ethambutol hydrochloride
Pharmaranks rates Ethambutol Hydrochloride 3.0/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Ethambutol Hydrochloride is a medication used to treat Nontuberculous Mycobacterium Infections, Tuberculosis.
Generic · by Lupin
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 →
Key facts
- Active ingredient
- Ethambutol Hydrochloride
- Form
- Tablet
- Strength
- Ethambutol Hydrochloride 100MG · Ethambutol Hydrochloride 400MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Lupin
- What the pharmacy pays
- ~$13.48 for 30 — not your price
- FDA application
- ANDA078939
What is Ethambutol Hydrochloride?
From the FDA label:Ethambutol hydrochloride is an oral chemotherapeutic agent which is specifically effective against actively growing microorganisms of the genus Mycobacterium , including M. tuberculosis. Ethambutol hydrochloride is a white, crystalline powder, It is freely soluble in water; soluble in alcohol and in methanol. The structural formula is: C 10 H 24 N 2 O 2 •2HCl M.W. 277.23 (+)-2,2’ (Ethylenediimino)-di-1-butanol dihydrochloride Each tablet, for oral administration, contains 100 mg or 400 mg Ethambutol Hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone and talc. Film coating contains: ethyl cellulose, hypromellose, macrogol, propylene glycol, talc and titanium dioxide. Ethambutplhcl
How to use
Ethambutol hydrochloride should not be used alone, in initial treatment or in retreatment. Ethambutol hydrochloride should be administered on a once every 24-hour basis only. Absorption is not significantly altered by administration with food. Therapy, in general, should be continued until bacteriological conversion has become permanent and maximal clinical improvement has occurred. Ethambutol hydrochloride is not recommended for use in pediatric patients under thirteen years of age since safe conditions for use have not been established. Initial Treatment In patients who have not received previous antituberculous therapy, administer ethambutol hydrochloride 15 mg/ kg (7 mg/lb) of body weight, as a single oral dose once every 24 hours. In the more recent studies, isoniazid has been administered concurrently in a single, daily, oral dose. Retreatment In patients who have received previous antituberculous therapy, administer ethambutol hydrochloride 25 mg/kg (11 mg/lb) of body weight, as a single oral dose once every 24 hours. Concurrently administer at least one other antituberculous drug to which the organisms have been demonstrated to be susceptible by appropriate in-vitro tests. Suitable drugs usually consist of those not previously used in the treatment of the patient. After 60 days of ethambutol hydrochloride administration, decrease the dose to 15 mg/kg (7 mg/lb) of body…
Side effects
Ethambutol hydrochloride may produce decreases in visual acuity, including irreversible blindness, which appear to be due to optic neuritis. Optic neuropathy including optic neuritis or retrobulbar neuritis occurring in association with ethambutol therapy may be characterized by one or more of the following events: decreased visual acuity, scotoma, color blindness, and/or visual defect. These events have also been reported in the absence of a diagnosis of optic or retrobulbar neuritis. Patients should be advised to report promptly to their physician any change of visual acuity. The change in visual acuity may be unilateral or bilateral and hence each eye must be tested separately and both eyes tested together. Testing of visual acuity should be performed before beginning ethambutol hydrochloride therapy and periodically during drug administration, except that it should be done monthly when a patient is on a dosage of more than 15 mg per kilogram per day. Snellen eye charts are recommended for testing of visual acuity. Studies have shown that there are definite fluctuations of one or two lines of the Snellen chart in the visual acuity of many tuberculous patients not receiving ethambutol. The following table may be useful in interpreting possible changes in visual acuity attributable to ethambutol. Initial Snellen Reading Reading Indicating Significant Decrease Significant…
Warnings
Important safety information
Ethambutol hydrochloride may produce decreases in visual acuity which appear to be due to optic neuritis. This effect may be related to dose and duration of treatment. This effect is generally reversible when administration of the drug is discontinued promptly. However, irreversible blindness has been reported. (See PRECAUTIONS and ADVERSE REACTIONS ). Liver toxicities including fatalities have been reported (see ADVERSE REACTIONS ). Baseline and periodic assessment of hepatic function should be performed.
Who should not take Ethambutol Hydrochloride
Ethambutol hydrochloride is contraindicated in patients who are known to be hypersensitive to this drug. It is also contraindicated in patients with known optic neuritis unless clinical judgement determines that it may be used. Ethambutol hydrochloride is contraindicated in patients who are unable to appreciate and report visual side effects or changes in vision (e.g., young children, unconscious patients).
Interactions
The results of a study of coadministration of ethambutol hydrochloride (50mg/kg) with an aluminum hydroxide containing antacid to 13 patients with tuberculosis showed a reduction of mean serum concentrations and urinary excretion of ethambutol of approximately 20% and 13%, respectively, suggesting that the oral absorption of ethambutol may be reduced by these antacid products. It is recommended to avoid concurrent administration of ethambutol with aluminum hydroxide containing antacids for at least 4 hours following ethambutol administration.
May treat (source: NIH RxClass)
Dosage forms
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
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Ethambutol Hydrochloride treat?
- Ethambutol Hydrochloride (Ethambutol Hydrochloride) may be used to treat nontuberculous mycobacterium infections, tuberculosis, 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 is Ethambutol Hydrochloride rated?
- pharmaranks gives Ethambutol Hydrochloride a composite score of 3.0 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 Ethambutol Hydrochloride 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 $13.48 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. Pharmacies pay less for a same-class option, Azasite — about $9.39 on the same basis.
- Is there a coupon or discount for Ethambutol Hydrochloride?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Ethambutol Hydrochloride. To pay less, Ethambutol Hydrochloride 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 Ethambutol Hydrochloride?
- Ethambutol Hydrochloride is marketed by Lupin. You can see Lupin's full profile, rating, and other products on pharmaranks.
- Is Ethambutol Hydrochloride a brand-name or generic drug?
- Ethambutol Hydrochloride is a generic medication; its active ingredient is Ethambutol Hydrochloride. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Ethambutol Hydrochloride available over the counter?
- No. Ethambutol Hydrochloride 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 Ethambutol Hydrochloride come in?
- Ethambutol Hydrochloride is currently marketed as tablet, per the FDA's National Drug Code Directory.
- Is Ethambutol Hydrochloride FDA-registered?
- Ethambutol Hydrochloride is on record with the U.S. FDA under application number ANDA078939. You can verify this on its official FDA label.
- Has Ethambutol Hydrochloride been recalled by the FDA?
- Yes. Ethambutol Hydrochloride 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 Ethambutol Hydrochloride safe?
- There's no single safe-or-not verdict. pharmaranks gives Ethambutol Hydrochloride a recall-safety score of 60/100, 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 Ethambutol Hydrochloride?
- Ethambutol Hydrochloride's side effects are taken directly from its FDA label. From the label: Ethambutol hydrochloride may produce decreases in visual acuity, including irreversible blindness, which appear to be due to optic neuritis. Optic neuropathy including optic neuritis or retrobulbar neuritis occurring in association with ethambutol therapy may be characterized by one or more of the f… 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.
What people report to the FDA about Ethambutol Hydrochloride
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 2,744 reports naming Ethambutol Hydrochloride, and the FDA flagged 82% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- pyrexia167 reports
- nausea132 reports
- vomiting123 reports
- drug intolerance106 reports
- dyspnoea96 reports
- cough94 reports
- diarrhoea89 reports
- immune reconstitution syndrome87 reports
Read these as a signal, not a rate. A report does not mean Ethambutol Hydrochloride caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label.
Source: openFDA drug/event (FAERS), retrieved September 25, 2026.
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ethambutol hydrochloride
60/100