Floxin Side Effects

Generic name: ofloxacin

Generic Name: Ofloxacin

Please note - some side effects for Floxin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Floxin - for the consumer

Floxin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Floxin:

Diarrhea; dizziness; headache; loss of appetite; nausea; sensitivity to sunlight; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; anxiety; bizarre behavior; bloody stools; confusion; convulsions; dark urine; decreased urination; depression; diarrhea (severe or continuing); difficulty swallowing; excessive urination, thirst, or hunger; fainting; fast or irregular heartbeat; fatigue; fever, chills, or unusual cough; hallucinations; hoarseness; joint or muscle pain or swelling; lightheadedness; loss of consciousness; mental or mood changes; nervousness; nightmares; pale stools; red, swollen, blistered, or peeling skin; restlessness; seizures; shortness of breath; shock (pale skin); sleeplessness; severe or persistent stomach pain/cramps; suicidal thoughts; tendon pain, inflammation, or swelling; tightness of the throat; tingling; tremors; unusual bruising or bleeding; unusual tiredness or weakness; urination problems; vaginal irritation or discharge; yellowing of skin or eyes.

Floxin Otic Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Floxin Otic Solution:

Itching of the ear; taste changes.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased hearing; ear irritation; hearing loss; redness, bleeding, or swelling.

For the professional

Floxin

Subjects with Otitis Externa

In a Phase III clinical trials performed in support of once-daily dosing, 799 subjects with otitis externa and intact tympanic membranes were treated with ofloxacin otic solution. The studies, which served as the basis for approval, were 020 (pediatric, adolescents and adults), 016 (adolescents and adults) and 017 (pediatric). The following treatment-related adverse events occurred in 2 or more of the subjects:

Study 020 (QD) was open and non-comparative.

An unexpected increased incidence of application site reaction was seen in studies 016/017 and was similar for both ofloxacin and the active control drug (neomycin-polymyxin B sulfate-hydrocortisone). This finding is believed to be the result of specific questioning of the subjects regarding the incidence of application site reactions.

In once daily dosing studies, there were also single reports of nausea, seborrhea, transient loss of hearing, tinnitus, otitis externa, otitis media, tremor, hypertension and fungal infection.

In twice daily dosing studies, the following treatment-related adverse events were each reported in a single subject: dermatitis, eczema, erythematous rash, follicular rash, hypoaesthesia, tinnitus, dyspepsia, hot flushes, flushing and otorrhagia.

Subjects with Acute Otitis Media with Tympanostomy Tubes (AOM TT) and Subjects with Chronic Suppurative Otitis Media (CSOM) with Perforated Tympanic Membranes

In Phase III clinical trials which formed the basis for approval, the following treatment-related adverse events occurred in 1% or more of the 656 subjects with non-intact tympanic membranes in AOM TT or CSOM treated twice-daily with ofloxacin otic solution:

Other treatment-related adverse reactions reported in subjects with non-intact tympanic membranes included: diarrhea (0.6%), nausea (0.3%), vomiting (0.3%), dry mouth (0.5%), headache (0.3%), vertigo (0.5%), otorrhagia (0.6%), tinnitus (0.3%), fever (0.3%). The following treatment-related adverse events were each reported in a single subject: application site reaction, otitis externa, urticaria, abdominal pain, dysaesthesia, hyperkinesia, halitosis, inflammation, pain, insomnia, coughing, pharyngitis, rhinitis, sinusitis, and tachycardia.

Post-Marketing Adverse Events

Cases of uncommon transient neurospsychiatric disturbances have been included in spontaneous post-marketing reports. A casual relationship with ofloxacin otic solution 0.3% is unknown.

Floxin Tablets

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:

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.

Post-Marketing Adverse Events

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

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.

By body system

General side effects

Ofloxacin 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 side effects

Pseudomembranous colitis may occur during or after therapy.

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, have been associated with pseudomembranous colitis, GI hemorrhage, intestinal perforation, pyrosis, and painful oral mucosa.

Nervous system side effects

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.

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, have been associated with agitation, restlessness, peripheral neuropathy, ataxia, incoordination, exacerbation of myasthenia gravis, exacerbation of extrapyramidal disorders, dysphasia, and lightheadedness.

Renal side effects

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

Hepatic side effects

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

Hematologic side effects

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, 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 side effects

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 side effects

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

Cardiovascular side effects

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.

Ofloxacin was associated with 2 cases of torsade de pointes reported to the FDA between 1996 and 2001.

Hypersensitivity side effects

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.

Hypersensitivity reactions have included rash (1%) and angioedema, urticaria, and vasculitis (less than 1%). Quinolones, including ofloxacin, 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.

Genitourinary side effects

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, have been associated with vaginal candidiasis, albuminuria, anuria, hematuria, and polyuria. Other quinolone class antibiotics have been associated with crystalluria and cylindruria.

Dermatologic side effects

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, have been associated with hyperpigmentation, erythema multiforme, erythema nodosum, exfoliative dermatitis, toxic epidermal necrolysis, photosensitivity/phototoxicity reaction, and vesiculobullous eruption.

Ocular side effects

Ocular side effects have included visual disturbances (1% to 3%) and photophobia (less than 1%). Quinolones, including ofloxacin, 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 side effects

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, have been associated with reversible disturbances of taste, smell, hearing, and equilibrium.

Respiratory side effects

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

Metabolic side effects

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, have been associated with hypoglycemia and hyperglycemia, especially in diabetic patients, acidosis, and elevations in serum triglycerides, serum cholesterol, and serum potassium.

Psychiatric side effects

Psychiatric side effects have included cognitive change, depression, dream abnormality, euphoria, hallucinations, and confusion in less than 1% of patients. Quinolones, including ofloxacin, 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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