Medication Safety Issues
Sound-alike/look-alike issues:
Dapoxetine may be confused with PARoxetine.
Hypersensitivity to dapoxetine or any component of the formulation; significant cardiac conditions including heart failure (class II-IV), conduction abnormalities (eg, AV block, sick sinus syndrome), significant ischemic or valvular heart disease, or history of syncope; history of mania or severe depression; moderate to severe hepatic impairment; concomitant use of strong CYP3A4 inhibitors; use with MAO inhibitors, other SSRIs, SNRIs, TCAs, thioridazine, or medicinal and herbal products with serotonergic effects (concurrently, within 7 days of discontinuing dapoxetine, or within 14 days of discontinuing the MAO inhibitor, SSRI, SNRI, TCA, thioridazine, or serotonergic medicinal or herbal product)
Product Availability (US)
Not available in US
Storage/Stability
Store at controlled room temperature.
Adverse Reactions
Frequency not always defined.
Cardiovascular: Flushing (1% to <10%), increased blood pressure (1% to <10%), palpitation
Central nervous system: Dizziness (6% to 11%), headache (6% to >10%), abnormal dreams (1% to <10%), agitation (1% to <10%), anxiety (1% to <10%), drowsiness (1% to <10%), irritability (1% to <10%), lack of concentration (1% to <10%), paresthesia (1% to <10%), restlessness (1% to <10%), yawning (1% to <10%), fatigue (1% to <10%), insomnia (1% to <10%), withdrawal syndrome (mild)
Dermatologic: Hyperhidrosis (1% to <10%)
Endocrine & metabolic: Decreased libido (≤10%)
Gastrointestinal: Nausea (11% to 22%; dose related), abdominal distention (1% to <10%), abdominal pain (1% to <10%), constipation (1% to <10%), diarrhea (1% to <10%), dyspepsia (1% to <10%), flatulence (1% to <10%), stomach discomfort (1% to <10%), upper abdominal pain (1% to <10%), vomiting (1% to <10%), xerostomia (1% to <10%)
Genitourinary: Erectile dysfunction (1% to <10%)
Neuromuscular & skeletal: Tremor (1% to <10%)
Ophthalmic: Blurred vision (1% to <10%)
Otic: Tinnitus (1% to <10%)
Respiratory: Sinus congestion (1% to <10%)
<1%, postmarketing, and/or case reports: Abnormality in thinking, akathisia, anorgasmia, apathy, bowel urgency, bruxism, confusion, depression, diaphoresis, disorientation, dysgeusia, ejaculation failure, epigastric distress, euphoria, eye pain, feeling abnormal, feeling hot, hot flash, hypersomnia, hypervigilance, hypotension, impaired consciousness, increased diastolic blood pressure, increased heart rate, intoxicated feeling, jitteriness, lethargy, mood changes, mydriasis, nervousness, nightmares, orgasm disturbance (male), orthostatic hypertension, orthostatic hypotension, paresthesia genital male, pruritus, sinoatrial arrest, sinus bradycardia, sleep disorder, sudden onset of sleep, syncope, systolic hypertension, tachycardia, vertigo, visual disturbance, weakness
