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Diclofenac sodium topical


Gel formulation of diclofenac.

Drugs List

  • diclofenac sodium 1% gel
  • Therapeutic Indications


    Relief of pain and inflammation due to trauma



    Depending on the size of the affected site to be treated, 2 to 4g of gel (a circular shaped mass approximately 2 to 2.5cm in diameter) should be applied three to four times daily, with four hours between applications (maximum 4 doses in 24 hours).


    (See Dosage; Adult)


    Children 14 years and over
    (See Dosage; Adult)


    Administration site infection
    Children under 14 years
    Occlusive dressings
    Open wounds
    Nasal polyps, angioedema, and bronchospastic reactivity to NSAIDs
    Third trimester of pregnancy

    Precautions and Warnings

    Allergic disposition
    Haemorrhagic diathesis
    First trimester of pregnancy
    Hepatic impairment
    History of asthma
    History of peptic ulcer
    Inflammatory bowel disease
    Renal impairment
    Second trimester of pregnancy

    NSAIDs may provoke or exacerbate asthma
    Contains propylene glycol: may cause irritation
    Some preps contain methyl & propylparaben; may cause allergic reactions
    Some products may contain soya or soya derivative
    Advise patient to wash hands after use
    Avoid contact with diseased or inflamed skin
    Avoid contact with eyes
    Avoid contact with mucous membranes
    Breastfeeding: Wash product off breasts prior to breastfeeding infant
    For topical use only
    Prolonged use over a large area may cause systemic absorption
    Discontinue if patient is attempting to conceive
    Discontinue treatment if rash occurs
    Advise patient to minimise exposure of treated areas to sunlight/sunlamps
    Discontinue and consult a doctor if there is no improvement within 3 days

    Serious skin reactions, including exfoliative dermatitis, Stevens Johnson syndrome and epidermal necrolysis have been associated with the administration of NSAIDs. The risk of occurrence is highest during the first month of treatment. Concomitant use of oral NSAID's should be cautioned.

    Pregnancy and Lactation


    Diclofenac sodium is contraindicated during pregnancy.

    The manufacturer does not recommend using diclofenac sodium during the first and second trimesters of pregnancy unless clearly necessary. The dose should be low and the duration as short as possible.

    Use of diclofenac sodium during the third trimester of pregnancy is contraindicated by the manufacturer. There is an increased risk of developmental effects including cardiopulmonary toxicity and renal dysfunction.


    Use diclofenac sodium with caution during breastfeeding.

    The manufacturer does not recommend breastfeeding whilst using diclofenac sodium unless advised by a healthcare professional. Avoid application to the breast area.

    Side Effects

    Abdominal pain
    Application site reaction
    Burning sensation (local)
    Contact dermatitis
    Dry skin
    Gastrointestinal disorder
    Hypersensitivity reactions
    Renal disorders
    Skin disorder
    Skin reddening


    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: November 2019

    Reference Sources

    Summary of Product Characteristics: Diclofenac 1% Gel. Typharm Ltd. Revised November 2019.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.