Side effects of agomelatine

Side effects of agomelatine are listed below. Not everyone experiences these side effects — the way an antidepressant affects you is quite individual, so you might need to try more than one to find the one that suits you best.

Remember that the risk of side effects with any medicine needs to be weighed against its benefit in treating your condition. Your doctor can help you weigh up the risks and benefits of taking a particular medicine. See also Is this medicine right for me?

Abnormal increases in liver enzymes, which can be a sign of a change in liver function, occurred slightly more often in people taking agomelatine versus placebo (1.1% v. 0.7%) in clinical trials. This did not cause any serious harm, and was usually reversible, but liver function tests are recommended before you start taking agomelatine, and after 3, 6, 12 and 24 weeks, to check how your liver is working. Ask your doctor about having a liver function test if you have not had one at any of the recommended times.

Agomelatine is a relatively new antidepressant, compared to other commonly used kinds such as SSRIs. Rare side effects are sometimes not known about until a new medicine is used by a large number of people. See ‘Just because a medicine is new, does that mean it’s better?’.

Frequency of side effects with agomelatine

Common (1% of people or more)Infrequent (between 0.1% and 1% of people)Rare (fewer than 0.1% of people)
  • Dizziness
  • Abnormal changes in liver function tests
  • Abdominal pain
  • Nausea
  • Diarrhoea
  • Anxiety
  • Blurred vision
  • Sleepiness
  • Fatigue
  • Excessive sweating
  • Rash
  • Itch
  • Hepatitis
  • Liver failure
This is not a complete list of agomelatine’s side effects. See the consumer medicine information (CMI) for more information.

Agomelatine and driving or operating machinery

Do not drive or operate machinery until you know how this medicine affects you.

Who can I ask about side effects?

If you’re concerned that you or someone in your care is having side effects related to a medicine, seek medical advice.

Call the NPS Medicines Line on 1300 MEDICINE (1300 633 424) to get information about your prescription, over-the-counter and complementary medicines (herbal, ‘natural’, vitamins and minerals) from a pharmacist. Your call will be answered by healthdirect Australia.

To report and discuss possible side effects, call the Adverse Medicines Events (AME) line on 1300 134 237 from anywhere in Australia (Mon–Fri, 9am–5pm).

Find out more about

If you are starting agomelatine, see 10 things you should know about antidepressants.

You can also read more about depression and the options for treating it.

For more information

The consumer medicine information (CMI) for your brand of agomelatine is available from our website or a pharmacist. If you have any concerns about side effects, talk to your health professional. The CMI includes:

  • How to take this medicine
  • What to do if you forget to take it
  • If you take too much (overdose)
  • Things you must and must not do while taking this medicine
  • Signs of severe reactions and what to do.
Reference
  • Australian Medicines Handbook 2015. Adelaide: Australian Medicines Handbook Pty Ltd; 2015 January. [Online]