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Levaquin (Levofloxacin) - Side Effects and Adverse Reactions

 


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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:

Body as a Whole - General Disorders: 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
Cardiovascular Disorders, General: Cardiac failure, hypertension, hypertension aggravated hypotension, postural hypotension
Central and Peripheral Nervous System Disorders: 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
Gastro-Intestinal System Disorders: Dry mouth, dysphagia, esophagitis, gastritis, gastroenteritis, gastroesophageal reflux, G.I. hemorrhage, glossitis, hemorrhoids, intestinal obstruction, pancreatitis, tongue edema, melena, stomatitis
Hearing and Vestibular Disorders: Earache, tinnitus
Heart Rate and Rhythm Disorders: Arrhythmia, arrhythmia ventricular, atrial fibrillation, bradycardia, cardiac arrest, ventricular fibrillation, heart block, palpitation, supraventricular tachycardia, ventricular tachycardia, tachycardia
Liver and Biliary System Disorders: Abnormal hepatic function, cholecystitis, cholelithiasis, elevated bilirubin, hepatic enzymes increased, hepatic failure, jaundice
Metabolic and Nutritional Disorders: Hypomagnesemia, thirst, dehydration, electrolyte abnormality, fluid overload, gout, hyperglycemia, hyperkalemia, hypernatremia, hypoglycemia, hypokalemia, hyponatremia, hypophosphatemia, nonprotein nitrogen increase, weight decrease
Musculo-Skeletal System Disorders: Arthralgia, arthritis, arthrosis, myalgia, osteomyelitis, skeletal pain, synovitis, tendonitis, tendon disorder
Myo, Endo, Pericardial and Valve Disorders: Angina pectoris, endocarditis, myocardial infarction
Neoplasms: Carcinoma, thrombocythemia
Other Special Senses Disorders: Parosmia, taste perversion
Platelet, Bleeding and Clotting Disorders: Hematoma, epistaxis, prothrombin decreased, pulmonary embolism, purpura, thrombocytopenia
Psychiatric Disorders: Abnormal dreaming, agitation, anorexia, confusion, depression, hallucination, impotence, nervousness, paroniria, sleep disorder, somnolence
Red Blood Cell Disorders: Anemia
Reproductive Disorders: Dysmenorrhea, leukorrhea
Resistance Mechanism Disorders: Abscess, bacterial infection, fungal infection, herpes simplex, moniliasis, otitis media, sepsis, viral infection
Respiratory System Disorders: 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
Skin and Appendages Disorders: Alopecia, bullous eruption, dry skin, eczema, genital pruritus, increased sweating, rash, skin exfoliation, skin ulceration, urticaria
Urinary System Disorders: Abnormal renal function, acute renal failure, dysuria, hematuria, oliguria, urinary incontinence, urinary retention, urinary tract infection
Vascular (Extracardiac) Disorders: Flushing, gangrene, phlebitis, purpura, thrombophlebitis (deep)
Vision Disorders: Abnormal vision, eye pain, conjunctivitis
White Cell and RES Disorders: Agranulocytosis, granulocytopenia, leukocytosis, lymphadenopathy

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.



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



See index of all Levaquin side effect reports >>

Drug label data at the top of this Page last updated: 2006-02-22

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