Levaquin Side Effects
Generic Name: 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.
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:
Seek medical attention right away if any of these SEVERE side effects occur when using Levaquin:Constipation; diarrhea; dizziness; gas; headache; light-headedness; 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, light-headedness, tiredness, or weakness; severe or persistent stomach pain or cramps; shortness of breath or trouble breathing; 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.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
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:
Seek medical attention right away if any of these SEVERE side effects occur when using Levaquin Solution:Constipation; diarrhea; dizziness; gas; headache; light-headedness; 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, light-headedness, tiredness, or weakness; severe or persistent stomach pain or cramps; shortness of breath or trouble breathing; 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.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
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:
Seek medical attention right away if any of these SEVERE side effects occur when using Levaquin Tablets:Constipation; diarrhea; dizziness; gas; headache; light-headedness; 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, light-headedness, tiredness, or weakness; severe or persistent stomach pain or cramps; shortness of breath or trouble breathing; 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.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopLevaquin Side Effects - for the Professional
Levaquin
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 (5.1)]
- Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.2)]
- Hypersensitivity Reactions [see Warnings and Precautions (5.3)]
- Other Serious and Sometimes Fatal Reactions [see Warnings and Precautions (5.4)]
- Hepatotoxicity [see Warnings and Precautions (5.5)]
- Central Nervous System Effects [see Warnings and Precautions (5.6)]
- Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (5.7)]
- Peripheral Neuropathy [see Warnings and Precautions (5.8)]
- Prolongation of the QT Interval [see Warnings and Precautions (5.9)]
- Musculoskeletal Disorders in Pediatric Patients [see Warnings and Precautions (5.10)]
- Blood Glucose Disturbances [see Warnings and Precautions (5.11)]
- Photosensitivity/Phototoxicity [see Warnings and Precautions (5.12)]
- Development of Drug Resistant Bacteria [see Warnings and Precautions (5.13)]
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 (2.5)].
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 (2.5)].
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.
| System/Organ Class | Adverse Reaction | % (N=7537) |
|---|---|---|
| Infections and Infestations | moniliasis | 1 |
| Psychiatric Disorders | insomnia* [see Warnings and Precautions (5.6)] |
4 |
| Nervous System Disorders | headache dizziness [see Warnings and Precautions (5.6)] |
6 3 |
| Respiratory, Thoracic and Mediastinal Disorders | dyspnea [see Warnings and Precautions (5.3)] | 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 (5.3)] pruritus |
2 1 |
| Reproductive System and Breast Disorders | vaginitis | 1† |
| General Disorders and Administration Site Conditions | edema | 1 |
| injection site reaction | 1 | |
| chest pain | 1 | |
| System/Organ Class | Adverse Reaction |
|---|---|
|
|
| Infections and Infestations | genital moniliasis |
| Blood and Lymphatic System Disorders | anemia thrombocytopenia granulocytopenia [see Warnings and Precautions (5.4)] |
| Immune System Disorders |
allergic reaction [see Warnings and Precautions (5.3,5.4)] |
| Metabolism and Nutrition Disorders | hyperglycemia hypoglycemia [see Warnings and Precautions (5.11)] hyperkalemia |
| Psychiatric Disorders | anxiety agitation confusion depression hallucination nightmare* [see Warnings and Precautions (5.6)] sleep disorder* anorexia abnormal dreaming* |
| Nervous System Disorders | tremor convulsions [see Warnings and Precautions (5.6)] paresthesia [see Warnings and Precautions (5.8)] 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 (5.7)] |
| Hepatobiliary Disorders | abnormal hepatic function increased hepatic enzymes increased alkaline phosphatase |
| Skin and Subcutaneous Tissue Disorders | urticaria [see Warnings and Precautions (5.3)] |
| Musculoskeletal and Connective Tissue Disorders | arthralgia tendinitis [see Warnings and Precautions (5.1)] myalgia skeletal pain |
| Renal and Urinary Disorders | abnormal renal function acute renal failure [see Warnings and Precautions (5.4)] |
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.
| System/Organ Class | Adverse Reaction |
|---|---|
| Blood and Lymphatic System Disorders | pancytopenia aplastic anemia leukopenia hemolytic anemia [see Warnings and Precautions (5.4)] 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 (5.6)] |
| Nervous System Disorders |
exacerbation of myasthenia gravis [see Warnings and Precautions (5.2)] anosmia ageusia parosmia dysgeusia peripheral neuropathy [see Warnings and Precautions (5.8)] isolated reports of encephalopathy abnormal electroencephalogram (EEG) dysphonia pseudotumor cerebri [see Warnings and Precautions (5.6)] |
| 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 (5.9)] tachycardia |
| Vascular Disorders | vasodilatation |
| Respiratory, Thoracic and Mediastinal Disorders | isolated reports of allergic pneumonitis [see Warnings and Precautions (5.4)] |
| Hepatobiliary Disorders | hepatic failure (including fatal cases) hepatitis jaundice [see Warnings and Precautions (5.4),(5.5)] |
| Skin and Subcutaneous Tissue Disorders | bullous eruptions to include: Stevens-Johnson Syndrome toxic epidermal necrolysis erythema multiforme [see Warnings and Precautions (5.4)] photosensitivity/phototoxicity reaction [see Warnings and Precautions (5.12)] leukocytoclastic vasculitis |
| Musculoskeletal and Connective Tissue Disorders | tendon rupture [see Warnings and Precautions (5.1)] muscle injury, including rupture rhabdomyolysis |
| Renal and Urinary Disorders | interstitial nephritis [see Warnings and Precautions (5.4)] |
| General Disorders and Administration Site Conditions | multi-organ failure pyrexia |
| Investigations | prothrombin time prolonged international normalized ratio prolonged muscle enzymes increased |
Side Effects by Body System - for Healthcare Professionals
General
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
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
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 electroencephalogram (EEG), exacerbation of myasthenia gravis, anosmia, ageusia, parosmia, dysgeusia, isolated reports of encephalopathy, dysphonia, pseudotumor cerebri, hypoacusis, tinnitus, and peripheral neuropathy have been reported during postmarketing experience.
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 tendinitis, partial tendon rupture, impaired memory, confusion, and impaired concentration, with some symptoms persisting after 1 year.
Hematologic
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
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, tachycardia, and torsade de pointes have been reported during postmarketing experience.
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.
Musculoskeletal
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 international units/L), myoglobinemia (86,000 mcg/L), and acute hepatic cytolysis (SGOT 555 international units/L, SGPT 249 international units/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.
Musculoskeletal side effects have included arthralgia, arthritis, arthrosis, myalgia, pathological fracture, osteomyelitis, synovitis, muscle weakness, tendon disorder, skeletal pain, and tendinitis in 0.1% to 0.9% of patients. Tendon rupture, muscle injury (including rupture), increased muscle enzymes, and rhabdomyolysis (including fatalities) have been reported during postmarketing experience.
Hypersensitivity
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.
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.
Metabolic
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
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.
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), hepatic failure (including fatal cases), hepatitis, and jaundice have been reported during postmarketing experience. Quinolone class antibiotics have been associated with hepatic necrosis.
Renal
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
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, pyrexia, anosmia, and hypoacusis have been reported during postmarketing experience.
Respiratory
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. Isolated reports of allergic pneumonitis have been reported during postmarketing experience. Quinolone class antibiotics have been associated with hiccough.
Psychiatric
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, paranoia, and isolated reports of suicide attempts or suicidal ideation have been reported during postmarketing experience.
Genitourinary
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
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, bullous eruptions (including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme), and leukocytoclastic vasculitis have been reported during postmarketing experience.
Ocular
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
Oncologic side effects have included carcinoma and thrombocythemia in 0.1% to 0.9% of patients.
Local
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.
TopMore Levaquin resources
- Levaquin Prescribing Information (FDA)
- Levaquin Consumer Overview
- Levaquin Monograph (AHFS DI)
- Levaquin MedFacts Consumer Leaflet (Wolters Kluwer)
- Levaquin Advanced Consumer (Micromedex) - Includes Dosage Information
- Levofloxacin Prescribing Information (FDA)
- Levofloxacin Professional Patient Advice (Wolters Kluwer)
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