Floxin

Last updated on RxList: 4/14/2021
Floxin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Floxin?

Floxin (ofloxacin) is a broad-spectrum fluoroquinolone antibiotic used to treat bacterial infections that cause bronchitis, pneumonia, chlamydia, gonorrhea, skin infections, urinary tract infections, and infections of the prostate.

What Are Side Effects of Floxin?

Side effects of Floxin include:

Dosage for Floxin

The usual dose of Floxin is 200 mg to 400 mg orally every 12 hours.

What Drugs, Substances, or Supplements Interact with Floxin?

Floxin may interact with antacids that contain calcium, magnesium or aluminum (such as Tums, Mylanta, or Rolaids), sucralfate, didanosine, or vitamin or mineral supplements containing calcium, iron, or zinc. Tell your doctor all medications and supplements you use.

Floxin During Pregnancy or Breastfeeding

Ofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Ofloxacin is excreted in human milk. Because of the potential for serious adverse reactions from ofloxacin in nursing infants, a decision should be made whether to discontinue breastfeeding or to discontinue the drug.

Additional Information

Our Floxin 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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Floxin 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).

Ofloxacin 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, ofloxacin 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.

Also, stop using ofloxacin 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;
  • little or no urination;
  • a seizure (convulsions);
  • increased pressure inside the skull--severe headaches, ringing in your ears, 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;
  • dizziness; or
  • headache.

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 Floxin (Ofloxacin)

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Floxin Professional Information

SIDE EFFECTS

The following is a compilation of the data for ofloxacin based on clinical experience with both the oral and intravenous formulations. The incidence of drug-related adverse reactions in patients during Phase 2 and 3 clinical trials was 11%. Among patients receiving multiple-dose therapy, 4% discontinued ofloxacin due to adverse experiences.

In clinical trials, the following events were considered likely to be drug-related in patients receiving multiple doses of ofloxacin:

nausea 3%, insomnia 3%, headache 1%, dizziness 1%, diarrhea 1%, vomiting 1%, rash 1%, pruritus 1%, external genital pruritus in women 1%, vaginitis 1%, dysgeusia 1%.

In clinical trials, the most frequently reported adverse events, regardless of relationship to drug, were:

nausea 10%, headache 9%, insomnia 7%, external genital pruritus in women 6%, dizziness 5%, vaginitis 5%, diarrhea 4%, vomiting 4%.

In clinical trials, the following events, regardless of relationship to drug, occurred in 1 to 3% of patients:

Abdominal pain and cramps, chest pain, decreased appetite, dry mouth, dysgeusia, fatigue, flatulence, gastrointestinal distress, nervousness, pharyngitis, pruritus, fever, rash, sleep disorders, somnolence, trunk pain, vaginal discharge, visual disturbances, and constipation.

Additional events, occurring in clinical trials at a rate of less than 1%, regardless of relationship to drug, were:

Body as a whole: asthenia, chills, malaise, extremity pain, pain, epistaxis

Cardiovascular System: cardiac arrest, edema, hypertension, hypotension, palpitations, vasodilation

Gastrointestinal System: Dyspepsia

Genital/Reproductive System: burning, irritation, pain and rash of the female genitalia; dysmenorrhea; menorrhagia; metrorrhagia

Musculoskeletal System: arthralgia, myalgia

Nervous System: seizures, anxiety, cognitive change, depression, dream abnormality, euphoria, hallucinations, paresthesia, syncope, vertigo, tremor, confusion

Nutritional/Metabolic: thirst, weight loss

Respiratory System: respiratory arrest, cough, rhinorrhea

Skin/Hypersensitivity: angioedema, diaphoresis, urticaria, vasculitis

Special Senses: decreased hearing acuity, tinnitus, photophobia

Urinary System: dysuria, urinary frequency, urinary retention

The following laboratory abnormalities appeared in ≥ 1.0% of patients receiving multiple doses of ofloxacin. It is not known whether these abnormalities were caused by the drug or the underlying conditions being treated.

Hematopoietic: anemia, leukopenia, leukocytosis, neutropenia, neutrophilia, increased band forms, lymphocytopenia, eosinophilia, lymphocytosis, thrombocytopenia, thrombocytosis, elevated ESR

Hepatic: elevated: alkaline phosphatase, AST (SGOT), ALT (SGPT) Serum chemistry: hyperglycemia, hypoglycemia, elevated creatinine, elevated BUN Urinary: glucosuria, proteinuria, alkalinuria, hyposthenuria, hematuria, pyuria

Post-Marketing Adverse Events

Additional adverse events, regardless of relationship to drug, reported from worldwide marketing experience with quinolones, including ofloxacin:

Clinical

Cardiovascular System: cerebral thrombosis, pulmonary edema, tachycardia, hypotension/shock, syncope, torsades de pointes

Endocrine/Metabolic: hyper-or hypoglycemia, especially in diabetic patients on insulin or oral hypoglycemic agents (See PRECAUTIONS: General and DRUG INTERACTIONS.)

Gastrointestinal System: hepatic dysfunction including: hepatic necrosis, jaundice (cholestatic or hepatocellular), hepatitis; intestinal perforation; hepatic failure (including fatal cases); pseudomembranous colitis (the onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment), GI hemorrhage; hiccough, painful oral mucosa, pyrosis (See WARNINGS.)

Genital/Reproductive System: vaginal candidiasis

Hematopoietic: anemia, including hemolytic and aplastic; hemorrhage, pancytopenia, agranulocytosis, leukopenia, reversible bone marrow depression, thrombocytopenia, thrombotic thrombocytopenic purpura, petechiae, ecchymosis/bruising (See WARNINGS.)

Musculoskeletal: tendinitis/rupture; weakness; rhabdomyolysis(See WARNINGS.)

Nervous System: nightmares; suicidal thoughts or acts, disorientation, psychotic reactions, paranoia; phobia, agitation, restlessness, aggressiveness/hostility, manic reaction, emotional lability; peripheral neuropathy, ataxia, incoordination; exacerbation of: myasthenia gravis and extrapyramidal disorders; dysphasia, lightheadedness (See WARNINGS and PRECAUTIONS.)

Respiratory System: dyspnea, bronchospasm, allergic pneumonitis, stridor (See WARNINGS.)

Skin/Hypersensitivity: anaphylactic (-toid) reactions/shock; purpura, serum sickness, erythema multiforme/Stevens-Johnson Syndrome, erythema nodosum, exfoliative dermatitis, hyperpigmentation, toxic epidermal necrolysis, conjunctivitis, photosensitivity/phototoxicity reaction, vesiculobullous eruption (See WARNINGS and PRECAUTIONS.)

Special Senses: diplopia, nystagmus, blurred vision, disturbances of: taste, smell, hearing and equilibrium, usually reversible following discontinuation

Urinary System: anuria, polyuria, renal calculi, renal failure, interstitial nephritis, hematuria (See WARNINGS and PRECAUTIONS.)

Laboratory

Hematopoietic: prolongation of prothrombin time

Serum chemistry: acidosis, elevation of: serum triglycerides, serum cholesterol, serum potassium, liver function tests including: GGTP, LDH, bilirubin

Urinary: albuminuria, candiduria

In clinical trials using multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with other quinolones. The relationship of the drugs to these events is not presently established.

CRYSTALLURIA and CYLINDRURIA HAVE BEEN REPORTED with other quinolones.

Read the entire FDA prescribing information for Floxin (Ofloxacin)

© Floxin Patient Information is supplied by Cerner Multum, Inc. and Floxin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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