Duloxetine

ATC code

N06AX21

Therapeutic class

Antidepressant · Serotonin and norepinephrine reuptake inhibitor (SNRI)

Forms

gastro-resistant hard capsule

Brand names

Cymbalta (Global) · Duloxetine Viatris (EU) · Duloxetine Mylan (EU) · DULOXETINA CINFAMED (ES)

Overall confidence

high

Regulatory sources consulted

AEMPS-CIMA-FT-88002:https://cima.aemps.es/cima/dochtml/ft/88002/FT_88002.html
EMA-EPAR-EMEA/H/C/003981:https://www.ema.europa.eu/en/medicines/human/EPAR/duloxetine-viatris-previously-duloxetine-mylan
CredibleMeds.org
Flockhart Table (CYP450)
AEMPS CIMA · nº registro 88002 ↗
EMA EPAR · EMEA/H/C/003981 ↗
RxNorm rxcui 72625 ↗

Approved indications

Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalised anxiety disorder.

Contraindications

Absolute

Hypersensitivity to the active substance.
Concomitant use with non-selective, irreversible monoamine oxidase inhibitors (MAOIs).
Hepatic disease resulting in hepatic impairment.
Concomitant use with potent CYP1A2 inhibitors such as fluvoxamine, ciprofloxacin or enoxacin.
Severe renal impairment (creatinine clearance < 30 ml/min).

Clinical warnings

Major warning · Suicide: Antidepressants increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults. Patients should be monitored for clinical worsening and emergence of suicidal tendencies. — EMA SPC
Major warning · Serotonin Syndrome: Potential risk when co-administered with other serotonergic agents (triptans, other SNRIs, SSRIs, tramadol, St. John's Wort). — EMA SPC

Drug interactions

HighFluvoxamineN06AB08
Mechanism: Potent inhibition of CYP1A2, a major metabolic pathway for duloxetine, significantly increasing its AUC (approx. 6-fold).
Recommendation: Concomitant use is contraindicated.
EMA SPC
HighMonoamine Oxidase Inhibitors (MAOIs)N06AF
Mechanism: Risk of serious or fatal serotonin syndrome due to additive effects on serotonin levels.
Recommendation: Contraindicated. Allow at least 14 days between discontinuation of an MAOI and initiation of duloxetine, and at least 5 days between discontinuation of duloxetine and initiation of an MAOI.
EMA SPC

Adverse events

Common (≥1%)

headache · somnolence · dizziness · nausea · dry mouth · constipation · decreased appetite · insomnia · fatigue

Rare but serious

serotonin syndrome · anaphylactic reaction · hyponatraemia · angle-closure glaucoma · hepatitis · Stevens-Johnson syndrome · rhabdomyolysis

Pregnancy and lactation

Pregnancy: Use only if the potential benefit justifies the potential risk to the fetus. Risk of persistent pulmonary hypertension of the newborn (PPHN) and neonatal withdrawal syndrome. Lactation: Excreted in human milk; not recommended.