Drug Information for Ofloxacin (Ranbaxy Pharmaceuticals Inc.): ADVERSE REACTIONS

  • 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% 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:


    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 (See PRECAUTIONS: General and Drug Interactions.)

    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 (See WARNINGS.)

    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 (See WARNINGS.)

    Musculoskeletal: tendinitis/rupture; weakness, rhabdomyolysis (See WARNINGS.)

    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 (See WARNINGSand PRECAUTIONS.)

    Respiratory System: dyspnea, bronchospasm, allergic pneumonitis, stridor (See WARNINGS.)

    Skin/Hypersensitivity: anaphylactic (-toid) reactions/shock; purpura, serum sickness, erythema multiforme/Stevens-Johnson Syndrome, erythema nodosum, exfoliative dermatitis, hyperpigmentation, toxic epidermal necrolysis, conjunctivitis, photosensitivity/phototoxicity reaction, vesiculobullous eruption (See WARNINGS and PRECAUTIONS.)

    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 (See WARNINGS and PRECAUTIONS.)


    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.


  • Drug Information Provided by National Library of Medicine (NLM).