Fluoroquinolone antibiotics

This patient information leaflet is for all patients who may be prescribed a fluoroquinolone antibiotic. Its aim is to outline the recent MHRA safety information in relation to these medicines. The MHRA is the regulatory body which is responsible for checking that medicines are acceptably safe to use.

Key information

• Fluoroquinolone medicines (ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, and ofloxacin) are effective antibiotics that treat serious and life-threatening infections. Your doctor has prescribed them for you as they are the best choice of antibiotic to treat your infection. There is, however, a risk of side effects when taking these medicines.
• Your doctor will advise you when and how to take antibiotics. Speak to your doctor if you think you are having a side effect.
• Fluoroquinolones have been reported to cause serious side effects involving tendons, muscles, joints, and nerves, also mental health effects which may include, but are not necessarily limited to, anxiety, panic attacks, and memory impairment. In a small proportion of patients, these side effects caused long-lasting or permanent disability.
• It is unclear how common these side effects are. At a rough estimate, between 1 and 10 in every 10,000 people who take a fluoroquinolone may experience a side effect.
• Fluoroquinolones have also been reported to cause psychiatric side effects including confusion, disorientation, anxiety, depression and suicidal thoughts or suicide attempts.
• You may not notice some changes in your mood and behaviour so it is very important to tell your friends and family that you are taking these medicines, and that they can have rare psychiatric side effects. Other people may notice changes and help you quickly identify any symptoms that you need to talk to your doctor about.
• If you develop thoughts of suicide or have attempted suicide, do not take any further doses of your fluoroquinolone, and talk to your doctor or another healthcare professional immediately

Stop taking your fluoroquinolone antibiotic and contact your doctor immediately if you have the following signs of a side effect:

• Tendon pain or swelling, often beginning in the ankle or calf - if this happens, rest the painful area until you can see your doctor.
• Pain in your joints or swelling in your shoulder, arms, or legs.
• Abnormal pain or sensations (such as persistent pins and needles, tingling, pricking, numbness, or burning), weakness in your body, especially in the legs or arms, or difficulty walking.
• Severe tiredness, depressed mood, anxiety, panic attacks, confusion, problems with your memory, or severe problems sleeping.
• Changes in your vision, taste, smell, or hearing.

Questions you may have about your medicine

What are fluoroquinolone antibiotics?

Fluoroquinolone antibiotics are a group of medicines that kill bacteria and have an important role in treating certain life- threatening infections. In the UK, the fluoroquinolones used are ciprofloxacin, delafloxacin, levofloxacin, moxifloxacin, and ofloxacin. This advice only applies to medicines that are swallowed, inhaled, or injected into the body.

Why has the advice about these medicines changed?

Restrictions on the use of fluoroquinolones were introduced in 2019 to minimise the risk of adverse side effects. In 2023 the MHRA reviewed the effectiveness of these restrictions in the UK and has taken additional action to further minimise the risk. The initial restrictions recommended that fluoroquinolones should not be used for conditions that are not serious or that get better on their own. This was because the expected benefits of using fluoroquinolones in these situations did not outweigh the risk of side effects. The new advice goes beyond this, stating that, in all their uses fluoroquinolones must now only be prescribed when other commonly recommended antibiotics are not appropriate.

What can I do if I think I’m having a side effect?

Tendon or muscle problems or feeling particularly unwell may be caused by events other than your medicines. It is therefore important for symptoms to be investigated. The best person to talk to is your doctor. If you are unable to see your doctor, you can call 111 for advice. Don’t delay in talking to your doctor if you think something is wrong.

Who can I tell about my side effects?

Please report any side effects to the MHRA via the Yellow Card scheme. Reports are confidential and help to improve the safety of medicines. Report side effects on the Yellow Card Scheme website (opens in a new tab) or search for Yellow Card scheme). You can also use the Yellow Card App, available on the Apple App Store or Google Play Store.

Contacts/Further information

If you require further advice or have any queries regarding information in this leaflet please contact our medicines information team. You can reach the team - email CUH medicines information (opens in a new tab) or call 01223 217502.