Noroxin Side Effects

Generic name: norfloxacin

Generic Name: Norfloxacin

Please note - some side effects for Noroxin 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).

Side Effects of Noroxin - for the consumer

Noroxin

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 Noroxin:

Diarrhea; dizziness; headache; loss of appetite; nausea; stomach upset or cramps; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or tarry stools; burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet; change in sense of touch or temperature; chest pain; dark urine or change in amount of urine; decreased amount of urine; fainting; fever, chills, or unusual cough; hallucinations; hearing changes (eg, ringing in the ears, hearing loss); inability to move or bear weight on a joint or tendon area; irregular heartbeat; joint pain or swelling; moderate to severe sunburn; mood or mental changes (eg, new or worsening anxiety, agitation, confusion, depression, restlessness, sleeplessness); muscle pain or weakness; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; pale stools; persistent sore throat; red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness; severe or persistent diarrhea; severe stomach pain or cramps; suicidal thoughts or actions; tremors; unusual bruising or bleeding; unusual fatigue; vaginal yeast infection; vision changes; yellowing of the skin or eyes.

For the professional

Noroxin

Single-Dose Studies

In clinical trials involving 82 healthy subjects and 228 patients with gonorrhea, treated with a single dose of norfloxacin, 6.5% reported drug-related adverse experiences. However, the following incidence figures were calculated without reference to drug relationship.

The most common adverse experiences (>1.0%) were: dizziness (2.6%), nausea (2.6%), headache (2.0%), and abdominal cramping (1.6%).

Additional reactions (0.3%-1.0%) were: anorexia, diarrhea, hyperhidrosis, asthenia, anal/rectal pain, constipation, dyspepsia, flatulence, tingling of the fingers, and vomiting.

Laboratory adverse changes considered drug-related were reported in 4.5% of patients/subjects. These laboratory changes were: increased AST (SGOT) (1.6%), decreased WBC (1.3%), decreased platelet count (1.0%), increased urine protein (1.0%), decreased hematocrit and hemoglobin (0.6%), and increased eosinophils (0.6%).

Multiple-Dose Studies

In clinical trials involving 52 healthy subjects and 1980 patients with urinary tract infections or prostatitis treated with multiple doses of norfloxacin, 3.6% reported drug-related adverse experiences. However, the incidence figures below were calculated without reference to drug relationship.

The most common adverse experiences (>1.0%) were: nausea (4.2%), headache (2.8%), dizziness (1.7%), and asthenia (1.3%).

Additional reactions (0.3%-1.0%) were: abdominal pain, back pain, constipation, diarrhea, dry mouth, dyspepsia/heartburn, fever, flatulence, hyperhidrosis, loose stools, pruritus, rash, somnolence, and vomiting.

Less frequent reactions (0.1%-0.2%) included: abdominal swelling, allergies, anorexia, anxiety, bitter taste, blurred vision, bursitis, chest pain, chills, depression, dysmenorrhea, edema, erythema, foot or hand swelling, insomnia, mouth ulcer, myocardial infarction, palpitation, pruritus ani, renal colic, sleep disturbances, and urticaria.

Abnormal laboratory values observed in these patients/subjects were: eosinophilia (1.5%), elevation of ALT (SGPT) (1.4%), decreased WBC and/or neutrophil count (1.4%), elevation of AST (SGOT) (1.4%), and increased alkaline phosphatase (1.1%). Those occurring less frequently included increased BUN, increased LDH, increased serum creatinine, decreased hematocrit, and glycosuria.

Post-Marketing

The most frequently reported adverse reaction in post-marketing experience is rash.

CNS effects characterized as generalized seizures, myoclonus and tremors have been reported with Noroxin. Visual disturbances have been reported with drugs in this class.

The following additional adverse reactions have been reported since the drug was marketed:

Hypersensitivity reactions have been reported including anaphylactoid reactions, angioedema, dyspnea, vasculitis, urticaria, arthritis, arthralgia and myalgia.

Toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, exfoliative dermatitis, photosensitivity/phototoxicity reactions.

Pseudomembranous colitis, hepatitis, jaundice including cholestatic jaundice and elevated liver function tests, pancreatitis (rare), stomatitis. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment.

Hepatic failure, including fatal cases.

On rare occasions, prolonged QTc interval and ventricular arrhythmia including torsades de pointes.

Interstitial nephritis, renal failure.

Peripheral neuropathy, Guillain-Barré syndrome, ataxia, paresthesia, hypoesthesia, psychic disturbances including psychotic reactions and confusion.

Tendinitis, tendon rupture; exacerbation of myasthenia gravis; elevated creatine kinase (CK).

Neutropenia; leukopenia; agranulocytosis; hemolytic anemia, sometimes associated with glucose-6-phosphate dehydrogenase deficiency; thrombocytopenia.

Hearing loss, tinnitus, diplopia, dysgeusia.

Other adverse events reported with quinolones include: agranulocytosis, albuminuria, candiduria, crystalluria, cylindruria, dysphagia, elevation of blood glucose, elevation of serum cholesterol, elevation of serum potassium, elevation of serum triglycerides, hematuria, hepatic necrosis, symptomatic hypoglycemia, nystagmus, postural hypotension, prolongation of prothrombin time, and vaginal candidiasis.

By body system

General side effects

Norfloxacin therapy is generally well tolerated and adverse effects are mild. Adverse effects were reported in 6.5% of subjects receiving single doses and 3.6% of subjects receiving multiple doses.

Gastrointestinal side effects

The onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment.

Gastrointestinal side effects have included nausea (2.6% to 4.2%), abdominal cramping (1.6%), and anorexia (0.1% to 1%). Abdominal pain, anal/rectal pain, constipation, diarrhea, dry mouth, dyspepsia, flatulence, heartburn, loose stools, and vomiting have been reported in 0.3% to 1% of patients. Abdominal swelling and mouth ulcer have been reported in 0.1% to 0.2% of patients. Dysgeusia, pseudomembranous colitis, pancreatitis, and stomatitis were reported during postmarketing experience. Quinolone class antibiotics have been associated with intestinal perforation and dysphasia.

Nervous system side effects

Nervous system side effects have included dizziness (1.7% to 2.6%), headache (2% to 2.8%), tingling of the fingers (0.3% to 1%), and somnolence (0.3% to 1%). Generalized seizures, myoclonus, tremors, peripheral neuropathy, Guillain-Barre syndrome, ataxia, paresthesia, hypoesthesia, and exacerbation of myasthenia gravis have been reported during postmarketing experience. Quinolones, including norfloxacin, have rarely been associated with sensory and sensorimotor axonal polyneuropathy resulting in paresthesias, hypoesthesias, dysesthesias, and weakness.

Seizures reported in association with norfloxacin therapy have occurred, generally in older patients. Norfloxacin should be used cautiously in patients who are predisposed to seizures. One patient with myasthenia gravis experienced a deterioration in her condition during two different courses of norfloxacin.

Hypersensitivity side effects

A 70-year-old male developed an itchy papulopustular eruption from the thighs to the abdomen after 3 days of therapy with norfloxacin. The patient was treated with prednisone for 15 days. A patch test one month later resulted in a reaction to quinolone mix.

A 71-year-old woman developed a fever and eosinophilia after 1 week of norfloxacin 400 mg three times a day. Laboratory results included an elevated white blood cell (WBC) count with 60.9% eosinophils as well as elevated hepatic transaminase levels, which returned to normal following the discontinuation of norfloxacin. Symptoms returned upon rechallenge 6 weeks later and resolved over several weeks after norfloxacin was replaced by ciprofloxacin.

Hypersensitivity reactions have included allergic reactions (0.1% to 0.2%), rash, systemic contact dermatitis, Stevens-Johnson syndrome, and eosinophilic necrotizing granulomatous hepatitis. Anaphylaxis, anaphylactoid reactions, angioedema, cardiovascular collapse, dyspnea, vasculitis, urticaria, arthritis, arthralgia, myalgia, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, and photosensitivity have also been reported.

Renal side effects

Renal side effects have included decreased renal function, nephrotic syndrome (which has occurred in patients treated with high doses), increased serum creatinine, and increased BUN (infrequent), interstitial nephritis and renal failure. Quinolone class antibiotics have been associated with renal calculi.

Hepatic side effects

Hepatic side effects have included elevated ALT (1.4%), AST (1.4% to 1.6%), alkaline phosphatase (1.1%), and LDH. Hepatitis, jaundice (including cholestatic jaundice and elevated liver function tests), and hepatic failure (including fatal cases) have been reported during postmarketing experience. Quinolone class antibiotics have been associated with hepatic necrosis.

Hematologic side effects

Eosinophilia was reported in 7.5% of one study population. Leukopenia and neutropenia have been reported in up to 1% of patients. Hemolytic anemia has sometimes been associated with glucose-6-phosphate dehydrogenase deficiency.

Hematologic side effects have included eosinophilia (1.5%), decreased WBC (1.3% to 1.4%), decreased neutrophil count (1.4%), decreased platelet count (1%), decreased hematocrit and hemoglobin (0.6%) and increased eosinophils (0.6%). Leukopenia, neutropenia, hemolytic anemia, agranulocytosis, prothrombin time prolongation, and thrombocytopenia have been reported during postmarketing experience.

Musculoskeletal side effects

Musculoskeletal side effects have included bursitis (0.1% to 0.2%), tendonitis, tendon rupture, and elevated creatine kinase. Bilateral arthritis of the ankles, myalgia, and rhabdomyolysis have also been reported.

Quinolones, including norfloxacin, have been associated with ruptures of the shoulder, hand, Achilles, and other tendons resulting in disability or requiring surgical repair. Elderly patients and patients concomitantly using corticosteroids may be at increased risk.

Renal transplant patients have an increased risk of Achilles tendonitis and rupture over the general population. Quinolone use has been shown to increase that risk further in this population (12% in quinolone-treated patients vs. 7% in patients not treated).

Other side effects

Other side effects have included asthenia (0.3 to 1.3%), fever (0.3% to 1%), back pain (0.3% to 1%), and foot or hand swelling, bitter taste, and chills in 0.1% to 0.2%. Transient hearing loss and tinnitus have been reported during postmarketing experience.

Dermatologic side effects

Dermatologic side effects have included rash (0.3% to 1%), pruritus (0.3% to 1%), erythema (0.1% to 0.2%), and urticaria (0.1% to 0.2%), and pruritus ani (0.1% to 0.2%). Rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis, and photosensitivity/phototoxicity reactions have been reported during postmarketing experience. Quinolone class antibiotics have been associated with erythema nodosum.

Genitourinary side effects

Genitourinary side effects have included increased urine protein (1%), dysmenorrhea (0.1% to 0.2%), crystalluria, and glycosuria. Quinolone class antibiotics have been associated with albuminuria, candiduria, cylindruria, hematuria, and vaginal candidiasis.

Crystalluria has occurred in patients taking doses greater than 1200 mg/day and whose urine pH was 7.0 to 7.8.

Endocrine side effects

Endocrine side effects have included hyperhidrosis (0.3% to 1%).

Cardiovascular side effects

Cardiovascular side effects have included chest pain, edema, myocardial infarction, and palpitation in 0.1% to 0.2% of patients. Prolonged QTc interval and ventricular arrhythmia including torsade de pointes have rarely been reported during postmarketing experience. Quinolone class antibiotics have been associated with postural hypotension.

Ocular side effects

Ocular side effects have included diplopia. Quinolone class antibiotics have been associated with nystagmus.

Metabolic side effects

Metabolic side effects including acidosis, symptomatic hypoglycemia, and elevations in serum triglycerides, serum cholesterol, blood glucose, and serum potassium have been associated with quinolone class antibiotics.

Respiratory side effects

Respiratory side effects associated with quinolone class antibiotics have included hiccough.

Psychiatric side effects

Psychiatric side effects have included anxiety, depression, insomnia, and sleep disturbances in 0.1% to 0.2% of patients. Psychic disturbances (including psychotic reactions and confusion) have been reported during postmarketing experience. Quinolone class antibiotics have been associated with manic reactions.

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