Delafloxacin Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 20, 2024.

Applies to delafloxacin: intravenous powder for solution.

Other dosage forms:

• oral tablet

Important warnings This medicine can cause some serious health issues

Intravenous route (powder for solution)

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects.

Discontinue delafloxacin immediately and avoid the use of fluoroquinolones, including delafloxacin, in patients who experience any of these serious adverse reactions.

Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis.

Avoid delafloxacin in patients with known history of myasthenia gravis.

Serious side effects of delafloxacin

Along with its needed effects, delafloxacin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking delafloxacin:

More common side effects

• diarrhea

Less common side effects

• anxiety
• bloody urine
• bluish color of the skin
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• changes in skin color
• chest pain or discomfort
• chills
• cold sweats
• confusion
• continuing ringing or buzzing or other unexplained noise in the ears
• cool, pale skin
• cough
• decreased frequency or amount of urine
• depression
• difficulty with moving
• dizziness or lightheadedness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fast, slow, irregular, pounding, or racing heartbeat or pulse
• feeling of constant movement of self or surroundings
• fever
• flushed, dry skin
• fruit-like breath odor
• headache
• hearing loss
• hives, itching, skin rash
• hoarseness
• increased blood pressure
• increased hunger
• increased thirst
• increased urination
• irritation
• joint pain, stiffness, or swelling
• loss of appetite
• loss of consciousness
• loss of taste
• lower back or side pain
• muscle cramps, pains, or stiffness
• nausea
• painful or difficult urination
• pounding in the ears
• redness of the skin
• seizures
• sensation of spinning
• shakiness
• slurred speech
• stomach pain
• swelling of the eyelids, face, lips, hands, fingers, lower legs, or feet
• swollen joints
• tenderness, pain, swelling, warmth, skin discoloration, or prominent superficial veins over the affected area
• tightness in the chest
• troubled breathing or swallowing
• unexplained weight loss
• unusual tiredness or weakness
• vomiting
• weight gain

Other side effects of delafloxacin

Some side effects of delafloxacin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common side effects

• abnormal dreams
• belching
• feeling of warmth
• heartburn
• indigestion
• pain or redness at the injection site
• redness of the face, neck, arms, and occasionally, the upper chest
• stomach discomfort, upset, or pain
• trouble sleeping

For healthcare professionals

Applies to delafloxacin: intravenous powder for injection, oral tablet.

General adverse events

In patients with acute bacterial skin and skin structure infections (ABSSSI), the most common side effects were nausea, diarrhea, headache, transaminase elevations, and vomiting. This drug was discontinued due to a side effect in 0.9% of ABSSSI patients; therapy was discontinued most commonly due to urticaria and hypersensitivity.

In patients with community-acquired bacterial pneumonia (CABP), the most common side effects were diarrhea and transaminase elevations. This drug was discontinued due to a side effect in 2.1% of CABP patients; therapy was discontinued most commonly due to transaminase elevations.^[Ref]

Gastrointestinal

• Common (1% to 10%): Nausea, diarrhea, vomiting
• Uncommon (0.1% to 1%): Erosive gastritis, stomatitis, abdominal pain, dyspepsia, gastroesophageal reflux disease, oral paresthesia, oral hypoesthesia, glossodynia, dry mouth, flatulence, constipation, discolored feces
• Frequency not reported: Oral candidiasis, Clostridioides difficile-associated diarrhea^[Ref]

Nervous system

• Common (1% to 10%): Headache
• Uncommon (0.1% to 1%): Peripheral neuropathy (including paresthesia, hypoesthesia), dizziness, dysgeusia, presyncope, tinnitus, vertigo
• Frequency not reported: Hypoesthesia, paresthesia, syncope, vestibular disorder, sensory axonal polyneuropathy, sensorimotor axonal polyneuropathy, dysesthesia

Fluoroquinolones:

• Frequency not reported: Peripheral neuropathy, central nervous system (CNS) effects (convulsions, increased intracranial pressure [including pseudotumor cerebri], toxic psychosis, severe headaches), neuropathies associated with paresthesia, memory impairment, impairment of hearing/vision/taste/smell
• Postmarketing reports: Exacerbation of myasthenia gravis^[Ref]

Cases of sensory or sensorimotor axonal polyneuropathy (affecting small and/or large axons) resulting in paresthesias, hypoesthesias, dysesthesias, and weakness have been reported.^[Ref]

Hepatic

• Common (1% to 10%): Transaminase elevations (included hypertransaminasemia, increased transaminases, increased ALT and AST, increased hepatic enzyme, increased ALT), hypertransaminasemia^[Ref]

Dermatologic

• Common (1% to 10%): Pruritus
• Uncommon (0.1% to 1%): Allergic dermatitis, urticaria, rash, alopecia, hyperhidrosis, cold sweat, night sweat
• Frequency not reported: Dermatitis^[Ref]

Other

• Common (1% to 10%): Fungal infection
• Uncommon (0.1% to 1%): Pyrexia, peripheral edema, fatigue, chills, medical device complication, wound complication, increased blood alkaline phosphatase, decreased blood albumin, flushing, C difficile infection
• Frequency not reported: Weakness

Fluoroquinolones:

• Frequency not reported: Gait disturbance, fatigue^[Ref]

Local

• Common (1% to 10%): Injection/infusion site reaction
• Uncommon (0.1% to 1%): Local swelling
• Frequency not reported: Infusion related reactions, infusion site extravasation, infusion site bruise, infusion site discomfort, infusion site edema, infusion site erythema, infusion site irritation, infusion site pain, infusion site phlebitis, infusion site swelling, infusion site thrombosis^[Ref]

Musculoskeletal

• Uncommon (0.1% to 1%): Reactive arthritis, arthralgia, myalgia, myositis, tendonitis, musculoskeletal pain (e.g., pain in extremity, back pain, neck pain), muscle weakness, muscle spasm, increased blood creatine phosphokinase

Fluoroquinolones:

• Frequency not reported: Tendinitis, tendon rupture, arthralgia, pain in extremities^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Hypersensitivity, seasonal allergy

Fluoroquinolones:

• Frequency not reported: Serious and sometimes fatal hypersensitivity (anaphylactic) reactions^[Ref]

Psychiatric

• Uncommon (0.1% to 1%): Anxiety, insomnia, abnormal dreams, auditory hallucination
• Frequency not reported: Agitation, confusional state

Fluoroquinolones:

• Frequency not reported: CNS effects (hallucinations, anxiety, depression, insomnia, confusion), sleep disorders^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Sinus tachycardia, palpitations, bradycardia, hypotension, hypertension, phlebitis
• Frequency not reported: Ventricular extrasystoles^[Ref]

Renal

• Uncommon (0.1% to 1%): Renal impairment
• Frequency not reported: Increased blood creatinine, renal failure^[Ref]

Hematologic

• Uncommon (0.1% to 1%): Thrombocytopenia, decreased hematocrit, decreased WBC count, decreased hemoglobin, decreased RBC count
• Frequency not reported: Agranulocytosis, anemia, leukopenia, neutropenia, pancytopenia^[Ref]

Metabolic

• Uncommon (0.1% to 1%): Hyperglycemia, hypoglycemia, decreased appetite

Other fluoroquinolones:

• Frequency not reported: Blood glucose disturbances^[Ref]

Respiratory

• Uncommon (0.1% to 1%): Dyspnea, cough, dry throat, sinusitis^[Ref]

Genitourinary

• Uncommon (0.1% to 1%): Hematuria, crystal urine present, urinary tract infection
• Frequency not reported: Vulvovaginal candidiasis^[Ref]

Ocular

• Uncommon (0.1% to 1%): Blurred vision, dry eye^[Ref]

Frequently asked questions

• What type of antibiotic is Baxdela?

Further information

Delafloxacin side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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