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Etodolac oral modified release

Updated 2 Feb 2023 | NSAIDs


Modified release formulations of etodolac.

Drugs List

  • etodolac 600mg modified release tablet
  • ETOLYN 600mg modified release tablet
  • ETOPAN XL 600mg tablets
  • LODINE SR 600mg tablets
  • Therapeutic Indications


    Rheumatoid arthritis


    Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.


    One tablet daily. If a lower dose is sufficient, etodolac 200mg or 300mg capsules may be used. The safety of doses in excess of 600mg per day has not been established.


    One tablet daily. If a lower dose is sufficient, etodolac 200mg or 300mg capsules may be used. The safety of doses in excess of 600mg per day has not been established.


    Children under 18 years
    History of gastrointestinal haemorrhage secondary to NSAID
    History of peptic ulcer
    Peptic ulcer
    Severe cardiac failure
    Severe hepatic impairment
    Severe renal impairment
    Third trimester of pregnancy

    Precautions and Warnings

    Females attempting to conceive
    Fluid retention
    Cardiac failure
    Cardiac impairment
    Cerebrovascular disorder
    Connective tissue disorder
    Crohn's disease
    First trimester of pregnancy
    Glucose-galactose malabsorption syndrome
    Hepatic impairment
    History of asthma
    Ischaemic heart disease
    Lactose intolerance
    Renal impairment
    Second trimester of pregnancy
    Severe peripheral arterial disease
    Systemic lupus erythematosus
    Ulcerative colitis

    Advise ability to drive/operate machinery may be affected by side effects
    Contains lactose
    Discontinue if signs of gastro-intestinal bleeding occur
    May affect platelet function
    Monitor liver function on prolonged therapy
    Monitor renal function in patients with cardiac impairment
    Monitor renal function in patients with hepatic impairment
    Patients on long-term therapy should be regularly reviewed
    Perform blood counts on prolonged use of this treatment
    High dose/long term use may increase risk of arterial thrombotic events
    NSAIDs may provoke bronchospasm/urticaria in susceptible patients
    Risk of gastro-intestinal bleeding increased in the elderly
    Severe gastro-intestinal side effects may occur without warning
    May affect results of some laboratory tests
    Discontinue if symptoms of peptic ulcer occur
    Discontinue treatment if skin rash or other allergic reaction occurs
    Maintain treatment at the lowest effective dose
    May cause impaired fertility

    Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with etodolac after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). Fluid retention and oedema have been reported with NSAID treatment.

    Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. Treatment should be discontinued at the first appearance of skin rash, mucosal lesions, or any other signs of hypersensitivity.

    In patients with renal impairment, cardiac impairment or hepatic impairment especially those taking diuretics, caution is required since the use of NSAIDs may result in deterioration of renal function. The dose should be kept as low as possible and renal function should be monitored.

    The risk of bleeding, ulceration or perforation is higher with increasing NSAID doses in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly. These patients should commence treatment on the lowest effective dose. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin or other drugs likely to increase gastrointestinal risk.

    In patients with systemic lupus erythematous and mixed connective tissue disorders there may be an increased risk of aseptic meningitis.

    Pregnancy and Lactation


    Drugs which inhibit prostaglandin biosynthesis may cause dystocia and delayed parturition as evidenced by studies in pregnant animals. Some inhibitors of prostaglandin biosynthesis have been shown to interfere with the closure of the ductus arteriosus. Safety in human pregnancy has not been established and etodolac should not be used during pregnancy.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    No reports describing the use of etodolac during lactation have been located. The low molecular weight (287), the excretion of etodolac into breast milk should be expected. Moreover, because of its long termination adult plasma half-life (7.3 hours), other agents e.g. ibuprofen may be preferred during lactation (Briggs, 2011).

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Effects on Ability to Drive and Operate Machinery

    The ability to drive or operate machinery may be affected by side effects such as dizziness, drowsiness or abnormal vision.

    Side Effects

    Abdominal pain
    Abnormal vision
    Anaphylactoid reaction
    Aseptic meningitis
    Cardiac failure
    Epigastric pain
    Exacerbation of colitis
    Exacerbation of Crohn's disease
    Eye changes
    Fluid retention
    Gastro-intestinal haemorrhage
    Gastro-intestinal ulceration
    Hepatic damage
    Hypersensitivity reactions
    Interstitial nephritis
    Liver function disturbances
    Nephrotic syndrome
    Papillary necrosis
    Peptic ulceration
    Peptic ulceration with perforation and haemorrhage
    Rectal bleeding
    Renal failure
    Stevens-Johnson syndrome
    Toxic epidermal necrolysis
    Ulcerative stomatitis
    Urinary frequency

    Effects on Laboratory Tests

    The presence of phenolic metabolites of etodolac in the urine may give a false positive bilirubin test result.


    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: February 2013

    Reference Sources

    British National Formulary, 64th Edition (2012) Pharmaceutical Press, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

    Summary of Product Characteristics: Etolyn 600 mg prolongd release tablets. Abdi Farma, Unipessoal Lda. Revised February 2015.
    Summary of Product Characteristics: Etopan XL. Taro Pharmaceuticals (UK) Ltd. Revised May 2006
    Summary of Product Characteristics: Lodine SR. Almirall Ltd. Revised October 2018.

    US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
    Available at:
    Etodolac Last revised: April 3, 2012
    Last accessed: February 12, 2013

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