Gemifloxacin is a fourth generation, oral fluoroquinolone antibiotic used in the therapy of mild-to-moderate respiratory tract infections caused by susceptible organisms. Gemifloxacin has been linked to rare instances of acute liver injury.


Gemifloxacin is an oral, fourth generation fluoroquinolone that is used to treat mild-to-moderate respiratory tract infections. Like other fluoroquinolones, gemifloxacin is active against a wide range of aerobic gram-positive and gram-negative organisms and is believed to act by inhibition of bacterial DNA gyrase and topoisomerase IV that are required for synthesis of bacterial mRNAs (transcription) and DNA replication. In contrast, DNA gyrases are not present in human [and other eukarotic] cells and the equivalent topoisomerases are not sensitive to fluoroquinolone inhibition. Gemifloxacin was approved for use in the United States in 2003 and has not been as commonly used as other fluoroquinolones such as ciprofloxacin and levofloxacin. Current indications are limited to acute exacerbations of chronic bronchitis and community acquired pneumonia. Gemifloxacin is available under the commercial name Factive in 320 mg tablets. The recommended dose is 320 mg once daily for 5 to 7 days. Common side effects include diarrhea, nausea, abdominal pain, headaches, skin rash and allergic reactions. The less common but more severe side effects of the fluoroquinolones include prolongation of the QT interval, seizures, hallucinations, tendon rupture, severe hypersensitivity reactions, Stevens Johnson syndrome, angioedema and photosensitivity.


Gemifloxacin (jem" i flox' a sin), like other fluoroquinolones, is associated with a low rate (1% to 7%) of serum enzyme elevations during therapy, although this rate may be slightly higher than occurs with placebo or comparative agents. These abnormalities are generally mild, asymptomatic and transient, resolving even with continuation of therapy. Too few cases of hepatotoxicity due to gemifloxacin have been reported to provide a reliable description of its clinical features and course. However, the liver injury due to the fluoroquinolones appears to be a class effect, and gemifloxacin injury appears to share these characteristics. It is a far less common cause of liver injury than ciprofloxacin, levofloxacin or moxifloxacin, but cases have been reported. In general, fluoroquinone hepatotoxicity is marked by a short time to onset (a few days to 3 weeks); often presenting abruptly with marked nausea, fatigue, abdominal pain and jaundice. The pattern of serum enzyme elevations can be either hepatocellular or cholestatic, and cases with the shorter times to onset are usually more hepatocellular with markedly elevated ALT levels, and occasionally, with rapid worsening of prothrombin time and signs of hepatic failure. The onset of illness may occur a few days after the medication is stopped. Many (but not all) cases have had allergic manifestations with fever, rash and eosinophilia. Autoantibodies are usually not present.

Likelihood score: D (possible rare cause of clinically apparent liver injury).

Mechanism of Injury

The mechanism of fluoroquinolone hepatotoxicity is suspected to be hypersensitivity. Rechallenge leads to recurrence and should be avoided.

Outcome and Management

While few cases of clinically apparent liver injury due to gemifloxacin have been reported, such injury does occur with other fluoroquinolones, even with brief periods of treatment (2 to 5 days). The severity of injury ranges from mild, asymptomatic and transient serum enzyme elevations to a mild, prolonged cholestatic hepatitis, to self-limited acute hepatocellular jaundice and even to acute liver failure. Cross reactivity of the hepatic injury between different fluoroquinolones has been demonstrated in a small number of cases, but should be assumed based upon the similarity of clinical patterns of injury and latency.

Drug Class: Antiinfective Agents

Other Drugs in the Subclass, Fluoroquinolones: Ciprofloxacin, Delafloxacin, Levofloxacin, Moxifloxacin, Norfloxacin, Ofloxacin



Gemifloxacin – Factive®


Antiinfective Agents


Product labeling at DailyMed, National Library of Medicine, NIH



References updated: 10 March 2020

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