Side Effects Caused by Piligy

The following side effects are reported in clinical studies which were observed frequently and were dose-related: nausea (11.0% and 22.2% when taking 30 mg and 60 mg of Canadian Priligy (Dapoxetine) respectively), dizziness (5.8% and 10.9%), headaches (5.6% and 8.8% ), diarrhea (3.5% and 6.9%), insomnia (2.1% and 3.9%), fatigue (2.0% and 4.1%). The most common phenomena, demanding treatment withdrawal were nausea (in 2.2% of patients) and dizziness (1.2%).

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Unwanted side-effects observed during clinical tests are listed below:

• Psychiatric disorders:
  • anxiety, agitation, restlessness, abnormal dreams, decreased libido – often (>1/100 to <1/10);
  • depression, depressed mood, state of euphoria, mood changes, nervousness, apathy, lethargy, confusion, disorientation, abnormal thinking, somatosensory amplification, sleep disorders, initial insomnia, middle insomnia, nightmares, bruxism, loss of libido, anorgasmia – frequent (>1/1000 to <1/100);
• Central nervous system disorders:
  • dizziness, headaches – very often (>1/10);
  • drowsiness, impaired concentration, tremor, paresthesia – often (>1/100 to <1/10);
  • syncope, including vasovagal syncope, postural dizziness, akathisia, dysgeusia, hypersomnia, lethargy, sedative state, depression of consciousness – frequent (>1/1000 to <1/100);
  • dizziness at physical exertion, suddenly falling asleep – rare (>1/10000 to <1/1000);
• Organs of sight disorders:
  • blurred vision – often (>1/100 to <1/10);
  • mydriasis, eye pain, vision disorders – frequent (>1/1000 to <1/100);
• Organs of hearing and labyrinth disorders:
  • tinnitus – often (> 1/100 to <1/10);
  • vertigo – frequent (> 1/1000 to <1/100);
• Cardiovascular system disorders:
  • «flushes» of blood – often (>1/100 to <1/10);
  • termination of sinus node activity, sinus bradycardia, tachycardia, decreased blood pressure, systolic hypertension – frequent (>1/1000 to <1/100);
  • hot «flushes» – rare (> 1/10000 <1/1000);
• Respiratory system disorders:
  • nasal congestion, yawning – often (>1/100 to <1/10); Digestive tract disorders: nausea – very often (>1/10);
  • diarrhea, vomiting, constipation, abdominal pain, dyspepsia, flatulence, stomach discomfort, bloating, dry mouth – often (>1/100 to <1/10);
• Skin and subcutaneous tissue disorders:
  • hyperhidrosis – often (>1/100 to <1/10);
  • itching, cold sweat – frequent (>1/1000 to <1/100);
• Reproductive system disorders:
  • erectile dysfunction – often (>1/100 to <1/10);
  • an absence of ejaculation, orgasm disturbance, including anorgasmia in men, male genitals paresthesia – frequent (>1/1000 to <1/100);
• General condition:
  • weakness, irritability – often (>1/100 to <1/10);
  • fatigue, hot feeling, anxiety, malaise, the feeling of alcohol intoxication – frequent (>1/1000 to <1/100);
• Changes in laboratory parameters:
  • increased blood pressure – often (>1/100 to <1/10);
  • increased heart rate, increased diastolic blood pressure, increased orthostatic blood pressure – frequent (>1/1000 to <1/100).

Individual Side Effects

Fainting with loss of consciousness, with bradycardia or termination of sinus node activity were observed in patients during Holter monitoring and have been reported in clinical studies. These adverse events are regarded as related to the use of the drug. Most of the cases occurred within first 3 hours after ingestion, after the first dose or associated with medical procedures (blood sampling, changes in body position, blood pressure measurement). Prodromal symptoms often preceded syncope.

The incidence of syncope and prodromal symptoms depends on the dosage which was demonstrated in patients treated with higher doses of the drug.

Effects of Drug Withdrawal

In case of sudden cancellation of long-term use of selective serotonin reuptake inhibitors for chronic depressive disorders treatment, there were observed the following symptoms:

• dysphoric state;
• irritability;
• agitation;
• dizziness;
• sensory disturbances (e. g., paresthesias);
• anxiety;
• confusion;
• headaches;
• lethargy;
• emotional lability;
• insomnia;
• hypomania.

Safety results showed the higher incidence of withdrawal symptoms in the form of mild to moderate insomnia and dizziness after drug withdrawal after 62 days of application.