Safety & Tolerability

BAXDELA Safety Profile

BAXDELA is well tolerated

Most Common Treatment-Emergent Adverse Events Occurred in ≥2.0% (pooled data from phase 3 trials)

+ aztreonam
Nausea 8% 6%
Diarrhea 8% 3%
Headachea 3% 6%
Transaminase elevationsb 3% 4%
Vomiting 2% 2%
aThe data are not an adequate basis for comparison of rates between the study drug and the active control.
bPooled reports include hypertransaminasaemia, increased transaminases, and increased ALT and AST.

Discontinuations Due to Treatment-Related Adverse Events (n/N)

BAXDELA Vancomycin + aztreonam
BAXDELA discontinuations chart due to treatment-related adverse events

Difference in discontinuation rate is not statistically significant.

Important Additional Safety Information

QT prolongation was not observed in patients taking BAXDELA in a QT study

  • Some fluoroquinolones have been associated with prolongation of the QT interval on electrocardiogram and infrequent cases of arrhythmia
  • A randomized, positive- and placebo-controlled, thorough QT study found no QT prolongation in patients taking BAXDELA compared with moxifloxacin

Photosensitivity was not observed in patients taking BAXDELA in a photosafety study

  • Fluoroquinolones have been associated with the potential for phototoxicity; however, a phase 1 study conducted in 52 healthy volunteers demonstrated no clinically relevant photosensitizing potential for BAXDELA compared with lomefloxacin
  • Potential for phototoxic reactions should always be considered when caring for patients taking BAXDELA or any other marketed fluoroquinolone


  • Postmarketing reports of severe hepatotoxicity (including acute hepatitis and fatal events) have been received for patients treated with fluoroquinolones
  • No cases of Hy’s lawa were reported in the BAXDELA clinical trials


  • Dysglycemia, including hypoglycemia, has been associated with all fluoroquinolones, which are believed to stimulate insulin release via interference with the K+/ATPase pump in pancreatic β cells
  • In phase 3 trials, the incidence of dysglycemia was similar to the incidence observed with vancomycin plus aztreonam

1. Data on file (included in BAXDELA New Drug Application). Melinta Therapeutics, Inc.; 2016.

aHy's law is a rule of thumb that a patient is at high risk of a fatal drug-induced liver injury if given a medication that causes hepatocellular injury with jaundice.

BAXDELA is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria.