{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "tramadol",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "Start at 25 mg/day and titrate in 25 mg increments as separate doses every 3 days to reach 100 mg/day (25 mg four times a day).",
        "source": "US FDA label for tramadol (Tramadol Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tramadol.json",
        "verbatim": true
      },
      {
        "text": "Thereafter the total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg/day (50 mg four times a day).",
        "source": "US FDA label for tramadol (Tramadol Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tramadol.json",
        "verbatim": true
      },
      {
        "text": "After titration, tramadol hydrochloride tablets 50 mg to 100 mg can be administered as needed for pain relief every 4 to 6 hours not to exceed 400 mg/day .",
        "source": "US FDA label for tramadol (Tramadol Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tramadol.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness of tramadol hydrochloride tablets in pediatric patients have not been established. Life-threatening respiratory depression and death have occurred in children who received tramadol [see Warnings and Precautions (5.6) ] .",
        "source": "US FDA label for tramadol (Tramadol Hydrochloride), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/tramadol.json",
        "verbatim": true
      },
      {
        "text": "Tramadol hydrochloride tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. ( 2.1 ) Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.",
        "source": "US FDA label for tramadol (Tramadol Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tramadol.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "( 2.3 , 2.4 ) Severe Renal Impairment : Increase the tramadol hydrochloride tablets dosing interval to 12 hours, and limit maximum daily dose to 200 mg.",
        "source": "US FDA label for tramadol (Tramadol Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tramadol.json",
        "verbatim": true
      },
      {
        "text": "Dosage Modification in Patients with Renal Impairment In all patients with creatinine clearance less than 30 mL/min, it is recommended that the dosing interval of tramadol hydrochloride tablets be increased to 12 hours, with a maximum daily dose of 200 mg.",
        "source": "US FDA label for tramadol (Tramadol Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tramadol.json",
        "verbatim": true
      },
      {
        "text": "Since only 7% of an administered dose is removed by hemodialysis, dialysis patients can receive their regular dose on the day of dialysis.",
        "source": "US FDA label for tramadol (Tramadol Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tramadol.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "( 2.3 ) Severe Hepatic Impairment : Recommended dose is 50 mg every 12 hours.",
        "source": "US FDA label for tramadol (Tramadol Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tramadol.json",
        "verbatim": true
      },
      {
        "text": "Dosage Modification in Patients with Hepatic Impairment The recommended dose for adult patients with severe hepatic impairment is 50 mg every 12 hours.",
        "source": "US FDA label for tramadol (Tramadol Hydrochloride), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/tramadol.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 regularly evaluate renal function. 8.6 Renal and Hepatic Impairment Impaired renal function results in a decreased rate and extent of excretion of tramadol and its active metabolite, M1.",
        "source": "US FDA label for tramadol (Tramadol Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/tramadol.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4)] .",
        "source": "US FDA label for tramadol (Tramadol Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/tramadol.json",
        "verbatim": true
      },
      {
        "text": "Available data with tramadol hydrochloride tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage.",
        "source": "US FDA label for tramadol (Tramadol Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/tramadol.json",
        "verbatim": true
      },
      {
        "text": "In animal reproduction studies, tramadol administration during organogenesis decreased fetal weights and reduced ossification in mice, rats, and rabbits at 1.4, 0.6, and 3.6 times the maximum recommended human daily dosage (MRHD).",
        "source": "US FDA label for tramadol (Tramadol Hydrochloride), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/tramadol.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Infertility Use of opioids for an extended period of time may cause reduced fertility in females and males of reproductive potential.",
        "source": "US FDA label for tramadol (Tramadol Hydrochloride), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/tramadol.json",
        "verbatim": true
      },
      {
        "text": "It is not known whether these effects on fertility are reversible [see Adverse Reactions (6.2) ] .",
        "source": "US FDA label for tramadol (Tramadol Hydrochloride), section 'nursing mothers', retrieved 2026-08-29",
        "cached_file": "labels/tramadol.json",
        "verbatim": true
      },
      {
        "text": "( 8.1 ) Lactation : Breastfeeding not recommended.",
        "source": "US FDA label for tramadol (Tramadol Hydrochloride), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/tramadol.json",
        "verbatim": true
      }
    ]
  }
}