Prescription medicine
Amantadine Brand names: Gocovri; first approved as Symmetrel
Amantadine (Symmetrel) is a prescription medicine with an FDA approval on record since 1968. FDA's NDC Directory lists it from 34 generic labelers, and pharmacies paid $0.143 per amantadine 100 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the amantadine FDA label on DailyMed (effective January 30, 2026, Strides Pharma Inc.); the NDA 16023 record on Drugs@FDA; every amantadine label on DailyMed.
Highlights of the record
FDA label of January 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageAmantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus.
Forms and strengths
- 68.5 mg
- 100 mg
- 137 mg
- 50 mg/5ml
- 100 mg/10ml
Capsule; tablet; solution; liquid-filled capsule; capsule (coated pellets).
On the market
- Earliest approval on file
- February 14, 1968 Symmetrel, Endo Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 35 first January 7, 1987; 21 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 36 of which 34 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- August 23, 2038 Gocovri capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.143 per capsule Amantadine 100 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 6 since 2013 0 Class I among all firms' recalls; latest February 13, 2026; 2 more by firms not listed as its makers
- FAERS reports
- 20,181 through July 30, 2026
What is amantadine used for?
From the label: indications and usageAmantadine hydrochloride capsules are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride capsules are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. […]
Conditions named in the indications of amantadine's FDA labels, with every medicine labeled for each:
From other amantadine labelsParkinson's disease: Parkinson's Disease/Syndrome Amantadine hydrochloride capsules are indicated in the treatment of idiopathic Parkinson's disease (Paralysis Agitans), postencephalitic parkinsonism and symptomatic parkinsonism which may follow injury to the …
FDA pharmacologic class: Influenza A M2 Protein Inhibitor.
Source: FDA drug label (Amantadine Hydrochloride), Strides Pharma Inc., effective January 30, 2026 (SPL set e4d8f36f-d668-4728-8dca-b1c22bd9aedb), via openFDA; the full label on DailyMed
What does the patient leaflet for amantadine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking GOCOVRI?Do not drive, operate machinery, or do other dangerous activities until you know how GOCOVRI affects you. Do not drink alcohol while taking GOCOVRI. It can increase your chances of getting serious side effects.
From the patient leaflet: How should I store GOCOVRI?Store GOCOVRI at room temperature between 68°F to 77°F (20°C to 25°C). Keep GOCOVRI and all medicines out of the reach of children.
Source: FDA drug label (GOCOVRI), Adamas Pharma, LLC, effective September 8, 2026 (SPL set 82ff865f-78f3-4c94-b6a9-727a54944b28), via openFDA; the full label on DailyMed
Is there a generic for amantadine (Symmetrel)?
The FDA approved the first generic amantadine on January 7, 1987. 35 generic applications are approved; 21 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists amantadine from 34 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Symmetrel capsules; a patent listed only for Gocovri capsules runs to August 23, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1968 earliest approval on file
- 1987 first generic approved
- 2038 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 amantadine (Symmetrel)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.143 per Amantadine 100 mg capsule, down 6% from $0.151 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.
- Amantadine 100 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Amantadine 100 mg capsule | Generic | $0.143 per capsule | $4.28 | -6% |
| Amantadine 100 mg tablet | Generic | $0.314 per tablet | $9.43 | -25% |
| Amantadine 50 mg/5 mL solution | Generic | $0.0498 per mL | n/a | +4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has amantadine been recalled?
The FDA's Enforcement Report lists 8 recalls naming amantadine since 2013: 0 Class I (the most serious), 8 Class II, 0 Class III; 2 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of amantadine 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 |
|---|---|---|---|
| February 13, 2026 | Class II | AvKARE | Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution. |
| April 26, 2023 | Class II | Akorn, Inc. | CGMP Deviations: Firm went out of business and could no longer continue stability studies. |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| December 2, 2019 | Class II | Jubilant Cadista Pharmaceuticals, Inc. | Presence of Foreign Substance: Presence of a foreign object in a single tablet. |
| March 30, 2018 | Class II | AVKARE Inc. | Failed Dissolution Specifications |
| June 19, 2017 | Class II | Apace KY LLC | Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: AMANTADINE HCL, Capsule, 100 mg may have potentially been mislabeled as one of the following drugs: ACARBOSE, Tablet, 25 mg, NDC … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: AMANTADINE HCL, Tablet, 100 mg may have potentially been mislabeled as one of the following drugs: MAGNESIUM CHLORIDE, Tablet, 64 mg … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the amantadine label say about other medicines?
The amantadine label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 11 other medicines name amantadine. 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 |
|---|---|---|
| Hydrochlorothiazide | drug interactions | Coadministration of triamterene and hydrochlorothiazide capsules resulted in a higher plasma amantadine concentration in a 61-year-old man receiving amantadine (hydrochloride capsules) 100 mg t.i.d. for Parkinson's disease. |
| Quinidine | drug interactions | Coadministration of quinine or quinidine with amantadine was shown to reduce the renal clearance of amantadine by about 30%. |
| Quinine | drug interactions | Coadministration of quinine or quinidine with amantadine was shown to reduce the renal clearance of amantadine by about 30%. |
| Sodium bicarbonate | drug interactions | Urine pH is altered by diet, drugs (e.g., carbonic anhydrase inhibitors, sodium bicarbonate), and clinical state of the patient (e.g., renal tubular acidosis or severe infections of the urinary tract). |
| Thioridazine | drug interactions | Coadministration of thioridazine has been reported to worsen the tremor in elderly patients with Parkinson's disease, however, it is not known if other phenothiazines produce a similar response. |
| Triamterene | drug interactions | Coadministration of triamterene and hydrochlorothiazide capsules resulted in a higher plasma amantadine concentration in a 61-year-old man receiving amantadine (hydrochloride capsules) 100 mg t.i.d. for Parkinson's disease. |
Other labels that name amantadine
Source: FDA drug label (Amantadine Hydrochloride), Strides Pharma Inc., effective January 30, 2026 (SPL set e4d8f36f-d668-4728-8dca-b1c22bd9aedb), via openFDA; the full label on DailyMed
What do FAERS reports show for amantadine?
The FDA Adverse Event Reporting System holds 20,181 reports that list amantadine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,112 are coded as a death and 6,573 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
What else is labeled for the same conditions as amantadine?
3 other medicines are given the same way (oral) and in the same FDA class as amantadine or labeled mainly for the same use (influenza), the same class first. Influenza lists all 5 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Rimantadine | Influenza | 1 labeler | n/a | No current entry |
| Oseltamivir | Influenza | 36 labelers | $0.150 per mL 6 mg/mL suspension | No current entry |
| Baloxavir marboxil | Influenza | none listed | $161.94 per tablet 40 mg tablet | No current entry |
Every medicine labeled for the same conditions as amantadine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does amantadine compare with medicines for the same use?
2 side-by-side pages set amantadine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to amantadine
- 3 medicines for the same use
- Other influenza a m2 protein inhibitors
- the pharmacologic class, with prices and generics
- Amantadine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other