Pregabalin is a medicine sold in the U.S. under 3 brand and generic names, for fibromyalgia, seizures and spinal cord injuries. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Lyrica (application NDA022488). Other pregabalin products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For adult indications, begin dosing at 150 mg/day. For partial-onset seizure dosing in pediatric patients 1 month of age and older, refer to section 2.4 . ( 2.2 , 2.3 , 2.4 , 2.5 , 2.6 ) • Dosing recommendations: INDICATION Dosing Regimen Maximum Dose DPN Pain ( 2.2 ) 3 divided doses per day 300 mg/day within 1 week. PHN ( 2.3 ) 2 or 3 divided doses per day 300 mg/day within 1 week. Maximum dose of 600 mg/day. Adjunctive Therapy for Partial-Onset Seizures in Pediatric and Adult Patients Weighing 30 kg or More ( 2.4 ) 2 or 3 divided doses per day Maximum dose of 600 mg/day. Adjunctive Therapy for Partial-Onset Seizures in Pediatric Patients Weighing Less than 30 kg ( 2.4 ) 1 month to less than 4 years: 3 divided doses per day 4 years and older: 2 or 3 divided doses per day 14 mg/kg/day. Fibromyalgia ( 2.5 ) 2 divided doses per day 300 mg/day within 1 week. Maximum dose of 450 mg/day. Neuropathic Pain Associated with Spinal Cord Injury ( 2.6 ) 2 divided doses per day 300 mg/day within 1 week. Maximum dose of 600 mg/day. • Dose should be adjusted in adult patients with reduced renal function. ( 2.7 ) 2.1 Important Administration Instructions Pregabalin is given orally with or without food. When discontinuing pregabalin, taper gradually over a minimum of 1 week [see Warnings and Precautions (5.4) ] . Because pregabalin is eliminated primarily by renal…
The following serious adverse reactions are described elsewhere in the labeling: • Angioedema [see Warnings and Precautions (5.1) ] • Hypersensitivity [see Warnings and Precautions (5.2) ] • Suicidal Behavior and Ideation [see Warnings and Precautions (5.3) ] • Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation [see Warnings and Precautions (5.4) ] • Respiratory Depression [see Warnings and Precautions (5.5) ] • Dizziness and Somnolence [see Warnings and Precautions (5.6) ] • Peripheral Edema [see Warnings and Precautions (5.7) ] • Weight Gain [see Warnings and Precautions (5.8) ] • Tumorigenic Potential [see Warnings and Precautions (5.9) ] • Ophthalmological Effects [see Warnings and Precautions (5.10) ] • Creatine Kinase Elevations [see Warnings and Precautions (5.11) ] • Decreased Platelet Count [see Warnings and Precautions (5.12) ] • PR Interval Prolongation [see Warnings and Precautions (5.13) ] Most common adverse reactions (greater than or equal to 5% and twice placebo) in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and thinking abnormal (primarily difficulty with concentration/attention). ( 6.1 ) Most common adverse reactions (greater than or equal to 5% and twice placebo) in pediatric patients for the treatment of partial-onset seizures are increased weight and increased appetite. ( 6.1 ) To report SUSPECTED…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
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| 1 | Not yet rated | Prescription | Capsule | Generic | $2 | View → | |
| 2 | Not yet rated | Prescription | Tablet | Generic | $2 | View → |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| PGBN;75 | 75 mg | white | capsule | — |
| 142;J | 150 mg | white | capsule | — |
| 554;25mg | 25 mg | white, orange | capsule | — |
| 555;50mg | 50 mg | white, orange | capsule | — |
| 556;75mg | 75 mg | orange | capsule | — |
| 557;100mg | 100 mg |
From the FDA Enforcement database. A recall covers specific lots — not the drug as a whole.
The elimination half-life of pregabalin is about 6.3 hours (mean, in adults with normal kidney function). Pregabalin has no active metabolite of concern — it is excreted almost entirely unchanged in the urine and barely metabolized — but its half-life is prolonged in people with reduced kidney function, because elimination is nearly proportional to creatinine clearance.
LYRICA (pregabalin) Capsules and Oral Solution — FDA prescribing information, DailyMed ↗Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Pregabalin oral solution is contraindicated in patients with known hypersensitivity to pregabalin or any of its components. Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy [see Warnings and Precautions (5.2) ] . • Known hypersensitivity to pregabalin or any of its components. ( 4 )
Since pregabalin is predominantly excreted unchanged in the urine, undergoes negligible metabolism in humans (less than 2% of a dose recovered in urine as metabolites), and does not bind to plasma proteins, its pharmacokinetics are unlikely to be affected by other agents through metabolic interactions or protein binding displacement. In vitro and in vivo studies showed that pregabalin is unlikely to be involved in significant pharmacokinetic drug interactions. Specifically, there are no pharmacokinetic interactions between pregabalin and the following antiepileptic drugs: carbamazepine, valproic acid, lamotrigine, phenytoin, phenobarbital, and topiramate. Important pharmacokinetic interactions would also not be expected to occur between pregabalin and commonly used antiepileptic drugs [see Clinical Pharmacology (12) ] . Pharmacodynamics Multiple oral doses of pregabalin were co-administered with oxycodone, lorazepam, or ethanol. Although no pharmacokinetic interactions were seen, additive effects on cognitive and gross motor functioning were seen when pregabalin was co-administered with these drugs. No clinically important effects on respiration were seen. Drug Interactions In Vitro Studies Pregabalin, at concentrations that were, in general, 10-times those attained in clinical trials, does not inhibit human CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4 enzyme…
| 3 | Not yet rated | Prescription | Capsule | Generic | $2 | View → |
| white |
| capsule |
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| 558;150mg | 150 mg | white, orange | capsule | — |
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| 559;200mg | 200 mg | white | capsule | — |
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| 560;225mg | 225 mg | orange | capsule | — |
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| 561;300mg | 300 mg | orange | capsule | — |
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| SG;354 | 150 mg | white | capsule | — |
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| SG;353 | 100 mg | orange | capsule | — |
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