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Avelox (Moxifloxacin Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical efficacy trials enrolled over 9,200 moxifloxacin orally and intravenously treated patients, of whom over 8,600 patients received the 400 mg dose. Most adverse events reported in moxifloxacin trials were described as mild to moderate in severity and required no treatment. Moxifloxacin was discontinued due to adverse reactions thought to be drug-related in 2.9% of orally treated patients and 6.3 % of sequentially (intravenous followed by oral) treated patients. The latter studies were conducted in community acquired pneumonia and complicated skin and skin structure infections and complicated intra-abdominal infections with, in general, a sicker patient population compared to the tablet studies.

Adverse reactions, judged by investigators to be at least possibly drug-related, occurring in greater than or equal to 2% of moxifloxacin treated patients were: nausea (6%), diarrhea (5%), dizziness (2%).

Additional clinically relevant uncommon events, judged by investigators to be at least possibly drug-related, that occurred in greater than or equal to 0.1% and less than 2% of moxifloxacin treated patients were:

BODY AS A WHOLE: abdominal pain, headache, asthenia, dehydration (secondary to diarrhea or reduced fluid intake), injection site reaction (including phlebitis), malaise, moniliasis, pain, allergic reaction

CARDIOVASCULAR: cardiac arrhythmia (not otherwise specified), tachycardia, palpitation, vasodilation, QT interval prolonged

DIGESTIVE: vomiting, abnormal liver function test (increased transaminases, increased bilirubin), dyspepsia, dry mouth, flatulence, oral moniliasis, constipation, GGTP increased, anorexia, stomatitis, glossitis

HEMIC AND LYMPHATIC: leukopenia, eosinophilia, prothrombin decrease (prothrombin time prolonged/International Normalized Ratio (INR) increased), thrombocythemia

METABOLIC AND NUTRITIONAL: lactic dehydrogenase increased, amylase increased

MUSCULOSKELETAL: arthralgia, myalgia

NERVOUS SYSTEM: insomnia, nervousness, vertigo, somnolence, anxiety, tremor

SKIN/APPENDAGES: rash (maculopapular, purpuric, pustular), pruritus, sweating, urticaria

SPECIAL SENSES: taste perversion

UROGENITAL: vaginal moniliasis, vaginitis

Additional clinically relevant rare events, judged by investigators to be at least possibly drug-related, that occurred in less than 0.1% of moxifloxacin treated patients were:

abnormal dreams, abnormal vision (visual disturbances temporally associated with CNS symptoms), agitation, amblyopia, amnesia, anemia, aphasia, arthritis, asthma, atrial fibrillation, back pain, chest pain, confusion, convulsions of various clinical manifestations (including grand mal convulsions), depersonalization, depression (potentially culminating in self-endangering behavior), dysphagia, dyspnea, ECG abnormal, emotional lability, face edema, gastritis, gastrointestinal disorder, hallucinations, hyperglycemia, hyperlipidemia, hypertension, hypertonia, hyperuricemia, hypesthesia, hypotension, incoordination, jaundice (predominantly cholestatic), kidney function abnormal, lab test abnormal (not specified), leg pain, paraesthesia, parosmia, pelvic pain, peripheral edema, photosensitivity/phototoxicity reactions, pseudomembranous colitis, prothrombin increase (prothrombin time decreased/International Normalized Ratio (INR) decreased), sleep disorders, speech disorders, supraventricular tachycardia, syncope, taste loss, tendon disorder, thinking abnormal, thrombocytopenia, thromboplastin decrease, tinnitus, tongue discoloration, ventricular tachycardia

Post-Marketing Adverse Event Reports:

Additional adverse events have been reported from worldwide post-marketing experience with moxifloxacin. 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. These events, some of them life-threatening, include anaphylactic reaction, anaphylactic shock, angioedema (including laryngeal edema), hepatic failure, including fatal cases, hepatitis (predominantly cholestatic), photosensitivity/phototoxicity reaction (see PRECAUTIONS), psychotic reaction (very rarely culminating in self-endangering behavior), renal dysfunction or renal failure, Stevens-Johnson syndrome, tendon rupture, toxic epidermal necrolysis, and ventricular tachyarrhythmias (including in very rare cases cardiac arrest and torsade de pointes, and usually in patients with concurrent severe underlying proarrhythmic conditions). Cases of altered coordination and abnormal gait as well as exacerbation of myasthenia gravis have also been reported.

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.



REPORTS OF SUSPECTED AVELOX SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Avelox. The information is not vetted and should not be considered as verified clinical evidence.

Possible Avelox side effects / adverse reactions in 70 year old female

Reported by a physician from United States on 2011-10-03

Patient: 70 year old female

Reactions: Rash

Suspect drug(s):
Avelox



Possible Avelox side effects / adverse reactions in 69 year old female

Reported by a physician from United States on 2011-10-03

Patient: 69 year old female

Reactions: Vomiting, Vertigo, Dizziness, Muscular Weakness, Tremor

Suspect drug(s):
Avelox



Possible Avelox side effects / adverse reactions in 65 year old male

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 65 year old male

Reactions: Dysgeusia, Ageusia

Suspect drug(s):
Avelox

Other drugs received by patient: Albuterol Inhaler; Soma; Forodesine; Aspirin; Simvastatin; Claritin-D 24 Hour; Metoprolol Tartrate; Codeine



See index of all Avelox side effect reports >>

Drug label data at the top of this Page last updated: 2009-08-06

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