo. Table 1 summarizes...
Dosage and Administration (2) 10/2014 Warnings and Precautions Intraoperative Floppy Iris Syndrome (5.5) 07/2014
Source: FDA SPL label for Tamsulosin Hydrochloride (Proficient Rx LP), effective 20200201. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 11,070 | 11,344 | 9,957 | 9,272 | 8,174 | 8,817 | 10,688 | 4,680 |
1,110 reports blaming this drug for every million Medicare prescriptions filled, which is 0.4× the typical drug on this site. (23,970 reports in 2024–2026, against 21,586,370 Medicare fills in one year. This is the one number here that accounts for how many people take the drug.)
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 07/2019 | Class II | Macleods Pharma Usa Inc | Failed Dissolution Specifications |
| 02/2019 | Class II | Ascend Laboratories LLC | Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Tamsulosin HCl | 21,583,278 | $14 |
| Flomax | 3,092 | $739 |
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.