February 21, 2018

Why is everyone talking about codeine?

codeine man blurry

A lot of people are talking about codeine, an opioid painkiller designed for acute, moderate-to-severe pain (think dental pain, or post-surgery pain).1

Codeine is often combined with other painkillers like paracetamol or ibuprofen, in products like Panadeine or Neurofen Plus. Historically, codeine — or ‘combination drugs’ containing codeine — were available over-the-counter in Australia. You didn’t need a prescription to purchase them.

On 1 February 2018 however, that changed. The Therapeutic Goods Administration (TGA) up-scheduled codeine from a Schedule 3 Drug to Schedule 4.2


The ‘schedule’ of any drug is the TGA’s way of classifying what drugs people can access in Australia. Schedule 8 drugs, for example, cannot be purchased. They’re classified as potentially too harmful. Schedule 3 drugs, like most cold and flu medications, are available over-the-counter. Schedule 4 means prescription-only.3

What this means is that medicine containing codeine can no longer be bought without a prescription.

The main reasons the TGA made this decision are: the risk of harm (death and dependence), and evidence that says low-dose medicines containing codeine (the sort you could previously obtain over-the-counter, typically less than 30 grams) offer very little additional benefit for chronic pain when compared to medicines without codeine.2, 3

Deaths and dependence

Codeine related deaths in Australia more than doubled between 2000 and 2009.3

In 2016, more than 500,000 Australians used over-the-counter codeine medications without medical supervision.4

In Victoria, pharmaceuticals, including a significant number of over-the-counter medications containing codeine, were responsible for 330 of the state’s 420 deaths in 2015.5 That’s 80 per cent.

Codeine, like all opioids, carries a risk of tolerance and dependence with regular use.1 You need more of the drug to experience your original level of pain relief, and discontinuing the drug causes significant physical and psychological distress.1 The need to take larger and larger doses of codeine is especially dangerous when the medication also contains paracetamol or anti-inflammatory drugs like ibuprofen.6 Overuse of paracetamol can cause liver disease and kidney failure and death,7 while ibuprofen overuse can cause internal bleeding, toxicity and death.6

Chronic pain

Chronic pain is daily pain that persists for longer than three months.8 Everyone’s experience of pain is different, but in Australia, one in five will experience chronic pain.8 Up to 80% of Australians will experience back pain at some point in their lives, and 10% will experience significant disability as a result.9 Unfortunately, while many people take medicines with codeine specifically for chronic back pain, recent evidence suggests that medicines containing codeine, at the sort of dose you could purchase over the counter, are no more effective for this condition than drugs without it.2, 10 There is similar data around use of codeine for arthritis and migraine.10

This means that a lot of people are taking increasing amounts of a drug that has significant health risks without experiencing significant benefits.

Some instances of chronic pain still require medicines that contain codeine, but any prolonged use of any pharmaceutical drug should be overseen by a health professional,11 and any chronic condition deserves support. There may be other strategies they can recommend either instead of or in combination with your current medications. This might include referral to a pain specialist or pain clinic.11, 12

Withdrawing from codeine

While restricting access to codeine is recommended for all the reasons we’ve discussed, there is concern that people may find themselves experiencing withdrawal without realising they have developed a dependence.10 Giving up codeine after using it for a long time is challenging as the body must get used to functioning without it.1 For this reason it’s important to seek advice from a medical professional.

Withdrawal symptoms usually start within a few hours after the last dose and are strongest 48 to 72 hours later.1

Symptoms can include:

  • cravings for codeine;
  • dilated pupils;
  • abdominal cramps, diarrhoea, nausea and vomiting;
  • lack of appetite;
  • runny nose and sneezing;
  • yawning and difficulty sleeping;
  • trembling, aching muscles and joints;
  • ‘goosebumps’, fever, chills, sweating; and
  • restlessness, irritability, nervousness and depression.

Help for the impacts of codeine and withdrawal

If your codeine use is affecting your health, family, relationships, work, school, financial or other life situations, there is help and support. This includes:

  1. Alcohol and Drug Foundation: What is codeine?
  2. Alcohol and Drug Foundation: Help and support
  3. Alcohol and Drug Foundation: Supporting a loved one through withdrawal
  4. NPS MedicineWise – medicines with codeine – What you need to know
  5. Therapeutic Goods Administration – Codeine information hub
  1. Alcohol and Drug Foundation, "Drug Facts - Codeine," 19 January 2018. [Online]. Available: www.adf.org.au/drug-facts/codeine/
  2. Therapeutic Goods Administration, "Codeine information hub" Department of Health, 31 January 2017. [Online]. Available: www.tga.gov.au/codeine-info-hub
  3. Therapeutic Goods Administration, "Final decision on re-scheduling of codeine: frequently asked questions," Department of Health, 20 December 2016. [Online]. Available: www.tga.gov.au/final-decision-re-scheduling-codeine-frequently-asked-questions
  4. S. A. Schug, M. D. Dobbin and J. L. Pilgrim, "Caution with the forthcoming rescheduling of over-the-counter codeine-containing analgesics," Med J Aust., vol. 208, no. 1, pp. 51-52, 2018
  5. Coroner’s Court of Victoria “Responses – Inquest into the death of Frank Edward Frood” Coroner’s Court of Victoria, 8 July 2016. [Online]. Available: www.coronerscourt.vic.gov.au/home/coroners+written+findings/responses+-+inquest+into+the+death+of+frank+edward+frood
  6. M. Y. Frei, S. Nielsen, M. D. Dobbin and C. L. Tobin, "Serious morbidity associated with misuse of over-the-counter codeine-ibuprofen analgesics: a series of 27 cases," Med J Aust., vol. 193, no. 5, pp. 294-6, 2010.
  7. A. Roxburgh, W. D. Hall, L. Burns, P. J. E. Saar, S. Nielsen and L. Degenhardt, "Trends and characteristics of accidental and intentional codeine overdose deaths in Australia," Med J Aust. , vol. 203, no. 7, p. 299, 2015.
  8. Pain Australia, "National Pain Strategy: Pain Management for All Australians," National Pain Summit Initiative, Sydney, 2010.
  9. A. M. Briggs and R. Buchbinder, "Back pain: a National Health Priority Area in Australia?," Medical Journal of Australia, vol. 190, no. 9, pp. 499-502, 2009.
  10. J. McCoy, R. Bruno and S. Nielsen, "Attitudes in Australia on the upscheduling of over-the-counter codeine to a prescription-only medication," Drug Alcohol Rev., vol. 37, no. 2, pp. 257-261, 2018.
  11. NPS Medicinewise, "Medicines with codeine – what you need to know," 2018. [Online]. Available: www.nps.org.au/medical-info/consumer-info/medicines-with-codeine-what-you-need-to-know
  12. Pain Management Network, "Chronic Pain Management Strategies," Agency for Clinical Innovation, 2014. [Online]. Available: www.painaustralia.org.au/getting-help/get-help-resources/factsheet

This article was written by Kit Kavanagh-Ryan from original research conducted by Dr Ben O’Mara.

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