Ofloxacin Side Effects
Brand Names: Floxin
Please note - some side effects for Ofloxacin 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 Ofloxacin - for the consumer
Ofloxacin
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 Ofloxacin:
Seek medical attention right away if any of these SEVERE side effects occur when using Ofloxacin: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.
Ofloxacin Drops
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 Ofloxacin Drops:
Seek medical attention right away if any of these SEVERE side effects occur when using Ofloxacin Drops:Blurred vision; burning or discomfort in the eye, including stinging, redness, and itching; dry eyes; eye pain; foreign body sensation; sensitivity to sunlight; tearing.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); infection (fever, chills, sore throat); itching; loss of consciousness; redness; unusual sensitivity to light.
Ofloxacin 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 Ofloxacin Solution:
Seek medical attention right away if any of these SEVERE side effects occur when using Ofloxacin 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
Ofloxacin 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 |
Postmarketing 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 |
| 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; 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 |
| 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.
ofloxacin - Includes detailed dosage instructions.
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