Skip to content
ppharmaranks
Menu
Thea Pharma logo

akten

Pharmaranks rates Akten 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Akten (Lidocaine Hydrochloride) is an amide local anesthetic used to treat Burns, Esophageal Diseases, Mouth Diseases, Myocardial Infarction.

Lidocaine Hydrochloride · by Thea Pharma

Available as a generic: Lidocaine Hydrochloride Preservative Free

⚠ FDA reports a current shortage of the injection form — availability differs between suppliers — see drug shortages →
70/100Limited · 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 22, 2026·How we rate

Pharmacy acquisition cost fell 7% — $0.2619 → $0.2434 per ml (CMS NADAC)source

Verified againstopenFDANIH DailyMedRxClass
Lower-cost optionsSave up to 74%
This medication~$0.24
Cheapest in class · exparel~$0.06
See FDA-approved alternatives

Key facts

Active ingredient
Lidocaine Hydrochloride
Form
Topical
Strength
Lidocaine Hydrochloride 3.5%
Type
Prescription (Rx)
Brand or generic
Brand-name
Manufacturer
Thea Pharma
What the pharmacy pays
~$0.24 per ml — not your price
FDA application
NDA022221

What is Akten?

From the FDA label:AKTEN (lidocaine hydrochloride ophthalmic gel) 3.5% contains lidocaine hydrochloride, an amide local anesthetic, as a sterile ophthalmic gel for topical ophthalmic use. AKTEN does not contain an anti-microbial preservative. Lidocaine hydrochloride is designated chemically as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl) monohydrochloride with a molecular formula of C 14 H 22 N 2 O ∙ HCl and molecular weight of 270.8. The structural formula of the active ingredient is: Each mL of AKTEN contains 35 mg of lidocaine hydrochloride as the active ingredient. Inactive ingredients: hypromellose, sodium chloride, and water for injection. The pH may be adjusted to 5.5 to 7.5 with hydrochloric acid and/or sodium hydroxide. AKTEN does not contain an anti-microbial preservative. Chemical Structure

How to use

The recommended dose of AKTEN is 2 drops applied to the ocular surface in the area of the planned procedure. AKTEN may be reapplied to maintain anesthetic effect. The recommended dose of AKTEN is 2 drops applied to the ocular surface in the area of the planned procedure. AKTEN may be reapplied to maintain anesthetic effect. ( 2 )

Side effects

Most common adverse reactions are conjunctival hyperemia, corneal epithelial changes, headache, and burning upon instillation. Most common adverse reactions are conjunctival hyperemia, corneal epithelial changes, headache, and burning upon instillation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Thea Pharma Inc. at 1-833-838-4028 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION.

Warnings

Important safety information

For Topical Ophthalmic Use: AKTEN is not for injection or intraocular administration. ( 5.1 ) Patients should not touch the eye for at least 10 to 20 minutes after using AKTEN as accidental injuries can occur due to insensitivity of the eye. ( 5.2 ) Corneal Opacification: Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss. ( 5.2 ) For Administration by Healthcare Provider: AKTEN is not intended for patient self-administration. ( 5.3 ) 5.1 For Topical Ophthalmic Use AKTEN is not for injection or intraocular administration. 5.2 Corneal Injury Due to Insensitivity Patients should not touch the eye for at least 10 to 20 minutes after using AKTEN as accidental injuries can occur due to insensitivity of the eye. 5.3 Corneal Opacification Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss. 5.4 For Administration by Healthcare Provider AKTEN is indicated for administration under the direct supervision of a healthcare provider. AKTEN is not intended for patient self-administration.

Who should not take Akten

None. None. ( 4 )

Overdose — what happens if you take too much

Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss. Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics or to unintended subarachnoid injection of local anesthetic solution. However, topical ocular application of AKTEN is not expected to result in systemic exposure.

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.

Drug class

How this class works, per Topical, Local, and Regional Anesthesia and Anesthetics - StatPearls - NCBI Bookshelf.

May treat (source: NIH RxClass)

See how Akten ranks — best-rated amide local anesthetic for:

Dosage forms

Topical

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 Akten treat?
Akten (Lidocaine Hydrochloride) may be used to treat burns, esophageal diseases, mouth diseases, myocardial infarction, pain, paroxysmal tachycardia, 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 Akten work?
Akten is a amide local anesthetic. Amide local anesthetics temporarily block the sodium channels that nerves use to fire, so the treated nerves can't send signals. This numbs pain in the area, and because the block reverses as the drug wears off, sensation returns afterward.
How is Akten rated?
pharmaranks gives Akten a composite score of 3.5 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 Akten 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 $0.24 per ml, 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, Exparel — about $0.06 on the same basis.
Is there a coupon or discount for Akten?
pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Akten. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
Who makes Akten?
Akten is marketed by Thea Pharma. You can see Thea Pharma's full profile, rating, and other products on pharmaranks.
Is Akten a brand-name or generic drug?
Akten is a brand-name product with the active ingredient Lidocaine Hydrochloride. Lower-cost generic equivalents containing Lidocaine Hydrochloride are available — ask your pharmacist.
Is Akten available over the counter?
No. Akten 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 Akten come in?
Akten is currently marketed as topical, per the FDA's National Drug Code Directory.
What class of drug is Akten?
Akten is classified as amide local anesthetic, antiarrhythmic, per the FDA's Established Pharmacologic Class.
Is Akten FDA-registered?
Akten is on record with the U.S. FDA under application number NDA022221. You can verify this on its official FDA label.
Has Akten been recalled by the FDA?
Akten has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
Is Akten safe?
There's no single safe-or-not verdict. pharmaranks gives Akten a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — 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 Akten?
Akten's side effects are taken directly from its FDA label. From the label: Most common adverse reactions are conjunctival hyperemia, corneal epithelial changes, headache, and burning upon instillation. Most common adverse reactions are conjunctival hyperemia, corneal epithelial changes, headache, and burning upon instillation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS,… 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.

Reviews

No reviews yet. Be the first to write one.

Write a review

Reviews are user opinions, not medical advice. Consult a licensed professional.

People also viewed

Compare Akten head-to-head

More amide local anesthetic drugs

Identify a pill by its imprint →Check a drug interaction →Drug recalls →

Browse medications A–Z

Research products from A to Z, compare independent ratings, and find alternatives.