{
 "query": "tamsulosin",
 "ingredient": "tamsulosin",
 "slug": "tamsulosin",
 "rxcui": "77492",
 "brands": [
  "Flomax"
 ],
 "names": [
  "tamsulosin",
  "tamsulosin hydrochloride"
 ],
 "classes": [
  {
   "id": "G04CA",
   "name": "Alpha-adrenoreceptor antagonists"
  }
 ],
 "alternatives": [
  "alfuzosin",
  "silodosin",
  "terazosin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 61
  },
  "boxed_warning": "",
  "indications_and_usage": "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. \u2022 Tamsulosin Hydrochloride Capsules is an alpha 1 adrenoceptor antagonist indicated for treatment of the signs and symptoms of benign prostatic hyperplasia (1) \u2022 Tamsulosin Hydrochloride Capsules are not indicated for the treatment of hypertension (1)",
  "contraindications": "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) ]. \u2022 Contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of Tamsulosin Hydrochloride Capsules ( 4 , 6.2)",
  "warnings_and_cautions": "\u00b7 Advise patients about the possibility of symptoms related to postural hypotension and to avoid situations where injury could result should syncope occur (5.1) \u00b7 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 ) \u00b7 Should not be used in combination with other alpha adrenergic blocking agents ( 5.2 , 7.2, 12.3 ) \u00b7 Exercise caution with concomitant administration of warfarin ( 5.2 , 7.4 , 12.3 ) \u00b7 Advise patients about the possibility and seriousness of priapism (5.3) \u00b7 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) \u00b7 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...",
  "warnings": "",
  "adverse_reactions": "\u2022 The most common adverse events (\u00b32% 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...",
  "drug_abuse_and_dependence": "DEPENDENCE",
  "controlled_substance": "",
  "recent_major_changes": "Dosage and Administration (2) 10/2014 Warnings and Precautions Intraoperative Floppy Iris Syndrome (5.5) 07/2014",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Patient Information) \u00b7 Hypotension Advise the patients about the possible occurrence of symptoms related to postural hypotension, such as dizziness, when taking Tamsulosin Hydrochloride Capsules, and they should be cautioned about driving, operating machinery, or performing hazardous tasks [ see Warnings and Precautions (5.1) ]. \u00b7 Drug Interactions Advise the patient that Tamsulosin Hydrochloride Capsules should not be used in combination with strong inhibitors of CYP3A4 [see Warnings and Precautions (5.2) and Drug Interactions (7.1)]. \u00b7 Priapism Advise the patient should be advised about the possibility of priapism as a result of treatment with Tamsulosin Hydrochloride Capsules and other similar medications. Patients should be informed that this reaction is extremely rare, but if not brought to immediate medical attention, can lead to permanent erectile dysfunction (impotence) [ see Warnings and Precautions (5.3) ]. \u00b7 Screening for Prostate Cancer Prostate cancer and BPH frequently co-exist; therefore, screened for the presence of prostate cancer prior to treatment with Tamsulosin Hydrochloride Capsules and at regular i...",
  "spl_medguide": "",
  "clinical_studies": "Four placebo-controlled clinical studies and one active-controlled clinical study enrolled a total of 2296 patients (1003 received Tamsulosin Hydrochloride Capsules 0.4 mg once daily, 491 received Tamsulosin Hydrochloride Capsules 0.8 mg once daily, and 802 were control patients) in the U.S. and Europe. In the two U.S. placebo-controlled, double-blind, 13-week, multicenter studies [Study 1 (US92-03A) and Study 2 (US93-01)], 1486 men with the signs and symptoms of BPH were enrolled. In both studies, patients were randomized to either placebo, Tamsulosin Hydrochloride Capsules 0.4 mg once daily, or Tamsulosin Hydrochloride Capsules 0.8 mg once daily. Patients in Tamsulosin Hydrochloride Capsules 0.8 mg once-daily treatment groups received a dose of 0.4 mg once daily for one week before increasing to the 0.8 mg once-daily dose. The primary efficacy assessments included: 1) total American Urological Association (AUA) Symptom Score questionnaire, which evaluated irritative (frequency, urgency, and nocturia), and obstructive (hesitancy, incomplete emptying, intermittency, and weak stream) symptoms, where a decrease in score is consistent with improvement in symptoms; and 2) peak urine fl...",
  "brand_name": "Tamsulosin Hydrochloride",
  "manufacturer": "Proficient Rx LP",
  "application_number": "ANDA207405",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20200201",
  "set_id": "06b44e53-c6e7-4e12-a8fd-572d092cfa70",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 115204,
  "serious": 83279,
  "death": 12985,
  "hospitalization": 43255,
  "primary_suspect": 114744,
  "top_reactions": [
   [
    "Fatigue",
    8606
   ],
   [
    "Diarrhoea",
    6368
   ],
   [
    "Dizziness",
    5969
   ],
   [
    "Dyspnoea",
    5941
   ],
   [
    "Death",
    5764
   ],
   [
    "Off Label Use",
    5496
   ],
   [
    "Drug Ineffective",
    5300
   ],
   [
    "Fall",
    5209
   ],
   [
    "Asthenia",
    4948
   ],
   [
    "Nausea",
    4606
   ],
   [
    "Pneumonia",
    3727
   ],
   [
    "Pain",
    3601
   ],
   [
    "Headache",
    3554
   ],
   [
    "Acute Kidney Injury",
    3285
   ],
   [
    "Arthralgia",
    3136
   ]
  ],
  "by_year": {
   "2019": 11070,
   "2020": 11344,
   "2021": 9957,
   "2022": 9272,
   "2023": 8174,
   "2024": 8817,
   "2025": 10688,
   "2026": 4680
  },
  "by_year_primary": {
   "2019": 11063,
   "2020": 11320,
   "2021": 9923,
   "2022": 9163,
   "2023": 8111,
   "2024": 8724,
   "2025": 10611,
   "2026": 4635
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20190717",
   "reason": "Failed Dissolution Specifications",
   "firm": "Macleods Pharma Usa Inc",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20190222",
   "reason": "Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.",
   "firm": "Ascend Laboratories LLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 16,
  "nda": 1,
  "anda": 15,
  "first_approval": "19970415",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 13,
  "labeling_recent": 0,
  "sponsors": [
   "ALKEM LABS LTD",
   "ASCENT PHARMS INC",
   "AUROBINDO PHARMA LTD",
   "CHARTWELL RX",
   "IMPAX LABS",
   "MACLEODS PHARMS",
   "PH HEALTH",
   "PHARMOBEDIENT"
  ],
  "unapproved": false,
  "first_approval_fmt": "04/15/1997"
 },
 "trials": {
  "total": 302,
  "completed": 188,
  "terminated": 24,
  "with_results": 56,
  "industry": 142,
  "phase3": 58,
  "results_share": 0.2978723404255319,
  "terminated_share": 0.07947019867549669
 },
 "pubmed": {
  "rct": 327,
  "meta": 63,
  "recent_rct": 51,
  "cochrane": [
   {
    "pmid": "21901681",
    "title": "WITHDRAWN: Tamsulosin for benign prostatic hyperplasia",
    "year": "2011"
   },
   {
    "pmid": "12535426",
    "title": "Tamsulosin for benign prostatic hyperplasia",
    "year": "2003"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "tamsulosin",
   "Flomax"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 21586370,
  "beneficiaries": 5499972,
  "spend": 310672953.95,
  "by_brand": [
   {
    "brand": "Tamsulosin HCl",
    "claims": 21583278,
    "per_claim": 14.288240947,
    "is_generic": true
   },
   {
    "brand": "Flomax",
    "claims": 3092,
    "per_claim": 739.28766171,
    "is_generic": false
   }
  ],
  "per_claim": 14.392088801868956
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 23970,
  "fills": 21586370,
  "per_million": 1110.4229196479075,
  "ratio": 0.4010267496287498,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "1,110 FDA reports naming it as the suspect drug per million Medicare fills, 0.4x the median drug on this site",
    "Death share in reports is near or below the FAERS average (1.2x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 66,
   "letter": "C",
   "why": [
    "327 randomized trials and 63 systematic reviews/meta-analyses indexed in PubMed",
    "2 independent Cochrane review(s) exist",
    "Only 30% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 92,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III across 15 generic makers (-3)",
    "Label lists recent major changes to warnings or indications (-5)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (15 applications)",
    "3 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 90,
 "grade": "A",
 "questions": [
  "The most-reported problems in FDA's adverse event data are fatigue, diarrhoea, dizziness, dyspnoea. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over alfuzosin, silodosin, terazosin? What would make you pick one of those instead?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}