Medical Editor: John P. Cunha, DO, FACOEP
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. Side effects of Floxin include:
- vaginal itching or discharge,
- skin itching,
- sleep problems,
- changes in your sense of taste, and
The usual dose of Floxin is 200 mg to 400 mg orally every 12 hours. 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. 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.
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.
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 ofloxacin and call your doctor at once if you have a serious side effect such as:
- diarrhea that is watery or bloody;
- seizure (convulsions);
- confusion, hallucinations, anxiety, feeling resltess, tremors, insomnia, nightmares, unusual thoughts or behavior, feeling light-headed;
- severe dizziness, fainting, fast or pounding heartbeat;
- sudden pain, snapping or popping sound, bruising, swelling, tenderness, stiffness, or loss of movement in any of your joints;
- easy bruising or bleeding;
- fever, swollen glands, general ill feeling;
- urinating less than usual or not at all;
- numbness, burning pain, or tingly feeling in your hands or feet;
- pale skin, dark colored urine, fever, weakness, jaundice (yellowing of the skin or eyes);;
- 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:
- nausea, vomiting, mild diarrhea;
- headache, dizziness;
- changes in your sense of taste;
- vaginal itching or discharge; or
- mild skin itching.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Floxin (Ofloxacin)
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:
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
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.