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).
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For the consumer For the professional
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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:
Seek medical attention right away if any of these SEVERE side effects occur when using Floxin:Diarrhea; dizziness; headache; loss of appetite; nausea; nervousness; 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; 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:
Seek medical attention right away if any of these SEVERE side effects occur when using Floxin Otic Solution:Itching of the ear; taste changes.
TopSevere 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:
| 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.
TopFloxin 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.
TopMore resources:
Ofloxacin Ophthalmic - Includes detailed dosage instructions.
Floxin - Includes detailed dosage instructions.
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