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Nalidixic acid Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 8, 2023.

Applies to nalidixic acid: oral suspension, oral tablet.

Serious side effects of Nalidixic acid

Along with its needed effects, nalidixic acid may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking nalidixic acid:

More common

Less common

Rare

Incidence not known

Get emergency help immediately if any of the following symptoms of overdose occur while taking nalidixic acid:

Symptoms of overdose

Other side effects of Nalidixic acid

Some side effects of nalidixic acid may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

Incidence not known

For Healthcare Professionals

Applies to nalidixic acid: compounding powder, oral suspension, oral tablet.

Hypersensitivity

Frequency not reported: Allergic reactions (including rash, pruritus, urticaria, angioedema, eosinophilia, arthralgia with joint stiffness and swelling, anaphylactoid reactions [including anaphylactic shock]), serious and occasionally fatal hypersensitivity (anaphylactoid) reactions[Ref]

Dermatologic

Frequency not reported: Rash, erythema multiforme, Stevens-Johnson syndrome, photosensitivity reactions (consisting of erythema and bullae on exposed skin surfaces), phototoxicity (moderate to severe)[Ref]

Rash was reported most often.

Photosensitivity reactions appeared to be related to the amount of sun exposure rather than amount of drug taken. Most reactions were reported following intense sun exposure during the summer. Large bullae developed most commonly on the dorsum of the hands and feet. Photosensitivity reactions usually resolved 2 weeks to 2 months after drug discontinuation. In some cases, bullae continued to appear with additional sun exposure or with mild skin trauma for up to 3 months after discontinuation of nalidixic acid. Recurrence of bullae have been reported after 1 year.[Ref]

Gastrointestinal

Frequency not reported: Nausea, vomiting, abdominal pain, diarrhea, Clostridium difficile associated diarrhea[Ref]

Nervous system

Rare (less than 0.1%): Convulsions/seizures, sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons (resulting in paresthesias, hypoesthesias, dysesthesias, weakness)

Frequency not reported: Drowsiness, weakness, headache, dizziness, vertigo, peripheral neuropathy, paresthesia

Infants and children:

Frequency not reported: Increased intracranial pressure with bulging anterior fontanel, papilledema, headache, 6th cranial nerve palsy[Ref]

Brief convulsions were usually associated with excessive doses. In general, the convulsions were reported in patients with predisposing factors such as epilepsy or cerebral atherosclerosis.[Ref]

Psychiatric

Toxic psychosis was usually associated with excessive doses.

Psychotic reactions involving delirium, photophobia, paranoia, and visual hallucinations have rarely been reported with nalidixic acid. Seizures may also be involved and hyperglycemia was often present.[Ref]

Rare (less than 0.1%): Toxic psychosis, psychotic reactions (involving delirium, photophobia, paranoia, visual hallucinations)[Ref]

Musculoskeletal

Frequency not reported: Arthralgias, myalgias, tendon disorders (including tendon rupture)[Ref]

Ocular

Visual disturbances usually resolved with dosage reduction or drug discontinuation.[Ref]

Rare (less than 0.1%): Reversible subjective visual disturbances without objective findings (including overbrightness of lights/photophobia, change in color perception, difficulty in focusing, decrease in visual acuity, double vision)[Ref]

Hematologic

Rare (less than 0.1%): Thrombocytopenia, leukopenia, eosinophilia, hemolytic anemia (sometimes associated with glucose 6-phosphate deficiency)[Ref]

Hemolytic anemia secondary to nalidixic acid most commonly occurred in patients with G6PD deficiency but was also reported in patients without this deficiency. Direct Coombs' tests were generally positive. Death from nalidixic acid induced hemolytic anemia has been reported.[Ref]

Metabolic

Rare (less than 0.1%): Metabolic acidosis, lactic acidosis[Ref]

Metabolic acidosis has been reported in a few patients, generally after an overdose of nalidixic acid. Lactic acidosis resulting in death occurred in a diabetic woman.[Ref]

Hepatic

Rare (less than 0.1%): Cholestasis[Ref]

References

1. Burt RA. Review of adverse reactions associated with cinoxacin and other drugs used to treat urinary tract infections. Urology. 1984;23:101-7.

2. Bilsland D, Douglas WS. Sunbed pseudoporphyria induced by nalidixic acid. Br J Dermatol. 1990;123:547.

3. Brauner GJ. Bullous photoreaction to nalidixic acid. Am J Med. 1975;58:576-80.

4. Garrett MH. "Negram" and photosensitivity reactions. Med J Aust. 1969;1:83.

5. Rubinstein A. Le-like disease caused by nalidixic acid. N Engl J Med. 1979;301:1288.

6. Valdivieso R, Pola J, Losada E, Subiza J, Armentia A, Zapata C. Severe anaphylactoid reaction to nalidixic acid. Allergy. 1988;43:71-3.

7. Ramsay CA, Obreshkova E. Photosensitivity from nalidixic acid. Br J Dermatol. 1974;91:523-8.

8. Birkett DA, Garretts M, Stevenson CJ. Phototoxic bullous eruptions due to nalidixic acid. Br J Dermatol. 1969;81:342-4.

9. Product Information. Neggram (nalidixic acid). Sanofi Winthrop Pharmaceuticals. PROD.

10. Paulson DF. Comparison of cinoxacin and nalidixic acid in patients with cystitis. Urology. 1982;20:138-40.

11. Iravani A, Richard GA, Baer H, Fennell R. Comparative efficacy and safety of nalidixic acid versus trimethoprim/sulfamethoxazole in treatment of acute urinary tract infections in college-age women. Antimicrob Agents Chemother. 1981;19:598-604.

12. Poc TE, Marion GS, Jackson DS. Seizures due to nalidixic acid therapy. South Med J. 1984;77:539-40.

13. Fraser AG, Harrower AD. Convulsions and hyperglycaemia asociated with nalidixic acid. Br Med J. 1977;2:1518.

14. Kremer L, Walton M, Wardle EN. Nalidixic acid and intracranial hypertension. Br Med J. 1967;4:488.

15. Leslie PJ, Cregeen RJ, Proudfoot AT. Lactic acidosis, hyperglycaemia and convulsions following nalidixic acid overdosage. Hum Toxicol. 1984;3:239-43.

16. Bailey RR, Natale R, Linton AL. Nalidixic acid arthralgia. Can Med Assoc J. 1972;107:604.

17. Carmichael AJ, Martin AM. Acute painful proximal myopathy associated with nalidixic acid. Br Med J. 1988;297:742.

18. Tafani O, Mazzoli M, Landini G, Alterini B. Fatal acute immune haemolytic anaemia caused by nalidixic acid. Br Med J. 1982;285:936-7.

19. Odeh M, Oliven A, Bassan H. Nalidixic acid-induced hemolytic anemia complicating halothane-induced hepatitis. Isr J Med Sci. 1992;28:294-6.

20. Gilbertson C, Jones DR. Haemolytic anaemia with nalidixic acid. Br Med J. 1972;4:493.

21. Phillips PJ, Need AG, Thomas DW, Conyers RA, Edwards JB, Lehmann D. Nalidixic acid and lactic acidosis. Aust N Z J Med. 1979;9:694-6.

22. Nogue S, Bertran A, Mas A, Nadal P, Anguita A, Milla J. Metabolic acidosis and coma due to an overdose of nalidixic acid. Intensive Care Med. 1979;5:141-2.

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.