Floxin Side Effects

Generic name: ofloxacin

Note: This document contains side effect information about ofloxacin. Some of the dosage forms listed on this page may not apply to the brand name Floxin.

Some side effects of Floxin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ofloxacin: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking ofloxacin (the active ingredient contained in Floxin) 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 of ofloxacin 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.

For Healthcare Professionals

Applies to ofloxacin: intravenous solution, oral tablet

General

Ofloxacin (the active ingredient contained in Floxin) therapy is generally well tolerated, and adverse effects are mild in nature. In clinical trials, 11% of patients experienced adverse events. Discontinuation of therapy due to adverse effects occurred in 4% of treated patients.

Gastrointestinal

Gastrointestinal side effects have included nausea (3% to 10%), diarrhea (1% to 4%), vomiting (1% to 4%), and dysgeusia (1%). Abdominal pain, cramps, decreased appetite, dry mouth, dysgeusia, flatulence, gastrointestinal distress, and constipation have been reported in 1% to 3% of patients, and dyspepsia in less than 1%. Quinolones, including ofloxacin (the active ingredient contained in Floxin) have been associated with pseudomembranous colitis, GI hemorrhage, intestinal perforation, pyrosis, and painful oral mucosa.

Pseudomembranous colitis may occur during or after therapy.

Nervous system

Nervous system side effects have included insomnia (3% to 7%), headache (1% to 9%), dizziness (1% to 5%). Fatigue, nervousness, sleep disorders, and somnolence have been reported in 1% to 3% of patients. Seizures, anxiety, paresthesia, syncope, vertigo, and tremor have been reported in less than 1% of patients. Idiopathic intracranial hypertension has also been reported. Quinolones, including ofloxacin (the active ingredient contained in Floxin) have been associated with agitation, restlessness, peripheral neuropathy, ataxia, incoordination, exacerbation of myasthenia gravis, exacerbation of extrapyramidal disorders, dysphasia, and lightheadedness.

Seizures are more likely to occur in elderly patients and in those with renal insufficiency.

One survey reported 6 cases of peripheral neuropathy associated with ofloxacin. In one case, a 49-year-old female developed diffuse numbness, "pins and needles" sensation, burning pain, memory loss, visual impairment, joint pain, palpitations, altered sense of smell, insomnia, tinnitus, and severe panic attacks, with some symptoms persisting after 3 years.

Renal

Renal side effects have included increased creatinine and BUN in 1% or more of patients. Quinolones, including ofloxacin (the active ingredient contained in Floxin) have been associated with renal calculi, renal failure, and interstitial nephritis.

Hepatic

Hepatic side effects have included elevated alkaline phosphatase, AST, and ALT in 1% or more of patients. Quinolones, including ofloxacin (the active ingredient contained in Floxin) have been associated with hepatic necrosis, jaundice (cholestatic or hepatocellular), hepatitis, hepatic failure
(including fatal cases), and elevated GGTP, LDH, and bilirubin.

Hematologic

Hematological side effects have included anemia, leukopenia, leukocytosis, neutropenia, neutrophilia, increased band forms, lymphocytopenia, eosinophilia, lymphocytosis, thrombocytopenia, thrombocytosis, and elevated ESR in 1% or more of patients. Quinolones, including ofloxacin (the active ingredient contained in Floxin) have been associated with anemia, including hemolytic and aplastic; hemorrhage, pancytopenia, agranulocytosis, leukopenia, reversible bone marrow depression, thrombocytopenia, thrombotic thrombocytopenic purpura, petechiae, prothrombin time prolongation, and ecchymosis/bruising.

Local

Local side effects reported in patients receiving parenteral therapy have included local reactions at the injection site (including phlebitis, swelling and erythema), occurring in approximately 2% of treated patients.

Musculoskeletal

Musculoskeletal side effects have included arthralgia and myalgia in less than 1% of patients. Quinolones, including ofloxacin (the active ingredient contained in Floxin) have been associated with tendonitis, tendon rupture, weakness, and rhabdomyolysis during postmarketing experience.

Cardiovascular

Ofloxacin (the active ingredient contained in Floxin) was associated with 2 cases of torsade de pointes reported to the FDA between 1996 and 2001.

Cardiovascular side effects have included cardiac arrest, edema, hypertension, hypotension, palpitations, and vasodilation in less than 1% of patients. Quinolones, including ofloxacin, have been associated with cerebral thrombosis, pulmonary edema, tachycardia, hypotension/shock, torsades de pointes, and syncope.

Hypersensitivity

Hypersensitivity reactions have included rash (1%) and angioedema, urticaria, and vasculitis (less than 1%). Quinolones, including ofloxacin (the active ingredient contained in Floxin) have been associated with anaphylaxis, anaphylactoid reactions, shock, purpura, serum sickness, erythema multiforme, Stevens-Johnson syndrome, erythema nodosum, exfoliative dermatitis, toxic epidermal necrolysis, photosensitivity/phototoxicity reaction, and vesiculobullous eruption.

A 75-year-old male developed toxic epidermal necrolysis and died of complications after receiving a total of 23.6 grams of oral ofloxacin over 51 days.

Genitourinary

Genitourinary side effects have included external genital pruritus in women (1% to 6%), vaginitis (1% to 5%), vaginal discharge (1% to 3%). Glucosuria, proteinuria, alkalinuria, hyposthenuria, hematuria, and pyuria have been reported in 1% or more of patients. Dysuria, urinary frequency, urinary retention, dysmenorrhea, menorrhagia, metrorrhagia, and burning, irritation, pain and rash of the female genitalia have been reported in less than 1% of patients. Quinolones, including ofloxacin (the active ingredient contained in Floxin) have been associated with vaginal candidiasis, albuminuria, anuria, hematuria, and polyuria. Other quinolone class antibiotics have been associated with crystalluria and cylindruria.

Dermatologic

Dermatologic side effects have included rash and pruritus in 1% to 3% of patients, and angioedema, diaphoresis, and urticaria in less than 1%. Quinolones, including ofloxacin (the active ingredient contained in Floxin) have been associated with hyperpigmentation, erythema multiforme, erythema nodosum, exfoliative dermatitis, toxic epidermal necrolysis, photosensitivity/phototoxicity reaction, and vesiculobullous eruption.

Ocular

Ocular side effects have included visual disturbances (1% to 3%) and photophobia (less than 1%). Quinolones, including ofloxacin (the active ingredient contained in Floxin) have been associated with diplopia, nystagmus, blurred vision, and conjunctivitis. Other quinolone class antibiotics have been associated with cataracts and multiple punctate lenticular opacities.

Other

Other side affects have included asthenia, chills, malaise, extremity pain, pain, epistaxis, decreased hearing acuity, and tinnitus in less than 1% of patients. Quinolones, including ofloxacin (the active ingredient contained in Floxin) have been associated with reversible disturbances of taste, smell, hearing, and equilibrium.

Respiratory

Respiratory side effects have included respiratory arrest, cough and rhinorrhea in less than 1% of patients. Quinolones, including ofloxacin (the active ingredient contained in Floxin) have been associated with dyspnea, bronchospasm, allergic pneumonitis, and stridor.

Metabolic

Metabolic side effects have included hyperglycemia and hypoglycemia in 1% or more of patients, and thirst and weight loss in less than 1%. Nephrogenic diabetic insipidus has also been reported. Quinolones, including ofloxacin (the active ingredient contained in Floxin) have been associated with hypoglycemia and hyperglycemia, especially in diabetic patients, acidosis, and elevations in serum triglycerides, serum cholesterol, and serum potassium.

Psychiatric

Psychiatric side effects have included cognitive change, depression, dream abnormality, euphoria, hallucinations, and confusion in less than 1% of patients. Quinolones, including ofloxacin (the active ingredient contained in Floxin) have been associated with nightmares, suicidal thought or acts, disorientation, psychotic reactions, paranoia, phobia, aggressiveness/hostility, manic reaction, and emotional lability.

In one patient, a psychotic reaction to ofloxacin presented with irritability, restlessness, insomnia, and irrational fear. The reaction was treated with haloperidol and resolved within 48 hours. One study suggests that the CNS effects of quinolones may be due to an interaction with the benzodiazepine-GABA receptor complex and may be controlled by benzodiazepine administration.

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