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Delafloxacin Side Effects

For the Consumer

Applies to delafloxacin: oral tablet

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 immediately if any of the following side effects occur while taking delafloxacin:

More common

Less common

  • 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
  • coma
  • confusion
  • continuing ringing or buzzing or other unexplained noise in the ears
  • cool, pale skin
  • cough or hoarseness
  • decreased frequency or amount of urine
  • depression
  • difficulty in 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 taste
  • lower back or side pain
  • muscle aches or cramps
  • muscle pains or stiffness
  • nausea
  • nervousness
  • 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

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

  • 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

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:

For Healthcare Professionals

Applies to delafloxacin: intravenous powder for injection, oral tablet

General

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 patients; therapy was discontinued most commonly due to urticaria and hypersensitivity.[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, vomiting
Frequency not reported: Abdominal pain, dyspepsia, oral candidiasis, Clostridium difficile-associated diarrhea[Ref]

Nervous system

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

Common (1% to 10%): Headache
Frequency not reported: Dizziness, hypoesthesia, paresthesia, dysgeusia, presyncope, syncope, tinnitus, vertigo, 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)
-Postmarketing reports: Exacerbation of myasthenia gravis[Ref]

Hepatic

Common (1% to 10%): Transaminase elevations (includes hypertransaminasemia, increased transaminases, increased ALT and AST)[Ref]

Musculoskeletal

Frequency not reported: Increased blood creatine phosphokinase, myalgia

Fluoroquinolones:
-Frequency not reported: Tendinitis, tendon rupture, arthralgia[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity

Fluoroquinolones:
-Frequency not reported: Severe and sometimes fatal hypersensitivity (anaphylactic) reactions[Ref]

Psychiatric

Frequency not reported: Anxiety, insomnia, abnormal dreams

Fluoroquinolones:
-Frequency not reported: CNS effects (hallucinations, anxiety, depression, insomnia, confusion)[Ref]

Cardiovascular

Frequency not reported: Sinus tachycardia, palpitations, bradycardia, hypotension, hypertension, phlebitis[Ref]

Dermatologic

Frequency not reported: Pruritus, urticaria, dermatitis, rash[Ref]

Renal

Frequency not reported: Increased blood creatinine, renal impairment, renal failure[Ref]

Other

Frequency not reported: Increased blood alkaline phosphatase, flushing, weakness, C difficile infection, fungal infection[Ref]

Metabolic

Frequency not reported: Hyperglycemia, hypoglycemia[Ref]

Local

Frequency not reported: 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]

Genitourinary

Frequency not reported: Vulvovaginal candidiasis[Ref]

Ocular

Frequency not reported: Blurred vision[Ref]

References

1. "Product Information. Baxdela (delafloxacin)." Melinta Therapeutics, Lincolnshire, IL.

Further information

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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