Below is some information on the possible side effects and other safety information to be aware of while taking RINVOQ. You should also read the full Consumer Medicine Information for things to be aware of, and to tell your doctor about, before starting RINVOQ treatment. If you are not sure whether you should start taking this medicine, talk to your doctor.

What side effects should I be mindful of when taking RINVOQ?

Like all medicines, RINVOQ may cause side effects. Sometimes they are serious, but most of the time they are not.1

The way that RINVOQ works means that it reduces the activity of your immune system.2 This can reduce your body’s ability to fight against infection and may make an infection that you already have worse, or make it more likely for you to get a new infection.1 Elderly patients taking RINVOQ may also be more prone to getting infections. Because of this, it is important to look out for the signs of infection.

Some important signs of infection to look out for are listed below. You should talk to your doctor or get medical help straight away if you get any signs of serious infection, such as:1

  • Fever, sweating or chills
  • Feeling short of breath
  • Warm, red or painful skin sores on your body
  • Feeling tired
  • Muscle aches
  • Blood in your phlegm, or mucus
  • Diarrhoea or stomach pain
  • Weight loss
  • Cough
  • Burning when you pass urine or passing urine more often than normal

Cases of shingles have been reported in some people taking RINVOQ. Tell your doctor if you develop a painful skin rash with blisters during your treatment, as this can be a sign of shingles.1

Cases of tuberculosis (TB) have been reported in some people taking RINVOQ. Signs of TB include a persistent cough, weight loss, night sweats and fever.1 If you are experiencing this, tell your doctor and seek medical help straight away.

Other important side effects and safety information

Tell your doctor and seek medical help immediately if you get pain, redness or swelling of the leg, chest pain, or shortness of breath, as these can be signs of blood clots in the veins.

People who have problems with their immune system are at increased risk of cancer, including lymphoma. Tell your doctor if you notice symptoms such as swelling of the glands in the neck, armpit or groin.

Tell your doctor if you notice any new spots on your skin, a spot that looks different, a sore that doesn't heal, a mole or freckle that has changed size, shape, colour or bleeds. Your doctor will conduct regular skin checks for any suspicious spots. You should wear sunscreen and a hat when outdoors and avoid getting sunburnt.

Do not take RINVOQ if you have an allergy to any medicine containing upadacitinib or any of the ingredients listed in the Consumer Medicine Information (CMI).

Go straight to the Emergency Department at your nearest hospital if you notice any signs or symptoms of an allergic reaction. These may include:

  • Difficulty breathing or swallowing
  • Swelling of the face, lips, tongue or throat
  • Severe itching of skin, with a red rash or raised bumps

Tell your doctor or pharmacist if you notice any of the following common side effects and they worry you:1

  • Symptoms that may suggest an infection in the nose or throat
  • Feeling sick in the stomach
  • Fever
  • Weight gain
  • Acne
  • Cold sores

Some of the side effects can only be found when your doctor does tests from time to time to check your progress, so make sure you keep your appointments for your blood tests.

Also, tell your doctor:1

  • Immediately if you become pregnant while taking RINVOQ
  • If you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines should not be taken together with RINVOQ.

Tell any other healthcare professionals (doctors, dentists, pharmacists, or nurses) who treat you that you are taking RINVOQ, including before receiving any immunisations (vaccines). Some vaccines should not be given while you are taking RINVOQ.1

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking RINVOQ. You can ask your doctor or pharmacist any questions you may have.

Other side effects not listed above may also occur in some people. You can ask your doctor, nurse or pharmacist any questions you may have.

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. The Therapeutic Goods Association (TGA) monitors some medicines to collect additional safety information. You can help by reporting any side effects you may get. You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems.