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Pristiq

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Pristiq

Pristiq Side Effects Center

Pharmacy Editor: Melissa Conrad Stöppler, MD

Pristiq (desvenlafaxine) is an antidepressant in a group of drugs called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). Desvenlafaxine is used to treat major depressive disorder and is given orally. Side effects can include dizziness, dry mouth, constipation, sleep problems, loss of appetite, and decreased sex drive. Other side effects may also occur.

Desvenlafaxine 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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Pristiq in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these 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 serious side effect such as:

  • seizure (convulsions);
  • agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination;
  • blurred vision, eye pain, or seeing halos around lights;
  • cough, chest tightness, trouble breathing;
  • easy bruising or bleeding (nosebleeds, bleeding gums), blood in your urine or stools, coughing up blood;
  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
  • severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling;
  • headache, trouble concentrating, memory problems, weakness, feeling unsteady, confusion, hallucinations, fainting, shallow breathing or breathing that stops;

Less serious side effects may include:

  • increased sweating;
  • dizziness, drowsiness;
  • loss of appetite;
  • tightness in your jaw;
  • mild nausea, 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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Pristiq Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Drowsiness, dizziness, nausea, dry mouth, constipation, loss of appetite, weight loss, blurred vision, nervousness, trouble sleeping, or excessive sweating may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Desvenlafaxine may increase blood pressure. Your blood pressure should be checked regularly while you are taking this medication.

An empty tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the medication.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: severe/pounding headache, shakiness (tremor), decreased interest in sex, changes in sexual ability, easy bruising/bleeding.

Get medical help right away if you have any very serious side effects, including: chest pain, persistent cough, shortness of breath, black stools, vomit that looks like coffee grounds, seizures, change in the amount of urine.

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Pristiq (Desvenlafaxine Extended-Release Tablets)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Pristiq FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 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 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

System Organ Class Preferred Term Percentage of Patients Reporting Reaction
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 200 mg 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

  Placebo PRISTIQ
50 mg 100 mg 200 mg 400 mg
Proteinuria 4 6 8 5 7

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 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 -0.4 -0.6 -0.9 -1.1

Treatment with PRISTIQ at all doses from 50 mg/day to 400 mg/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/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/day 1.3%
PRISTIQ 100 mg/day 0.7%
PRISTIQ 200 mg/day 1.1%
PRISTIQ 400 mg/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.

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

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Pristiq - User Reviews

Pristiq User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Pristiq sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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