{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "tranexamic acid",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "• Before Extraction: Administer 10 mg/kg actual body weight of tranexamic acid injection intravenously with replacement therapy as a single-dose.",
        "source": "US FDA label for tranexamic acid (Tranexamic acid), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tranexamic-acid.json",
        "verbatim": true
      },
      {
        "text": "( 2.1 ) • After Extraction: Administer 10 mg/kg actual body weight of tranexamic acid injection intravenously 3 to 4 times daily for 2 to 8 days.",
        "source": "US FDA label for tranexamic acid (Tranexamic acid), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tranexamic-acid.json",
        "verbatim": true
      },
      {
        "text": "( 2.2 , 8.6 ) 2.1 Recommended Dosage The recommended dose of tranexamic acid injection is 10 mg/kg actual body weight administered as a single intravenous dose immediately before tooth extractions.",
        "source": "US FDA label for tranexamic acid (Tranexamic acid), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tranexamic-acid.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "There are limited data concerning the use of tranexamic acid in pediatric patients with hemophilia who are undergoing tooth extraction. The limited data suggest that there are no significant pharmacokinetic differences between adults and pediatric patients.",
        "source": "US FDA label for tranexamic acid (Tranexamic acid), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/tranexamic-acid.json",
        "verbatim": true
      },
      {
        "text": "• Before Extraction: Administer 10 mg/kg actual body weight of tranexamic acid injection intravenously with replacement therapy as a single-dose. ( 2.1 ) • After Extraction: Administer 10 mg/kg actual body weight of tranexamic acid injection intravenously 3 to 4 times daily for 2 to 8 days. ( 2.1 ) • Infuse undiluted solution no more than 1 mL/minute to avoid hypotension. ( 2.3 ) • Reduce the dosage for patients with renal impairment.",
        "source": "US FDA label for tranexamic acid (Tranexamic acid), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tranexamic-acid.json",
        "verbatim": true
      },
      {
        "text": "• Before Extraction: Administer 10 mg/kg actual body weight of tranexamic acid injection intravenously with replacement therapy as a single-dose.",
        "source": "US FDA label for tranexamic acid (Tranexamic acid), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tranexamic-acid.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "( 2.3 ) • Reduce the dosage for patients with renal impairment.",
        "source": "US FDA label for tranexamic acid (Tranexamic acid), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tranexamic-acid.json",
        "verbatim": true
      },
      {
        "text": "Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration (2.2) , Clinical Pharmacology (12.3) ] . 8.6 Renal Impairment Reduce the dosage of tranexamic acid in patients with renal impairment, based on the patient’s serum creatinine [see Dosage and Administration (2.2) , Clinical Pharmacology (12.3) ] .",
        "source": "US FDA label for tranexamic acid (Tranexamic acid), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/tranexamic-acid.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "No liver-impairment dose in this label. Not a statement that none is needed.",
        "source": "Read and found silent: the US FDA label for tranexamic acid (Tranexamic acid), retrieved 2026-08-29",
        "cached_file": "labels/tranexamic-acid.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Available data from published studies, case series and case reports with tranexamic acid use in pregnant women in the second and third trimester and at the time of delivery have not clarified whether there is a drug-associated risk of miscarriage or adverse maternal or fetal outcomes.",
        "source": "US FDA label for tranexamic acid (Tranexamic acid), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/tranexamic-acid.json",
        "verbatim": true
      },
      {
        "text": "There are 2 (0.02%) infant cases with structural abnormalities that resulted in death when tranexamic acid was used during conception or the first trimester of pregnancy; however, due to other confounding factors the risk of major birth defects with use of tranexamic acid during pregnancy is not clear.",
        "source": "US FDA label for tranexamic acid (Tranexamic acid), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/tranexamic-acid.json",
        "verbatim": true
      },
      {
        "text": "Tranexamic acid is known to pass the placenta and appears in cord blood at concentrations approximately equal to maternal concentration (see Data) .",
        "source": "US FDA label for tranexamic acid (Tranexamic acid), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/tranexamic-acid.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Contraception Concomitant use of tranexamic acid, which is an antifibrinolytic, with hormonal contraceptives may increase the risk for thromboembolic adverse reactions.",
        "source": "US FDA label for tranexamic acid (Tranexamic acid), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/tranexamic-acid.json",
        "verbatim": true
      },
      {
        "text": "Advise patients to use an effective alternative (nonhormonal) contraceptive method [see Warnings and Precautions ( 5.2 ), Drug Interactions (7.1) ] .",
        "source": "US FDA label for tranexamic acid (Tranexamic acid), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/tranexamic-acid.json",
        "verbatim": true
      },
      {
        "text": "Intravenous doses of 200 mg/kg/day showed slightly retarded weight gain in pregnant rabbits. 8.2 Lactation Risk Summary Published literature reports the presence of tranexamic acid in human milk.",
        "source": "US FDA label for tranexamic acid (Tranexamic acid), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/tranexamic-acid.json",
        "verbatim": true
      }
    ]
  }
}