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Norfloxacin Side Effects

Applies to norfloxacin: oral tablet

General

This drug was generally well tolerated and side effects were mild. Side effects were reported in 6.5% of subjects receiving single doses and 3.6% of subjects receiving multiple doses.[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, abdominal cramping

Uncommon (0.1% to 1%): Abdominal pain, anal/rectal pain, constipation, diarrhea, dry mouth, dyspepsia/heartburn, flatulence, loose stools, vomiting, abdominal swelling, mouth ulcer, pruritus ani

Rare (0.01% to 0.1%): Pseudomembranous colitis, pancreatitis

Postmarketing reports: Stomatitis

Quinolones:

-Frequency not reported: Intestinal perforation[Ref]

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

Pseudomembranous colitis and pancreatitis have also been reported during postmarketing experience.[Ref]

Nervous system

Cases of sensory or sensorimotor axonal polyneuropathy (affecting small and/or large axons) resulting in paresthesias, hypoesthesias, dysesthesias, and weakness have been reported.

Seizures reported in association with this drug have occurred, generally in older patients. A patient with myasthenia gravis had her condition deteriorate during 2 different courses of this drug.

Paresthesia, polyneuropathy (including Guillain-Barre syndrome), tinnitus, and exacerbation of myasthenia gravis have also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Headache, dizziness

Uncommon (0.1% to 1%): Tingling of the fingers, somnolence/drowsiness, bitter taste

Rare (less than 0.1%): Peripheral sensory neuropathy/sensory axonal polyneuropathy, peripheral sensory motor neuropathy/sensorimotor axonal polyneuropathy, paresthesia, polyneuropathy, Guillain-Barre syndrome, seizures, tinnitus, exacerbation of myasthenia gravis

Frequency not reported: Dysesthesia, altered taste

Postmarketing reports: Generalized seizures, convulsions, myoclonus, tremors, peripheral neuropathy (may be irreversible), ataxia, hypoesthesia, hearing loss, dysgeusia, hypertonia, dysarthria, dysphasia

Quinolones:

-Postmarketing reports: Dysphasia[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergies/allergic reactions

Rare (0.01% to 0.1%): Anaphylactic/anaphylactoid reactions

Postmarketing reports: Hypersensitivity reactions (including anaphylactoid reactions, anaphylaxis, angioedema, dyspnea, vasculitis, urticaria, arthritis, arthralgia, myalgia, interstitial nephritis, DRESS syndrome)[Ref]

Renal

Interstitial nephritis has also been reported during postmarketing experience.[Ref]

Rare (0.01% to 0.1%): Interstitial nephritis

Frequency not reported: Decreased renal function, nephrotic syndrome (which has occurred in patients treated with high doses), increased BUN/serum urea, increased serum creatinine

Postmarketing reports: Renal failure

Quinolones:

-Frequency not reported: Renal calculi[Ref]

Hepatic

Common (1% to 10%): Elevated ALT, elevated AST, cholestatic hepatitis, hepatitis

Frequency not reported: Eosinophilic necrotizing granulomatous hepatitis

Postmarketing reports: Jaundice (including cholestatic jaundice), elevated liver function tests, hepatic failure (including fatal cases)

Quinolones:

-Frequency not reported: Hepatic necrosis[Ref]

Hepatitis has also been reported during postmarketing experience.[Ref]

Hematologic

Common (1% to 10%): Eosinophilia, decreased WBC, decreased neutrophil count, decreased platelet count

Uncommon (0.1% to 1%): Decreased hematocrit, decreased hemoglobin, increased eosinophils, leukopenia, neutropenia, thrombocytopenia, prothrombin time prolongation

Rare (0.01% to 0.1%): Hemolytic anemia

Postmarketing reports: Agranulocytosis

Quinolones:

-Postmarketing reports: Agranulocytosis, prothrombin time prolongation[Ref]

Eosinophilia was reported in 7.5% of 1 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.

Leukopenia, neutropenia, hemolytic anemia, prothrombin time prolongation, and thrombocytopenia have also been reported during postmarketing experience.[Ref]

Musculoskeletal

Quinolones, including this drug, 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 tendinitis and rupture over the general population. Quinolone use has been shown to increase that risk further in this population (12% in quinolone-treated patients versus 7% in patients not treated).

There have been 23 reports of tendinitis submitted to the Australian Adverse Drug Reactions Committee (ADRAC) between 2006 and 2008, including reports of Achilles tendonitis, tendon rupture, and tendon pain and swelling. The reports were primarily in male patients (15 cases) older than 56 years who used ciprofloxacin for 2 to 14 days. In 19 of the reported cases, a fluoroquinolone (generally ciprofloxacin) was the primary suspect; however, details of concomitant serious medical conditions were not documented in most of the reports.

Tendinitis and tendon rupture have also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Rhabdomyolysis

Uncommon (0.1% to 1%): Bursitis, back pain

Rare (0.01% to 0.1%): Tendinitis, tendosynovitis, myalgia/muscle pains, joint pains, joint inflammation

Very rare (less than 0.01%): Tendon rupture (e.g., Achilles tendon)

Frequency not reported: Bilateral arthritis of the ankles

Postmarketing reports: Elevated creatine kinase, muscle spasms[Ref]

Other

Common (1% to 10%): Asthenia, elevated alkaline phosphatase

Uncommon (0.1% to 1%): Fever, fatigue, chest pain, foot or hand swelling, chills, edema

Rare (0.01% to 0.1%): Tiredness

Frequency not reported: Weakness, elevated LDH

Quinolones:

-Postmarketing reports: Elevated serum triglycerides, elevated serum cholesterol, elevated serum potassium[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, pruritus, hyperhidrosis, erythema, urticaria

Rare (0.01% to 0.1%): Petechiae, hemorrhagic bullae/papules with vasculitis, skin reactions, exfoliative dermatitis, toxic epidermal necrolysis (Lyell's syndrome), erythema multiforme, Stevens-Johnson syndrome, photosensitivity, angioedema

Frequency not reported: Systemic contact dermatitis

Postmarketing reports: Leukocytoclastic vasculitis, drug rash with eosinophilia and systemic symptoms (DRESS syndrome), photosensitivity/phototoxicity reactions, periorbital erythema

Quinolones:

-Frequency not reported: Erythema nodosum, photosensitivity (phototoxic reactions, photosensitization with vesiculation, redness, swelling, discoloration)[Ref]

Rash, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, pruritus, and exfoliative dermatitis have also been reported during postmarketing experience. Rash has been reported as the most common side effect during postmarketing experience.

A 70-year-old male developed systemic contact dermatitis, an itchy papulopustular eruption from the thighs to the abdomen, after 3 days of therapy with this drug. The patient was treated with prednisone for 15 days. A patch test 1 month later resulted in a reaction to quinolone mix.

Photosensitivity has been reported in patients extensively exposed to sunlight or sunbeds during ongoing therapy with quinolone-like agents.[Ref]

Genitourinary

Crystalluria has occurred in patients taking doses greater than 1200 mg/day and whose urine pH was 7 to 7.8.

Crystalluria and vaginal candidiasis have also been reported during postmarketing experience.[Ref]

Common (1% to 10%): Increased urine protein

Uncommon (0.1% to 1%): Dysmenorrhea, renal colic, crystalluria

Rare (0.01% to 0.1%): Vaginal candidiasis

Frequency not reported: Glycosuria, vaginal swelling

Postmarketing reports: Proteinuria

Quinolones:

-Postmarketing reports: Crystalluria, albuminuria, candiduria, cylindruria, hematuria, vaginal candidiasis[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Myocardial infarction, palpitation

Frequency not reported: Tachycardia, ECG QT prolonged, cardiovascular collapse

Postmarketing reports: Prolonged QTc interval, ventricular arrhythmia (including torsade de pointes)

Quinolones:

-Postmarketing reports: Postural hypotension[Ref]

Ocular

Uncommon (0.1% to 1%): Blurred vision

Rare (0.01% to 0.1%): Visual disturbance, increased lacrimation

Postmarketing reports: Diplopia, uveitis, nystagmus, conjunctivitis, eye pain/irritation, hemophthalmia

Quinolones:

-Postmarketing reports: Nystagmus, visual disturbances[Ref]

Visual disturbances have also been reported during postmarketing experience.[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia

Rare (0.01% to 0.1%): Loss of appetite

Postmarketing reports: Dysglycemia

Quinolones:

-Frequency not reported: Acidosis

-Postmarketing reports: Symptomatic hypoglycemia, elevated blood glucose[Ref]

Respiratory

Quinolones:

-Frequency not reported: Hiccough[Ref]

Psychiatric

Uncommon (0.1% to 1%): Anxiety, depression, insomnia, sleep disturbances

Rare (0.01% to 0.1%): Mood changes, nervousness, irritability, euphoria, disorientation, hallucinations, confusion, psychic disturbances, psychotic reactions

Quinolones:

-Frequency not reported: Manic reactions[Ref]

Psychic disturbances (including psychotic reactions) and confusion have also been reported during postmarketing experience.[Ref]

References

1. "Norfloxacin (noroxin)." Med Lett Drugs Ther 29 (1987): 25-7

2. Wolfson JS, Hooper DC "Norfloxacin: a new targeted fluoroquinolone antimicrobial agent." Ann Intern Med 108 (1988): 238-51

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. Walker RC, Wright AJ "The quinolones." Mayo Clin Proc 62 (1987): 1007-12

5. "Product Information. Noroxin (norfloxacin)." Merck & Co, Inc, West Point, PA.

6. Sabbour MS, El Bokl MA, Osman LM "Experiences on the efficacy and safety of nalidixic acid, oxolinic acid, cinoxacin and norfloxacin in the treatment of urinary tract infections (UTI)." Infection 12 (1984): 377-80

7. Anonymous. "Prevention of bacterial infection in neutropenic patients with hematologic malignancies." Ann Intern Med 115 (1991): 7-12

8. Ehrenpreis ED, Lievens MW, Craig RM "Clostridium difficile-associated diarrhea after norfloxacin." J Clin Gastroenterol 12 (1990): 188-9

9. Waites KB, Canupp KC, DeVivo MJ "Efficacy and tolerance of norfloxacin in treatment of complicated urinary tract infection in outpatients with neurogenic bladder secondary to spinal cord injury." Urology 38 (1991): 589-96

10. The Urinary Tract Infection Study Group "Coordinated mulicenter study of norfloxacin versus trimethoprim-sulfamethoxazole treatment of symptomatic urinary tract infection." J Infect Dis 155 (1987): 170-7

11. Anastasio GD, Menscer D, Little JM "Norfloxacin and seizures." Ann Intern Med 109 (1988): 169-70

12. Rauser EH, Ariano RE, Anderson BA "Exacerbation of myasthenia gravis by norfloxacin." DICP 24 (1990): 207-8

13. Bjornsson E, Olsson R, Remotti H "Norfloxacin-induced eosinophilic necrotizing granulomatous hepatitis." Am J Gastroenterol 95 (2000): 3662-4

14. Ferguson J, Johnson BE "Clinical and laboratory studies of the photosensitizing potential of norfloxacin, a 4-quinolone broad-spectrum antibiotic." Br J Dermatol 128 (1993): 285-95

15. Shelley ED, Shelley WB "The subcorneal pustular drug eruption: an example induced by norfloxacin." Cutis 42 (1988): 24-7

16. Roujeau JC, Kelly JP, Naldi L, et al. "Medication use and the risk of Stevens-Johnson syndrome or toxic epidermal necrolysis." N Engl J Med 333 (1995): 1600-7

17. Alonso MD, Martin JA, Quirce S, Davila I, Lezaun A, Sanchez Cano M "Fixed eruption caused by ciprofloxacin with cross-sensitivity to norfloxacin." Allergy 48 (1993): 296-7

18. Sahin MT, Ozturkcan S, Inanir I, Filiz EE "Norfloxacin-induced toxic epidermal necrolysis." Ann Pharmacother 39 (2005): 768-70

19. Hanson B, Dhondt A, Depierreux M, Lustman F "Nephrotic syndrome after norfloxacin." Nephron 74 (1996): 446

20. Boelaert J, de Jaegere PP, Daneels R, Schurgers M, Gordts B "Case report of renal failure during norfloxacin therapy." Clin Nephrol 25 (1986): 272

21. Hestin D, Hanesse B, Frimat L, Renaudin JM, Netter P, Kessler M "Norfloxacin-induced nephrotic syndrome." Lancet 345 (1995): 732-3

22. Lucena MI, Andrade RJ, SanchezMartinez H, PerezSerrano JM, GomezOutes A "Norfloxacin-induced cholestatic jaundice." Am J Gastroenterol 93 (1998): 2309-11

23. Davoren P, Mainstone K "Norfloxacin-induced hepatitis." Med J Aust 159 (1993): 423,

24. RomeroGomez M, Garcia ES, Fernandez MC "Norfloxacin-induced acute cholestatic hepatitis in a patient with alcoholic liver cirrhosis." Am J Gastroenterol 94 (1999): 2324-5

25. Lopez-Navidad A, Domingo P, Cadafalch J, Farrerons J "Norfloxacin-induced hepatotoxicity." J Hepatol 11 (1990): 277-8

26. Patoia L, Guerciolini R, Menichetti F, Bucaneve G, Del Favero A "Norfloxacin and neutropenia." Ann Intern Med 107 (1987): 788-9

27. Mofredj A, Boudjema H, Cadranel JF "Norfloxacin-induced eosinophilia in a cirrhotic patient." Ann Pharmacother 36 (2002): 1107-8

28. Kaplan DS "Norfloxacin and protime elevation." Am J Gastroenterol 85 (1990): 901

29. Donck JB, Segaert MF, Vanrenterghem YF "Fluoroquinolones and achilles tendinopathy in renal transplant recipients." Transplantation 58 (1994): 736-7

30. Jeandel C, Manciaux MA, Bannwarth B, et al "Arthritis induced by norfloxacin." J Rheumatol 16 (1989): 560-1

31. Guis S, Jouglard J, Kozak-Ribbens G, et al. "Malignant hyperthermia susceptibility revealed by myalgia and rhabdomyolysis during fluoroquinolone treatment." J Rheumatol 28 (2001): 1405-6

32. Adverse Drug Reactions Advisory Committee (ADRAC) and the Adverse Drug Reactions Unit of the TGA "Australian Adverse Drug Reactions Bulletin. Available from: URL: http://www.tga.gov.au/adr/aadrb/aadr0810.htm." ([2008 Oct]):

33. Khaliq Y, Zhanel GG "Fluoroquinolone-Associated Tendinopathy: A Critical Review of the Literature." Clin Infect Dis 36 (2003): 1404-1410

34. Terry JB "Norfloxacin induced arthralgia." J Rheumatol 22 (1995): 793-4

35. Silvestre JF, Alfonso R, Moragon M, Ramon R, Botella R "Systemic contact dermatitis due to norfloxacin with a positive patch test to quinoline mix." Contact Dermatitis 39 (1998): 83

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.