Moxifloxacin Side Effects

Some side effects of moxifloxacin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to moxifloxacin: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking moxifloxacin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using moxifloxacin and call your doctor at once if you have a serious side effect such as:

• severe dizziness, fainting, fast or pounding heartbeats;

• sudden pain, snapping or popping sound, bruising, swelling, tenderness, stiffness, or loss of movement in any of your joints;

• diarrhea that is watery or bloody;

• confusion, hallucinations, depression, insomnia or nightmares, unusual thoughts or behavior, feeling light-headed;

• seizure (convulsions);

• severe headache, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes;

• pale or yellowed skin, dark colored urine, fever, weakness;

• urinating less than usual or not at all;

• easy bruising or bleeding;

• numbness, tingling, or unusual pain anywhere in your body;

• the first sign of any skin rash, no matter how mild; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects of moxifloxacin may include:

• nausea, mild diarrhea;

• headache, dizziness;

• blurred vision;

• feeling nervous, anxious, or agitated;

• mild skin itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to moxifloxacin: intravenous solution, oral tablet

General

Moxifloxacin has been generally well tolerated with most adverse events reported as mild to moderate and requiring no treatment. Moxifloxacin was discontinued due to adverse reactions in 5% of patients overall, 4.1% of patients received 400 mg orally, 3.9% received 400 mg intravenously, and 8.2% received 400 mg intravenous/oral sequential treatment. The most common side effects leading to discontinuation with the oral dose were nausea (0.8%), diarrhea (0.5%), dizziness (0.5%), and vomiting (0.4%). The most common side effect leading to discontinuation with the intravenous dose was rash (0.5%). The most common side effects leading to discontinuation with the intravenous/oral sequential dose were diarrhea (0.5%) and pyrexia (0.4%).

Gastrointestinal

Common (1% to 10%): Nausea (6.9%), diarrhea (6%), vomiting (2.4%), constipation (1.9%), abdominal pain (1.5%), upper abdominal pain (1.1%), dyspepsia (1%)
Uncommon (0.1% to 1%): Dry mouth, abdominal discomfort, abdominal distention, gastritis, gastroesophageal reflux disease, oral candidiasis, oral fungal infection, gastroenteritis, anorexia, flatulence
Frequency not reported: Clostridium difficile associated diarrhea, dysphagia, gastrointestinal disorder, pseudomembranous colitis, stomatitis, glossitis, tongue discoloration

The onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment. If diarrhea occurs and it is unresponsive to discontinuation of drug and/or standard therapy, pseudomembranous colitis should be considered.

Nervous system

Common (1% to 10%): Headache (4.2%), dizziness (3%), insomnia (1.9%)
Uncommon (0.1% to 1%): Somnolence, tremor, dysgeusia, lethargy, paresthesia, tension headache, hallucinations, hypoesthesia, syncope, tinnitus, vertigo
Rare (less than 0.1%): Orofacial dyskinesia (at least 1 case)
Frequency not reported: Amnesia, aphasia, confusion, convulsions of various clinical manifestations (including grand mal convulsions), incoordination, parosmia, sleep disorders, speech disorders, abnormal thinking, sensory and sensorimotor axonal polyneuropathy (resulting in paresthesias, hypoesthesias, dysesthesias, weakness)
Postmarketing reports: Altered coordination, abnormal gait, exacerbation of myasthenia gravis, muscle weakness, peripheral neuropathy, polyneuropathy, hearing impairment (including deafness; reversible in most cases)

Cardiovascular

Uncommon (0.1% to 1%): Atrial fibrillation, palpitations, tachycardia, congestive cardiac failure, angina pectoris, cardiac failure, cardiac arrest, bradycardia, hypertension, hypotension, phlebitis, increased blood pressure, prolonged electrocardiogram QT interval
Frequency not reported: Abnormal ECG, arrhythmias, atrial flutter, ST-T wave changes, supraventricular tachycardia, cardiac arrhythmia (not otherwise specified), vasodilation, ventricular extrasystoles, ventricular tachycardia
Postmarketing reports: Ventricular tachyarrhythmias (including in very rare cases cardiac arrest and torsade de pointes, and usually in patients with concurrent severe underlying proarrhythmic conditions)

The mean QTc interval prolongation in a study of 787 patients receiving moxifloxacin was 6 msec vs. 1 msec for a comparator group of patients receiving another antibiotic. There were 38 outliers in the moxifloxacin group (QTc interval greater than 450 msec for men or 470 msec for women) vs. 28 outliers in the comparator group.

In another study (n=48), there were greater increases in the QT and QTc interval with 800 mg moxifloxacin than with 1000 mg levofloxacin or 1500 mg ciprofloxacin.

Elderly patients experienced more ECG abnormalities than younger patients.

Hematologic

Increased MCH, neutrophils, WBCs, albumin, and PT ratio, and decreased hemoglobin, RBCs, neutrophils, eosinophils, basophils, and PT ratio have been reported in greater than or equal to 2% of patients; however, it has not been determined if these laboratory abnormalities were due to the drug or the underlying condition being treated.

Common (1% to 10%): Anemia (1.1%), increased MCH, increased neutrophils, increased WBCs, increased albumin, increased PT ratio, decreased hemoglobin, decreased RBCs, decreased neutrophils, decreased eosinophils, decreased basophils, decreased PT ratio
Uncommon (0.1% to 1%): Prolonged prothrombin time, thrombocythemia, eosinophilia, neutropenia, thrombocytopenia, leukocytosis, leukopenia, increased platelet count, decreased hemoglobin, increased white blood cell count, decreased hematocrit, increased eosinophil count, prolonged activated partial thromboplastin time
Frequency not reported: Increased prothrombin (decreased prothrombin time, decreased INR), decreased thromboplastin, decreased prothrombin (increased INR)
Postmarketing reports: Agranulocytosis, pancytopenia

Hepatic

Common (1% to 10%): Increased alanine aminotransferase (1.1%), increased bilirubin, decreased bilirubin
Uncommon (0.1% to 1%): Abnormal liver function tests, abnormal hepatic function, increased aspartate aminotransferase, increased transaminases, increased blood bilirubin, increased hepatic enzyme, increased gamma-glutamyltransferase
Frequency not reported: Jaundice (primarily cholestatic), acute fulminant hepatic failure, acute liver injury
Postmarketing reports: Hepatic failure (including fatal cases), jaundice, acute hepatic necrosis, hepatitis (primarily cholestatic)

Increased and decreased bilirubin have been reported in greater than or equal to 2% of patients; however, it has not been determined if these laboratory abnormalities were due to the drug or the underlying condition being treated.

A 69-year-old male developed jaundice, pruritus, weight loss, dark urine, elevated lever function tests (total bilirubin, 28.45 mg/dL; conjugated bilirubin, 20.6 mg/dL; alkaline phosphatase, 249 units/L; ALT, 58 units/L) 3 weeks after a 5-day course of oral moxifloxacin. A liver biopsy showed portal inflammatory infiltrates with lymphocytes and eosinophils and predominantly casts in canaliculi. Liver function tests normalized over 2 months.

A 23-year-old female developed acute fulminant hepatitis (transaminases up to 8500 units/L) with hepatocellular necrosis, toxic epidermal necrolysis, and encephalopathy after 3 days of moxifloxacin treatment. The condition culminated in multiple organ failure, acute respiratory distress syndrome, and death, despite a liver transplant.

Metabolic

Increased ionized calcium, chloride, and globulin, and decreased glucose, pO2, and amylase have been reported in greater than or equal to 2% of patients; however, it has not been determined if these laboratory abnormalities were due to the drug or the underlying condition being treated.

Common (1% to 10%): Hypokalemia (1%), increased ionized calcium, increased chloride, increased globulin, decreased glucose, decreased pO2, decreased amylase
Uncommon (0.1% to 1%): Hyperglycemia, hypoglycemia, hyperlipidemia, decreased appetite, dehydration, increased blood alkaline phosphatase, increased blood amylase, increased blood lactate dehydrogenase, increased blood glucose, increased lipase, increased blood triglycerides, increased blood uric acid
Frequency not reported: Dehydration (secondary to diarrhea or reduced fluid intake), hyperuricemia

Other

Common (1% to 10%): Pyrexia (1.1%)
Uncommon (0.1% to 1%): Fatigue, chest pain, asthenia, peripheral edema, pain, malaise, edema, chills, chest discomfort, candidiasis, fungal infection, facial pain
Frequency not reported: Pelvic pain, leg pain, back pain, abnormal laboratory test (not specified), taste loss, taste perversion, tongue discoloration

Musculoskeletal

Uncommon (0.1% to 1%): Back pain, pain in extremity, arthralgia, myalgia, muscle spasms, musculoskeletal chest pain, musculoskeletal pain
Frequency not reported: Arthritis, hypertonia, tendon disorder
Postmarketing reports: Tendon rupture

Hypersensitivity

Frequency not reported: Allergic reaction, face edema
Postmarketing reports: Anaphylactic reaction, anaphylactic shock, angioedema (including laryngeal edema)

Psychiatric

Uncommon (0.1% to 1%): Nervousness, confusional state, agitation, depression, restlessness, disorientation, anxiety
Frequency not reported: Abnormal dreams, depersonalization, depression (potentially culminating in self-endangering behavior), emotional lability
Postmarketing reports: Psychotic reaction (very rarely culminating in self-injurious behavior, such as suicidal ideation/thoughts or suicide attempts)

Dermatologic

Uncommon (0.1% to 1%): Rash, pruritus, hyperhidrosis, erythema, allergic dermatitis, night sweats, urticaria
Frequency not reported: Maculopapular rash, purpuric rash, pustular rash
Postmarketing reports: Toxic epidermal necrolysis, photosensitivity/phototoxicity reactions, Stevens-Johnson syndrome

Genitourinary

Uncommon (0.1% to 1%): Dysuria, vulvovaginal candidiasis, vulvovaginal mycotic infection, vaginal infection, vulvovaginal pruritus
Frequency not reported: Vaginitis

Local

Uncommon (0.1% to 1%): Infusion site extravasation
Frequency not reported: Injection site reactions (including phlebitis)

Ocular

Uncommon (0.1% to 1%): Blurred vision
Frequency not reported: Amblyopia, abnormal vision (visual disturbances temporally associated with central nervous system [CNS] symptoms)
Postmarketing reports: Vision loss (especially in the course of CNS reactions, transient in most cases)

Renal

Uncommon (0.1% to 1%): Increased blood creatinine, increased blood urea, renal failure, acute renal failure
Frequency not reported: Abnormal kidney function
Postmarketing reports: Renal dysfunction, interstitial nephritis

Respiratory

Uncommon (0.1% to 1%): Dyspnea, wheezing, bronchospasm, asthma
Postmarketing reports: Allergic pneumonitis

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