Desvenlafaxine Extended-release Tablets

Name: Desvenlafaxine Extended-release Tablets

Side effects

The following adverse reactions are discussed in greater detail in other sections of the label.

  • Hypersensitivity [see CONTRAINDICATIONS]
  • Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see WARNINGS AND PRECAUTIONS]
  • Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]
  • Elevated Blood Pressure [see WARNINGS AND PRECAUTIONS]
  • Abnormal Bleeding [see WARNINGS AND PRECAUTIONS]
  • Angle Closure Glaucoma [see WARNINGS AND PRECAUTIONS]
  • Activation of Mania/Hypomania [see WARNINGS AND PRECAUTIONS]
  • Discontinuation Syndrome [see WARNINGS AND PRECAUTIONS]
  • Seizure [see WARNINGS AND PRECAUTIONS]
  • Hyponatremia [see WARNINGS AND PRECAUTIONS]
  • Interstitial Lung Disease and Eosinophilic Pneumonia [see WARNINGS AND PRECAUTIONS]

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.

Patient exposure

PRISTIQ was evaluated for safety in 8,394 patients diagnosed with major depressive disorder who participated in multiple-dose pre-marketing studies, representing 2,784 patient-years of exposure. Of the total 8,394 patients exposed to at least one dose of PRISTIQ; 2,116 were exposed to PRISTIQ for 6 months, representing 1,658 patient-years of exposure, and 421 were exposed for one year, representing 416 patient-years of exposure.

Adverse Reactions Reported As Reasons For Discontinuation Of Treatment

In the pre-marketing pooled 8-week placebo-controlled studies in patients with MDD, 1,834 patients were exposed to PRISTIQ (50 to 400 mg). Of the 1,834 patients, 12% discontinued treatment due to an adverse reaction, compared with 3% of the 1,116 placebo-treated patients. At the recommended dose of 50 mg, the discontinuation rate due to an adverse reaction for PRISTIQ (4.1%) was similar to the rate for placebo (3.8%). For the 100 mg dose of PRISTIQ the discontinuation rate due to an adverse reaction was 8.7%.

The most common adverse reactions leading to discontinuation in at least 2% and at a rate greater than placebo of the PRISTIQ treated patients in the short-term studies, up to 8 weeks, were: nausea (4%); dizziness, headache and vomiting (2% each). In a longer-term study, up to 9 months, the most common was vomiting (2%).

Common Adverse Reactions In Placebo-Controlled MDD Studies

The most commonly observed adverse reactions in PRISTIQ treated MDD patients in pre-marketing pooled 8- week, placebo-controlled, fixed-dose studies (incidence ≥ 5% and at least twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders.

Table 2 shows the incidence of common adverse reactions that occurred in ≥ 2% of PRISTIQ treated MDD patients and twice the rate of placebo at any dose in the pre-marketing pooled 8-week, placebo-controlled, fixed dose clinical studies

Table 2: Common Adverse Reactions ( ≥ 2% in any Fixed-Dose Group and Twice the Rate of Placebo) in Pre-marketing Pooled MDD 8-Week Placebo-Controlled Studies

Percentage of Patients Reporting Reaction
System Organ Class
Preferred Term		 PRISTIQ
Placebo
(n=636)		 50 mg
(n=317)		 100 mg
(n=424)		 200 mg
(n=307)		 400 mg
(n=317)
Cardiac disorders
  Blood pressure increased 1

Warnings

Included as part of the PRECAUTIONS section.

Where can i get more information?

Your pharmacist can provide more information about desvenlafaxine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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