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Baxdela Side Effects

Generic name: delafloxacin

Medically reviewed by Drugs.com. Last updated on Jan 26, 2024.

Note: This document contains side effect information about delafloxacin. Some dosage forms listed on this page may not apply to the brand name Baxdela.

Applies to delafloxacin: oral tablet. Other dosage forms:

Warning

Oral route (Tablet)

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 Baxdela

Along with its needed effects, delafloxacin (the active ingredient contained in Baxdela) 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

Other side effects of Baxdela

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

Other side effects of Baxdela

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

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

References

1. Product Information. Baxdela (delafloxacin). Melinta Therapeutics, Inc. 2017.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

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.