Levaquin Side Effects Center

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Medical Editor: John P. Cunha, DO, FACOEP

What Is Levaquin?

Levaquin (levofloxacin) is an antibiotic for treating several types of bacterial infections. Levaquin is available in generic form.

What Are Side Effects of Levaquin?

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.

Dosage for Levaquin

The usual dose of Levaquin is 250-750 mg given once daily for 5-60 days depending on the type of infection.

What Drugs, Substances, or Supplements Interact with Levaquin?

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 During Pregnancy and Breastfeeding

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.

Additional Information

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.

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Levaquin Consumer Information

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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).

In rare cases, levofloxacin may cause damage to your aorta, the main blood artery of the body. This could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.

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.

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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
Nervous System Disorders	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
Skin and Subcutaneous Tissue Disorders	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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