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adverse reactions
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 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, torsade 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; exacerbation of: myasthenia gravis and extrapyramidal disorders; dysphasia, lightheadedness (see WARNINGS and 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. CRYSTALLURIA and CYLINDRURIA HAVE BEEN REPORTED with other quinolones.
adverse reactions table
<table ID="id_8ebd4afb-c80e-42c9-8b2e-0649e9bb62b2" border="1" width="421"> <col span="1" width="30.4%"/> <col span="1" width="69.6%"/> <tbody> <tr> <td>Body as a Whole:</td> <td>asthenia, chills, malaise, extremity pain, pain, epistaxis</td> </tr> <tr> <td>Cardiovascular System:</td> <td>cardiac arrest, edema, hypertension, hypotension, palpitations, vasodilation</td> </tr> <tr> <td>Gastrointestinal System:</td> <td>dyspepsia</td> </tr> <tr> <td>Genital/Reproductive System:</td> <td>burning, irritation, pain and rash of the female genitalia; dysmenorrhea; menorrhagia; metrorrhagia</td> </tr> <tr> <td>Musculoskeletal System:</td> <td>arthralgia, myalgia</td> </tr> <tr> <td>Nervous System:</td> <td>seizures, anxiety, cognitive change, depression, dream abnormality, euphoria, hallucinations, paresthesia, syncope, vertigo, tremor, confusion</td> </tr> <tr> <td>Nutritional/Metabolic:</td> <td>thirst, weight loss</td> </tr> <tr> <td>Respiratory System:</td> <td>respiratory arrest, cough, rhinorrhea</td> </tr> <tr> <td>Skin/Hypersensitivity:</td> <td>angioedema, diaphoresis, urticaria, vasculitis</td> </tr> <tr> <td>Special Senses:</td> <td>decreased hearing acuity, tinnitus, photophobia</td> </tr> <tr> <td>Urinary System:</td> <td>dysuria, urinary frequency, urinary retention</td> </tr> </tbody> </table>
adverse reactions table
<table ID="id_66c5f9db-f778-4e07-8227-4041748b0cf6" border="1" width="419"> <col span="1" width="32.2%"/> <col span="1" width="67.8%"/> <tbody> <tr> <td>Cardiovascular System:</td> <td>cerebral thrombosis, pulmonary edema, tachycardia, hypotension/shock, syncope, torsade de pointes</td> </tr> <tr> <td>Endocrine/Metabolic:</td> <td>hyper- or hypoglycemia, especially in diabetic patients on insulin or oral hypoglycemic agents (see <content styleCode="bold">PRECAUTIONS</content>, <content styleCode="bold"> General </content>and <content styleCode="bold">Drug Interactions</content>). </td> </tr> <tr> <td>Gastrointestinal System:</td> <td>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 <content styleCode="bold">WARNINGS</content>). </td> </tr> <tr> <td>Genital/Reproductive System:</td> <td>vaginal candidiasis</td> </tr> <tr> <td>Hematopoietic:</td> <td>anemia, including hemolytic and aplastic; hemorrhage, pancytopenia, agranulocytosis, leukopenia, reversible bone marrow depression, thrombocytopenia, thrombotic thrombocytopenic purpura, petechiae, ecchymosis/bruising (see <content styleCode="bold">WARNINGS</content>). </td> </tr> <tr> <td>Musculoskeletal:</td> <td>tendinitis/rupture; weakness; rhabdomyolysis (see <content styleCode="bold">WARNINGS</content>). </td> </tr> <tr> <td>Nervous System:</td> <td>nightmares; suicidal thoughts or acts, disorientation, psychotic reactions, paranoia; phobia, agitation, restlessness, aggressiveness/hostility, manic reaction, emotional lability; peripheral neuropathy, ataxia, incoordination; exacerbation of: myasthenia gravis and extrapyramidal disorders; dysphasia, lightheadedness (see <content styleCode="bold">WARNINGS</content> and <content styleCode="bold">PRECAUTIONS</content>). </td> </tr> <tr> <td>Respiratory System:</td> <td>dyspnea, bronchospasm, allergic pneumonitis, stridor (see <content styleCode="bold">WARNINGS</content>). </td> </tr> <tr> <td>Skin/Hypersensitivity:</td> <td>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 <content styleCode="bold">WARNINGS </content>and <content styleCode="bold">PRECAUTIONS</content>). </td> </tr> <tr> <td>Special Senses:</td> <td>diplopia, nystagmus, blurred vision, disturbances of: taste, smell, hearing and equilibrium, usually reversible following discontinuation</td> </tr> <tr> <td>Urinary System:</td> <td>anuria, polyuria, renal calculi, renal failure, interstitial nephritis, hematuria (see <content styleCode="bold">WARNINGS </content>and <content styleCode="bold">PRECAUTIONS</content>). </td> </tr> </tbody> </table>