Ofloxacin Side Effects

Brand Names: Floxin, Floxin I.V.

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.

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:

Diarrhea; dizziness; headache; loss of appetite; nausea; sensitivity to sunlight; trouble sleeping; vomiting.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); agitation; anxiety; bizarre behavior; bloody stools; burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet; change in sense of touch or temperature; confusion; convulsions; dark urine; decreased urination; depression; diarrhea (severe or continuing); difficulty swallowing; excessive urination, thirst, or hunger; fainting; fast or irregular heartbeat; fatigue; fever, chills, or unusual cough; hallucinations; joint pain or swelling; light-headedness; loss of consciousness; mental or mood changes; muscle pain or weakness; nervousness; nightmares; pale stools; red, swollen, blistered, or peeling skin; restlessness; seizures; shortness of breath; shock (pale skin); sleeplessness; severe or persistent stomach pain or cramps; shortness of breath or trouble breathing; suicidal thoughts; tendon pain, inflammation, or swelling; tightness of the throat; tremors; unusual bruising or bleeding; unusual tiredness or weakness; urination problems; vaginal irritation or discharge; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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:

Blurred vision; burning or discomfort in the eye, including stinging, redness, and itching; dry eyes; eye pain; foreign body sensation; sensitivity to sunlight; tearing.

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

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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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:

Itching of the ear; taste changes.

Seek medical attention right away if any of these SEVERE side effects occur when using Ofloxacin 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.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Ofloxacin Side Effects - for the Professional

Ofloxacin

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, torsade 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; 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/phototoxicity reaction, 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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Side Effects by Body System - for Healthcare Professionals

General

Ofloxacin therapy is generally well tolerated, and adverse effects are mild in nature. In clinical trials, 11% of patients experienced adverse events. Discontinuation of therapy due to adverse effects occurred in 4% of treated patients.

Gastrointestinal

Gastrointestinal side effects have included nausea (3% to 10%), diarrhea (1% to 4%), vomiting (1% to 4%), and dysgeusia (1%). Abdominal pain, cramps, decreased appetite, dry mouth, dysgeusia, flatulence, gastrointestinal distress, and constipation have been reported in 1% to 3% of patients, and dyspepsia in less than 1%. Quinolones, including ofloxacin, have been associated with pseudomembranous colitis, GI hemorrhage, intestinal perforation, pyrosis, and painful oral mucosa.

Pseudomembranous colitis may occur during or after therapy.

Nervous system

Nervous system side effects have included insomnia (3% to 7%), headache (1% to 9%), dizziness (1% to 5%). Fatigue, nervousness, sleep disorders, and somnolence have been reported in 1% to 3% of patients. Seizures, anxiety, paresthesia, syncope, vertigo, and tremor have been reported in less than 1% of patients. Idiopathic intracranial hypertension has also been reported. Quinolones, including ofloxacin, have been associated with agitation, restlessness, peripheral neuropathy, ataxia, incoordination, exacerbation of myasthenia gravis, exacerbation of extrapyramidal disorders, dysphasia, and lightheadedness.

Seizures are more likely to occur in elderly patients and in those with renal insufficiency.

One survey reported 6 cases of peripheral neuropathy associated with ofloxacin. In one case, a 49-year-old female developed diffuse numbness, "pins and needles" sensation, burning pain, memory loss, visual impairment, joint pain, palpitations, altered sense of smell, insomnia, tinnitus, and severe panic attacks, with some symptoms persisting after 3 years.

Renal

Renal side effects have included increased creatinine and BUN in 1% or more of patients. Quinolones, including ofloxacin, have been associated with renal calculi, renal failure, and interstitial nephritis.

Hepatic

Hepatic side effects have included elevated alkaline phosphatase, AST, and ALT in 1% or more of patients. Quinolones, including ofloxacin, have been associated with hepatic necrosis, jaundice (cholestatic or hepatocellular), hepatitis, hepatic failure
(including fatal cases), and elevated GGTP, LDH, and bilirubin.

Hematologic

Hematological side effects have included anemia, leukopenia, leukocytosis, neutropenia, neutrophilia, increased band forms, lymphocytopenia, eosinophilia, lymphocytosis, thrombocytopenia, thrombocytosis, and elevated ESR in 1% or more of patients. Quinolones, including ofloxacin, have been associated with anemia, including hemolytic and aplastic; hemorrhage, pancytopenia, agranulocytosis, leukopenia, reversible bone marrow depression, thrombocytopenia, thrombotic thrombocytopenic purpura, petechiae, prothrombin time prolongation, and ecchymosis/bruising.

Local

Local side effects reported in patients receiving parenteral therapy have included local reactions at the injection site (including phlebitis, swelling and erythema), occurring in approximately 2% of treated patients.

Musculoskeletal

Musculoskeletal side effects have included arthralgia and myalgia in less than 1% of patients. Quinolones, including ofloxacin, have been associated with tendonitis, tendon rupture, weakness, and rhabdomyolysis during postmarketing experience.

Cardiovascular

Ofloxacin was associated with 2 cases of torsade de pointes reported to the FDA between 1996 and 2001.

Cardiovascular side effects have included cardiac arrest, edema, hypertension, hypotension, palpitations, and vasodilation in less than 1% of patients. Quinolones, including ofloxacin, have been associated with cerebral thrombosis, pulmonary edema, tachycardia, hypotension/shock, torsades de pointes, and syncope.

Hypersensitivity

Hypersensitivity reactions have included rash (1%) and angioedema, urticaria, and vasculitis (less than 1%). Quinolones, including ofloxacin, have been associated with anaphylaxis, anaphylactoid reactions, shock, purpura, serum sickness, erythema multiforme, Stevens-Johnson syndrome, erythema nodosum, exfoliative dermatitis, toxic epidermal necrolysis, photosensitivity/phototoxicity reaction, and vesiculobullous eruption.

A 75-year-old male developed toxic epidermal necrolysis and died of complications after receiving a total of 23.6 grams of oral ofloxacin over 51 days.

Genitourinary

Genitourinary side effects have included external genital pruritus in women (1% to 6%), vaginitis (1% to 5%), vaginal discharge (1% to 3%). Glucosuria, proteinuria, alkalinuria, hyposthenuria, hematuria, and pyuria have been reported in 1% or more of patients. Dysuria, urinary frequency, urinary retention, dysmenorrhea, menorrhagia, metrorrhagia, and burning, irritation, pain and rash of the female genitalia have been reported in less than 1% of patients. Quinolones, including ofloxacin, have been associated with vaginal candidiasis, albuminuria, anuria, hematuria, and polyuria. Other quinolone class antibiotics have been associated with crystalluria and cylindruria.

Dermatologic

Dermatologic side effects have included rash and pruritus in 1% to 3% of patients, and angioedema, diaphoresis, and urticaria in less than 1%. Quinolones, including ofloxacin, have been associated with hyperpigmentation, erythema multiforme, erythema nodosum, exfoliative dermatitis, toxic epidermal necrolysis, photosensitivity/phototoxicity reaction, and vesiculobullous eruption.

Ocular

Ocular side effects have included visual disturbances (1% to 3%) and photophobia (less than 1%). Quinolones, including ofloxacin, have been associated with diplopia, nystagmus, blurred vision, and conjunctivitis. Other quinolone class antibiotics have been associated with cataracts and multiple punctate lenticular opacities.

Other

Other side affects have included asthenia, chills, malaise, extremity pain, pain, epistaxis, decreased hearing acuity, and tinnitus in less than 1% of patients. Quinolones, including ofloxacin, have been associated with reversible disturbances of taste, smell, hearing, and equilibrium.

Respiratory

Respiratory side effects have included respiratory arrest, cough and rhinorrhea in less than 1% of patients. Quinolones, including ofloxacin, have been associated with dyspnea, bronchospasm, allergic pneumonitis, and stridor.

Metabolic

Metabolic side effects have included hyperglycemia and hypoglycemia in 1% or more of patients, and thirst and weight loss in less than 1%. Nephrogenic diabetic insipidus has also been reported. Quinolones, including ofloxacin, have been associated with hypoglycemia and hyperglycemia, especially in diabetic patients, acidosis, and elevations in serum triglycerides, serum cholesterol, and serum potassium.

Psychiatric

Psychiatric side effects have included cognitive change, depression, dream abnormality, euphoria, hallucinations, and confusion in less than 1% of patients. Quinolones, including ofloxacin, have been associated with nightmares, suicidal thought or acts, disorientation, psychotic reactions, paranoia, phobia, aggressiveness/hostility, manic reaction, and emotional lability.

In one patient, a psychotic reaction to ofloxacin presented with irritability, restlessness, insomnia, and irrational fear. The reaction was treated with haloperidol and resolved within 48 hours. One study suggests that the CNS effects of quinolones may be due to an interaction with the benzodiazepine-GABA receptor complex and may be controlled by benzodiazepine administration.

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