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Levaquin

Last reviewed on RxList: 3/14/2017
Levaquin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 03/14/2017

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 any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using levofloxacin and call your doctor at once if you have a serious side effect such as:

  • chest pain and severe dizziness, fainting, fast or pounding heartbeats;
  • sudden pain, snapping or popping sound, bruising, swelling, tenderness, stiffness, or loss of movement in any of your joints;
  • diarrhea that is watery or bloody;
  • confusion, hallucinations, depression, tremors, feeling restless or anxious, unusual thoughts or behavior, insomnia, nightmares, seizure (convulsions);
  • severe headache, ringing in your ears, nausea, vision problems, pain behind your eyes;
  • pale skin, fever, weakness, easy bruising or bleeding;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • urinating less than usual or not at all;
  • numbness, burning pain, or tingly feeling in your hands or feet;
  • the first sign of any skin rash, no matter how mild; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • mild diarrhea, constipation, vomiting;
  • sleep problems (insomnia);
  • mild headache or dizziness; or
  • vaginal itching or discharge.

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:

Crystalluria and cylindruria have been reported with quinolones, including Levofloxacin. Therefore, adequate hydration of patients receiving Levofloxacin 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 Levofloxacin 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 Levofloxacin for a wide variety of infectious diseases [see INDICATIONS AND USAGE]. Patients received Levofloxacin 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 Levofloxacin doses of 750 mg once daily, 250 mg once daily, and 500 mg once or twice daily. Discontinuation of Levofloxacin 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 Levofloxacin-treated patients and less common adverse reactions, occurring in 0.1 to < 1% of Levofloxacin-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 Levofloxacin

System/Organ Class Adverse Reaction % (N=7537)
Infections and Infestations moniliasis 1
Psychiatric Disorders insomnia* [see WARNINGS AND PRECAUTIONS] 4
Nervous System Disorders headache dizziness [see WARNINGS AND PRECAUTIONS] 6 3
Respiratory, Thoracic and Mediastinal Disorders dyspnea [see WARNINGS AND PRECAUTIONS] 1
nausea 7
diarrhea 5
Gas tro inte s tinal Disorders 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
*N=7274
†N=3758 (women)

Table 5: Less Common (0.1 to 1%) Adverse Reactions Reported in Clinical Trials with Levofloxacin (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* tremor convulsions [see WARNINGS AND PRECAUTIONS]
Nervous System Disorders paresthesia [see WARNINGS AND PRECAUTIONS] 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]
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 Levofloxacin. 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 Levofloxacin.� 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.

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: anaphyl actic /anaphyl actoid reactions anaphylactic shock angioneurotic edema serum sickness [see WARNINGS AND PRECAUTIONS]
Psychiatric Disorders psychosis paranoia isolated reports of suicide attempt and suicidal ideation [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 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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