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Pristiq

Last reviewed on RxList: 2/14/2018
Pristiq Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 2/14/2018

Pristiq (desvenlafaxine) is type of antidepressant called a selective serotonin and norepinephrine reuptake inhibitor (SNRI) used to treat major depressive disorder. Side effects of Pristiq include:

The recommended dose for Pristiq is 50 mg once daily, with or without food. Pristiq may interact with any medicine for pain, arthritis, fever, or swelling; other medicines that make you sleepy (such as cold or allergy medicines, sedatives, narcotic pain medicines, sleeping pills, muscle relaxers, and medicines for seizures or anxiety), blood thinners, diuretics (water pills), linezolid, lithium, metoclopramide, midazolam, St. John's wort, tramadol, L-tryptophan, antibiotics, antifungals, heart or blood pressure medications, HIV/AIDS medicines, migraine headache medications, or other antidepressants. Tell your doctor all medications and supplements you use. Pristiq may harm an unborn baby and should be used in pregnancy only when clearly needed. Also, babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Our Pristiq Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Learn to Spot Depression: Symptoms, Warning Signs, Medication See Slideshow
Pristiq Consumer Information

Get emergency medical help if you have signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • a seizure (convulsions);
  • easy bruising or bleeding (nosebleeds, bleeding gums), blood in your urine or stools, coughing up blood;
  • blurred vision, eye pain or swelling, or seeing halos around lights;
  • cough, chest discomfort, trouble breathing; or
  • low levels of sodium in the body--headache, confusion, severe weakness, memory problems, feeling unsteady, hallucinations.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects may include:

  • dizziness, drowsiness, anxiety;
  • increased sweating;
  • nausea, decreased appetite, constipation;
  • sleep problems (insomnia); or
  • decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Pristiq (Desvenlafaxine Extended-Release Tablets)

QUESTION

Depression is a(n) __________ . See Answer
Pristiq Professional Information

SIDE EFFECTS

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

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 premarketing 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 8week, 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 Placebo
(n=636)
PRISTIQ
50 mg
(n=317)
100 mg
(n=424)
200 mg
(n=307)
400 mg
(n=317)
Cardiac disorders
Blood pressure increased 1 1 1 2 2
Gastrointestinal disorders
Nausea 10 22 26 36 41
Dry mouth 9 11 17 21 25
Constipation 4 9 9 10 14
Vomiting 3 3 4 6 9
General disorders and administration site conditions
Fatigue 4 7 7 10 11
Chills 1 1 <1 3 4
Feeling jittery 1 1 2 3 3
Metabolism and nutrition disorders
Decreased appetite 2 5 8 10 10
Nervous system disorders
Dizziness 5 13 10 15 16
Somnolence 4 4 9 12 12
Tremor 2 2 3 9 9
Disturbance in attention <1 <1 1 2 1
Psychiatric disorders
Insomnia 6 9 12 14 15
Anxiety 2 3 5 4 4
Nervousness 1 <1 1 2 2
Abnormal dreams 1 2 3 2 4
Renal and urinary disorders
Urinary hesitation 0 <1 1 2 2
Respiratory, thoracic and mediastinal disorders
Yawning <1 1 1 4 3
Skin and subcutaneous tissue disorders
Hyperhidrosis 4 10 11 18 21
Special Senses
Vision blurred 1 3 4 4 4
Mydriasis <1 2 2 6 6
Vertigo 1 2 1 5 3
Tinnitus 1 2 1 1 2
Dysgeusia 1 1 1 1 2
Vascular disorders
Hot flush <1 1 1 2 2

Sexual Function Adverse Reactions

Table 3 shows the incidence of sexual function adverse reactions that occurred in ≥ 2% of PRISTIQ treated MDD patients in any fixed-dose group (pre-marketing pooled 8-week, placebo-controlled, fixed -dose, clinical studies).

Table 3: Sexual Function Adverse Reactions (≥ 2% in Men or Women in any PRISTIQ Group) During the On-Therapy Period

  Placebo
(n=239)
PRISTIQ
50 mg
(n=108)
100 mg
(n=157)
200 mg
(n=131)
400 mg
(n=154)
Men only
Anorgasmia 0 0 3 5 8
Libido decreased 1 4 5 6 3
Orgasm abnormal 0 0 1 2 3
Ejaculation delayed <1 1 5 7 6
Erectile dysfunction 1 3 6 8 11
Ejaculation disorder 0 0 1 2 5
Ejaculation failure 0 1 0 2 2
Sexual dysfunction 0 1 0 0 2
  Placebo
(n=397)
PRISTIQ
50 mg
(n=209)
100 mg
(n=267)
200 mg
(n=176)
400 mg
(n=163)
Women only
Anorgasmia 0 1 1 0 3

Other Adverse Reactions Observed In Premarketing And Postmarketing Clinical Studies

Other infrequent adverse reactions, not described elsewhere in the label, occurring at an incidence of < 2% in MDD patients treated with PRISTIQ were:

Cardiac disorders - Tachycardia.

General disorders and administration site conditions - Asthenia.

Investigations - Weight increased, liver function test abnormal, blood prolactin increased.

Musculoskeletal and connective tissue disorders - Musculoskeletal stiffness.

Nervous system disorders -Syncope, convulsion, dystonia.

Psychiatric disorders - Depersonalization, bruxism.

Renal and urinary disorders - Urinary retention.

Skin and subcutaneous tissue disorders - Rash, alopecia, photosensitivity reaction, angioedema.

In clinical studies, there were uncommon reports of ischemic cardiac adverse reactions, including myocardial ischemia, myocardial infarction, and coronary occlusion requiring revascularization; these patients had multiple underlying cardiac risk factors. More patients experienced these events during PRISTIQ treatment as compared to placebo.

Laboratory, ECG And Vital Sign Changes Observed In MDD Clinical Studies

The following changes were observed in pre-marketing placebo-controlled, short-term MDD studies with PRISTIQ.

Lipids

Elevations in fasting serum total cholesterol, LDL (low density lipoproteins) cholesterol, and triglycerides occurred in the controlled studies. Some of these abnormalities were considered potentially clinically significant.

The percentage of patients who exceeded a predetermined threshold value is shown in Table 4.

Table 4: Incidence (%) of Patients With Lipid Abnormalities of Potential Clinical Significance*

  Placebo PRISTIQ
50 mg 100 mg 200mg 400 mg
Total Cholesterol *(Increase of ≥ 50 mg/dl and an absolute value of ≥ 261 mg/dl) 2 3 4 4 10
LDL Cholesterol *(Increase ≥ 50 mg/dl and an absolute value of ≥ 190 mg/dl) 0 1 0 1 2
Triglycerides, fasting *(Fasting: ≥ 327 mg/dl) 3 2 1 4 6

Proteinuria

Proteinuria, greater than or equal to trace, was observed in the pre-marketing fixed-dose controlled studies (see Table 5). This proteinuria was not associated with increases in BUN or creatinine and was generally transient.

Table 5: Incidence (%) of Patients with Proteinuria in the Fixed-dose Clinical Studies

Treatment Group Proportion of Patients with Sustained Hypertension
Placebo 0.5%
PRISTIQ 50 mg per day 1.3%
PRISTIQ 100 mg per day 0.7%
PRISTIQ 200 mg per day 1.1%
PRISTIQ 400 mg per day 2.3%

Vital Sign Changes

Table 6 summarizes the changes that were observed in placebo-controlled, short-term, pre-marketing studies with PRISTIQ in patients with MDD (doses 50 to 400 mg).

Table 6: Mean Changes in Vital Signs at Final on Therapy for All Short-term, Fixed-dose Controlled Studies

  Placebo PRISTIQ
50 mg 100 mg 200 mg 400 mg
Blood pressure
Supine systolic bp (mm Hg) -1.4 1.2 2.0 2.5 2.1
Supine diastolic bp (mm Hg) -0.6 0.7 0.8 1.8 2.3
Pulse rate
Supine pulse (bpm) -0.3 1.3 1.3 0.9 4.1
Weight (kg) 0.0 -0.4 -0.6 -0.9 -1.1

Treatment with PRISTIQ at all doses from 50 mg per day to 400 mg per day in controlled studies was associated with sustained hypertension, defined as treatment-emergent supine diastolic blood pressure (SDBP) ≥90 mm Hg and ≥10 mm Hg above baseline for 3 consecutive on-therapy visits (see Table 7). Analyses of patients in PRISTIQ pre-marketing short-term controlled studies who met criteria for sustained hypertension revealed a consistent increase in the proportion of patients who developed sustained hypertension. This was seen at all doses with a suggestion of a higher rate at 400 mg per day.

Table 7: Proportion of Patients with Sustained Elevation of Supine Diastolic Blood Pressure

Treatment Group Proportion of Patients with Sustained Hypertension
Placebo 0.5%
PRISTIQ 50 mg per day 1.3%
PRISTIQ 100 mg per day 0.7%
PRISTIQ 200 mg per day 1.1%
PRISTIQ 400 mg per day 2.3%

Orthostatic Hypotension

In the pre-marketing short-term, placebo-controlled clinical studies with doses of 50 to 400 mg, systolic orthostatic hypotension (decrease ≥30 mm Hg from supine to standing position) occurred more frequently in patients ≥65 years of age receiving PRISTIQ (8%, 7/87) versus placebo (2.5%, 1/40), compared to patients <65 years of age receiving PRISTIQ (0.9%, 18/1,937) versus placebo (0.7%, 8/1,218).

Postmarketing Experience

The following adverse reaction has been identified during post-approval use of PRISTIQ. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

Skin and subcutaneous tissue disorders - Stevens-Johnson syndrome.

Gastrointestinal disorders - Pancreatitis acute.

Cardiovascular system - Takotsubo cardiomyopathy.

Read the entire FDA prescribing information for Pristiq (Desvenlafaxine Extended-Release Tablets)

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© Pristiq Patient Information is supplied by Cerner Multum, Inc. and Pristiq Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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