Medical Information
United States
 

In order to provide you with relevant and meaningful content we need to know more about you.

Please choose the category that best describes you.

Existe información en español para pacientes y cuidadores, para acceder, haga clic sobre “Select” al lado de “I am a U.S. Patient / Caregiver”.

This content is intended for U.S. Healthcare Professionals. Would you like to proceed?

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

Levofloxacin in 5% Dextrose Injection, USP Adverse Reactions

6 ADVERSE REACTIONS

6.1 Serious and Otherwise Important Adverse Reactions

The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:

Hypotension has been associated with rapid or bolus intravenous infusion of levofloxacin. Levofloxacin should be infused slowly over 60 to 90 minutes, depending on dosage [see Dosage and Administration (2.5)].

Crystalluria and cylindruria have been reported with quinolones, including levofloxacin. Therefore, adequate hydration of patients receiving levofloxacin should be maintained to prevent the formation of a highly concentrated urine [see Dosage and Administration (2.5)].

6.2 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 levofloxacin in 7,537 patients in 29 pooled Phase 3 clinical trials. The population studied had a mean age of 50 years (approximately 74% of the population was <65 years of age), 50% were male, 71% were Caucasian, 19% were Black. Patients were treated with levofloxacin for a wide variety of infectious diseases [see Indications and Usage (1)]. Patients received levofloxacin doses of 750 mg once daily, 250 mg once daily, or 500 mg once or twice daily. Treatment duration was usually 3–14 days, and the mean number of days on therapy was 10 days.

The overall incidence, type and distribution of adverse reactions was similar in patients receiving levofloxacin doses of 750 mg once daily, 250 mg once daily, and 500 mg once or twice daily. Discontinuation of levofloxacin due to adverse drug reactions occurred in 4.3% of patients overall, 3.8% of patients treated with the 250 mg and 500 mg doses and 5.4% of patients treated with the 750 mg dose. The most common adverse drug reactions leading to discontinuation with the 250 and 500 mg doses were gastrointestinal (1.4%), primarily nausea (0.6%); vomiting (0.4%); dizziness (0.3%); and headache (0.2%). The most common adverse drug reactions leading to discontinuation with the 750 mg dose were gastrointestinal (1.2%), primarily nausea (0.6%), vomiting (0.5%); dizziness (0.3%); and headache (0.3%).

Adverse reactions occurring in ≥1% of levofloxacin-treated patients and less common adverse reactions, occurring in 0.1 to <1% of levofloxacin-treated patients, are shown in Table 4 and Table 5, respectively. The most common adverse drug reactions (≥3%) are nausea, headache, diarrhea, insomnia, constipation, and dizziness.

Table 4: Common (≥1%) Adverse Reactions Reported in Clinical Trials with Levofloxacin
System/Organ Class Adverse Reaction %
(N=7,537)
*
N=7,274
N=3,758 (women)
Infections and Infestations moniliasis1
Psychiatric Disorders insomnia* [see Warnings and Precautions (5.4)]4
Nervous System Disordersheadache
dizziness [see Warnings and Precautions (5.4)]
6
3
Respiratory, Thoracic and Mediastinal Disordersdyspnea [see Warnings and Precautions (5.7)] 1
Gastrointestinal Disordersnausea
diarrhea
constipation
abdominal pain
vomiting
dyspepsia
7
5
3
2
2
2
Skin and Subcutaneous Tissue Disorders rash [see Warnings and Precautions (5.7)]
pruritus
2
1
Reproductive System and Breast Disorders vaginitis1
General Disorders and Administration Site Conditions edema
injection site reaction
chest pain
1
1
1
Table 5: Less Common (0.1 to 1%) Adverse Reactions Reported in Clinical Trials with Levofloxacin (N=7,537)
System/Organ Class Adverse Reaction
*
N=7,274
Infections and Infestations genital moniliasis
Blood and Lymphatic System Disorders anemia
thrombocytopenia
granulocytopenia
[see Warnings and Precautions (5.6)]
Immune System Disorders allergic reaction [see Warnings and Precautions (5.6, 5.7)]
Metabolism and Nutrition Disorders hyperglycemia
hypoglycemia
[see Warnings and Precautions (5.13)]
hyperkalemia
Psychiatric Disorders anxiety
agitation
confusion
depression
hallucination
nightmare*
[see Warnings and Precautions (5.4)]
sleep disorder*
anorexia
abnormal dreaming*
Nervous System Disorders tremor
convulsions
[see Warnings and Precautions (5.4)]
paresthesia
[see Warnings and Precautions (5.3)]
vertigo
hypertonia
hyperkinesias
abnormal gait
somnolence*
syncope
Respiratory, Thoracic and Mediastinal Disorders epistaxis
Cardiac Disorders cardiac arrest
palpitation
ventricular tachycardia
ventricular arrhythmia
Vascular Disorders phlebitis
Gastrointestinal Disorders gastritis
stomatitis
pancreatitis
esophagitis
gastroenteritis
glossitis
pseudomembranous/ C. difficile colitis [see Warnings and Precautions (5.10)]
Hepatobiliary Disorders abnormal hepatic function
increased hepatic enzymes
increased alkaline phosphatase
Skin and Subcutaneous Tissue Disorders urticaria [see Warnings and Precautions (5.7)]
Musculoskeletal and Connective Tissue Disorders arthralgia
tendinitis
[see Warnings and Precautions (5.2)]
myalgia
skeletal pain
Renal and Urinary Disorders abnormal renal function
acute renal failure [see Warnings and Precautions (5.6)]

In clinical trials using multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with quinolones, including levofloxacin. The relationship of the drugs to these events is not presently established.

6.3 Postmarketing Experience

Table 6 lists adverse reactions that have been identified during post-approval use of levofloxacin. 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 6: Postmarketing Reports Of Adverse Drug Reactions
System/Organ Class Adverse Reaction
Blood and Lymphatic System Disorders pancytopenia
aplastic anemia
leukopenia
hemolytic anemia
[see Warnings and Precautions (5.6)]
eosinophilia
Immune System Disorders hypersensitivity reactions, sometimes fatal including:
anaphylactic/anaphylactoid reactions
anaphylactic shock
angioneurotic edema
serum sickness
[see Warnings and Precautions (5.6, 5.7)]
Psychiatric Disorders psychosis
paranoia
isolated reports of suicidal ideation, suicide attempt and completed suicide
[see Warnings and Precautions (5.4)]
Nervous System Disorders exacerbation of myasthenia gravis [see Warnings and Precautions (5.5)]
anosmia
ageusia
parosmia
dysgeusia
peripheral neuropathy (may be irreversible) [see Warnings and Precautions (5.3)]
isolated reports of encephalopathy
abnormal electroencephalogram (EEG)
dysphonia
pseudotumor cerebri [see Warnings and Precautions (5.4)]
Eye Disorders uveitis
vision disturbance, including diplopia
visual acuity
reduced vision
blurred scotoma
Ear and Labyrinth Disorders hypoacusis
tinnitus
Cardiac Disorders isolated reports of torsade de pointes
electrocardiogram QT prolonged
[see Warnings and Precautions (5.11)]
tachycardia
Vascular Disorders vasodilatation
Respiratory, Thoracic and Mediastinal Disorders isolated reports of allergic pneumonitis [see Warnings and Precautions (5.6)]
Hepatobiliary Disorders hepatic failure (including fatal cases)
hepatitis
jaundice
[see Warnings and Precautions (5.6), (5.8)]
Skin and Subcutaneous Tissue Disorders bullous eruptions to include:
Stevens-Johnson Syndrome
toxic epidermal necrolysis
Acute Generalized Exanthematous Pustulosis (AGEP)
fixed drug eruptions
erythema multiforme
[see Warnings and Precautions (5.6)]
photosensitivity/phototoxicity reaction [see Warnings and Precautions (5.14)]
leukocytoclastic vasculitis
Musculoskeletal and Connective Tissue Disorders tendon rupture [see Warnings and Precautions (5.2)]
muscle injury, including rupture
rhabdomyolysis
Renal and Urinary Disorders interstitial nephritis [see Warnings and Precautions (5.6)]
General Disorders and Administration Site Conditions multi-organ failure
pyrexia
Investigations prothrombin time prolonged
international normalized ratio prolonged
muscle enzymes increased
Did you find an answer to your question? Yes No
Didn’t find what you were looking for? Contact us.
Report Adverse Event