Pregabalin

ATC code

N03AX16

Therapeutic class

Antiepileptic and GABA analogue · Alpha-2-delta ligand

Forms

oral capsule

Brand names

Pregabalin Accord (EU) · Lyrica (Global)

Overall confidence

medium

Regulatory sources consulted

Approved indications

Adjunctive therapy in adults with partial seizures with or without secondary generalisation.
Treatment of Generalised Anxiety Disorder (GAD) in adults.
Second-line treatment for moderate to severe Restless Legs Syndrome (RLS). · off-label

Contraindications

Absolute

Hypersensitivity to the active substance or to any of the excipients.

Clinical warnings

Major warning · Dizziness and somnolence, which could increase the occurrence of accidental injury (fall) in the elderly population. — EMA
Major warning · Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents. Patients should be monitored for signs of suicidal ideation and behaviours. — EMA
Major warning · Potential for abuse, misuse, and dependence. Patients should be carefully evaluated for a history of drug abuse and observed for signs of pregabalin misuse, abuse, or dependence. — EMA

Drug interactions

HighOpioids (e.g., Oxycodone)N02AA05
Mechanism: Additive CNS depressant effect, risk of respiratory depression, profound sedation, and coma.
Recommendation: Closely monitor for respiratory depression and sedation. Consider dose reduction of one or both drugs. There is a high risk of misuse and dependence.
EMA SPC
HighBenzodiazepines (e.g., Lorazepam)N05BA06
Mechanism: Additive CNS depressant effect, risk of respiratory depression, profound sedation, and coma.
Recommendation: Closely monitor for respiratory depression and sedation. Avoid combination if possible, especially in patients at risk for abuse.
EMA SPC
ModerateAlcoholV03AB16
Mechanism: Potentiation of effects on cognitive and gross motor function.
Recommendation: Advise patients not to consume alcohol during treatment with pregabalin.
EMA SPC

Adverse events

Common (≥1%)

Dizziness · Somnolence · Headache · Weight gain · Blurred vision · Dry mouth · Ataxia · Confusion

Rare but serious

Angioedema · Congestive heart failure · Severe respiratory depression · Rhabdomyolysis · Hypersensitivity reactions

Pregnancy and lactation

Should not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus. It is excreted in human milk; a decision must be made whether to discontinue breast-feeding or to discontinue therapy.

Recent literature (PubMed)

A systematic review and meta-analysis of the effectiveness and adverse events of gabapentin and pregabalin for sciatica pain.
Giménez-Campos MS, et al. · Aten Primaria · 2022 · Relevance 5/5
Revisión sistemática y metaanálisis que concluye que no hay evidencia suficiente para apoyar el uso rutinario de pregabalina y gabapentina para el dolor de la ciática, debido a la falta de efectividad demostrada.
Restless legs syndrome. Pathophysiology, diagnosis and treatment.
Castillo-Álvarez F, et al. · Med Clin (Barc) · 2025 · Relevance 4/5
Revisión sobre el síndrome de piernas inquietas que posiciona a los ligandos α2δ (como la pregabalina) como tratamiento de segunda línea, por delante de los agonistas dopaminérgicos debido a un mejor perfil a largo plazo.
Preoperative pregabalin prevents succinylcholine-induced fasciculation and myalgia: A meta-analysis of randomized trials.
Vélez PA, et al. · Rev Esp Anestesiol Reanim (Engl Ed) · 2024 · Relevance 3/5
Metaanálisis que demuestra que el uso preoperatorio de gabapentinoides (incluida la pregabalina) reduce la incidencia de mialgias postoperatorias inducidas por succinilcolina.