Medicines advice | Medicines alerts

Updated safety messaging about fluoroquinolone antibiotics

The MHRA (Medicines and Healthcare products Regulatory Agency), which is responsible for the safety of medicines in the UK, has recently published an alert about the safety of a particular group of antibiotics called fluoroquinolones. This is because of concerns about rare but potentially serious side-effects affecting the muscles, tendons, joints and nerves, and psychiatric side-effects.

April 9, 2024

What are fluoroquinolones?

These antibiotics are used to treat serious and life-threatening infections. They include ciprofloxacin, levofloxacin, moxifloxacin and ofloxacin. The safety concern only relates to these antibiotics when they are taken by mouth, inhaled (breathed in) or given by injection. It does not apply to eye or ear drops.

The safety concern does not apply to any other types of antibiotic. 

What is the concern?

  • Fluoroquinolones can occasionally cause serious side-effects involving the tendons, muscles, joints and nerves, such as:
      • Pain or swelling in the tendons, which often starts in the ankle or calf (lower leg)
      • Pain or swelling in the joints
      • Pain or unusual sensations such as persistent pins and needles, tingling, prickling, numbness or burning
      • Weakness in the body, especially in the legs or arms, or difficulty walking
      • Severe tiredness
      • Depressed mood, anxiety, panic attacks, confusion, memory problems
      • Difficulty sleeping
      • Changes in eyesight, taste, smell or hearing.
  • These side effects may cause long-lasting or permanent disability in some patients. There is not treatment for the side-effects.
  • Fluoroquinolones have also been reported to cause psychiatric side-effects in a small number of patients. These effects include confusion, disorientation, anxiety, depression and suicidal thoughts or suicide attempts.
  • The side effects are rare, meaning that they may affect between 1 and 10 people in every 10,000 who take a fluoroquinolone.

Is this new information?

These rare side-effects of fluoroquinolones are already known about. Since 2019 the use of these antibiotics has been restricted to severe infections. The MHRA has now restricted their use further, and they can only be used if other antibiotics haven’t worked.

Should I be worried?

If your doctor recommends treatment with a fluoroquinolone antibiotic, this is likely to be because your child has a serious infection and other antibiotics haven’t worked. Your doctor should explain the benefits and risks. For most children, the potential benefit of treatment with a fluoroquinolone antibiotic is much higher than the risk of harm.

If your child is given these antibiotics, tell your doctor immediately if you notice any of the side-effects described above.

Where can I get more information?

The MHRA has published new guidance for patients, available from their website here.