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]
- Exacerbation of Myasthenia Gravis [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 Class |
Adverse Reaction |
% (N=7537) |
Infections and Infestations
|
moniliasis |
1 |
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 |
7 |
diarrhea |
5 |
constipation |
3 |
abdominal pain |
2 |
vomiting |
2 |
dyspepsia |
2 |
Skin and Subcutaneous Tissue Disorders
|
rash [see Warnings and Precautions]
pruritus |
2 1 |
Reproductive System and Breast Disorders
|
vaginitis |
1N=3758 (women)
|
General Disorders and Administration Site Conditions
|
edema |
1 |
injection site reaction |
1 |
chest pain |
1 |
Table 7: Less Common (0.1 to 1%) Adverse Reactions Reported in Clinical Trials with LEVAQUIN® (N=7537)
System/Organ Class |
Adverse 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 (5.3,
5.4) ]
|
Metabolism and Nutrition Disorders
|
hyperglycemia hypoglycemia
[see Warnings and Precautions]
hyperkalemia
|
Psychiatric Disorders
|
anxiety agitation confusion depression hallucination nightmare
[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 pseudomembranous/ 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 tendinitis
[see Warnings and Precautions]
myalgia skeletal pain |
Renal and Urinary Disorders
|
abnormal renal function acute renal failure [see Warnings and Precautions]
|
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 Class |
Adverse 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 (5.3, 5.4) ]
|
Psychiatric Disorders
|
psychosis paranoia isolated reports of suicide attempt and suicidal ideation
[see Warnings and Precautions]
|
Nervous System Disorders
|
exacerbation of myasthenia gravis [see Warnings and Precautions]
anosmia ageusia parosmia dysgeusia peripheral neuropathy [see Warnings and Precautions]
isolated reports of encephalopathy abnormal electroencephalogram (EEG) dysphonia pseudotumor cerebri [see Warnings and Precautions]
|
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 ]
|
Skin and Subcutaneous Tissue Disorders
|
bullous eruptions to include: Stevens-Johnson Syndrome toxic epidermal necrolysis erythema multiforme
[see Warnings and Precautions]
photosensitivity/phototoxicity 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
|