Prescription medicine
Amikacin Brand names: Arikayce
Amikacin (Arikayce) is a prescription medicine with an FDA approval on record since 2018. FDA's NDC Directory lists it from 6 generic labelers, and pharmacies paid $2.33 per mL (Amikacin sulf 500 mg/2 mL vial) in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the amikacin FDA label on DailyMed (effective December 10, 2025, Qilu Pharmaceutical Co., Ltd.); the NDA 207356 record on Drugs@FDA; every amikacin label on DailyMed.
Highlights of the record
FDA label of December 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Patients treated with parenteral aminoglycosides should be under close clinical observation because of the potential ototoxicity and nephrotoxicity associated with their use. Safety for treatment periods which are longer than 14 days has not been established. Neurotoxicity, manifested as vestibular and permanent bilateral auditory ototoxicity, can occur in patients with preexisting renal damage and in patients with normal renal function treated at higher doses and/or for periods longer than those recommended. The risk of aminoglycoside-induced ototoxicity is greater in patients with renal damage. High frequency deafness usually occurs first and can be detected only by audiometric testing. Vertigo may occur and may be evidence of vestibular injury. Other manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions. The risk of hearing loss due to aminoglycosides increases with the degree of exposure to either high peak or high trough serum concentrations. Patients developing cochlear damage may not have symptoms during therapy to warn them of developing eighth-nerve toxicity, and total or partial irreversible bilateral deafness may occur after the drug has been discontinued. Aminoglycoside-induced ototoxicity is usually irreversible. Aminoglycosides are potentially nephrotoxic. […]
Used for
From the label: indications and usageAmikacin Sulfate Injection is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella-Enterobacter-Serratia species, and Acinetobacter ( Mima-Herellea ) species.
Forms and strengths
- 1 g/4ml
- 250 mg/ml
- 500 mg/2ml
- 590 mg/8.4ml
Injection (solution); injection; suspension.
On the market
- Earliest approval on file
- September 28, 2018 Arikayce Kit, Insmed Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 20 first January 22, 1981; 7 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 6 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- May 15, 2035 Arikayce Kit suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $2.33 per mL Amikacin sulf 500 mg/2 mL vial
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2013 2 Class I among all firms' recalls; latest May 21, 2019; 6 more by firms not listed as its makers
- FAERS reports
- 18,617 through July 30, 2026
What is amikacin used for?
From the label: indications and usageAmikacin Sulfate Injection is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella-Enterobacter-Serratia species, and Acinetobacter ( Mima-Herellea ) species. […]
Conditions named in the indications of amikacin's FDA labels, with every medicine labeled for each:
From other amikacin labelsBacterial infections: INDICATIONS AND USAGE Amikacin Sulfate Injection is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of …
FDA pharmacologic class: Aminoglycoside Antibacterial.
Source: FDA drug label (Amikacin Sulfate), Qilu Pharmaceutical Co., Ltd., effective December 10, 2025 (SPL set 20fa61ef-11e2-4d01-82ea-b5412cefaead), via openFDA; the full label on DailyMed
What does the patient leaflet for amikacin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ARIKAYCE?ARIKAYCE can cause serious side effects, including: allergic inflammation of the lungs: These respiratory problems may be symptoms of allergic inflammation of the lungs and often come with: fever coughing fast breathing wheezing shortness of breath coughing up of blood (hemoptysis): Coughing up blood is a serious and common side effect of ARIKAYCE. severe breathing problems: Severe breathing problems can be symptoms of bronchospasm. Bronchospasm is a serious and common side effect of ARIKAYCE. Bronchospasm symptoms include: shortness of breath wheezing difficult or labored breathing coughing or chest tightness worsening of chronic obstructive pulmonary disease (COPD): This is a serious and common side effect of ARIKAYCE. serious allergic reactions: Serious allergic reactions that may lead to death have happened to people who take ARIKAYCE. Stop taking ARIKAYCE right away and get emergency medical help if you have any of the following symptoms of a serious allergic reaction: hives itching redness or blushing of the skin (flushing) swollen lips, tongue or throat trouble breathing or wheezing shortness of breath noisy high-pitched breathing (stridor) cough nausea vomiting diarrhea feel cramps in your stomach area fast heart rate feeling light headed feeling faint loss of control of the bowels or bladder (incontinence) dizziness While using ARIKAYCE these side effects may become serious enough that treatment in a hospital is needed. Call your healthcare provider or get medical help right away if you have any of these serious side effects while taking ARIKAYCE. Your healthcare provider may ask you to stop using ARIKAYCE for a short period of time or completely stop using ARIKAYCE.
From the patient leaflet: How should I store ARIKAYCE?Store ARIKAYCE vials refrigerated between 36°F to 46°F (2°C to 8°C) until the expiration date on the vial. Do not freeze. After ARIKAYCE has been stored in the refrigerator, any unused medicine must be thrown away (disposed of) after the expiration date on the vial. Store ARIKAYCE vials at room temperature between 68°F to 77°F (20°C to 25°C) for up to 4 weeks. After ARIKAYCE has been stored at room temperature any unused medicine must be thrown away (disposed of) at the end of 4 weeks. Use an opened ARIKAYCE vial right away. Throw away the ARIKAYCE vial right away after use. Keep ARIKAYCE and all medicines out of the reach of children.
Source: FDA drug label (ARIKAYCE), Insmed Incorporated, effective August 4, 2026 (SPL set 499ab990-2b21-474f-aaba-d86388965f40), via openFDA; the full label on DailyMed
Is there a generic for amikacin (Arikayce)?
The FDA approved the first generic amikacin on January 22, 1981. 20 generic applications are approved; 7 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists amikacin from 6 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 14 patents for Arikayce Kit suspension, the last expiring on May 15, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 1981 first generic approved
- 2035 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for amikacin (Arikayce)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.33 per mL (Amikacin sulf 500 mg/2 mL vial), down 23% from $3.03 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Amikacin sulf 500 mg/2 mL vial (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Amikacin sulf 500 mg/2 mL vial | Generic | $2.33 per mL | $4.66 per vial | -23% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has amikacin been recalled?
The FDA's Enforcement Report lists 10 recalls naming amikacin since 2013: 2 Class I (the most serious), 8 Class II, 0 Class III; 1 still ongoing. 6 of them are by firms that FDA's NDC Directory does not list as a maker of amikacin and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 27, 2022 | Class II | Sentara Infusion Services not a listed maker | Lack of sterility assurance |
| May 21, 2019 | Class I | Heritage Pharmaceuticals, Inc. | Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP … |
| July 29, 2016 | Class II | Teva Pharmaceuticals USA | CGMP Deviations |
| March 9, 2016 | Class I | Teva Pharmaceuticals USA | Presence of Particulate Matter: particulate matter identified as glass in one vial. |
| May 29, 2013 | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy not a listed maker | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes |
| May 28, 2013 | Class II | Main Street Family Pharmacy, LLC not a listed maker | The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone … |
| April 10, 2013 | Class II | FVS Holdings, Inc. dba. Green Valley Drugs not a listed maker | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the amikacin label say about other medicines?
The amikacin label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 6 other medicines name amikacin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amphotericin b | boxed warning | Concurrent and/or sequential systemic, oral or topical use of other neurotoxic or nephrotoxic products, particularly bacitracin, cisplatin, amphotericin B, cephaloridine, paromomycin, viomycin, polymyxin B, colistin, vancomycin, or other aminoglycosides should be avoided. |
| Bacitracin | boxed warning | Concurrent and/or sequential systemic, oral or topical use of other neurotoxic or nephrotoxic products, particularly bacitracin, cisplatin, amphotericin B, cephaloridine, paromomycin, viomycin, polymyxin B, colistin, vancomycin, or other aminoglycosides should be avoided. |
| Cisplatin | boxed warning | Concurrent and/or sequential systemic, oral or topical use of other neurotoxic or nephrotoxic products, particularly bacitracin, cisplatin, amphotericin B, cephaloridine, paromomycin, viomycin, polymyxin B, colistin, vancomycin, or other aminoglycosides should be avoided. |
| Ethacrynic acid | boxed warning | The concurrent use of amikacin with potent diuretics (ethacrynic acid, or furosemide) should be avoided since diuretics by themselves may cause ototoxicity. |
| Furosemide | boxed warning | The concurrent use of amikacin with potent diuretics (ethacrynic acid, or furosemide) should be avoided since diuretics by themselves may cause ototoxicity. |
| Paromomycin | boxed warning | Concurrent and/or sequential systemic, oral or topical use of other neurotoxic or nephrotoxic products, particularly bacitracin, cisplatin, amphotericin B, cephaloridine, paromomycin, viomycin, polymyxin B, colistin, vancomycin, or other aminoglycosides should be avoided. |
| Polymyxin b | boxed warning | Concurrent and/or sequential systemic, oral or topical use of other neurotoxic or nephrotoxic products, particularly bacitracin, cisplatin, amphotericin B, cephaloridine, paromomycin, viomycin, polymyxin B, colistin, vancomycin, or other aminoglycosides should be avoided. |
| Streptomycin | warnings | Aminoglycosides cross the placenta and there have been several reports of total irreversible, bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. |
| Succinylcholine | boxed warning | The possibility of these phenomena should be considered if aminoglycosides are administered by any route, especially in patients receiving anesthetics, neuromuscular blocking agents such as tubocurarine, succinylcholine, decamethonium, or in patients receiving massive transfusions of citrate - anticoagulated blood. |
| Vancomycin | boxed warning | Concurrent and/or sequential systemic, oral or topical use of other neurotoxic or nephrotoxic products, particularly bacitracin, cisplatin, amphotericin B, cephaloridine, paromomycin, viomycin, polymyxin B, colistin, vancomycin, or other aminoglycosides should be avoided. |
Other labels that name amikacin
Source: FDA drug label (Amikacin Sulfate), Qilu Pharmaceutical Co., Ltd., effective December 10, 2025 (SPL set 20fa61ef-11e2-4d01-82ea-b5412cefaead), via openFDA; the full label on DailyMed
What do FAERS reports show for amikacin?
The FDA Adverse Event Reporting System holds 18,617 reports that list amikacin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 3,805 are coded as a death and 7,908 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
How does amikacin compare with medicines for the same use?
9 side-by-side pages set amikacin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other aminoglycoside antibacterials
- the pharmacologic class, with prices and generics
- Amikacin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other