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Moxifloxacin Side Effects

Not all side effects for moxifloxacin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to moxifloxacin: oral tablet

Other dosage forms:

In addition to its needed effects, some unwanted effects may be caused by moxifloxacin. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking moxifloxacin:

Rare
  • Abdominal or stomach cramps
  • abdominal or stomach tenderness
  • black, tarry stools
  • bleeding gums
  • blisters
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blood in the urine or stools
  • blurred vision
  • bone pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain
  • chills
  • clay-colored stools
  • cough
  • crying
  • dark urine
  • diarrhea, watery and severe, which may also be bloody
  • difficult or labored breathing
  • difficulty with moving
  • difficulty with swallowing
  • discouragement
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • excessive muscle tone
  • fainting
  • fast, irregular, pounding, or racing heartbeat or pulse
  • feeling of unreality
  • feeling of warmth or heat
  • feeling sad or empty
  • fever
  • flushed, dry skin
  • flushing or redness of the skin, especially on the face and neck
  • fruit-like breath odor
  • headache
  • hyperventilation
  • increased hunger
  • increased sensitivity of the skin to sunlight
  • increased thirst
  • increased urination
  • irregular heartbeat recurrent
  • irritability
  • joint pain, stiffness, or swelling
  • lack of coordination
  • loss of appetite
  • loss of interest or pleasure
  • lower back, side, or stomach pain
  • mood or mental changes
  • muscle aching or cramping
  • muscle pains or stiffness
  • muscle tension or tightness
  • nausea or vomiting
  • nervousness
  • noisy breathing
  • pain
  • pain in the pelvis
  • pain, warmth, or burning in the fingers, toes, and legs
  • painful or difficult urination
  • painful, swollen joints
  • pale skin
  • pinpoint red spots on the skin
  • pounding in the ears
  • problems with speech or speaking
  • problems with vision or hearing
  • quick to react or overreact emotionally
  • rapid weight gain
  • rapidly changing moods
  • redness or other discoloration of the skin
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • seizures
  • sensation of the skin burning
  • sense of detachment from self or body
  • severe sunburn
  • shakiness in the legs, arms, hands, or feet
  • skin rash or itching
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • sweating
  • swelling of the feet or lower legs
  • swelling or puffiness of the face
  • swollen glands
  • tightness in the chest
  • tingling of the hands or feet
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • troubled breathing with exertion
  • unexplained weight loss
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • vomiting of blood
  • yellow eyes or skin
Incidence not known
  • Blistering, peeling, or loosening of the skin
  • burning, numbness, tingling, or painful sensations
  • change in the ability to see colors, especially blue or yellow
  • difficulty with chewing or talking
  • double vision
  • drooping eyelids
  • eye pain
  • general feeling of tiredness or weakness
  • hives
  • hoarseness
  • irregular or slow heart rate
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • muscle weakness
  • no blood pressure or pulse
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red, irritated eyes
  • red skin lesions, often with a purple center
  • severe headache
  • severe tiredness
  • stomach pain, continuing
  • stopping of heart
  • unconsciousness
  • unsteadiness or awkwardness
  • unusual behavior, such as disorientation to time or place, failure to recognize people, hyperactivity, or restlessness
  • weakness in the arms, hands, legs, or feet

Some of the side effects that can occur with moxifloxacin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Rare
  • Acid or sour stomach
  • bad, unusual, or unpleasant (after) taste
  • belching
  • burning feeling in the chest or stomach
  • change in sense of smell
  • change in taste
  • changes in vision
  • continuing ringing or buzzing or other unexplained noise in the ears
  • difficulty having a bowel movement (stool)
  • excess air or gas in the stomach or intestines
  • fear or nervousness
  • feeling of constant movement of self or surroundings
  • full feeling
  • general feeling of discomfort or illness
  • hearing loss
  • heartburn
  • impaired vision
  • indigestion
  • itching of the vagina or genital area
  • lack or loss of strength
  • loss of memory
  • pain during sexual intercourse
  • passing of gas
  • problems with memory
  • redness, swelling, or soreness of the tongue
  • sensation of spinning
  • sleepiness or unusual drowsiness
  • sore mouth or tongue
  • stomach discomfort, upset, or pain
  • thick, white vaginal discharge with no odor or with a mild odor
  • white patches in the mouth or on the tongue

For Healthcare Professionals

Applies to moxifloxacin: intravenous solution, oral tablet

General

The most common side effects were nausea, diarrhea, headache, and dizziness. This drug was discontinued due to side effects in 5% of patients overall, 4.1% of patients using 400 mg orally, 3.9% using 400 mg IV, and 8.2% using 400 mg IV/oral sequential therapy. The most common side effects leading to discontinuation with the oral dose were nausea, diarrhea, dizziness, and vomiting. The most common side effect leading to discontinuation with the IV dose was rash. The most common side effects leading to discontinuation with the IV/oral sequential dose were diarrhea and pyrexia.[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, vomiting, constipation, gastrointestinal pain, abdominal pain, upper abdominal pain, dyspepsia, decreased amylase
Uncommon (0.1% to 1%): Dry mouth, abdominal discomfort, abdominal distention, gastritis, gastroesophageal reflux disease, oral candidiasis, oral fungal infection, gastroenteritis, flatulence, increased blood amylase, antibiotic-associated colitis (including pseudomembranous colitis, life-threatening complications)
Rare (0.01% to 0.1%): Dysphagia, stomatitis
Frequency not reported: Clostridium difficile-associated diarrhea, gastrointestinal disorder, pseudomembranous colitis, glossitis, tongue discoloration[Ref]

Decreased amylase has been reported in at least 2% of patients; however, it has not been determined if this laboratory abnormality was due to the drug or the underlying condition being treated.

Antibiotic-associated colitis (including pseudomembranous colitis; associated with life-threatening complications in very rare cases) was reported more often with IV therapy (with or without subsequent oral therapy).

The onset of pseudomembranous colitis symptoms has been reported during or after antimicrobial treatment.[Ref]

Nervous system

Seizures (including grand mal convulsions) were reported more often with IV therapy (with or without subsequent oral therapy).

Disturbed coordination leading to fall with injuries was reported, particularly in elderly patients.

Peripheral neuropathy (may be irreversible), polyneuropathy, hearing impairment (including deafness; reversible in most cases), and exacerbation of myasthenia gravis have also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Somnolence, tremor, dysgeusia, lethargy, paresthesia/dysesthesia, tension headache, hypoesthesia, syncope (i.e., acute and short-lasting loss of consciousness), tinnitus, vertigo, convulsions/seizures of various clinical manifestations (including grand mal convulsions), taste disorder, sleep disorders
Rare (0.01% to 0.1%): Smell disorders (including anosmia), disturbed coordination (including gait disturbances, especially due to dizziness or vertigo), disturbed attention, speech disorders, amnesia, peripheral neuropathy, polyneuropathy, hearing impairment (including deafness; usually reversible)
Very rare (less than 0.01%): Ageusia, hyperesthesia, exacerbation of myasthenia gravis
Frequency not reported: Aphasia, incoordination, parosmia, abnormal thinking, sensory and sensorimotor axonal polyneuropathy (resulting in paresthesias, hypoesthesias, dysesthesias, weakness), orofacial dyskinesia, taste loss, taste perversion
Postmarketing reports: Altered coordination, disturbed coordination (leading to fall with injuries), abnormal gait[Ref]

Cardiovascular

Common (1% to 10%): QT prolongation
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 ECG QT interval, ventricular tachyarrhythmias, vasodilation
Very rare (less than 0.01%): Unspecified arrhythmias, torsade de pointes, cardiac arrest
Frequency not reported: Abnormal ECG, arrhythmias, atrial flutter, ST-T wave changes, supraventricular tachycardia, ventricular extrasystoles, ventricular tachycardia[Ref]

QT prolongation was commonly reported in patients with hypokalemia, otherwise, it was uncommon.

Ventricular tachyarrhythmias and hypotension were reported more often with IV therapy (with or without subsequent oral therapy).

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

Ventricular tachyarrhythmias (including very rare cases of cardiac arrest and torsade de pointes) have also been reported during postmarketing experience, usually in patients with concurrent severe underlying proarrhythmic conditions (e.g., clinically significant bradycardia, acute myocardial ischemia).[Ref]

Hematologic

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

Agranulocytosis has also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Anemia, increased mean corpuscular hemoglobin (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/INR increased, 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
Rare (0.01% to 0.1%): Abnormal thromboplastin level
Very rare (less than 0.01%): Increased prothrombin level/decreased INR, abnormal prothrombin level/INR, agranulocytosis
Frequency not reported: Decreased thromboplastin, decreased prothrombin/increased INR
Postmarketing reports: Pancytopenia

Other fluoroquinolones:
-Very rare (less than 0.01%): Hemolytic anemia[Ref]

Hepatic

Common (1% to 10%): Increased ALT, increased bilirubin, decreased bilirubin, increased GGT, increased transaminases
Uncommon (0.1% to 1%): Abnormal liver function tests, abnormal hepatic function, increased aspartate aminotransferase, increased transaminases, increased blood bilirubin, increased hepatic enzyme, hepatic impairment (including increased lactate dehydrogenase)
Rare (0.01% to 0.1%): Jaundice, hepatitis (primarily cholestatic)
Very rare (less than 0.01%): Fulminant hepatitis (potentially leading to life-threatening liver failure [including fatal cases])
Frequency not reported: Acute fulminant hepatic failure, acute liver injury
Postmarketing reports: Hepatic failure (including fatal cases), acute hepatic necrosis[Ref]

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

Increased GGT was reported more often with IV therapy (with or without subsequent oral therapy).

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 therapy. The condition culminated in multiple organ failure, acute respiratory distress syndrome, and death, despite a liver transplant.

Hepatitis (primarily cholestatic) and jaundice have also been reported during postmarketing experience.[Ref]

Metabolic

Common (1% to 10%): Hypokalemia, increased ionized calcium, increased chloride, increased globulin, decreased glucose, decreased pO2
Uncommon (0.1% to 1%): Hyperglycemia, hypoglycemia, anorexia, hyperlipidemia, decreased appetite, dehydration, increased blood alkaline phosphatase, increased blood lactate dehydrogenase, increased blood glucose, increased lipase, increased blood triglycerides, increased blood uric acid, decreased food intake
Rare (0.01% to 0.1%): Hyperuricemia
Postmarketing reports: Dehydration (secondary to diarrhea or reduced fluid intake)

Other fluoroquinolones:
-Very rare (less than 0.01%): Hypernatremia, hypercalcemia[Ref]

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

Other

Common (1% to 10%): Pyrexia, superinfections (due to resistant bacteria or fungi [e.g., oral and vaginal candidiasis])
Uncommon (0.1% to 1%): Fatigue, chest pain, asthenia, peripheral edema, unspecific pain, malaise, edema, chills, chest discomfort, candidiasis, fungal infection, facial pain, feeling unwell (primarily asthenia or fatigue), painful conditions (including pain in back, chest, pelvic, extremities)
Frequency not reported: Abnormal laboratory test (not specified), face edema[Ref]

Edema was reported more often with IV therapy (with or without subsequent oral therapy).[Ref]

Psychiatric

Common (1% to 10%): Insomnia
Uncommon (0.1% to 1%): Nervousness, confusional state, psychomotor hyperactivity/agitation, depression, restlessness, disorientation, anxiety, hallucinations
Rare (0.01% to 0.1%): Abnormal dreams, emotional lability
Very rare (less than 0.01%): Depersonalization, psychotic reactions
Frequency not reported: Self-endangering behavior
Postmarketing reports: Self-injurious behavior (e.g., suicidal ideation/thoughts, suicide attempts)[Ref]

Hallucination was reported more often with IV therapy (with or without subsequent oral therapy).

Psychotic reactions and/or depression, very rarely culminating in self-injurious behavior (such as suicidal ideation/thoughts or suicide attempts), have been reported during postmarketing experience.[Ref]

Local

Common (1% to 10%): Injection site reactions, infusion site reactions
Uncommon (0.1% to 1%): Infusion site extravasation, infusion site thrombophlebitis/phlebitis[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Arthralgia, myalgia, muscle spasms, musculoskeletal chest pain, musculoskeletal pain
Rare (0.01% to 0.1%): Tendonitis, increased muscle tone and cramping, muscle weakness, muscle cramp, muscle twitching
Very rare (less than 0.01%): Arthritis, tendon rupture, muscle rigidity
Frequency not reported: Hypertonia, tendon disorder
Postmarketing reports: Gait disturbance (due to muscular, tendon, or joint symptoms)

Other fluoroquinolones:
-Very rare (less than 0.01%): Rhabdomyolysis[Ref]

Tendon rupture has also been reported during postmarketing experience.[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reaction
Rare (0.01% to 0.1%): Anaphylactic/anaphylactoid reaction, allergic edema/angioedema (including laryngeal edema; potentially life-threatening)
Very rare (less than 0.01%): Anaphylactic/anaphylactoid shock (potentially life-threatening)[Ref]

Anaphylactic reaction, anaphylactic shock, and angioedema (including laryngeal edema) have also been reported during postmarketing experience.[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, pruritus, hyperhidrosis, erythema, allergic dermatitis, night sweats, urticaria, dry skin
Very rare (less than 0.01%): Bullous skin reactions (like Stevens-Johnson syndrome or toxic epidermal necrolysis; potentially life-threatening)
Frequency not reported: Maculopapular rash, purpuric rash, pustular rash
Postmarketing reports: Toxic epidermal necrolysis, photosensitivity/phototoxicity reactions, Stevens-Johnson syndrome[Ref]

Genitourinary

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

Ocular

Uncommon (0.1% to 1%): Visual disturbances (including blurred vision, diplopia; especially during central nervous system [CNS] reactions)
Very rare (less than 0.01%): Transient vision loss (especially during CNS reactions)
Frequency not reported: Amblyopia, abnormal vision (visual disturbances temporally associated with CNS symptoms)[Ref]

Vision loss (especially during CNS reactions) has also been reported during postmarketing experience; most cases were transient.[Ref]

Renal

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

Renal impairment (including increased BUN and creatinine) and renal failure (due to dehydration, particularly in elderly patients with preexisting renal disorders) were reported more often with IV therapy (with or without subsequent oral therapy).[Ref]

Respiratory

Uncommon (0.1% to 1%): Dyspnea (including asthmatic conditions), wheezing, bronchospasm, asthma
Postmarketing reports: Allergic pneumonitis, laryngeal edema[Ref]

References

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2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Iannini PB, Kubin R, Reiter C, Tillotson G "Reassuring safety profile of moxifloxacin." Clin Infect Dis 32 (2001): 1112-4

4. "Product Information. Avelox (moxifloxacin)" Bayer, West Haven, CT.

5. Carroll DN "Moxifloxacin-induced Clostridium difficile-associated diarrhea." Pharmacotherapy 23 (2003): 1517-9

6. Gallagher JC, Du JK, Rose C "Severe pseudomembranous colitis after moxifloxacin use: a case series (January)." Ann Pharmacother 43 (2008):

7. Chang CM, Lee NY, Lee HC, et al. "Moxifloxacin-associated neutropenia in a cirrhotic elderly woman with lower extremity cellulitis (April)." Ann Pharmacother 42 (2008): 580-3

8. Ott SR, Allewelt M, Lorenz J, Reimnitz P, Lode H "Moxifloxacin vs ampicillin/sulbactam in aspiration pneumonia and primary lung abscess." Infection 36 (2008): 23-30

9. Mittal SO, Machado DG, Jabbari B "Orofacial dyskinesia after moxifloxacin treatment-a case with normal hepatorenal function and review of literature." Clin Neuropharmacol 35 (2012): 292-4

10. Owens RC Jr, Nolin TD "Antimicrobial-Associated QT Interval Prolongation: Pointes of Interest." Clin Infect Dis 43 (2006): 1603-1611

11. Badshah A, Janjua M, Younas F, Halabi AR, Cotant JF "Moxifloxacin-Induced QT Prolongation and Torsades: An Uncommon Effect of a Common Drug." Am J Med Sci 338 (2009): 164-6

12. Noel GJ, Natarajan J, Chien S, Hunt TL, Goodman DB, Abels R "Effects of three fluoroquinolones on QT interval in healthy adults after single doses." Clin Pharmacol Ther 73 (2003): 292-303

13. Siepmann M, Kirch W "Drug points - Tachycardia associated with moxifloxacin." Br Med J 322 (2001): 23

14. Lapi F, Wilchesky M, Kezouh A, Benisty JI, Ernst P, Suissa S "Fluoroquinolones and the risk of serious arrhythmia: a population-based study." Clin Infect Dis 55 (2012): 1457-65

15. Briasoulis A, Agarwal V, Pierce WJ "QT Prolongation and Torsade de Pointes Induced by Fluoroquinolones: Infrequent Side Effects from Commonly Used Medications." Cardiology 120 (2011): 103-110

16. Nori S, Nebesio C, Brashear R, Travers JB "Moxifloxacin-associated drug hypersensitivity syndrome with toxic epidermal necrolysis and fulminant hepatic failure." Arch Dermatol 140 (2004): 1537-8

17. Deenadayalu V, Orinion E, Veeneman E, Yoo HY "Acute fulminant hepatic failure and toxic epidermal necrolysis associated with the use of moxifloxacin." Am J Gastroenterol 98(9S) (2003): S211-S212

18. Paterson JM, Mamdani MM, Manno M, Juurlink DN "Fluoroquinolone therapy and idiosyncratic acute liver injury: a population-based study." CMAJ 184 (2012): 1565-70

19. Soto S, Lopez-Roses L, Avila S, et al. "Moxifloxacin-induced acute liver injury." Am J Gastroenterol 97 (2002): 1853-4

20. Donck JB, Segaert MF, Vanrenterghem YF "Fluoroquinolones and achilles tendinopathy in renal transplant recipients." Transplantation 58 (1994): 736-7

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22. Cerner Multum, Inc. "Australian Product Information." O 0

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