NegGram Side Effects

Please note - some side effects for NegGram 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 NegGram - for the Consumer

NegGram

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 NegGram:

Diarrhea; dizziness; drowsiness; feeling of a whirling motion; headache; nausea; rash; stomach pain or discomfort; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred or decreased vision; burning or tingling sensation; changes in color vision; convulsions; decrease in ability to sense pain, temperature, or body position; double vision; itching; numbness; pain; pain, redness, or swelling of a tendon; seeing halos around lights; weakness.

NegGram Suspension

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 NegGram Suspension:

Diarrhea; dizziness; drowsiness; feeling of a whirling motion; headache; nausea; rash; stomach pain or discomfort; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred or decreased vision; burning or tingling sensation; changes in color vision; convulsions; decrease in ability to sense pain, temperature, or body position; double vision; itching; numbness; pain; pain, redness, or swelling of a tendon; seeing halos around lights; weakness.

NegGram Side Effects - for the Professional

NegGram

Reactions reported after oral administration of NegGram include the following.

CNS effects:

drowsiness, weakness, headache, dizziness and vertigo. Reversible subjective visual disturbances without objective findings have occurred infrequently (generally with each dose during the first few days of treatment). These reactions include overbrightness of lights, change in color perception, difficulty in focusing, decrease in visual acuity, and double vision. They usually disappeared promptly when dosage was reduced or therapy was discontinued. Toxic psychosis or brief convulsions have been reported rarely, usually following excessive doses. In general, the convulsions have occurred in patients with predisposing factors such as epilepsy or cerebral arteriosclerosis. In infants and children receiving therapeutic doses of NegGram, increased intracranial pressure with bulging anterior fontanel, papilledema, and headache has occasionally been observed. A few cases of 6th cranial nerve palsy have been reported. Although the mechanisms of these reactions are unknown, the signs and symptoms usually disappeared rapidly with no sequelae when treatment was discontinued.

Gastrointestinal:

abdominal pain, nausea, vomiting, and diarrhea.

Allergic:

rash, pruritus, urticaria, angioedema, eosinophilia, arthralgia with joint stiffness and swelling, and anaphylactoid reaction, including anaphylactic shock. Erythema Multiforme and Stevens-Johnson syndrome have been reported with nalidixic acid and other drugs in this class. Rash was the most frequently reported adverse reaction. Photosensitivity reactions consisting of erythema and bullae on exposed skin surfaces usually resolve completely in 2 weeks to 2 months after NegGram is discontinued; however, bullae may continue to appear with successive exposures to sunlight or with mild skin trauma for up to 3 months after discontinuation of drug.

Other:

rarely, cholestasis, paresthesia, metabolic acidosis, thrombocytopenia, leukopenia, or hemolytic anemia, sometimes associated with glucose 6-phosphate dehydrogenase deficiency and peripheral neuropathy.

Side Effects by Body System

Hypersensitivity

Hypersensitivity reactions have included rash, pruritus, urticaria, angioedema, eosinophilia, arthralgia with joint stiffness and swelling, anaphylactic shock, anaphylactoid reactions, erythema multiforme, and Stevens-Johnson syndrome. Photosensitivity reactions characterized by erythema and bullae have been reported and usually resolve in 2 weeks to 2 months after discontinuation of nalidixic acid.

Photosensitivity reactions to nalidixic acid appear to be related to the amount of sun exposure rather than amount of drug taken. Most reactions are reported following intense sun exposure during the summer. Large bullae develop most commonly on the dorsum of the hands and feet. Following acute reactions, skin fragility may exist and sun sensitivity persists for up to three months after nalidixic acid administration. Recurrence of bullae have been reported after one year.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, abdominal pain, and diarrhea.

Nervous system

Psychotic reactions involving delirium, photophobia, paranoia, and visual hallucinations have rarely been reported with nalidixic acid. Seizures may also be involved and hyperglycemia is often present. Seizures have been reported in patients with underlying seizure disorders or atherosclerosis. Increased intracranial pressure, bulging anterior fontanel, papilledema, headache, and 6th cranial nerve palsy have been reported in pediatric patients.

Nervous system side effects have included drowsiness, weakness, headache, dizziness, vertigo, peripheral neuropathy, and paresthesia. Toxic psychosis and seizures have been rarely reported, usually in association with excessive doses.

Ocular

Ocular side effects have included photophobia, changes in color perception, difficulty in focusing, decreases in visual acuity, and double vision. These effects usually resolve with dosage reduction or drug discontinuation.

Hematologic

Hematologic side effects have rarely included thrombocytopenia, leukopenia, eosinophilia, and hemolytic anemia (sometimes associated with glucose 6-phosphate deficiency).

Hemolytic anemia secondary to nalidixic acid most commonly occurs in patients with G6PD deficiency but has also been reported in patients without this deficiency. Direct Coomb's tests are generally positive. Death from nalidixic acid induced hemolytic anemia has been reported.

Musculoskeletal

Musculoskeletal side effects have included arthralgias and myalgias.

Metabolic

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.

Metabolic side effects have rarely included metabolic acidosis and lactic acidosis.

Hepatic

Hepatic side effects have rarely included cholestasis.

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