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Levaquin (Levofloxacin) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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:

  • Tendon Effects [see Warnings and Precautions ]
  • Hypersensitivity Reactions [see Warnings and Precautions]
  • Other Serious and Sometimes Fatal Reactions [see Warnings and Precautions]
  • Hepatotoxicity [see Warnings and Precautions]
  • Central Nervous System Effects [see Warnings and Precautions]
  • Clostridium difficile -Associated Diarrhea [see Warnings and Precautions]
  • Peripheral Neuropathy [see Warnings and Precautions]
  • Prolongation of the QT Interval [see Warnings and Precautions]
  • Musculoskeletal Disorders in Pediatric Patients [see Warnings and Precautions]
  • Blood Glucose Disturbances [see Warnings and Precautions]
  • Photosensitivity/Phototoxicity [see Warnings and Precautions]
  • Development of Drug Resistant Bacteria [see Warnings and Precautions]

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

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

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 LEVAQUIN® in 7537 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 LEVAQUIN® for a wide variety of infectious diseases [see Indications and Usage (1) ] . Patients received LEVAQUIN® 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 LEVAQUIN® doses of 750 mg once daily, 250 mg once daily, and 500 mg once or twice daily. Discontinuation of LEVAQUIN® 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 LEVAQUIN®-treated patients and less common adverse reactions, occurring in 0.1 to <1% of LEVAQUIN®-treated patients, are shown in Table 6 and Table 7, respectively. The most common adverse drug reactions (≥3%) are nausea, headache, diarrhea, insomnia, constipation, and dizziness.

Table 6: Common (≥1%) Adverse Reactions Reported in Clinical Trials with LEVAQUIN®
System/Organ ClassAdverse Reaction%
(N=7537)
Infections and Infestations moniliasis1
Psychiatric Disorders insomniaN = 7274 [see Warnings and Precautions]
4
Nervous System Disorders headache
dizziness [see Warnings and Precautions]
6
3
Respiratory, Thoracic and Mediastinal Disorders dyspnea [see Warnings and Precautions] 1
Gastrointestinal Disorders nausea
diarrhea
constipation
abdominal pain
vomiting
dyspepsia
7
5
3
2
2
2
Skin and Subcutaneous Tissue Disorders rash [see Warnings and Precautions]
pruritus
2
1
Reproductive System and Breast Disorders vaginitis1N=3758 (women)
General Disorders and Administration Site Conditions edema
injection site reaction
chest pain
1
1
1
Table 7: Less Common (0.1 to 1%) Adverse Reactions Reported in Clinical Trials with LEVAQUIN® (N=7537)
System/Organ ClassAdverse Reaction
Infections and Infestations genital moniliasis
Blood and Lymphatic System Disorders

anemia
thrombocytopenia
granulocytopenia
[see Warnings and Precautions]
Immune System Disorders
allergic reaction [See Warnings and Precautions (5.2, 5.3) ]
Metabolism and Nutrition Disorders hyperglycemia
hypoglycemia
[see Warnings and Precautions]

hyperkalemia
Psychiatric Disorders anxiety
agitation
confusion
depression
hallucination
nightmare 1
[see Warnings and Precautions]

sleep disorder
anorexia
abnormal dreaming
Nervous System Disorders tremor
convulsions
[see Warnings and Precautions]

paresthesia [see Warnings and Precautions]
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
pseudomembraneous/ C. difficile colitis [see Warnings and Precautions]
Hepatobiliary Disorders abnormal hepatic function
increased hepatic enzymes
increased alkaline phosphatase
Skin and Subcutaneous Tissue Disorders urticaria [see Warnings and Precautions]
Musculoskeletal and Connective Tissue Disorders arthralgia
tendonitis
[see Warnings and Precautions]

myalgia
skeletal pain
Renal and Urinary Disorders abnormal renal function
acute renal failure [see Warnings and Precautions]

1 N = 7274

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 LEVAQUIN®. The relationship of the drugs to these events is not presently established.

Postmarketing Experience

Table 8 lists adverse reactions that have been identified during post-approval use of LEVAQUIN®. Because these reactions are reported voluntarily from a population of uncertain size, reliably estimating their frequency or establishing a causal relationship to drug exposure is not always possible.

Table 8: Postmarketing Reports Of Adverse Drug Reactions
System/Organ ClassAdverse Reaction
Blood and Lymphatic System Disorders pancytopenia
aplastic anemia
leukopenia
hemolytic anemia
[see Warnings and Precautions]

eosinophilia
Immune System Disorders hypersensitivity reactions, sometimes fatal including:
  anaphylactic/anaphylactoid reactions
  anaphylactic shock
  angioneurotic edema
  serum sickness
[see Warnings and Precautions (5.2, 5.3) ]
Psychiatric Disorders psychosis
paranoia
isolated reports of suicide attempt and suicidal ideation
[see Warnings and Precautions]
Nervous System Disorders
anosmia
ageusia
parosmia
dysgeusia
peripheral neuropathy [see Warnings and Precautions]
isolated reports of encephalopathy
abnormal electroencephalogram (EEG)
dysphonia
Eye Disorders 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 ]

tachycardia
Vascular Disorders vasodilatation
Respiratory, Thoracic and Mediastinal Disorders isolated reports of allergic pneumonitis [see Warnings and Precautions]
Hepatobiliary Disorders hepatic failure (including fatal cases)
hepatitis
jaundice
[see Warnings and Precautions 5.3, 5.4) ]
Skin and Subcutaneous Tissue Disorders bullous eruptions to include:
  Stevens-Johnson Syndrome
  toxic epidermal necrolysis
  erythema multiforme
[see Warnings and Precautions]

photosensitivity/photoxicity reaction [see Warnings and Precautions]
leukocytoclastic vasculitis
Musculoskeletal and Connective Tissue Disorders tendon rupture [see Warnings and Precautions]
muscle injury, including rupture
rhabdomyolysis
Renal and Urinary Disorders interstitial nephritis [see Warnings and Precautions]
General Disorders and Administration Site Conditions multi-organ failure
pyrexia
Investigations prothrombin time prolonged
international normalized ratio prolonged
muscle enzymes increased



REPORTS OF SUSPECTED LEVAQUIN SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Levaquin side effects / adverse reactions in 28 year old male

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

Patient: 28 year old male weighing 68.0 kg (149.7 pounds)

Reactions: Arthralgia, Pain in Extremity

Suspect drug(s):
Levaquin



Possible Levaquin side effects / adverse reactions in 48 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-03

Patient: 48 year old female weighing 83.9 kg (184.6 pounds)

Reactions: Grand MAL Convulsion, Impaired Driving Ability

Suspect drug(s):
Levaquin



Possible Levaquin side effects / adverse reactions in 41 year old male

Reported by a lawyer from United States on 2011-10-04

Patient: 41 year old male

Reactions: Tendon Rupture, Joint Injury

Suspect drug(s):
Levaquin



See index of all Levaquin side effect reports >>

Drug label data at the top of this Page last updated: 2008-10-20

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