Levaquin Side Effects

Generic name: levofloxacin

Generic Name: levofloxacin,Levofloxacin

Please note - some side effects for Levaquin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Levaquin - for the consumer

Levaquin

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Levaquin:

Constipation; diarrhea; dizziness; gas; headache; lightheadedness; nausea; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody or tarry stools; chest pain; decreased or painful urination; fainting; fast or irregular heartbeat; fever, chills, sore throat, or unusual cough; hallucinations; inability to move or bear weight on a joint or tendon area; moderate or severe sunburn; mood or mental changes (eg, new or worsening anxiety, nervousness, agitation, confusion, depression, restlessness, sleeplessness); muscle pain or weakness; new or worsening nightmares; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea; severe or persistent dizziness, lightheadedness, tiredness, or weakness; severe or persistent stomach pain/cramps; shortness of breath; suicidal thoughts or actions; symptoms of high or low blood sugar (eg, dizziness; fainting; fast breathing; flushing; increased thirst, hunger, or urination; increased sweating; vision changes); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the skin or eyes); symptoms of nerve problems (eg, changes in perception of heat or cold; decreased sensation of touch; unusual burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet); tremors; unusual bruising or bleeding; vaginal discharge, irritation, or odor; vision changes; wheezing.

Levaquin Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Levaquin Solution:

Constipation; diarrhea; dizziness; gas; headache; lightheadedness; nausea; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody or tarry stools; chest pain; decreased or painful urination; decreased sensation of touch; fainting; fast or irregular heartbeat; fever, chills, sore throat, or unusual cough; hallucinations; inability to move or bear weight on a joint or tendon area; moderate or severe sunburn; mood or mental changes (eg, agitation, confusion, depression, nervousness, new or worsening anxiety, restlessness, sleeplessness); muscle pain or weakness; new or worsening nightmares; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea; severe or persistent dizziness, lightheadedness, tiredness, or weakness; severe or persistent stomach pain/cramps; shortness of breath; suicidal thoughts or actions; symptoms of high or low blood sugar (eg, dizziness; fainting; fast breathing; flushing; increased sweating; increased thirst, hunger, or urination; vision changes); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the skin or eyes); symptoms of nerve problems (eg, changes in perception of heat or cold; unusual burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet); tremors; unusual bruising or bleeding; vaginal discharge, irritation, or odor; vision changes; wheezing.

Levaquin Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Levaquin Tablets:

Constipation; diarrhea; dizziness; gas; headache; lightheadedness; nausea; stomach pain.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody or tarry stools; chest pain; decreased or painful urination; fainting; fast or irregular heartbeat; fever, chills, sore throat, or unusual cough; hallucinations; inability to move or bear weight on a joint or tendon area; moderate or severe sunburn; mood or mental changes (eg, agitation, confusion, depression, nervousness, new or worsening anxiety, restlessness, sleeplessness); muscle pain or weakness; new or worsening nightmares; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea; severe or persistent dizziness, lightheadedness, tiredness, or weakness; severe or persistent stomach pain/cramps; shortness of breath; suicidal thoughts or actions; symptoms of high or low blood sugar (eg, dizziness; fainting; fast breathing; flushing; increased sweating; increased thirst, hunger, or urination; vision changes); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the skin or eyes); symptoms of nerve problems (eg, changes in perception of heat or cold; decreased sensation of touch; unusual burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet); tremors; unusual bruising or bleeding; vaginal discharge, irritation, or odor; vision changes; wheezing.

By body system

General side effects

Levofloxacin therapy is generally well tolerated. Adverse reactions were reported in 6.7% of patients in clinical trials and therapy was discontinued due to adverse effects in 4.3% (3.8% treated with 250 mg and 500 mg doses; 5.4% treated with 750 mg doses).

Gastrointestinal side effects

Clostridium difficile diarrhea occurred in 11 of 490 study patients (2.2%) receiving levofloxacin.

Gastrointestinal side effects have included nausea (1.3% to 7%), diarrhea (1% to 5.7%), constipation (0.1% to 3.3%), abdominal pain (0.4% to 2.6%), flatulence (0.2% to 1.4%), dyspepsia (0.3% to 2.3%), vomiting (0.2% to 2.4%), and taste perversion (0.2%). Anorexia, dry mouth, dysphagia, gastroenteritis, GI hemorrhage, pancreatitis, tongue edema, glossitis, gastritis, gastroesophageal reflux, melena, esophagitis, stomatitis, and intestinal obstruction have been reported in 0.1% to 0.9% of patients. Pseudomembranous/Clostridium difficile colitis and ageusia have been reported during postmarketing experience. Quinolone class antibiotics have been associated with intestinal perforation.

Nervous system side effects

One survey reported 33 cases of peripheral neuropathy associated with levofloxacin, ranging in severity from mild and reversible to severe and persistent. In one case, a 51-year-old female developed "electrical" sensations, numbness, allodynia, multiple severe tendonitis, partial tendon rupture, impaired memory, confusion, and impaired concentration, with some symptoms persisting after 1 year.

Nervous system side effects have included insomnia (0.4% to 4.6%), dizziness (0.3% to 2.5%), headache (0.1% to 6.1%), and nervousness (0.1%). Abnormal coordination, coma, convulsions, hyperkinesia, hypertonia, hypoesthesia, involuntary muscle contractions, hyperesthesia, paresthesia, paralysis, somnolence, speech disorder, stupor, tremor, vertigo, encephalopathy, abnormal gait, leg cramps, ataxia, migraine, and intracranial hypertension have been reported in 0.1% to 0.9% of patients. Abnormal EEGs and peripheral neuropathy have been reported during postmarketing experience. Quinolone class antibiotics have been associated with possible exacerbation of myasthenia gravis.

Hematologic side effects

Hematologic side effects have included decreased lymphocytes in 2.2% to 2.4% of patients and abnormal WBCs (unspecified), anemia, abnormal platelets, epistaxis, agranulocytosis, granulocytopenia, hematoma, leukocytosis, lymphadenopathy, decreased prothrombin, pulmonary embolism, purpura, and thrombocytopenia in 0.1% to 0.9% of patients. Hemolytic anemia, eosinophilia, leukopenia, pancytopenia, aplastic anemia, and an increase in the International Normalized Ratio (INR)/prothrombin time have been reported during postmarketing experience.

Cardiovascular side effects

Levofloxacin was associated with 13 cases of torsade de pointes reported to the FDA between 1996 and 2001.

The risk of arrhythmias may be lessened by avoiding use in patients with hypokalemia, significant bradycardia, or concurrent treatment with class Ia or III antiarrhythmic agents.

An 88-year-old woman developed a prolonged QTc interval while being treated with levofloxacin 500 mg once a day. The QTc interval increased from 450 msec to 577 msec by the fourth day of treatment. Levofloxacin was discontinued after the patient experienced runs of ventricular tachycardia. The QTc interval then decreased to 437 msec two days after discontinuing levofloxacin.

A 65-year-old woman with hypokalemia (2.8 mEq/L), hypomagnesemia (1.5 mEq/L), and renal insufficiency (Scr 7.7 mg/dL, BUN 34 mg/dL) developed a QTc interval of 605 ms (baseline 435-485 ms), several episodes of torsade de pointes, and cardiac arrest after 3 days of levofloxacin 250 mg/day IV. The QTc interval decreased to 399 ms and no further arrhythmias occurred after discontinuation of levofloxacin and electrolyte replacement.

Cardiovascular side effects have included angina pectoris, arrhythmia, atrial fibrillation, bradycardia, cardiac arrest, cardiac failure, cerebrovascular disorder, circulatory failure, coronary thrombosis, flushing, heart block, hypertension, aggravated hypertension, hypotension, myocardial infarction, palpitation, phlebitis, postural hypotension, purpura, supraventricular tachycardia, tachycardia, deep thrombophlebitis, ventricular arrhythmia, ventricular fibrillation, and ventricular tachycardia in 0.1% to 0.9% of patients. Vasodilation, QT interval prolongation/prolonged electrocardiogram QT, and torsade de pointes have been reported during postmarketing experience.

Musculoskeletal side effects

Musculoskeletal side effects have included arthralgia, arthritis, arthrosis, myalgia, pathological fracture, osteomyelitis, synovitis, muscle weakness, tendon disorder, skeletal pain, and tendonitis in 0.1% to 0.9% of patients. Tendon rupture, muscle injury (including rupture), and rhabdomyolysis (including fatalities) have been reported during postmarketing experience.

Achilles tendon rupture occurred in 4 of 489 study patients (3217 treatment days) after 1 to 10 days of levofloxacin treatment.

Severe rhabdomyolysis occurred in a 77-year-old female after 6 days of oral levofloxacin therapy. She developed acute renal failure (serum creatinine 678 micromole/L), hyperkalemia (6.8 micromole/L), anuria, elevated creatine kinase (30,400 IU/L), myoglobinemia (86,000 mcg/L), and acute hepatic cytolysis (SGOT 555 IU/L, SGPT 249 IU/L). The fluid/electrolyte disorders and creatine kinase and myoglobin levels improved with hemodialysis; however, the patient died of a myocardial infarction and respiratory failure after 13 days.

Hypersensitivity side effects

Hypersensitivity side effects have included allergic reaction (0.1%), vasculitis, and allergic interstitial nephritis. Hypersensitivity reactions (sometimes fatal and including anaphylactic shock, anaphylactoid reaction, serum sickness, and angioneurotic edema), allergic pneumonitis, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis (including fatalities) have been reported during postmarketing experience. Quinolone class antibiotics have been associated with erythema nodosum.

A 78-year-old female developed toxic epidermal necrolysis 2 days after parenteral levofloxacin therapy. The rash , initially manifested as an erythematous rash, blistering, and mucosal sloughing but progressed to exfoliation involving three-quarters of the patient's body surface area including mucosa. A positive Nikolsky sign was noted.

A 15-year-old male developed fatal toxic epidermal necrolysis taking levofloxacin for 9 days. The rash progressed over 40 hours to involve 80% of his body surface area with a positive Nikolsky sign and involvement of the eyes and oral, nasal, and perianal mucosa.

Metabolic side effects

A 79-year-old male with type 2 diabetes mellitus developed severe hypoglycemia (blood glucose 6 mg/dL) and became unresponsive 6 hours after receiving one dose of intravenous levofloxacin 250 mg. Blood glucose levels subsequently ranged between 40 to 159 mg/dL with dextrose doses and infusions; however, he did not regain consciousness and expired 2 days later.

Metabolic side effects have included hypomagnesemia, thirst, aggravated diabetes mellitus, dehydration, hyperglycemia, hyperkalemia, hypoglycemia (including fatalities), hypokalemia, gout, hypernatremia, hypophosphatemia, increased LDH, weight decrease, fluid overload, face edema, hyponatremia, increased nonprotein nitrogen, and electrolyte abnormalities in 0.1% to 0.9% of patients. Decreased blood glucose has been reported in 2.2% of patients. Quinolone class antibiotics have been associated with acidosis, symptomatic hypoglycemia, and elevations in serum triglycerides and serum cholesterol.

Hepatic side effects

Hepatic side effects have included abnormal hepatic function, jaundice, cholecystitis, cholelithiasis, hepatic failure, hepatic coma, elevated liver enzymes, and bilirubinemia in 0.1% to 0.9% of patients. Acute hepatocellular injury has also been reported. Severe hepatotoxicity (including acute hepatitis and fatal events) has been reported during postmarketing experience. Quinolone class antibiotics have been associated with hepatic necrosis.

A 74-year-old female developed hepatotoxicity and significant increases in AST (4962 units/L), ALT (7071 units/L), alkaline phosphatase (90 units/L), and total bilirubin (2.5 mg/dL) after starting levofloxacin therapy. Levels returned to normal within a week after discontinuation.

Severe hepatotoxicity usually occurred within 14 days (most within 6 days) after starting levofloxacin and most cases were not associated with hypersensitivity. The majority of fatal hepatotoxicity cases occurred in patients 65 years or older and most were not associated with hypersensitivity.

Renal side effects

Renal side effects have included abnormal renal function and acute renal failure in 0.1% to 0.9% of patients. Interstitial nephritis has been reported during postmarketing experience. Quinolone class antibiotics have been associated with renal calculi.

A 73-year-old male developed vasculitis and acute renal failure within 3 days of initiating oral levofloxacin. Symptoms included significantly decreased urine output (0.5 L/d to 0.7 L/d), palpable purpura, erythematous skin lesions, and increased serum creatinine (6.4 mg/dL) and BUN (190 mg/dL). The condition resolved within 4 weeks after discontinuation of levofloxacin. Due to the possibility that this may have been an allergic reaction, rechallenge was not attempted.

Other side effects

Other side effects have included pain (1.3% to 1.4%), fatigue (1.2% to 1.3%), chest pain (1.2%), back pain (1.1% to 1.2%), and aggravated condition (0.1%). Asthenia, fever, malaise, rigors, substernal chest pain, syncope, ascites, changed temperature sensation, ear disorder (unspecified), enlarged abdomen, hot flashes, edema, gangrene, influenza-like symptoms, leg pain, multiple organ failure, parosmia, earache, tinnitus, abscess, herpes simplex, bacterial infection, viral infection, moniliasis, otitis media, sepsis and fungal infection have been reported in 0.1% to 0.9% of patients. Dysphonia, multisystem organ failure, anosmia, and hypoacusis have been reported during postmarketing experience.

Respiratory side effects

Respiratory side effects have included rhinitis (1.1% to 1.2%), dyspnea (1.1% to 1.3%), sinusitis (1.1%), and pharyngitis (1.1%). Bronchitis, chronic obstructive airway disease, laryngitis, pleurisy, pneumonitis, upper respiratory tract infection, asthma, cough, dyspnea, hemoptysis, hypoxia, pleural effusion, respiratory insufficiency, airway obstruction, ARDS, aspiration, bronchospasm, emphysema, pneumonia, pneumothorax, pulmonary collapse, pulmonary edema, respiratory depression, and respiratory disorder have been reported in 0.1% to 0.9% of patients. Quinolone class antibiotics have been associated with hiccough.

Psychiatric side effects

Psychiatric side effects have included abnormal dreaming, paroniria, agitation, anxiety, confusion, depression, hallucination, nervousness, paranoia, sleep disorder, aggressive reaction, delirium, emotional lability, impaired concentration, manic reaction, mental deficiency, and withdrawal syndrome in 0.1% to 0.9% of patients. Psychosis and isolated reports of suicide attempts or suicidal ideation have been reported during postmarketing experience.

Genitourinary side effects

Genitourinary side effects have included vaginitis (0.5% to 1.8%) and genital moniliasis (0.1% to 0.2%). Dysmenorrhea, hematuria, dysuria, oliguria, urinary incontinence, urinary retention, leukorrhea, genital pruritus, ejaculation failure, impotence, and urinary tract infection have been reported in 0.1% to 0.9% of patients. Quinolone class antibiotics have been associated with albuminuria, candiduria, crystalluria, cylindruria, and vaginal candidiasis.

Dermatologic side effects

Dermatologic side effects have included rash (0.3% to 1.4%) and pruritus (0.2% to 1.3%). Dry skin, increased sweating, skin disorder, skin exfoliation, skin ulceration, urticaria, bullous eruption, erythematous rash, alopecia, and eczema have been reported in 0.1% to 0.9% of patients. Maculopapular rash has been reported in less than 0.1% of patients. Photosensitivity/phototoxicity reaction and leukocytoclastic vasculitis have been reported during postmarketing experience.

Ocular side effects

Ocular side effects have included abnormal vision, eye pain, and conjunctivitis in 0.1% to 0.9% of patients. Vision disturbances (including diplopia, reduced visual acuity, blurred vision, and scotomata) have been reported during postmarketing experience. Quinolone class antibiotics have been associated with nystagmus, cataracts, and multiple punctate lenticular opacities.

Oncologic side effects

Oncologic side effects have included carcinoma and thrombocythemia in 0.1% to 0.9% of patients.

Local side effects

Local side effects have included injection site reactions (0.1% to 0.2%), injection site pain (0.2%), and injection site inflammation (0.1%) after IV infusion.

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