{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "tamsulosin",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Tamsulosin hydrochloride capsules 0.4 mg once daily is recommended as the dose for the treatment of the signs and symptoms of BPH.",
        "source": "US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tamsulosin.json",
        "verbatim": true
      },
      {
        "text": "For those patients who fail to respond to the 0.4 mg dose after 2 to 4 weeks of dosing, the dose of tamsulosin hydrochloride capsules can be increased to 0.8 mg once daily.",
        "source": "US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tamsulosin.json",
        "verbatim": true
      },
      {
        "text": "If tamsulosin hydrochloride capsules administration is discontinued or interrupted for several days at either the 0.4 mg or 0.8 mg dose, therapy should be started again with the 0.4 mg once-daily dose. • 0.4 mg once daily taken approximately one-half hour following the same meal each day.Tamsulosin hydrochloride capsules should not be crushed, chewed or opened.",
        "source": "US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tamsulosin.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Tamsulosin hydrochloride capsules are not indicated for use in pediatric populations. Efficacy and positive benefit/risk of tamsulosin hydrochloride was not demonstrated in two studies conducted in patients 2 years to 16 years of age with elevated detrusor leak point pressure (>40 cm H 2 O) associated with known neurological disorder (e.g., spina bifida).",
        "source": "US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/tamsulosin.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "(8.5 , 12.3) • Renal Impairment: Has not been studied in patients with end-stage renal disease.",
        "source": "US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/tamsulosin.json",
        "verbatim": true
      },
      {
        "text": "No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and the other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology (12.3) ] .",
        "source": "US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/tamsulosin.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "(8.6 , 12.3) • Hepatic Impairment: Has not been studied in patients with severe hepatic impairment.",
        "source": "US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/tamsulosin.json",
        "verbatim": true
      },
      {
        "text": "However, patients with end-stage renal disease (CL cr <10 mL/min/1.73 m 2 ) have not been studied [see Clinical Pharmacology (12.3) ] . 8.7 Hepatic Impairment Patients with moderate hepatic impairment do not require an adjustment in tamsulosin hydrochloride capsules dosage.",
        "source": "US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/tamsulosin.json",
        "verbatim": true
      },
      {
        "text": "Tamsulosin hydrochloride has not been studied in patients with severe hepatic impairment [see Clinical Pharmacology (12.3) ] .",
        "source": "US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/tamsulosin.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Teratogenic Effects, Pregnancy Category B.",
        "source": "US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/tamsulosin.json",
        "verbatim": true
      },
      {
        "text": "Administration of tamsulosin hydrochloride to pregnant female rats at dose levels up to approximately 50 times the human therapeutic AUC exposure (300 mg/kg/day) revealed no evidence of harm to the fetus.",
        "source": "US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/tamsulosin.json",
        "verbatim": true
      },
      {
        "text": "Administration of tamsulosin hydrochloride to pregnant rabbits at dose levels up to 50 mg/kg/day produced no evidence of fetal harm.",
        "source": "US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/tamsulosin.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Tamsulosin hydrochloride capsules are not indicated for use in women.",
        "source": "US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/tamsulosin.json",
        "verbatim": true
      },
      {
        "text": "Tamsulosin hydrochloride capsules are not indicated for use in women. 8.3 Nursing Mothers Tamsulosin hydrochloride capsules are not indicated for use in women. 8.4 Pediatric Use Tamsulosin hydrochloride capsules are not indicated for use in pediatric populations.",
        "source": "US FDA label for tamsulosin (Tamsulosin Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/tamsulosin.json",
        "verbatim": true
      }
    ]
  }
}