NegGram Side Effects

Generic Name: nalidixic acid

Note: This page contains side effects data for the generic drug nalidixic acid. It is possible that some of the dosage forms included below may not apply to the brand name NegGram.

It is possible that some side effects of NegGram may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to nalidixic acid: oral suspension, oral tablet

As well as its needed effects, nalidixic acid (the active ingredient contained in NegGram) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking nalidixic acid, check with your doctor immediately:

More common
  • Skin rash
Less common
  • Blurred or decreased vision
  • change in color vision
  • confusion
  • double vision
  • halos around lights
  • lightheadedness
  • overbright appearance of lights
  • restlessness
  • tremor
Rare
  • Abdominal or stomach cramps or pain (severe)
  • blistering, peeling, or loosening of the skin and mucous membranes
  • bulging of fontanel (soft spot) on top of the head of an infant
  • burning or tingling skin sensation
  • changes in facial skin color
  • chills
  • convulsions (seizures)
  • dark or amber urine
  • diarrhea, watery and severe, which may also be bloody
  • fever
  • general feeling of discomfort or illness
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • headache (severe)
  • hives
  • hoarseness
  • increased frequency of breathing
  • itching
  • joint pain, stiffness, or swelling
  • mood or other mental changes
  • nausea or vomiting
  • pale skin
  • pale stools
  • red skin lesions, often with a purple center
  • shortness of breath
  • sore throat
  • sudden trouble in swallowing or breathing
  • swelling of the face, mouth, hands, or feet
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • visual changes
  • yellow eyes or skin
Incidence not known
  • Black, tarry stools
  • bone pain
  • burning, numbness, tingling, or painful sensations
  • chest pain
  • cough
  • difficulty with swallowing
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lower back or side pain
  • painful or difficult urination
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the skin
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • tightness in the chest
  • unsteadiness or awkwardness
  • weakness in the arms, hands, legs, or feet
  • welts
  • wheezing

If any of the following symptoms of overdose occur while taking nalidixic acid, get emergency help immediately:

Symptoms of overdose
  • Aggressive and violent behavior
  • change in the ability to see colors, especially blue or yellow
  • drowsiness
  • headache
  • loss of appetite
  • rapid, deep breathing
  • trouble with sleeping
  • unable to sleep
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Some nalidixic acid side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Diarrhea
  • dizziness
  • feeling of constant movement of self or surroundings
  • stomach pain
  • weakness
Less common
  • Increased sensitivity of the skin to sunlight
Incidence not known
  • Difficulty with moving
  • muscle pain or stiffness

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

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 (the active ingredient contained in NegGram) Recurrence of bullae have been reported after 1 year.[Ref]

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]

Gastrointestinal

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

Nervous system

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]

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]

Psychiatric

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

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]

Musculoskeletal

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

Ocular

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]

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

Hematologic

Hemolytic anemia secondary to nalidixic acid (the active ingredient contained in NegGram) 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]

Rare (less than 0.1%): Thrombocytopenia, leukopenia, eosinophilia, hemolytic anemia (sometimes associated with glucose 6-phosphate deficiency)[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 23 (1984): 101-7

2. Rubinstein A "Le-like disease caused by nalidixic acid." N Engl J Med 301 (1979): 1288

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

4. Bilsland D, Douglas WS "Sunbed pseudoporphyria induced by nalidixic acid." Br J Dermatol 123 (1990): 547

5. Ramsay CA, Obreshkova E "Photosensitivity from nalidixic acid." Br J Dermatol 91 (1974): 523-8

6. Brauner GJ "Bullous photoreaction to nalidixic acid." Am J Med 58 (1975): 576-80

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

8. Garrett MH ""Negram" and photosensitivity reactions." Med J Aust 1 (1969): 83

9. "Product Information. NegGram (nalidixic acid)." Sanofi Winthrop Pharmaceuticals, New York, NY.

10. Paulson DF "Comparison of cinoxacin and nalidixic acid in patients with cystitis." Urology 20 (1982): 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 19 (1981): 598-604

12. Fraser AG, Harrower AD "Convulsions and hyperglycaemia asociated with nalidixic acid." Br Med J 2 (1977): 1518

13. Bailey RR, Natale R, Linton AL "Nalidixic acid arthralgia." Can Med Assoc J 107 (1972): 604

14. Poc TE, Marion GS, Jackson DS "Seizures due to nalidixic acid therapy." South Med J 77 (1984): 539-40

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

16. Kremer L, Walton M, Wardle EN "Nalidixic acid and intracranial hypertension." Br Med J 4 (1967): 488

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

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

19. Gilbertson C, Jones DR "Haemolytic anaemia with nalidixic acid." Br Med J 4 (1972): 493

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

21. Phillips PJ, Need AG, Thomas DW, Conyers RA, Edwards JB, Lehmann D "Nalidixic acid and lactic acidosis." Aust N Z J Med 9 (1979): 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 5 (1979): 141-2

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