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What the label lists and what reports show

Delafloxacin side effects

Delafloxacin's FDA label: “Most common adverse reactions (incidence ≥ 2%) are nausea, diarrhea, headache, transaminase elevations, and vomiting.” FAERS holds 240 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (76 reports).

  • No generic listed
  • Boxed warning

Check it at the source: the delafloxacin FDA label on DailyMed (effective August 1, 2025, Melinta Therapeutics, LLC); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of BAXDELA?

BAXDELA may cause serious side effects, including: See " What is the most important information I should know about BAXDELA? " Serious allergic reactions. Serious allergic reactions, including death, can happen in people taking fluoroquinolones, including BAXDELA, even after only 1 dose. Stop taking BAXDELA and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction: hives swelling of the lips, tongue, face rapid heartbeat skin rash trouble breathing or swallowing throat tightness, hoarseness faint Skin rash may happen in people taking fluoroquinolones even after only 1 dose. Stop taking BAXDELA at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to BAXDELA. Clostridium difficile-associated diarrhea (CDAD). […]

Source: FDA drug label, Melinta Therapeutics, LLC, effective August 1, 2025 (SPL set fb77637a-88d9-4aea-958f-e270030ce30d), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Most common adverse reactions (incidence ≥ 2%) are nausea, diarrhea, headache, transaminase elevations, and vomiting.

Table 4 Selected Adverse Reactions Occurring in ≥ 2% of Patients Receiving BAXDELA in the Pooled Adult Phase 3 ABSSSI Clinical Trials

Adverse ReactionsBAXDELA N = 741 (%)Vancomycin/aztreonam N = 751 (%)
Nausea8%6%
Diarrhea8%3%
Headache The data are not an adequate basis for comparison of rates between the study…3%6%
Transaminase Elevations Pooled reports include hypertransaminasaemia, increased…3%4%
Vomiting2%2%

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling: Disabling and Potentially Irreversible Serious Adverse Reactions [see Warnings and Precautions (5.1) ] Tendinitis and Tendon Rupture [see Warnings and Precautions (5.2) ] Peripheral Neuropathy [see Warnings and Precautions (5.3) ] Central Nervous System Effects [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.6) ] Clostridium difficile -Associated Diarrhea [see Warnings and Precautions (5.7) ] Blood Glucose Disturbances [see Warnings and Precautions (5.10) ] Most common adverse reactions (incidence ≥ 2%) are nausea, diarrhea, headache, transaminase elevations, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Melinta Therapeutics at 1-844-633-6568 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of BAXDELA cannot be directly compared to rates in the clinical trials of another drug and may not reflect rates observed in practice. Overview of the Safety Evaluation of BAXDELA BAXDELA was evaluated in three Phase 3 multicenter, multinational, randomized, double-blind clinical trials. …

Source: FDA drug label, Melinta Therapeutics, LLC, effective August 1, 2025 (SPL set fb77637a-88d9-4aea-958f-e270030ce30d), via openFDA; the full label on DailyMed

What do FAERS reports show?

240 reports list delafloxacin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 19 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

  • Diarrhoea (named in the label)76
  • Off Label Use (a use or a product term, not a reaction)28
  • Nausea (named in the label)19
  • Decreased Appetite14
  • Rash (named in the label)13
  • Malaise12
  • Arthralgia (named in the label)10
  • Drug Effective For Unapproved Indication (a use or a product term, not a reaction)10
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)10
  • Tremor (named in the label)10
  • Hypertension (named in the label)9
  • Pallor9
  • Presyncope (named in the label)9
  • Autonomic Nervous System Imbalance8
  • Drug Ineffective (a use or a product term, not a reaction)7
  • Pain In Extremity7
  • Abdominal Discomfort6
  • Pain6
  • Paraesthesia (named in the label)6
  • Vomiting (named in the label)6
  • Dyspnoea5
  • Faeces Soft5
  • Fatigue5
  • Neuropathy Peripheral5
  • Pruritus (named in the label)5

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Delafloxacin: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions