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neomycin sulfate

Pharmaranks rates Neomycin Sulfate 2.4/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Neomycin Sulfate is an aminoglycoside antibacterial used to treat Escherichia Coli Infections, Hepatic Encephalopathy, Bacterial Skin Diseases.

Aminoglycoside Antibacterial · by Teva

48/100Limited · 1 source

Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →

Rated against independent regulatory sources·Last updated August 20, 2026·How we rate
Verified againstopenFDANIH DailyMedRxClass

Key facts

Active ingredient
Neomycin Sulfate
Form
Topical, Tablet
Strength
Neomycin Sulfate 500MG
Type
Prescription (Rx)
Brand or generic
Generic
Manufacturer
Teva
What the pharmacy pays
~$25.36 for 30 — not your price
FDA application
ANDA060304

What is Neomycin Sulfate?

From the FDA label:Neomycin sulfate tablets, USP, for oral administration, contain neomycin which is an antibiotic obtained from the metabolic products of the actinomycete Streptomyces fradiae . Structurally, neomycin sulfate may be represented as follows: C 23 H 46 N 6 O 13 ·2½ H 2 SO 4 MW 614.67 Chemically, it is 0 -2,6-diamino-2,6-dideoxy-α-D-glucopyranosyl-(1→3)- 0 -β-D-ribofuranosyl-(1→5)- 0 -[2,6-diamino-2,6-dideoxy-α-D-glucopyranosyl-(1→4)]-2-deoxy-D-streptamine. Neomycin B is identical except that the a-D-glucopyranosyl residue in the neobiosamine moiety is β-L-idopyranosyl. Each tablet contains 500 mg neomycin sulfate (equivalent to 350 mg neomycin base). Inactive ingredients: calcium stearate, povidone. chemical-structure

How to use

Neomycin Sulfate is sold in more than one form (Topical and Tablet), and each is dosed differently. The instructions below come from the FDA label for application ANDA060304 — follow the label that came with the product you were actually prescribed.

To minimize the risk of toxicity, use the lowest possible dose and the shortest possible treatment period to control the condition. Treatment for periods longer than two weeks is not recommended. Hepatic Coma For use as an adjunct in the management of hepatic coma, the recommended dose is 4 to 12 grams per day given in the following regimen: Withdraw protein from diet. Avoid use of diuretic agents. Give supportive therapy, including blood products, as indicated. Give neomycin sulfate tablets in doses of 4 to 12 grams of neomycin sulfate per day (eight to 24 tablets) in divided doses. Treatment should be continued over a period of five to six days, during which time protein should be returned incrementally to the diet. If less potentially toxic drugs cannot be used for chronic hepatic insufficiency, neomycin in doses of up to four grams daily (eight tablets per day) may be necessary. The risk for the development of neomycin-induced toxicity progressively increases when treatment must be extended to preserve the life of a patient with hepatic encephalopathy who has failed to fully respond. Frequent periodic monitoring of these patients to ascertain the presence of drug toxicity is mandatory (see PRECAUTIONS ). Also, neomycin serum concentrations should be monitored to avoid potentially toxic levels. The benefits to the patient should be weighed against the risks of…

Side effects

The most common adverse reactions to oral neomycin sulfate 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 sections).

FDA Boxed Warning (the FDA’s most serious warning)

Boxed (black-box) warning — from the FDA label

Patients treated with neomycin should be under close clinical observation because of the potential toxicity associated with their use. NEUROTOXICITY (INCLUDING OTOTOXICITY) AND NEPHROTOXICITY FOLLOWING THE ORAL USE OF NEOMYCIN SULFATE HAVE BEEN REPORTED, EVEN WHEN USED IN RECOMMENDED DOSES. THE POTENTIAL FOR NEPHROTOXICITY, PERMANENT BILATERAL AUDITORY OTOTOXICITY AND SOMETIMES VESTIBULAR TOXICITY IS PRESENT IN PATIENTS WITH NORMAL RENAL FUNCTION WHEN TREATED WITH HIGHER DOSES OF NEOMYCIN AND/OR FOR LONGER PERIODS THAN RECOMMENDED. Serial, vestibular and audiometric tests, as well as tests of renal function, should be performed (especially in high-risk patients). THE RISK OF NEPHROTOXICITY AND OTOTOXICITY IS GREATER IN PATIENTS WITH IMPAIRED RENAL FUNCTION. Ototoxicity is often delayed in onset and patients developing cochlear damage will not have symptoms during therapy to warn them of developing eighth nerve destruction and total or partial deafness may occur long after neomycin has been discontinued. Neuromuscular blockage and respiratory paralysis have been reported following the oral use of neomycin. The possibility of the occurrence of neuromuscular blockage and respiratory paralysis should be considered if neomycin is administered, especially to patients receiving anesthetics, neuromuscular blocking agents such as tubocurarine, succinylcholine, decamethonium, or in patients receiving massive transfusions of citrate anticoagulated blood. If blockage occurs, calcium salts may reverse these phenomena but mechanical respiratory assistance may be necessary. Concurrent and/or sequential systemic, oral or topical use of other aminoglycosides, including paromomycin and other potentially nephrotoxic and/or neurotoxic drugs such as bacitracin, cisplatin, vancomycin, amphotericin B, polymyxin B, colistin and viomycin, should be avoided because the toxicity may be additive. Other factors which increase the risk of toxicity are advanced age and dehydration. The concurrent use of neomycin with potent diuretics such as ethacrynic acid or furosemide should be avoided, since certain diuretics by themselves may cause ototoxicity. In addition, when administered intravenously, diuretics may enhance neomycin toxicity by altering the antibiotic concentration in serum and tissue.

Warnings

Important safety information

(see BOXED WARNINGS) Additional manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions. The risk of hearing loss continues after drug withdrawal. Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycoside antibiotics cross the placenta and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects to fetus or newborn have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. Animal reproduction studies of neomycin have not been conducted. If neomycin is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Risk of Ototoxicity Due to Mitochondrial DNA Variants Cases of ototoxicity with aminoglycosides have been observed in patients with certain variants in the mitochondrially encoded 12S rRNA gene ( MT-RNR1 ), particularly the m.1555A>G variant. Ototoxicity occurred in some patients even when their aminoglycoside serum levels were within the recommended range. Mitochondrial DNA variants are present in less than 1% of the general US population, and the proportion of the variant carriers who may develop ototoxicity as well as the severity of ototoxicity is unknown. In case of known maternal history of ototoxicity due to aminoglycoside use or a known mitochondrial DNA variant in the patient, consider alternative treatments other than aminoglycosides unless the increased risk of permanent hearing loss is outweighed by the severity of infection and lack of safe and effective alternative therapies.

Who should not take Neomycin Sulfate

Neomycin sulfate oral preparations are contraindicated in the presence of intestinal obstruction and in individuals with a history of hypersensitivity to the drug. Patients with a history of hypersensitivity or serious toxic reaction to other aminoglycosides may have a cross-sensitivity to neomycin. Neomycin sulfate oral preparations are contraindicated in patients with inflammatory or ulcerative gastrointestinal disease because of the potential for enhanced gastrointestinal absorption of neomycin.

Overdose — what happens if you take too much

Because of low absorption, it is unlikely that acute overdosage would occur with oral neomycin sulfate. However, prolonged administration could result in sufficient systemic drug levels to produce neurotoxicity, ototoxicity and/or nephrotoxicity. Hemodialysis will remove neomycin sulfate from the blood.

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

Interactions

Caution should be taken in concurrent or serial use of other neurotoxic and/or nephrotoxic drugs because of possible enhancement of the nephrotoxicity and/or ototoxicity of neomycin (see boxed WARNINGS ). Caution should also be taken in concurrent or serial use of other amino-glycosides and polymyxins because they may enhance neomycin’s nephrotoxicity and/or ototoxicity and potentiate neomycin sulfate’s neuromuscular blocking effects. Oral neomycin inhibits the gastrointestinal absorption of penicillin V, oral vitamin B-12, methotrexate and 5-fluorouracil. The gastrointestinal absorption of digoxin also appears to be inhibited. Therefore, digoxin serum levels should be monitored. Oral neomycin sulfate may enhance the effect of coumarin in anticoagulants by decreasing vitamin K availability.

Drug class

How this class works, per Aminoglycosides - StatPearls - NCBI Bookshelf.

May treat (source: NIH RxClass)

See how Neomycin Sulfate ranks — best-rated aminoglycoside antibacterial for:

Dosage forms

Topical and Tablet

The forms currently marketed in the U.S., per the FDA National Drug Code Directory.

Ways to save

Ask for the generic

Same active ingredient, far cheaper. Is there a generic? →

Request a 90-day supply

Bulk fills usually lower the per-dose price vs monthly refills.

Use copay cards

Manufacturer copay cards & patient-assistance programs — especially for brand drugs.

Compare alternatives

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Frequently asked questions

What does Neomycin Sulfate treat?
Neomycin Sulfate (Neomycin Sulfate) may be used to treat escherichia coli infections, hepatic encephalopathy, bacterial skin diseases, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
How does Neomycin Sulfate work?
Neomycin Sulfate is a aminoglycoside antibacterial. Aminoglycosides kill bacteria by latching onto the germ's protein-making machinery (the 30S ribosomal subunit). This jams and misreads the bacterial genetic code so the microbe builds faulty proteins it can't survive on, which is why these drugs destroy the bacteria rather than just stopping their growth.
How is Neomycin Sulfate rated?
pharmaranks gives Neomycin Sulfate a composite score of 2.4 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
How much does Neomycin Sulfate cost?
Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $25.36 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
Is there a coupon or discount for Neomycin Sulfate?
pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Neomycin Sulfate. To pay less, Neomycin Sulfate is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
Who makes Neomycin Sulfate?
Neomycin Sulfate is marketed by Teva. You can see Teva's full profile, rating, and other products on pharmaranks.
Is Neomycin Sulfate a brand-name or generic drug?
Neomycin Sulfate is a generic medication; its active ingredient is Neomycin Sulfate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
Is Neomycin Sulfate available over the counter?
No. Neomycin Sulfate is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
What forms does Neomycin Sulfate come in?
Neomycin Sulfate is currently marketed as topical and tablet, per the FDA's National Drug Code Directory.
What class of drug is Neomycin Sulfate?
Neomycin Sulfate is classified as aminoglycoside antibacterial, per the FDA's Established Pharmacologic Class.
Is Neomycin Sulfate FDA-registered?
Neomycin Sulfate is on record with the U.S. FDA under application number ANDA060304. You can verify this on its official FDA label.
Has Neomycin Sulfate been recalled by the FDA?
Yes. Neomycin Sulfate has 1 recorded FDA recall event in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
Is Neomycin Sulfate safe?
There's no single safe-or-not verdict. pharmaranks gives Neomycin Sulfate a recall-safety score of 48/100, based on its FDA recall history (1 recorded recall event) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
What are the side effects of Neomycin Sulfate?
Neomycin Sulfate's side effects are taken directly from its FDA label. From the label: The most common adverse reactions to oral neomycin sulfate 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.

Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.

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neomycin sulfate

48/100