Tramadol

DRUG INFORMATION

  ADULT
    - 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
    - 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
    - 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

  CHILD
    - 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
    - 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

  RENAL IMPAIRMENT
    - ( 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
    - 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
    - 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

  HEPATIC IMPAIRMENT
    - ( 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
    - 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
    - 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

  PREGNANCY
    - 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
    - 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
    - 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

  BREASTFEEDING
    - 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
    - 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
    - ( 8.1 ) Lactation : Breastfeeding not recommended.
      Source: US FDA label for tramadol (Tramadol Hydrochloride), section 'use in
      specific populations', retrieved 2026-08-29