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Avelox

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Avelox

Avelox

Avelox Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

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, vomiting, mouth sores, headache, 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);
  • 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 immediately if any of these rare but very serious side effects occur: unusual bruising/bleeding, signs of a new infection (e.g., new/persistent fever, persistent sore throat), unusual change in the amount of urine, signs of liver problems (e.g., unusual tiredness, stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine).

Seek immediate medical attention if any of these rare but very serious side effects occur: severe/persistent headache, vision changes, shaking (tremors), seizures, severe dizziness, fainting, fast/irregular heartbeat, mental/mood changes (e.g., anxiety, confusion, hallucinations, depression, rare thoughts of suicide).

Moxifloxacin may rarely cause serious nerve problems that may be reversible if identified and treated early. Seek immediate medical attention if you develop any of the following symptoms: pain/numbness/burning/tingling/weakness in any part of the body, changes in how you sense touch/pain/temperature/body position/vibration.

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. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal 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, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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)

SIDE EFFECTS

Serious and Otherwise Important 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 Trial 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 <65 years of age), 50% were male, 63% were Caucasian, 12% were Asian and 9% were Black. Patients received AVELOX 400 mg once daily PO, IV, or sequentially (IV followed by PO). Treatment duration was usually 6-10 days, and the mean number of days on therapy was 9 days.

Discontinuation of AVELOX due to adverse events occurred in 5.0% of patients overall, 4.1% of patients treated with 400 mg PO, 3.9% with 400 mg IV and 8.2% with sequential therapy 400 mg PO/IV. The most common adverse events leading to discontinuation with the 400 mg PO doses were nausea (0.8%), diarrhea (0.5%), dizziness (0.5%), and vomiting (0.4%). The most common adverse event leading to discontinuation with the 400 mg IV dose was rash (0.5%). The most common adverse events leading to discontinuation with the 400 mg IV/PO sequential dose were diarrhea (0.5%), pyrexia (0.4%).

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 (≥ 1.0%) Adverse Reactions Reported in Active-Controlled Clinical Trials with AVELOX

System Organ Class Adverse Reactionsa %
(N=14,981)
Blood and Lymphatic System Disorders Anemia 1.1
Gastrointestinal Disorders Nausea 6.9
Diarrhea 6.0
Vomiting 2.4
Constipation 1.9
Abdominal pain 1.5
Abdominal pain upper 1.1
Dyspepsia 1.0
General Disorders and Administration Site Conditions Pyrexia 1.1
Investigations Alanine aminotransferase increased 1.1
Metabolism and Nutritional Disorder Hypokalemia 1
Nervous System Disorders Headache 4.2
Dizziness 3.0
Psychiatric Disorders Insomnia 1.9
a MedDRA Version 12.0

Table 3 : Less Common (0.1 to <1.0%) Adverse Reactions Reported in Active-Controlled Clinical Trials with AVELOX (N=14,981)

System Organ Class Adverse Reactionsa
Blood and Lymphatic System Disorders Thrombocythemia
Eosinophilia
Neutropenia
Thrombocytopenia
Leukopenia
Leukocytosis
Cardiac Disorders Atrial fibrillation Palpitations Tachycardia Cardiac failure congestive Angina pectoris Cardiac failure Cardiac arrest Bradycardia
Ear and Labyrinth Disorders Vertigo
Tinnitus
Eye Disorders Vision blurred
Gastrointestinal Disorders Dry mouth
Abdominal discomfort
Flatulence
Abdominal distention
Gastritis
Gastroesophageal reflux disease
General Disorders and Administration Site Conditions Fatigue
Chest pain
Asthenia
Edema peripheral
Pain
Malaise
Infusion site extravasation
Edema
Chills
Chest discomfort
Facial pain
Hepatobiliary disorders Hepatic function abnormal
Infections and Infestations Vulvovaginal candidiasis
Oral candidiasis
Vulvovaginal mycotic infection
Candidiasis
Vaginal infection
Oral fungal infection
Fungal infection
Gastroenteritis
Investigations Aspartate aminotransferase increased
Gamma-glutamyltransferase increased
Blood alkaline phosphatase increased
Hepatic enzyme increased
Electrocardiogram QT prolonged
Blood lactate dehydrogenase increased
Platelet count increased
Blood amylase increased
Blood glucose increased
Lipase increased
Hemoglobin decreased
Blood creatinine increased
Transaminases increased
White blood cell count increased
Blood urea increased
Liver function test abnormal
Hematocrit decreased
Prothrombin time prolonged
Eosinophil count increased
Activated partial thromboplastin time prolonged
Blood bilirubin increased
Blood triglycerides increased
Blood uric acid increased
Blood pressure increased
Metabolism and Nutrition Disorders Hyperglycemia
Anorexia
Hypoglycemia
Hyperlipidemia
Decreased appetite
Dehydration
Musculoskeletal and Connective Tissue Disorders Back pain
Pain in extremity
Arthralgia
Myalgia
Muscle spasms
Musculoskeletal chest pain
Musculoskeletal pain
Nervous System Disorders Dysgeusia
Somnolence
Tremor
Lethargy
Paresthesia
Tension headache
Hypoesthesia
Syncope
Psychiatric Disorders Anxiety
Confusional state
Agitation
Depression
Nervousness
Restlessness
Hallucination
Disorientation
Renal and Urinary Disorders Renal failure
Dysuria
Renal failure acute
Reproductive System and Breast Disorders Vulvovaginal pruritus
Respiratory, Thoracic, and Mediastinal Disorders Dyspnea
Asthma
Wheezing
Bronchospasm
Skin and Subcutaneous Tissue Disorders Rash
Pruritus
Hyperhidrosis
Erythema
Urticaria
Dermatitis allergic
Night sweats
Vascular disorders Hypertension
Hypotension
Phlebitis
a MedDRA Version 12.0

Laboratory Changes

Changes in laboratory parameters, without regard to drug relationship, which are not listed above and which occurred in ≥ 2% of patients and at an incidence greater than in controls included: increases in MCH, neutrophils, WBCs, PT ratio, ionized calcium, chloride, albumin, globulin, bilirubin; decreases in hemoglobin, RBCs, neutrophils, eosinophils, basophils, PT ratio, glucose, 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 lists adverse reactions that have been identified during post-approval use of AVELOX. Because these events 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 Pancytopenia [see WARNINGS AND PRECAUTIONS]
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) Jaundice 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 [see WARNINGS AND PRECAUTIONS]
Nervous System Disorders Altered coordination Abnormal gait [see WARNINGS AND PRECAUTIONS] 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 Renal dysfunction 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) »

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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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