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Tramadol oral standard release

Updated 2 Feb 2023 | Opioid analgesics


Standard release oral formulations of tramadol hydrochloride.

Drugs List

  • tramadol 2.5mg/drop (100mg/ml) oral drops
  • tramadol 50mg capsules
  • tramadol 50mg orodispersible tablets sugar-free
  • tramadol 50mg soluble tablet sugar-free
  • tramadol 50mg/5ml oral solution sugar-free
  • ZAMADOL 50mg capsules
  • ZAMADOL MELT 50mg orodispersible tablet
  • ZYDOL 50mg capsules
  • ZYDOL 50mg soluble tablet
  • Therapeutic Indications


    Pain - moderate to severe


    As with all analgesic drugs, the dose of tramadol hydrochloride should be adjusted according to the intensity of the pain and the clinical response of the individual patients.


    Acute pain
    An initial dose of 50 to 100mg (20 to 40 drops of oral drops) is usually necessary. This can be followed by doses of 50mg or 100mg not more frequently than 4 hourly, and duration of therapy should be matched to clinical need. Oral drops should be given three to four times a day. The lowest effective dose should be used in all formulations.
    A total daily dose of 400mg (160 oral drops) should not be exceeded except in special clinical circumstances.

    Pain associated with chronic conditions
    Initial dose of 50mg (20 oral drops) and then titrate dose according to pain severity.
    Increasing the dosage in increments every 2 to 3 days should reduce the incidence of adverse events.
    A total daily dose of 400mg (160 oral drops) should not be exceeded except in special clinical circumstances.


    12 years and over
    (See Dosage; Adults)

    Patients with Renal Impairment

    Glomerular filtration rate 10 to 20ml/minute: Initially 50mg to 100mg every 8 hours.
    Glomerular filtration rate less than 10ml/minute: Initially 50mg every 8 hours.

    Some brands recommend:
    Creatinine clearance between 10 and 30ml/minute: Increase dosage interval to 12 hours.
    Creatinine clearance less than 10ml/minute: Not recommended.


    Acute alcohol intoxication
    Children under 12 years
    Risk of paralytic ileus
    Within 2 weeks of discontinuing MAOIs
    Acute asthma
    Acute respiratory depression
    Chronic obstructive pulmonary disease
    Head trauma
    Long QT syndrome
    Raised intracranial pressure
    Severe hepatic impairment
    Severe renal impairment
    Torsade de pointes
    Uncontrolled epileptic disorder

    Precautions and Warnings

    Children aged 12 to 18 years
    Family history of long QT syndrome
    Impaired consciousness
    Patients over 75 years
    Predisposition to seizures
    Adrenal insufficiency
    Benign prostatic hyperplasia
    Biliary tract disorder
    CYP2D6 poor metaboliser genotype
    CYP2D6 ultra-rapid metaboliser genotype
    Electrolyte imbalance
    Epileptic disorder
    Excessive bronchial secretions
    Gastrointestinal obstruction
    Glucose-galactose malabsorption syndrome
    Hereditary fructose intolerance
    History of alcohol abuse
    History of drug misuse
    History of seizures
    History of torsade de pointes
    Inflammatory bowel disease
    Mild hepatic impairment
    Mild renal impairment
    Myasthenia gravis
    Opioid dependence
    Psychiatric disorder
    Respiratory depression
    Respiratory impairment
    Sleep apnoea

    Children under 18 years: Increased risk of rare and severe adverse effects
    Correct electrolyte disorders before treatment
    CYP2D6 ultra-rapid metaboliser genotype: Increased risk of opioid toxicity
    Reduce dose and/or alter dose interval in patients with hepatic impairment
    Reduce dose and/or alter dose interval in patients with renal impairment
    Some formulations contain aspartame - caution in phenylketonuria
    Advise patient ability to drive or operate machinery may be impaired
    Advise patient drowsiness may affect ability to drive or operate machinery
    Advise patient not to drive until they know how the medicine affects them
    Advise patient this medicine may be subject to driving restrictions
    Not suitable as a substitute in opioid-dependent patients
    Some formulations contain propylene glycol
    Some formulations contain sucrose
    Consider monitoring ECG in patients at risk of QT prolongation
    Monitor at regular intervals as withdrawal symptoms & dependence may occur
    Monitor patient for signs and symptoms of respiratory depression
    Monitor patients for signs and symptoms of Serotonin Syndrome
    Monitor patients receiving concurrent anticoagulants
    Monitor patients with a history of alcoholism and drug abuse
    Monitor serum electrolytes
    Neonate exposed in utero: Monitor for neonatal withdrawal syndrome
    Patients on long-term therapy should be regularly reviewed
    Potential for drug abuse
    Tolerance and dependence may occur
    When used with SSRIs, risk of Serotonin syndrome
    Consider dose reduction if sleep-related breathing disorders occur
    Consider dose reduction or change in opioid if evidence of hyperalgesia
    Consider dose reduction or discontinuation if serotonin syndrome suspected
    Increased risk of central sleep apnoea and sleep-related hypoxemia
    May cause convulsions
    May increase risk of seizure
    Neonate exposed in labour: Risk of respiratory depression
    Prolonged use at high doses may result in hyperalgesia
    Withdrawal symptoms after long-term normal use on abrupt cessation
    Avoid abrupt withdrawal
    Maintain treatment at the lowest effective dose
    Reduce dose and/or alter dose interval in elderly patients
    Advise patient not to take St John's wort concurrently
    Advise patient to avoid alcohol during treatment
    Advise that effects are potentiated by CNS depressants (including alcohol)

    Not recommended during potentially light planes of general anaesthesia due to a possibly increased intra-operative recall reported.

    Not recommended in children at risk of impaired respiratory function including those with neuromuscular disorders, severe cardiac or respiratory conditions, upper respiratory or lung infections, multiple trauma or extensive surgical procedures. Extreme caution and monitoring for signs of opioid toxicity is also advised in children following tonsillectomy and/or adenoidectomy for obstructive sleep apnoea.

    Strategy for ending treatment with tramadol hydrochloride should be discussed with the patient before starting treatment in order to minimise risk of drug withdrawal syndrome and addiction.

    Pregnancy and Lactation


    Tramadol hydrochloride is contraindicated during pregnancy.

    The manufacturer does not recommend the use of tramadol hydrochloride during pregnancy. Prolonged use of tramadol hydrochloride during pregnancy may result in drug dependency in the foetus and withdrawal symptoms in the neonate.

    At the time of writing there is limited published information regarding the use of tramadol during pregnancy, however tramadol is known to cross the placenta, and administration of tramadol during labour may cause respiratory depression in the neonate (Briggs, 2015). Tramadol does not affect uterine contractility. Animal studies have shown adverse effects on the development of organs, bone formation and neonatal mortality with very large concentrations of tramadol. No teratogenic effects have been observed.


    Use tramadol with caution during breastfeeding.

    The manufacturer does not recommend the use of tramadol during breastfeeding, tramadol and its metabolites are secreted into breast milk, which may cause respiratory depression in the infant.

    LactMed (2021) state that healthy full term infants are unlikely to be adversely affected by exposure to tramadol via breast milk, however, if used in infants, the infant should be monitored for increased sleepiness, breathing difficulties, difficulty breastfeeding and limpness, and medical advice sought immediately should any of these occur.

    Effects on Ability to Drive and Operate Machinery

    This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988 (England and Wales). When prescribing this medicine: Advise patient the medicine can affect cognitive function and is likely to affect ability to drive. Advise patient not to drive until they know how the medicine affects them.


    Advise patients that the capsules should be taken whole, not divided or chewed, with sufficient liquid, independent of meals.
    Advise patients that the orodispersible tablet should be allowed to rapidly disperse in the mouth before swallowing. Alternatively, the tablet may be dispersed in half a glass of water, stirred and drunk immediately, independent of meals.
    Advise patients that the soluble tablet should be dissolved in at least 50ml of water and taken independently of meals.
    Advise patients that the oral drops should be diluted with water, and taken independently of meals.
    Tramadol may cause drowsiness, and this effect may be potentiated by alcohol and other CNS depressants. Ambulant patients should be warned not to drive or operate machinery if affected.

    Side Effects

    Aggravation of existing asthma
    Allergic reaction
    Blood dyscrasias
    Blurred vision
    Cardiovascular collapse
    Changes in cognitive and sensorial capacity
    Changes in mental activity
    Difficulty in micturition
    Disturbances of appetite
    Dry mouth
    Epileptiform seizures
    Gastric irritation
    Impaired co-ordination
    Increases in hepatic enzymes
    Involuntary muscle contractions
    Mood changes
    Muscle weakness
    Orthostatic hypotension
    Respiratory depression
    Serotonin syndrome
    Sleep disturbances
    Speech disturbances
    Urinary retention
    Withdrawal symptoms

    Withdrawal Symptoms and Signs

    Withdrawal symptoms may occur after long-term use on abrupt cessation. When patient no longer requires treatment, advise to taper dose gradually to prevent withdrawal. Tapering dose may take weeks to months. Risk of neonatal withdrawal syndrome in newborn infants if used during pregnancy. The opiod drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia and palpitations. Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: April 2013

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    NICE Evidence Services Available at: Last accessed: 17 March 2022

    Summary of Product Characteristics: Tramadol hydrochloride capsules. Actavis UK Ltd. Revised November 2012.
    Summary of Product Characteristics: Tramadol Hydrochloride 10mg/ml Oral Solution. Morningside Healthcare Ltd. Revised November 2021.
    Summary of Product Characteristics: Tramadol 100mg/ml oral drops. Mercury Pharma Group. Revised April 2012.

    Summary of Product Characteristics: Zamadol capsules. Meda Pharmaceuticals. Revised September 2012.
    Summary of Product Characteristics: Zamadol Melt. Meda Pharmaceuticals. Revised September 2012.

    Summary of Product Characteristics: Zydol Soluble Tablets. Grunenthal Ltd. Revised March 2020.
    Summary of Product Characteristics: Zydol capsules. Grunenthal Ltd. Revised March 2020.

    The Renal Drug Handbook. Fifth Edition (2019) ed. Ashley, C. and Dunleavy, A. Radcliffe Publishing Ltd, London.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Tramadol Last revised: 20 September 2021
    Last accessed: 17 March 2022 Government departments. Department for Transport. Publications. Drug driving and medicine: advice for healthcare professionals. Drug driving: Guidance for healthcare professionals on drug driving. Available at: Last accessed: 6 January 2015 New drug driving offence implications for medicines packaging. Medicines Regulatory News. 10 December 2013. Available at: Last accessed: 6 January 2015

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