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Avelox Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Last reviewed on RxList 4/29/2015

Avelox (moxifloxacin) is a fluoroquinolone antibiotic that inhibits certain bacteria that may cause infections such as pneumonia, bronchitis, and others that may infect the sinuses, skin or abdomen. Avelox is available as generic moxifloxacin. Common side effects of Avelox include abdominal discomfort, diarrhea, nausea, vomiting, mouth sores, headache, dizziness, blurred vision, nervousness, anxiety, agitation, skin itching, and vaginal discomfort (itch or burning sensation). Due to tendon, joint and bone problems, patients under 18 years of age should not be given Avelox (or other fluoroquinolones).

Avelox is available in tablets of 400 mg strength, and is usually given as a 400 mg strength dose once per day. Length of therapy depends on the type of infection. Serious side effects of Avelox include severe diarrhea, acute allergic reactions, renal problems, and connective tissue problems (tendon rupture and joint problems), muscle pain, confusion, agitation, depression, and skin problems. In addition, the drug may prolong the QT heartbeat interval cause warfarin (Coumadin) levels to be higher than normal and make symptoms of myasthenia gravis worse. Avelox should be used during pregnancy and lactating women only if the potential benefit justifies the potential risk to the fetus or infant. As stated above, Avelox should not be used in pediatric patients. Although Avelox may be effective against a wide range of bacteria, good clinical practice suggests the sensitivities of infective organisms to Avelox be determined.

Our Avelox Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Avelox in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Avelox (Moxifloxacin HCL)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Avelox Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea, diarrhea, dizziness, lightheadedness, headache, weakness, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: unusual bruising/bleeding, signs of a new infection (such as new/persistent fever, persistent sore throat), unusual change in the amount of urine, signs of liver problems (such as unusual tiredness, stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine).

Get medical help right away if you have any very serious side effects, including: severe/persistent headache, vision changes, shaking (tremors), seizures, severe dizziness, fainting, fast/irregular heartbeat, mental/mood changes (such as anxiety, confusion, hallucinations, depression, rare thoughts of suicide).

Rarely, this medication may cause serious, possibly permanent, nerve problems (peripheral neuropathy). Stop taking moxifloxacin and tell your doctor right away if you have any of the following symptoms: pain/numbness/burning/tingling/weakness in your arms, hands, legs, or feet, changes in how you sense touch/pain/temperature/vibration/body position.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Avelox (Moxifloxacin HCL)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Avelox FDA Prescribing Information: Side Effects
(Adverse Reactions)


The following serious and otherwise important adverse reactions are discussed in greater detail in the WARNINGS AND PRECAUTIONS section of the label:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to AVELOX in 14981 patients in 71 active controlled Phase II-IV clinical trials in different indications [see INDICATIONS AND USAGE]. The population studied had a mean age of 50 years (approximately 73% of the population was less than 65 years of age), 50% were male, 63% were Caucasian, 12% were Asian and 9% were Black. Patients received AVELOX 400 mg once daily oral, intravenous, or sequentially (intravenous followed by oral). Treatment duration was usually 6 to 10 days, and the mean number of days on therapy was 9 days.

Discontinuation of AVELOX due to adverse reactions occurred in 5% of patients overall, 4% of patients treated with 400 mg PO, 4% with 400 mg intravenous and 8% with sequential therapy 400 mg oral/intravenous. The most common adverse reactions ( > 0.3%) leading to discontinuation with the 400 mg oral doses were nausea, diarrhea, dizziness, and vomiting. The most common adverse reaction leading to discontinuation with the 400 mg intravenous dose was rash. The most common adverse reactions leading to discontinuation with the 400 mg intravenous/oral sequential dose were diarrhea, pyrexia.

Adverse reactions occurring in 1% of AVELOX-treated patients and less common adverse reactions, occurring in 0.1 to 1% of AVELOX-treated patients, are shown in Tables 2 and Table 3, respectively. The most common adverse drug reactions (3%) are nausea, diarrhea, headache, and dizziness.

Table 2: Common (1% or more) Adverse Reactions Reported in Active-Controlled Clinical Trials with AVELOX

System Organ Class Adverse Reactions %
Blood and Lymphatic System Disorders Anemia 1
Gastrointestinal Disorders Nausea 7
Diarrhea 6
Vomiting 2
Constipation 2
Abdominal pain 2
Dyspepsia 1
General Disorders and Administration Site Conditions Pyrexia 1
Investigations Alanine aminotransferase increased 1
Metabolism and Nutritional Disorder Hypokalemia 1
Nervous System Disorders Headache 4
Dizziness 3
Psychiatric Disorders Insomnia 2

Table 3: Less Common (0.1 to less than 1%) Adverse Reactions Reported in Active-Controlled Clinical Trials with AVELOX (N=14,981)

System Organ Class Adverse Reactions
Blood and Lymphatic System Disorders Thrombocythemia
Cardiac Disorders Atrial fibrillation
System Organ Class Adverse Reactions
Angina pectoris
Cardiac failure
Cardiac arrest
Ear and Labyrinth Disorders Vertigo
Eye Disorders Vision blurred
Gastrointestinal Disorders Dry mouth
Abdominal discomfort
Abdominal distention
Gastroesophageal reflux disease
General Disorders and Administration Site Conditions Fatigue
Chest pain
Infusion site extravasation
Chest discomfort
Facial pain
Hepatobiliary disorders Hepatic function abnormal
Infections and Infestations Candidiasis
Vaginal infection
Fungal infection
Investigations Aspartate aminotransferase increased
Gamma-glutamyltransferase increased
Blood alkaline phosphatase increased
Electrocardiogram QT prolonged
Blood lactate dehydrogenase increased
Blood amylase increased
Lipase increased
Blood creatinine increased
Blood urea increased
Hematocrit decreased
Prothrombin time prolonged
Eosinophil count increased
Activated partial thromboplastin time prolonged
Blood triglycerides increased
Blood uric acid increased
Metabolism and Nutrition Disorders Hyperglycemia
Decreased appetite
Musculoskeletal and Connective Tissue Disorders Back pain
Pain in extremity
Muscle spasms
Musculoskeletal pain
Nervous System Disorders Dysgeusia
System Organ Class Adverse Reactions
Psychiatric Disorders Anxiety
Confusional state
Renal and Urinary Disorders Renal failure
Reproductive System and Breast Disorders Vulvovaginal pruritus
Respiratory, Thoracic, and Mediastinal Disorders Dyspnea
Skin and Subcutaneous Tissue Disorders Rash
Dermatitis allergic
Night sweats
Vascular Disorders Hypertension

Laboratory Changes

Changes in laboratory parameters, which are not listed above and which occurred in 2% or more of patients and at an incidence greater than in controls included: increases in mean corpuscular hemoglobin (MCH), neutrophils, white blood cells (WBCs), prothrombin time (PT) ratio, ionized calcium, chloride, albumin, globulin, bilirubin; decreases in hemoglobin, red blood cells (RBCs), neutrophils, eosinophils, basophils, glucose, oxygen partial pressure (pO2), bilirubin, and amylase. It cannot be determined if any of the above laboratory abnormalities were caused by the drug or the underlying condition being treated.

Postmarketing Experience

Table 4 below lists adverse reactions that have been identified during post-approval use of AVELOX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Table 4: Postmarketing Reports of Adverse Drug Reactions

System Organ Class Adverse Reaction
Blood and Lymphatic System Disorders Agranulocytosis
Cardiac Disorders Ventricular tachyarrhythmias (including in very rare cases cardiac arrest and torsade de pointes, and usually in patients with concurrent severe underlying proarrhythmic conditions)
Ear and Labyrinth Disorders Hearing impairment, including deafness (reversible in majority of cases)
Eye Disorders Vision loss (especially in the course of CNS reactions, transient in majority of cases)
Hepatobiliary Disorders Hepatitis (predominantly cholestatic)
Hepatic failure (including fatal cases)
Acute hepatic necrosis [see WARNINGS AND PRECAUTIONS]
Immune System Disorders Anaphylactic reaction
Anaphylactic shock
Angioedema (including laryngeal edema) [see WARNINGS AND PRECAUTIONS]
Musculoskeletal and Connective Tissue Disorders Tendon rupture [seeWARNINGS AND PRECAUTIONS]
Nervous System Disorders Altered coordination
Myasthenia gravis (exacerbation of) [see WARNINGS AND PRECAUTIONS]
Muscle weakness
Peripheral neuropathy (that may be irreversible), polyneuropathy [see WARNINGS AND PRECAUTIONS]
Psychiatric Disorders Psychotic reaction (very rarely culminating in self-injurious behavior, such as suicidal ideation/thoughts or suicide attempts [see WARNINGS AND PRECAUTIONS]
Renal and Urinary Disorders Interstitial nephritis [see WARNINGS AND PRECAUTIONS]
Respiratory, Thoracic and Mediastinal Disorders Allergic pneumonitis [see WARNINGS AND PRECAUTIONS]
Skin and Subcutaneous Tissue Disorders Photosensitivity/phototoxicity reaction [see WARNINGS AND PRECAUTIONS]
Stevens-Johnson syndrome
Toxic epidermal necrolysis [see WARNINGS AND PRECAUTIONS]

Read the entire FDA prescribing information for Avelox (Moxifloxacin HCL)

Avelox - User Reviews

Avelox User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Avelox sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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