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Noroxin

Last reviewed on RxList: 8/4/2016
Noroxin Side Effects Center

Last reviewed on RxList 6/25/2015

Noroxin (norfloxacin) is a fluoroquinolone antibiotic used to treat bacterial infections of the prostate and urinary tract. Noroxin also treats gonorrhea. Common side effects of Noroxin include nausea, diarrhea, dizziness, stomach cramps, heartburn, rectal pain, lightheadedness, muscle and joint aches, back pain, sweating, vaginal itching or discharge, or headache. The fluoroquinolone class of drugs may cause increased tendon and soft tissues injuries.

The dose of Noroxin depends on the type of infection being treated. Noroxin may adversely interact with blood thinners, NSAIDs, oral steroids, insulin or diabetes medication you take by mouth, clozapine, cyclosporine, nitrofurantoin, probenecid, ropinirol, tacrine, theophylline, or tizanidine. Tell your doctor all medications you are taking. During pregnancy, Noroxin should be used only if prescribed by your doctor. It is unknown if this drug passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breast-feeding.

Our Noroxin Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Noroxin Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking norfloxacin and call your doctor at once if you have sudden pain, snapping or popping sound, bruising, swelling, tenderness, stiffness, or loss of movement in any of your joints. Rest the joint until you receive medical care or instructions.

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
  • irregular heart rhythm, new or worsening cough, trouble breathing;
  • hallucinations, tremors, feeling restless or anxious, unusual thoughts or behavior, seizure (convulsions);
  • ringing in your ears, vision problems, pain behind your eyes;
  • confusion, nausea and vomiting, swelling, rapid weight gain, urinating less than usual or not at all;
  • numbness, burning, pain, or tingly feeling in your hands or feet;
  • pain in your upper stomach, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • pale skin, easy bruising or bleeding, muscle weakness, fever, swollen glands, general ill feeling;
  • the first sign of any skin rash, no matter how mild; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • mild nausea or diarrhea, stomach cramps, heartburn;
  • rectal pain;
  • headache, dizziness;
  • sweating;
  • back pain; or
  • vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Noroxin (Norfloxacin)

Noroxin Professional Information

SIDE EFFECTS

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 (see WARNINGS). 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

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

Skin

Toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, exfoliative dermatitis, photosensitivity/phototoxicity reactions (see PRECAUTIONS), leukocytoclastic vasculitis, drug rash with eosinophilia and systemic symptoms (DRESS syndrome).

Gastrointestinal

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 (see WARNINGS).

Hepatic

Hepatic failure, including fatal cases.

Cardiovascular

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

Renal

Interstitial nephritis, renal failure.

Nervous System/Psychiatric

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

Musculoskeletal

Tendinitis, tendon rupture; exacerbation of myasthenia gravis (see WARNINGS, Exacerbation of myasthenia gravis); elevated creatine kinase (CK), muscle spasms.

Hematologic

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

Special Senses

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.

Read the entire FDA prescribing information for Noroxin (Norfloxacin)

Related Resources for Noroxin

Read the Noroxin User Reviews »

© Noroxin Patient Information is supplied by Cerner Multum, Inc. and Noroxin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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