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Floxin Side Effects Center
Pharmacy Editor: Melissa Conrad Stöppler, MD
Floxin (ofloxacin) is a broad-spectrum antibiotic for oral administration. Ofloxacin is in a group of antibiotics called fluoroquinolones and is used to treat bacterial infections that cause bronchitis, pneumonia, chlamydia, gonorrhea, skin infections, urinary tract infections, and infections of the prostate. Side effects can include nausea, vomiting, dizziness, dizziness, itching, sleep problems, and restlessness. Other side effects can also occur.
Ofloxacin is not known to cause problems in the fetus in animal studies; however, there are no adequate and well-controlled studies in pregnant women. Ofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Ofloxacin is excteted in human milk. Because of the potential for serious adverse reactions from ofloxacin in nursing infants, a decision should be made whether to discontinue nursing 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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Floxin in Detail - Patient Information: Side Effects
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) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Floxin Overview - Patient Information: Side Effects
Upset stomach, nausea, diarrhea, headache, dizziness, lightheadedness, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: sunburn-like skin reaction (sun sensitivity), shaking, mental/mood changes (e.g., nervousness, confusion, hallucinations, rare thoughts of suicide).
Tell your doctor immediately if any of these rare but very serious side effects occur: severe/persistent headache, vision problems, hearing changes, unsteadiness, seizures, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine, unusual tiredness, easy bruising/bleeding, signs of a new infection (e.g., fever, persistent sore throat), unusual change in the amount of urine.
Seek immediate medical attention if any of these rare but very serious side effects occur: severe dizziness, fainting, fast/irregular heartbeat.
Ofloxacin may rarely cause serious nerve problems that may be reversible if identified and treated early. Seek immediate medical attention if you develop any of the following symptoms: pain/numbness/burning/tingling/weakness in any part of the body, changes in how you sense touch/pain/temperature/body position/vibration.
This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.
Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chest pain.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Floxin (Ofloxacin)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Floxin FDA Prescribing 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:
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) »
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