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Levaquin

Last reviewed on RxList: 10/29/2018
Levaquin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 10/29/2018

Levaquin (levofloxacin) is an antibiotic for treating several types of bacterial infections. Levaquin is available in generic form. Common side effects of Levaquin include:

  • nausea,
  • vomiting,
  • diarrhea,
  • headache,
  • constipation,
  • difficulty sleeping (insomnia),
  • dizziness,
  • abdominal pain,
  • rash,
  • abdominal gas,
  • itching, and
  • vaginal itching or discharge.

Levaquin has been associated with tendinitis and tendon rupture. Levaquin can alter the normal bacteria in the colon and cause pseudomembranous colitis. Patients taking Levaquin can develop photosensitivity (sensitivity to sunlight) and patients may sunburn more easily.

The usual dose of Levaquin is 250-750 mg given once daily for 5-60 days depending on the type of infection. Levaquin may interact with antacids that contain magnesium or aluminum, sucralfate, didanosine, vitamin or mineral supplements that contain iron or zinc, blood thinners, insulin or oral diabetes medications, theophylline, antibiotics, antidepressants, anti-malaria medications, medicine to prevent or treat nausea and vomiting, medicines to treat psychiatric disorders, migraine headache medicines, narcotics, nonsteroidal anti-inflammatory drugs (NSAIDs), or steroids. Tell your doctor all medications and supplements you use. Levaquin has not been adequately evaluated in pregnant women and is not recommended for use in breastfeeding women because of the risk of adverse effects in the infant.

Our Levaquin Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Levaquin Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Levofloxacin can cause serious side effects, including tendon problems, side effects on your nerves (which may cause permanent nerve damage), serious mood or behavior changes (after just one dose), or low blood sugar (which can lead to coma).

Stop taking this medicine and call your doctor at once if you have:

  • low blood sugar--headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, or feeling anxious or shaky;
  • nerve symptoms in your hands, arms, legs, or feet--numbness, weakness, tingling, burning pain;
  • serious mood or behavior changes--nervousness, confusion, agitation, paranoia, hallucinations, memory problems, trouble concentrating, thoughts of suicide; or
  • signs of tendon rupture--sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions).

Stop taking levofloxacin and call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody;
  • fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
  • the first sign of any skin rash, no matter how mild;
  • muscle weakness, breathing problems;
  • seizure (convulsions);
  • increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or
  • liver problems--upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • nausea, constipation, diarrhea;
  • headache, dizziness; or
  • trouble sleeping.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Levaquin (Levofloxacin)

Levaquin Professional Information

SIDE EFFECTS

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:

  • Disabling and Potentially Irreversible Serious Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Tendinitis and Tendon Rupture [see WARNINGS AND PRECAUTIONS]
  • Peripheral Neuropathy [see WARNINGS AND PRECAUTIONS]
  • Central Nervous System Effects [see WARNINGS AND PRECAUTIONS]
  • Exacerbation of Myasthenia Gravis [see WARNINGS AND PRECAUTIONS]
  • Other Serious and Sometimes Fatal Reactions [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Clostridium difficile-Associated Diarrhea [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]

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]. 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 4 and Table 5, respectively. The most common adverse drug reactions (≥3%) are nausea, headache, diarrhea, insomnia, constipation, and dizziness.

Table 4: Common (≥1%) Adverse Reactions Reported in Clinical Trials with LEVAQUIN®*

System/Organ Class Adverse Reaction %
(N=7537)
Infections and Infestations moniliasis 1
Psychiatric Disorders insomnia [see WARNINGS AND PRECAUTIONS] 4
Nervous System Disorders headache 6
dizziness [see WARNINGS AND PRECAUTIONS] 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] 2
pruritus 1
Reproductive System and Breast Disorders vaginitis 1
General Disorders and Administration Site Conditions edema 1
injection site reaction 1
chest pain 1
*pool of studies included IV and oral administration
N = 7274
N = 3758 (women)

Table 5: 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]
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 *
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]
*N = 7274

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 6 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, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Table 6: 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]
Psychiatric Disorders psychosis
paranoia
isolated reports of suicidal ideation, suicide attempt and completed suicide
[see WARNINGS AND PRECAUTIONS]
Nervous System Disorders exacerbation of myasthenia gravis [see WARNINGS AND PRECAUTIONS]
anosmia
ageusia
parosmia
dysgeusia
peripheral neuropathy (may be irreversible) [see WARNINGS AND PRECAUTIONS]
isolated reports of encephalopathy abnormal electroencephalogram (EEG)
dysphonia
pseudotumor cerebri [see WARNINGS AND PRECAUTIONS]
Eye Disorders uveitis
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
  Acute Generalized Exanthematous Pustulosis (AGEP)
  fixed drug eruptions
  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

Read the entire FDA prescribing information for Levaquin (Levofloxacin)

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