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Side Effects > Floxin

Floxin Side Effects

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).


For the consumer

For the professional

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; nervousness; sensitivity to sunlight; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Floxin:

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; depression; diarrhea (severe or continuing); difficulty swallowing; excessive urination, thirst, or hunger; fatigue; fever; hallucinations; hoarseness; increased pressure within the head; joint or muscle pain or swelling; lightheadedness; loss of consciousness; nervousness; nightmares; pale stools; paranoia; rapid heartbeat; rash, skin burning, redness, swelling, blisters, itching, or skin inflammation; restlessness; seizures; shock (pale skin); sleeplessness; stomach pain/cramps; suicidal thoughts; tendon pain, inflammation, or swelling; tightness of the throat; tingling; tremors; 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.

Seek medical attention right away if any of these SEVERE side effects occur when using Floxin Otic Solution:

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.

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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:

Incidence Rate

Adverse Event
Studies 002/003†
BID
(N=229)
Studies 016/017†
QD
(N=3109)
Studies 002†
QD
(N=489)

†Studies 002/003 (BID) and 016/017 (QD) were active-controlled and comparative.

Application Site 3% 16.8% 0.6%
Reaction
Pruritus 4% 1.2% 1.0%
Earache 1% 0.6% 0.8%
Dizziness 1% 0.0% 0.6%
Headache 0% 0.3% 0.2%
Vertigo 1% 0.0% 0.0%

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:

Adverse Event Incidence (N=656)
Taste Perversion 7%
Earache 1%
Pruritus 1%
Paraesthesia 1 %.
Rash 1%
Dizziness 1%

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.

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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:

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
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
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
Musculoskeletal: tendinitis/rupture; weakness; rhabdomyolysis
Nervous System: nightmares; suicidal thoughts or acts, disorientation, psychotic reactions, paranoia; phobia, agitation, restlessness, aggressiveness/hostility, manic reaction, emotional lability; peripheral neuropathy, ataxia, incoordination; possible exacerbation of: myasthenia gravis and extrapyramidal disorders; dysphasia, lightheadedness
Respiratory System: dyspnea, bronchospasm, allergic pneumonitis, stridor
Skin/Hypersensitivity: anaphylactic (-toid) reactions/shock; purpura, serum sickness, erythema multiforme/Stevens-Johnson Syndrome, erythema nodosum, exfoliative dermatitis, hyperpigmentation, toxic epidermal necrolysis, conjunctivitis, photosensitivity, vesiculobullous eruption
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
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.

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More resources:

Cerner Multum Floxin

PDR Floxin

MedFacts Floxin

Micromedex Ofloxacin Ophthalmic - Includes detailed dosage instructions.

Micromedex Floxin - Includes detailed dosage instructions.

FDA Ofloxacin

FDA Floxin

Facts & Comparisons Ofloxacin

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