Neo-Fradin Side Effects

Generic Name: neomycin

Please note - some side effects for Neo-Fradin 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 Neo-Fradin - for the Consumer

Neo-Fradin Solution

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 Neo-Fradin Solution:

Diarrhea; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; dizziness; hearing loss; muscle twitching; ringing in ears; seizures; skin tingling or numbness; vaginal irritation or discharge; stomach pain/cramps.

Neo-Fradin Side Effects - for the Professional

Neo-Fradin

The most common adverse reactions to oral neomycin are nausea, vomiting, and diarrhea. The "Malabsorption Syndrome" characterized by increased fecal fat, decreased serum carotene and fall in xylose absorption has been reported with prolonged therapy. Nephrotoxicity, ototoxicity, and neuromuscular blockage have been reported (see boxed WARNINGS and PRECAUTIONS section).

Side Effects by Body System

General

Since oral neomycin is absorbed systemically after oral administration, its use may result in nephrotoxicity, neurotoxicity and/or ototoxicity, even at recommended doses and in patients with normal renal function.

Renal

The major renal side effect of oral neomycin is nephrotoxicity, which has occurred even at recommended doses and in patients with normal renal function.

Early signs of nephropathy include mild proteinuria, sloughing of renal tubular epithelial cells, formation of cellular casts, and decreases in creatinine clearance. Often there is a high output renal failure where daily urine volume may appear unchanged until significant increases in serum creatinine and BUN levels occur.

Neomycin damages renal tubules by causing tubular epithelial cell necrosis. It is considered the most nephrotoxic aminoglycoside.

Nervous system

Early symptoms of neomycin-induced auditory toxicity may manifest as high tone hearing loss, tinnitus, or a feeling of fullness in the ear, or its onset may be asymptomatic. If ototoxicity occurs, the onset of hearing loss is between several days to 6 weeks after therapy begins; however, it may not occur for months or years after neomycin has been discontinued. Symptoms of vestibulotoxicity may include tinnitus, vertigo and ataxia.

Neomycin is considered more ototoxic than vestibulotoxic. It progressively accumulates in the inner ear and which leads to sensory hair cell loss in the in the cochlea and damage to the stria vascularis. In an animal study, neomycin was found to be more ototoxic than gentamicin, kanamycin and dihydrostreptomycin.

One case report series describes 5 cases of hearing impairment associated with long-term oral neomycin therapy for hepatic encephalopathy. Doses ranged from 2 to 12 g/day and were administered for 8 to 28 months; in 2 cases paromomycin was also administered. Renal failure did not occur.

Nervous system side effects associated with oral neomycin therapy have included neuromuscular blockade, respiratory paralysis, and eighth cranial nerve damage with hearing loss, even at recommended doses and in patients with normal renal function. Symptoms of neurotoxicity include numbness, tingling, muscle twitching, and convulsions.

Other

Oral neomycin therapy may result in overgrowth of nonsusceptible organisms, especially fungi.

A case of fatal Candida albicans pyelonephritis and septicemia following preoperative bowel preparation with oral neomycin and bacitracin has been reported.

Gastrointestinal

Gastrointestinal side effects most commonly include nausea, vomiting and diarrhea. Clostridium difficile colitis has also been reported with oral neomycin therapy.

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