Prescription medicine
Pregabalin Brand names: Lyrica
Pregabalin (Lyrica) is a prescription medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 52 generic labelers, and pharmacies paid $0.0571 per pregabalin 100 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- DEA Schedule V
Check it at the source: the pregabalin FDA label on DailyMed (effective April 15, 2025, Viatris Specialty LLC); the NDA 21446 record on Drugs@FDA; every pregabalin label on DailyMed.
Highlights of the record
FDA label of April 15, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageLYRICA is indicated for:
Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for the treatment of partial‑onset seizures in patients 1 month of age and older
Management of fibromyalgia
Management of neuropathic pain associated with spinal cord injury LYRICA is indicated for:
Neuropathic pain associated with diabetic peripher
Forms and strengths
- 25 mg
- 50 mg
- 75 mg
- 82.5 mg
- 100 mg
- 150 mg
- 165 mg
- 200 mg
- 225 mg
- 300 mg
- 330 mg
- 20 mg/ml
Capsule; film-coated extended-release tablet; solution.
On the market
- Earliest approval on file
- December 30, 2004 Lyrica, Upjohn; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 52 first July 19, 2019; 30 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 55 of which 52 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- May 2, 2027 Lyrica CR tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0571 per capsule Pregabalin 100 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2013 0 Class I among all firms' recalls; latest May 16, 2024; 2 more by firms not listed as its makers
- FAERS reports
- 270,624 through July 30, 2026
What is pregabalin used for?
From the label: indications and usageLYRICA is indicated for:
Management of neuropathic pain associated with diabetic peripheral neuropathy
Management of postherpetic neuralgia
Adjunctive therapy for the treatment of partial‑onset seizures in patients 1 month of age and older
Management of fibromyalgia
Management of neuropathic pain associated with spinal cord injury LYRICA is indicated for:
Neuropathic pain associated with diabetic peripheral neuropathy (DPN) ( 1 )
Postherpetic neuralgia (PHN) ( 1 )
Adjunctive therapy for the treatment of partial‑onset seizures in patients 1 month of age and older ( 1 )
Fibromyalgia ( 1 )
Neuropathic pain associated with spinal cord injury
Conditions named in the indications of pregabalin's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Lyrica), NDA021446 (Upjohn), as published by Viatris Specialty LLC, effective April 15, 2025 (SPL set d4734e7d-5079-455e-8ff5-8f4539c998a9), via openFDA; the full label on DailyMed
What does the patient leaflet for pregabalin 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 LYRICA?LYRICA may cause serious side effects including: • serious, even life-threatening, allergic reactions • suicidal thoughts or actions • serious breathing problems • swelling of your hands, legs and feet • dizziness and sleepiness These serious side effects are described below: • Serious, even life-threatening, allergic reactions. Stop taking LYRICA and call your healthcare provider right away if you have any of these signs of a serious allergic reaction: o swelling of your face, mouth, lips, gums, tongue, throat or neck o trouble breathing o rash, hives (raised bumps) or blisters • Like other antiepileptic drugs, LYRICA may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. This can happen while you take LYRICA or after stopping. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: o thoughts about suicide or dying o attempts to commit suicide o new or worse depression o new or worse anxiety o feeling agitated or restless o panic attacks o trouble sleeping (insomnia) o new or worse irritability o acting aggressive, being angry, or violent o acting on dangerous impulses o an extreme increase in activity and talking (mania) o other unusual changes in behavior or mood If you have suicidal thoughts or actions, do not stop LYRICA without first talking to a healthcare provider. o Stopping LYRICA suddenly can cause serious problems. o Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. […]
From the patient leaflet: What should I avoid while taking LYRICA?Do not drive a car, work with machines, or do other dangerous activities until you know how LYRICA affects you. • Do not drink alcohol while taking LYRICA. LYRICA and alcohol can affect each other and increase side effects such as sleepiness and dizziness.
From the patient leaflet: How should I store LYRICA?Store LYRICA capsules and oral solution at room temperature between 68°F to 77°F (20°C to 25°C) in its original package. • Safely throw away any LYRICA that is out of date or no longer needed. Keep LYRICA and all medicines out of the reach of children.
Source: FDA drug label (Lyrica), NDA021446 (Upjohn), as published by Viatris Specialty LLC, effective April 15, 2025 (SPL set d4734e7d-5079-455e-8ff5-8f4539c998a9), via openFDA; the full label on DailyMed
Is there a generic for pregabalin (Lyrica)?
The FDA approved the first generic pregabalin on July 19, 2019. 52 generic applications are approved; 30 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 6 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists pregabalin from 52 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 Lyrica capsules; a patent listed only for Lyrica CR tablets runs to May 2, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2004 earliest approval on file
- 2019 first generic approved
- 2027 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 pregabalin (Lyrica)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0571 per Pregabalin 100 mg capsule, down 15% from $0.0673 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Pregabalin 50 mg capsule (generic)
- Lyrica 75 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Pregabalin 100 mg capsule | Generic | $0.0571 per capsule | $1.71 | -15% |
| Pregabalin 150 mg capsule | Generic | $0.0542 per capsule | $1.63 | -7% |
| Pregabalin 20 mg/mL solution | Generic | $0.153 per mL | n/a | -1% |
| Pregabalin 200 mg capsule | Generic | $0.0593 per capsule | $1.78 | -9% |
| Pregabalin 225 mg capsule | Generic | $0.0635 per capsule | $1.90 | -8% |
| Pregabalin 25 mg capsule | Generic | $0.0414 per capsule | $1.24 | -19% |
| Pregabalin 300 mg capsule | Generic | $0.0665 per capsule | $2.00 | -11% |
| Pregabalin 50 mg capsule | Generic | $0.0471 per capsule | $1.41 | -6% |
| Pregabalin 75 mg capsule | Generic | $0.0528 per capsule | $1.58 | -15% |
| Pregabalin ER 165 mg tablet | Generic | $1.81 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $54.43 | -29% |
| Pregabalin ER 330 mg tablet | Generic | $2.12 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $63.73 | -41% |
| Pregabalin ER 82.5 mg tablet | Generic | $3.00 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $90.13 | -18% |
| Lyrica 100 mg capsule | Brand | $9.70 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $290.87 | -0.1% |
| Lyrica 150 mg capsule | Brand | $9.69 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $290.63 | -0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has pregabalin been recalled?
The FDA's Enforcement Report lists 7 recalls naming pregabalin since 2013: 0 Class I (the most serious), 6 Class II, 1 Class III; 1 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of pregabalin 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 |
|---|---|---|---|
| May 16, 2024 | Class III | Rising Pharma Holding, Inc. | Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of … |
| October 22, 2021 | Class II | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient. |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| January 11, 2016 | Class II | Pfizer Inc. | FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: PREGABALIN, Capsule, 25 mg may have potentially been mislabeled as one of the following drugs: CHOLECALCIFEROL, Capsule, 2000 units, NDC … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: PREGABALIN, Capsule, 200 mg may have potentially been mislabeled as one of the following drugs: LOSARTAN POTASSIUM, Tablet, 50 mg, NDC … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the pregabalin label say about other medicines?
The pregabalin label names 15 other medicines in its interaction, contraindication or warning sections. The labels of 22 other medicines name pregabalin. 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 |
|---|---|---|
| Caffeine | drug interactions | Therefore, an increase in the metabolism of coadministered CYP1A2 substrates (e.g., theophylline, caffeine) or CYP3A4 substrates (e.g. midazolam, testosterone) is not anticipated. |
| Carbamazepine | drug interactions | Specifically, there are no pharmacokinetic interactions between pregabalin and the following antiepileptic drugs: carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital, and topiramate. |
| Divalproex | drug interactions | Specifically, there are no pharmacokinetic interactions between pregabalin and the following antiepileptic drugs: carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital, and topiramate. |
| Erythromycin | drug interactions | Co-administration of the prokinetic drug erythromycin with LYRICA CR did not result in any clinically important changes in the pharmacokinetics of LYRICA CR [see Clinical Pharmacology (12) ]. |
| Gabapentin | drug interactions | No pharmacokinetic interactions were observed between LYRICA and carbamazepine, gabapentin, lamotrigine, oral contraceptive, phenobarbital, phenytoin, topiramate, and valproic acid. |
| Lamotrigine | drug interactions | Specifically, there are no pharmacokinetic interactions between pregabalin and the following antiepileptic drugs: carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital, and topiramate. |
| Lorazepam | drug interactions | Pharmacodynamics Multiple oral doses of LYRICA were co-administered with oxycodone, lorazepam, or ethanol. |
| Midazolam | drug interactions | Therefore, an increase in the metabolism of coadministered CYP1A2 substrates (e.g., theophylline, caffeine) or CYP3A4 substrates (e.g. midazolam, testosterone) is not anticipated. |
| Oxycodone | drug interactions | Pharmacodynamics Multiple oral doses of LYRICA were co-administered with oxycodone, lorazepam, or ethanol. |
| Phenobarbital | drug interactions | Specifically, there are no pharmacokinetic interactions between pregabalin and the following antiepileptic drugs: carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital, and topiramate. |
| Phenytoin | drug interactions | Specifically, there are no pharmacokinetic interactions between pregabalin and the following antiepileptic drugs: carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital, and topiramate. |
| Testosterone | drug interactions | Therefore, an increase in the metabolism of coadministered CYP1A2 substrates (e.g., theophylline, caffeine) or CYP3A4 substrates (e.g. midazolam, testosterone) is not anticipated. |
| Theophylline | drug interactions | Therefore, an increase in the metabolism of coadministered CYP1A2 substrates (e.g., theophylline, caffeine) or CYP3A4 substrates (e.g. midazolam, testosterone) is not anticipated. |
| Topiramate | drug interactions | Specifically, there are no pharmacokinetic interactions between pregabalin and the following antiepileptic drugs: carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital, and topiramate. |
Every other medicine the pregabalin label names
| Medicine named | Section | What the label says |
|---|---|---|
| Valproic acid | drug interactions | Specifically, there are no pharmacokinetic interactions between pregabalin and the following antiepileptic drugs: carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital, and topiramate. |
Other labels that name pregabalin
Source: FDA drug label (Lyrica), NDA021446 (Upjohn), as published by Viatris Specialty LLC, effective April 15, 2025 (SPL set d4734e7d-5079-455e-8ff5-8f4539c998a9), via openFDA; the full label on DailyMed
What do FAERS reports show for pregabalin?
The FDA Adverse Event Reporting System holds 270,624 reports that list pregabalin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 22,084 are coded as a death and 77,266 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 pregabalin?
3 other medicines are given the same way (oral) and in the same FDA class as pregabalin or labeled mainly for the same use (nerve pain and fibromyalgia), the same class first. Nerve pain and fibromyalgia lists all 6 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 |
|---|---|---|---|---|
| Gabapentin | Seizures and epilepsy, Nerve pain and fibromyalgia | 87 labelers | $0.0218 per capsule 100 mg capsule | No current entry |
| Milnacipran | Nerve pain and fibromyalgia | 4 labelers | $2.82 per tablet 100 mg tablet | No current entry |
| Gabapentin enacarbil | Nerve pain and fibromyalgia | none listed | $17.93 per tablet 300 mg tablet | No current entry |
Every medicine labeled for the same conditions as pregabalin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does pregabalin compare with medicines for the same use?
10 side-by-side pages set pregabalin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to pregabalin
- 3 medicines for the same use
- Pregabalin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other