No black box warning on record for Ciprofloxacin

As of the latest FDA labeling reviewed, Ciprofloxacin (ciprofloxacin hydrochloride) does not carry a black box warning. Standard warnings and precautions still apply — see the full Ciprofloxacin medicine page for the complete safety profile.

Other warnings & precautions

Serious Adverse Reactions (Boxed Warning): Fluoroquinolones including ciprofloxacin are associated with disabling and potentially irreversible serious adverse reactions that may occur together: tendinitis and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue immediately and avoid fluoroquinolones if any of these occur. Reserve fluoroquinolones for infections with no alternative options.
Tendinitis and Tendon Rupture: Risk is significantly higher in patients over 60 years, those receiving concomitant corticosteroids, and kidney, heart, or lung transplant patients. Achilles tendon rupture is most common but any tendon can be affected. Can occur during or up to several months after stopping therapy.
Peripheral Neuropathy: Symptoms can include pain, burning, tingling, numbness, weakness, or altered sensation. Can occur shortly after initiation and may be permanent. Discontinue at first sign of neuropathy.
Aortic Aneurysm: FDA warning (2018) — fluoroquinolones may increase the risk of aortic dissection or aneurysm, particularly in elderly patients. Avoid in patients at risk for aortic aneurysm unless no alternative antibiotic.
Not First-Line for CAP: Ciprofloxacin has poor activity against S. pneumoniae. It should not be used as first-line therapy for community-acquired pneumonia unless a respiratory fluoroquinolone (levofloxacin, moxifloxacin) is chosen.

Other warnings & precautions

Serious Adverse Reactions (Boxed Warning): Fluoroquinolones including ciprofloxacin are associated with disabling and potentially irreversible serious adverse reactions that may occur together: tendinitis and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue immediately and avoid fluoroquinolones if any of these occur. Reserve fluoroquinolones for infections with no alternative options.

Tendinitis and Tendon Rupture: Risk is significantly higher in patients over 60 years, those receiving concomitant corticosteroids, and kidney, heart, or lung transplant patients. Achilles tendon rupture is most common but any tendon can be affected. Can occur during or up to several months after stopping therapy.

Peripheral Neuropathy: Symptoms can include pain, burning, tingling, numbness, weakness, or altered sensation. Can occur shortly after initiation and may be permanent. Discontinue at first sign of neuropathy.

Aortic Aneurysm: FDA warning (2018) — fluoroquinolones may increase the risk of aortic dissection or aneurysm, particularly in elderly patients. Avoid in patients at risk for aortic aneurysm unless no alternative antibiotic.

Not First-Line for CAP: Ciprofloxacin has poor activity against S. pneumoniae. It should not be used as first-line therapy for community-acquired pneumonia unless a respiratory fluoroquinolone (levofloxacin, moxifloxacin) is chosen.

Ciprofloxacin Black Box Warning

No black box warning on record for Ciprofloxacin

Other warnings & precautions

Ciprofloxacin Black Box Warning

No black box warning on record for Ciprofloxacin

Other warnings & precautions