ADVERSE REACTIONS
The incidence of drug-related adverse reactions in patients during Phase 3 clinical trials conducted in North America was 6.2%. Among patients receiving levofloxacin therapy, 4.3% discontinued levofloxacin therapy due to adverse experiences. The overall incidence, type and distribution of adverse events was similar in patients receiving levofloxacin doses of 750 mg once daily compared to patients receiving doses from 250 mg once daily to 500 mg twice daily.
In clinical trials, the following events were considered likely to be drug-related in patients receiving levofloxacin:
nausea 1.2%, diarrhea 1.0%, vaginitis 0.6%, insomnia 0.4%, abdominal pain 0.4%, flatulence 0.3%, pruritus 0.3%, dizziness 0.3%, rash 0.3%, dyspepsia 0.2%, genital moniliasis 0.2%, moniliasis 0.2%, taste perversion 0.2%, vomiting 0.2%, injection site pain 0.2%, injection site reaction 0.2%, injection site inflammation 0.1%, constipation 0.1%, fungal infection 0.1%, genital pruritis 0.1%, headache 0.1%, nervousness 0.1%, rash erythematous 0.1%, urticaria 0.1% anorexia 0.1%, somnolence 0.1%, agitation 0.1%, rash maculopapular 0.1%, tremor 0.1%, condition aggravated 0.1%, allergic reaction 0.1%.
In clinical trials, the following events occurred in >3% of patients, regardless of drug relationship:
nausea 7.1%, headache 6.2%, diarrhea 5.5%, insomnia 5.1%, constipation 3.5%.
In clinical trials, the following events occurred in 1 to 3% of patients, regardless of drug relationship:
abdominal pain 2.7%,dizziness 2.5%, vomiting 2.5%, dyspepsia 2.3%, vaginitis 1.7%, rash 1.6%, chest pain 1.4%, pruritus 1.3%, sinusitis 1.3%, dyspnea 1.4%, fatigue 1.4%, flatulence 1.2%, pain 1.6%, back pain 1.2%, rhinitis 1.2%, anxiety 1.2%, pharyngitis 1.2%.
In clinical trials, the following events, of potential medical importance, occurred at a rate of 0.1% to 0.9%, regardless of drug relationship:
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Body as a Whole - General Disorders:
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Ascites, allergic reaction, asthenia, drug level increase, edema, enlarged abdomen, fever, headache, hot flashes, influenza-like symptoms, leg pain, malaise, rigors, substernal chest pain, syncope, multiple organ failure, changed temperature sensation, withdrawal syndrome
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Cardiovascular Disorders, General:
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Cardiac failure, hypertension, hypertension aggravated hypotension, postural hypotension
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Central and Peripheral Nervous System Disorders:
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Convulsions (seizures), dysphonia, hyperesthesia, hyperkinesia, hypertonia, hypoesthesia, involuntary muscle contractions, migraine, paresthesia, paralysis, speech disorder, stupor, tremor, vertigo, encephalopathy, abnormal gait, leg cramps, intracranial hypertension, ataxia
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Gastro-Intestinal System Disorders:
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Dry mouth, dysphagia, esophagitis, gastritis, gastroenteritis, gastroesophageal reflux, G.I. hemorrhage, glossitis, hemorrhoids, intestinal obstruction, pancreatitis, tongue edema, melena, stomatitis
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Hearing and Vestibular Disorders:
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Earache, tinnitus
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Heart Rate and Rhythm Disorders:
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Arrhythmia, arrhythmia ventricular, atrial fibrillation, bradycardia, cardiac arrest, ventricular fibrillation, heart block, palpitation, supraventricular tachycardia, ventricular tachycardia, tachycardia
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Liver and Biliary System Disorders:
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Abnormal hepatic function, cholecystitis, cholelithiasis, elevated bilirubin, hepatic enzymes increased, hepatic failure, jaundice
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Metabolic and Nutritional Disorders:
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Hypomagnesemia, thirst, dehydration, electrolyte abnormality, fluid overload, gout, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, hypophosphatemia, nonprotein nitrogen increase, weight decrease
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Musculo-Skeletal System Disorders:
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Arthralgia, arthritis, arthrosis, myalgia, osteomyelitis, skeletal pain, synovitis, tendonitis, tendon disorder
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Myo, Endo, Pericardial and Valve Disorders:
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Angina pectoris, endocarditis, myocardial infarction
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Neoplasms:
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Carcinoma, thrombocythemia
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Other Special Senses Disorders:
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Parosmia, taste perversion
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Platelet, Bleeding and Clotting Disorders:
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Hematoma, epistaxis, prothrombin decreased, pulmonary embolism, purpura, thrombocytopenia
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Psychiatric Disorders:
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Abnormal dreaming, agitation, anorexia, confusion, depression, hallucination, impotence, nervousness, paroniria, sleep disorder, somnolence
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Red Blood Cell Disorders:
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Anemia
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Reproductive Disorders:
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Dysmenorrhea, leukorrhea
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Resistance Mechanism Disorders:
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Abscess, bacterial infection, fungal infection, herpes simplex, moniliasis, otitis media, sepsis, viral infection
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Respiratory System Disorders:
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Airways obstruction, aspiration, asthma, bronchitis, bronchospasm, chronic obstructive airway disease, coughing, hemoptysis, epistaxis, hypoxia, laryngitis, pharyngitis, pleural effusion, pleurisy, pneumonitis, pneumonia, pneumothorax, pulmonary collapse, pulmonary edema, respiratory depression, respiratory insufficiency, upper respiratory tract infection
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Skin and Appendages Disorders:
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Alopecia, bullous eruption, dry skin, eczema, genital pruritus, increased sweating, rash, skin exfoliation, skin ulceration, urticaria
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Urinary System Disorders:
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Abnormal renal function, acute renal failure, dysuria, hematuria, oliguria, urinary incontinence, urinary retention, urinary tract infection
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Vascular (Extracardiac) Disorders:
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Flushing, gangrene, phlebitis, purpura, thrombophlebitis (deep)
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Vision Disorders:
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Abnormal vision, eye pain, conjunctivitis
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White Cell and RES Disorders:
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Agranulocytosis, granulocytopenia, leukocytosis, lymphadenopathy
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In clinical trials using multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with other quinolones. The relationship of the drugs to these events is not presently established.
Crystalluria and cylindruria have been reported with other quinolones.
The following markedly abnormal laboratory values appeared in >2% of patients receiving levofloxacin. It is not known whether these abnormalities were caused by the drug or the underlying condition being treated.
Blood Chemistry: decreased glucose (2.2%)
Hematology: decreased lymphocytes (2.2%)
POST-MARKETING ADVERSE REACTIONS
Additional adverse events reported from worldwide post-marketing experience with levofloxacin include:
allergic pneumonitis, anaphylactic shock, anaphylactoid reaction, dysphonia, abnormal EEG, encephalopathy, eosinophilia, erythema multiforme, hemolytic anemia, multi-system organ failure, increased International Normalized Ratio (INR)/prothrombin time, Stevens-Johnson Syndrome, tendon rupture, torsades de pointes, vasodilation.
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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO LEVAQUIN
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 cosidered as verified clinical evidence.
Possible Levaquin side effects / adverse reactions in 38 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2007-01-02
Patient: 38 year old female weighing 87.5 kg (192.6 pounds)
Reactions: Anxiety, Anorexia, Insomnia, Depression, Constipation, Paraesthesia
Suspect drug(s):
Levaquin
Dosage: 1 pill once a day po
Administration route: Oral
Indication: Diarrhoea
Start date: 2006-12-20
End date: 2006-12-24
Levaquin
Dosage: 1 pill once a day po
Administration route: Oral
Indication: Gastroenteritis Viral
Start date: 2006-12-20
End date: 2006-12-24
Possible Levaquin side effects / adverse reactions in 48 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2007-01-03
Patient: 48 year old female weighing 52.2 kg (114.8 pounds)
Reactions: Anxiety, Chest Discomfort, Anaphylactic Reaction, Pleurisy, Tachycardia, Respiratory Distress
Adverse event resulted in: life threatening event, hospitalization
Suspect drug(s):
Levaquin
Dosage: 1 tablet qd po
Administration route: Oral
Indication: Craniotomy
Start date: 2006-12-14
End date: 2006-12-16
Levaquin
Dosage: 1 tablet qd po
Administration route: Oral
Indication: Postoperative Care
Start date: 2006-12-14
End date: 2006-12-16
Possible Levaquin side effects / adverse reactions in 35 year old male
Reported by a consumer/non-health professional from United States on 2007-01-03
Patient: 35 year old male weighing 78.0 kg (171.6 pounds)
Reactions: Arthralgia
Suspect drug(s):
Levaquin
Possible Levaquin side effects / adverse reactions in 87 year old male
Reported by a pharmacist from United States on 2007-01-08
Patient: 87 year old male weighing 91.6 kg (201.5 pounds)
Reactions: Hypoglycaemia
Adverse event resulted in: hospitalization
Suspect drug(s):
Levaquin
Possible Levaquin side effects / adverse reactions in 48 year old female
Reported by a pharmacist from United States on 2007-01-09
Patient: 48 year old female
Reactions: Rash Erythematous, Infusion Related Reaction
Suspect drug(s):
Levaquin
Dosage: 500 mg once iv drip lees than 10 minutes
Indication: Prophylaxis
Start date: 2006-11-17
End date: 2006-11-17
Levaquin
Dosage: 500 mg once iv drip lees than 10 minutes
Indication: Surgery
Start date: 2006-11-17
End date: 2006-11-17
Possible Levaquin side effects / adverse reactions in 60 year old male
Reported by a consumer/non-health professional from United States on 2007-01-09
Patient: 60 year old male weighing 90.7 kg (199.6 pounds)
Reactions: Hypotrichosis, Hair Colour Changes
Suspect drug(s):
Levaquin
Dosage: 1 tablet once daily orally
Administration route: Oral
Indication: Bronchitis
Start date: 2006-12-09
Levaquin
Dosage: 1 tablet once daily orally
Administration route: Oral
Indication: Bronchitis
Start date: 2006-12-19
Other drugs received by patient: Tussionex Pennkinetic Susp; Acyclovir; Lisinopril; Amitriptyline HCL
Possible Levaquin side effects / adverse reactions in 79 year old male
Reported by a pharmacist from Canada on 2007-01-10
Patient: 79 year old male weighing 105.0 kg (231.0 pounds)
Reactions: Hypoglycaemia
Adverse event resulted in: death
Suspect drug(s):
Levaquin
Indication: Pneumonia Aspiration
Glyburide
Indication: Drug USE FOR Unknown Indication
Other drugs received by patient: Nitroglycerin; Allopurinol Sodium; Aspirin; Clopidogrel; Doxazosin Mesylate; Levothyroxine Sodium; Simvastatin; Atenolol; Metoclopramide; Diltiazem HCL; Escitalopram Oxalate; Fluconazole; Pantoprazole Sodium; Sodium Bicarbonate; Mirtazapine
Possible Levaquin side effects / adverse reactions in 48 year old male
Reported by a pharmacist from United States on 2007-01-11
Patient: 48 year old male weighing 62.6 kg (137.7 pounds)
Reactions: Rash
Suspect drug(s):
Levaquin
Dosage: 500mg, 500mg qd, oral
Administration route: Oral
Indication: Biopsy Prostate
Start date: 2006-11-01
End date: 2006-11-03
Levaquin
Dosage: 500mg, 500mg qd, oral
Administration route: Oral
Indication: Prophylaxis
Start date: 2006-11-01
End date: 2006-11-03
Possible Levaquin side effects / adverse reactions in 43 year old female
Reported by a consumer/non-health professional from United States on 2007-01-11
Patient: 43 year old female weighing 48.5 kg (106.8 pounds)
Reactions: Burning Sensation, Paraesthesia
Suspect drug(s):
Levaquin
Possible Levaquin side effects / adverse reactions in 30 year old female
Reported by a consumer/non-health professional from United States on 2007-01-11
Patient: 30 year old female weighing 59.0 kg (129.7 pounds)
Reactions: Tinnitus, Dyspnoea, Palpitations, Restlessness, Insomnia
Suspect drug(s):
Levaquin
Other drugs received by patient: Protonix; Estrostep; Yasmin; Ibuprofen
Possible Levaquin side effects / adverse reactions in 74 year old female
Reported by a individual with unspecified qualification from United States on 2007-01-16
Patient: 74 year old female weighing 56.7 kg (124.7 pounds)
Reactions: Arthralgia, Musculoskeletal Pain, Tendonitis, Arthritis
Adverse event resulted in: disablity
Suspect drug(s):
Levaquin
Possible Levaquin side effects / adverse reactions in 79 year old female
Reported by a pharmacist from United States on 2007-01-17
Patient: 79 year old female weighing 73.4 kg (161.5 pounds)
Reactions: Blood Glucose Decreased
Adverse event resulted in: hospitalization
Suspect drug(s):
Levaquin
Possible Levaquin side effects / adverse reactions in 57 year old female
Reported by a pharmacist from United States on 2007-01-17
Patient: 57 year old female
Reactions: Drug Effect Decreased, Mouth Haemorrhage, Thrombocytopenia
Adverse event resulted in: hospitalization
Suspect drug(s):
Levaquin
Other drugs received by patient: Altace; Avonex
Possible Levaquin side effects / adverse reactions in 74 year old male
Reported by a individual with unspecified qualification from United States on 2007-01-19
Patient: 74 year old male
Reactions: Swelling Face, Oedema Peripheral
Suspect drug(s):
Levaquin
Dosage: 500 mg once daily
Indication: Otitis Media
Start date: 2006-10-25
Levaquin
Dosage: 500 mg once daily
Indication: Otitis Media
Start date: 2006-11-04
Possible Levaquin side effects / adverse reactions in 56 year old female
Reported by a individual with unspecified qualification from United States on 2007-01-24
Patient: 56 year old female weighing 63.5 kg (139.7 pounds)
Reactions: Tendon Pain, Pain in Extremity, Chills, Muscle Twitching, Muscle Spasms
Suspect drug(s):
Levaquin
Possible Levaquin side effects / adverse reactions in 57 year old female
Reported by a consumer/non-health professional from United States on 2007-01-24
Patient: 57 year old female weighing 74.8 kg (164.7 pounds)
Reactions: Myalgia, Respiratory Disorder, Muscle Swelling, Musculoskeletal Stiffness
Suspect drug(s):
Levaquin
Possible Levaquin side effects / adverse reactions in female
Reported by a pharmacist from United States on 2007-01-24
Patient: female
Reactions: Arthralgia, Myopathy
Suspect drug(s):
Levaquin
Possible Levaquin side effects / adverse reactions in female
Reported by a pharmacist from United States on 2007-01-25
Patient: female
Reactions: Arthralgia, Myopathy
Suspect drug(s):
Levaquin
Possible Levaquin side effects / adverse reactions in 63 year old male
Reported by a consumer/non-health professional from United States on 2007-01-25
Patient: 63 year old male weighing 127.0 kg (279.4 pounds)
Reactions: Abasia, Tendonitis
Suspect drug(s):
Levaquin
Possible Levaquin side effects / adverse reactions in 47 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2007-01-26
Patient: 47 year old male weighing 63.5 kg (139.7 pounds)
Reactions: Drug Hypersensitivity
Suspect drug(s):
Levaquin
Dosage: once daily po
Administration route: Oral
Indication: Cyst
Start date: 2006-04-01
End date: 2006-04-14
Levaquin
Dosage: once daily po
Administration route: Oral
Indication: Infection
Start date: 2006-04-01
End date: 2006-04-14
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