Nefopam

ATC code

N02BG06

Therapeutic class

Non-opioid analgesic · Centrally-acting analgesic

Forms

injectable solution

Brand names

NEPHODOL (ES) · NEFOPAM VENIPHARM (FR) · Acupan (FR)

Overall confidence

high

Regulatory sources consulted

ANSM SPC: https://base-donnees-publique.medicaments.gouv.fr/affichageDoc.php?specid=69707679&typedoc=R
AEMPS CIMA: https://cima.aemps.es/cima/dochtml/ft/90988/FT_90988.html
PubMed PMID:39465454 ↗
PubMed PMID:39129451 ↗
PubMed PMID:35218404 ↗
PubMed PMID:36869313 ↗
AEMPS CIMA · nº registro 90988 ↗
ANSM BDPM · CIS 69707679 ↗
RxNorm rxcui 7285 ↗

Approved indications

Symptomatic treatment of acute painful conditions, particularly postoperative pain.
Prevention of postoperative catheter-related bladder discomfort (CRBD). · off-label

Contraindications

Absolute

Hypersensitivity to nefopam or any of the excipients.
Children under 15 years of age.
Convulsions or history of convulsive disorders.
Risk of urinary retention related to urethroprostatic disorders.
Risk of angle-closure glaucoma.

Clinical warnings

Major warning · Risk of pharmacodependence and abuse, particularly in patients with a history of substance abuse or mental health disorders. — ANSM
Use with caution in patients with cardiovascular disease due to its tachycardic effect. — ANSM
Nefopam is neither an opioid nor an opioid antagonist. Discontinuing an opioid in a dependent patient may precipitate a withdrawal syndrome. — ANSM

Drug interactions

HighAlcoholV03AB
Mechanism: Increased sedative effect due to additive CNS depressant effects.
Recommendation: Avoid consuming alcoholic beverages and medications containing alcohol during treatment.
ANSM SPC
ModerateOther sedative drugs (opioids, benzodiazepines, neuroleptics, H1 antihistamines)N05
Mechanism: Increased central nervous system depression. Impaired alertness can make driving and using machinery dangerous.
Recommendation: Take the combination into account. Monitor for sedation and patient alertness.
ANSM SPC

Adverse events

Common (≥1%)

somnolence · nausea · vomiting · hyperhidrosis · dizziness · tachycardia · palpitations · dry mouth · urinary retention

Rare but serious

convulsions · hypersensitivity reactions (anaphylactic shock) · coma · hallucinations · confusional state · abuse and pharmacodependence

Pregnancy and lactation

Due to the absence of human clinical data and animal studies, its use is not recommended during pregnancy and lactation as a precautionary measure.

Recent literature (PubMed)

Pain management after laparoscopic cholecystectomy: A systematic review and procedure-specific postoperative pain management (PROSPECT) recommendations.
Bourgeois C, et al. · Eur J Anaesthesiol · 2024 · Relevance 5/5
Las guías PROSPECT para la colecistectomía laparoscópica NO recomiendan el uso de nefopam debido a la limitada o nula evidencia sobre la mejora de las puntuaciones de dolor.
Pharmacological Pain Treatment in Older Persons.
Pickering G, et al. · Drugs Aging · 2024 · Relevance 4/5
Una revisión de expertos europeos posiciona al nefopam como un tratamiento de segunda línea para el dolor nociceptivo de leve a moderado en personas mayores, después del paracetamol y los AINEs, aunque se desaconseja en el RCP francés para esta población.
Different interventions for preventing postoperative catheter-related bladder discomfort: a systematic review and meta-analysis.
Li S, et al. · Eur J Clin Pharmacol · 2022 · Relevance 4/5
Este metaanálisis concluye que el nefopam es uno de los fármacos eficaces para prevenir el malestar vesical postoperatorio relacionado con el catéter (CRBD).
Comparative effectiveness of interventions for managing urological postoperative catheter-related bladder discomfort: a systematic review and network meta-analysis.
Ren J, et al. · BMC Urol · 2023 · Relevance 4/5
Un metaanálisis en red sobre el CRBD en cirugía urológica clasificó al nefopam como una de las mejores intervenciones para reducir la incidencia de eventos moderados a graves, aunque la evidencia es limitada por el escaso número de estudios.