Applies to delafloxacin: oral tablet. Other dosage forms:

• intravenous powder for solution

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

More common

• Diarrhea

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
• 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

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

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:

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]