(desvenlafaxine succinate)

Prescribing Information
Download Prescribing Information

HIGHLIGHTS OF PRESCRIBING INFORMATION

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use PRISTIQ safely and effectively. See full prescribing information for PRISTIQ.

PRISTIQ® (desvenlafaxine) Extended-Release Tablets, for oral use
Initial U.S. Approval: 2008

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

See full prescribing information for complete boxed warning.

•
Increased the risk of suicidal thoughts and behaviors in children, adolescents and young adults taking antidepressants (5.1).
•
Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors (5.1).
•
PRISTIQ is not approved for use in pediatric patients (8.4).

INDICATIONS AND USAGE

PRISTIQ is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) (1).

DOSAGE AND ADMINISTRATION

•
Recommended dose: 50 mg once daily with or without food (2.1).
•
There was no evidence that doses greater than 50 mg per day confer any additional benefit (2.1).
•
The 25 mg per day dose is intended for a gradual reduction in dose when discontinuing treatment or dosing in severe renal and end-stage renal disease patients (2.1).
•
Discontinuation: Reduce dose gradually whenever possible (2.1).
•
Take tablets whole; do not divide, crush, chew, or dissolve (2.1).
•
Moderate renal impairment: Maximum dose 50 mg per day (2.2).
•
Severe renal impairment and end-stage renal disease: Maximum dose 25 mg per day or 50 mg every other day (2.2).
•
Moderate to severe hepatic impairment: Maximum dose 100 mg per day (2.3).

DOSAGE FORMS AND STRENGTHS

•
PRISTIQ extended-release tablets: 25 mg, 50 mg and 100 mg (3).
•
Each tablet contains 38 mg, 76 mg or 152 mg of desvenlafaxine succinate equivalent to 25 mg, 50 mg or 100 mg of desvenlafaxine, respectively (3).

CONTRAINDICATIONS

•
Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or any excipients in the PRISTIQ formulation (4).
•
Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with PRISTIQ or within 7 days of stopping treatment with PRISTIQ. Do not use PRISTIQ within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start PRISTIQ in a patient who is being treated with linezolid or intravenous methylene blue (4).

WARNINGS AND PRECAUTIONS

•
Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue PRISTIQ and serotonergic agents and initiate supportive treatment (5.2).
•
Elevated Blood Pressure: Control hypertension before initiating treatment. Monitor blood pressure regularly during treatment (5.3).
•
Increased Risk of Bleeding: Concomitant use of aspirin, NSAIDs, other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk (5.4).
•
Angle Closure Glaucoma: Avoid use of antidepressants, including PRISTIQ, in patients with untreated anatomically narrow angles treated (5.5).
•
Activation of Mania/Hypomania: Use cautiously in patients with Bipolar Disorder. Caution patients about risk of activation of mania/hypomania (5.6).
•
Discontinuation Syndrome: Taper dose when possible and monitor for discontinuation symptoms (5.7).
•
Seizure: Can occur. Use cautiously in patients with seizure disorder (5.8).
•
Hyponatremia: Can occur in association with SIADH (5.9).
•
Interstitial Lung Disease and Eosinophilic Pneumonia: Can occur (5.10).
•
Sexual Dysfunction: PRISTIQ may cause symptoms of sexual dysfunction (5.11).

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥5% and 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 (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

USE IN SPECIFIC POPULATIONS

•
Pregnancy: Third trimester use may result in neonatal discontinuation syndrome (8.1).
•
Geriatric Use: There is an increased incidence of orthostatic hypotension in desvenlafaxine treated patients ≥ 65 years (6.1 and 8.5).

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 6/2025

Medication Guide

MEDICATION GUIDE

This Medication Guide has been approved by the U.S. Food and Drug Administration.     Revised: 6/2025

MEDICATION GUIDE
PRISTIQ® (pris-TEEK)
(desvenlafaxine)
extended-release tablets

What is the most important information I should know about PRISTIQ?
PRISTIQ can cause serious side effects, including:

•
Increased risk of suicidal thoughts or actions in some children and young adults within the first few months of treatment. PRISTIQ is not for use in children.
•
Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.

How can I watch for and try to prevent suicidal thoughts and actions?

 
o
Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
o
Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
o
Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.
 
Call your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:
o
thoughts about suicide or dying
o
attempts to commit suicide
o
new or worse depression
o
new or worse anxiety
o
feeling very agitated or restless
o
panic attacks
o
trouble sleeping (insomnia)
o
new or worse irritability
o
acting aggressive, being angry, or violent
o
acting on dangerous impulses
o
an extreme increase in activity and talking (mania)
o
other unusual changes in behavior or mood

What is PRISTIQ?

•
PRISTIQ is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder (MDD). PRISTIQ belongs to a class of medicines known as serotonin and norepinephrine reuptake inhibitors (SNRIs).

Do not take PRISTIQ if you:

•
are allergic to desvenlafaxine succinate, venlafaxine hydrochloride, or any of the ingredients in PRISTIQ. See the end of this Medication Guide for a complete list of ingredients in PRISTIQ.
•
take a monoamine oxidase inhibitor (MAOI).
•
have stopped taking an MAOI in the last 14 days. Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI.
•
are being treated with the antibiotic linezolid or the intravenous methylene blue.

Do not start taking an MAOI for at least 7 days after you stop treatment with PRISTIQ.

Before taking PRISTIQ tell your healthcare provider about all your medical conditions, including if you:

•
have high blood pressure
•
have heart problems
•
have cerebrovascular problems or had a stroke
•
have or had bleeding problems
•
have, or have a family history of, bipolar disorder, mania or hypomania
•
have high cholesterol or high triglycerides
•
have or had depression, suicidal thoughts or behavior
•
have kidney or liver problems
•
have or had seizures or convulsions
•
have low sodium levels in your blood
•
are pregnant or plan to become pregnant. Talk to your healthcare provider about the risk to your unborn baby if you take PRISTIQ during pregnancy.
o
Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with PRISTIQ.
o
If you become pregnant during treatment with PRISTIQ, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants.
•
are breastfeeding or plan to breastfeed. PRISTIQ can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with PRISTIQ.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
PRISTIQ and other medicines may affect each other causing possible serious side effects. PRISTIQ may affect the way other medicines work and other medicines may affect the way PRISTIQ works.
Especially tell your healthcare provider if you take:

•
other MAOIs
•
medicines to treat migraine headaches known as triptans
•
tricyclic antidepressants
•
lithium
•
tramadol, fentanyl, meperidine, methadone, or other opioids
•
tryptophan
•
buspirone
•
amphetamines
•
St. John's Wort
•
other medicines containing desvenlafaxine or venlafaxine
•
medicines that can affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), warfarin
•
medicines used to treat mood, anxiety, psychotic, or thought disorders, including selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs)

Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take PRISTIQ with your other medicines.
Do not start or stop any other medicines during treatment with PRISTIQ without talking to your healthcare provider first. Stopping PRISTIQ suddenly may cause you to have serious side effects. See, "What are the possible side effects of PRISTIQ?"
Know the medicines you take. Keep a list of them to show to your healthcare providers when you get a new medicine.

How should I take PRISTIQ?

•
Take PRISTIQ exactly as your healthcare provider tells you to.
•
Take PRISTIQ 1 time a day at about the same time each day.
•
PRISTIQ may be taken either with or without food.
•
Swallow PRISTIQ tablets whole, with fluid. Do not divide, crush, chew, or dissolve PRISTIQ tablets.
•
When you take PRISTIQ, you may see something in your stool that looks like a tablet. This is the empty shell from the tablet after the medicine has been absorbed by your body.
•
If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What should I avoid while taking PRISTIQ?

•
Do not drive a car or operate heavy machinery until you know how PRISTIQ affects you.
•
You should not drink alcohol while taking PRISTIQ.

What are the possible side effects of PRISTIQ?
PRISTIQ can cause serious side effects, including:

•
See, "What is the most important information I should know about PRISTIQ?"
•
Serotonin syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take PRISTIQ with certain other medicines. See, "Do not take PRISTIQ if you:" Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following signs and symptoms of serotonin syndrome:
o
agitation
o
confusion
o
fast heart beat
o
dizziness
o
flushing
o
tremors, stiff muscles, or muscle twitching
o
seizures
o
seeing or hearing things that are not real (hallucinations)
o
coma
o
changes in blood pressure
o
sweating
o
high body temperature (hyperthermia)
o
loss of coordination
o
nausea, vomiting, diarrhea
•
New or worsened high blood pressure (hypertension). Your healthcare provider should check your blood pressure before and during treatment with PRISTIQ. If you have high blood pressure, it should be controlled before you start treatment with PRISTIQ.
•
Increased chance of bleeding or bruising. Taking PRISTIQ with aspirin, NSAIDs, or blood thinners may add to this risk. Tell your healthcare provider right away about any unusual bleeding or bruising.
•
Eye problems (angle closure glaucoma). Many antidepressant medicines, including PRISTIQ, may cause a certain type of eye problem called angle-closure glaucoma. Call your healthcare provider if you have changes in your vision or eye pain.
•
Discontinuation syndrome. Suddenly stopping PRISTIQ when you take higher doses may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include the following, some of which can be severe and last for a long time:
o
dizziness
o
irritability and agitation
o
anxiety
o
sweating
o
aggressiveness (including hostility, rage)
o
tremor
o
sweating
o
seizures
o
ringing in your ears (tinnitus)
o
nausea
o
problems sleeping
o
tiredness
o
confusion
o
electric shock sensation (paresthesia)
o
headache
o
diarrhea
o
abnormal dreams
o
changes in your mood
o
hypomania
o
problems with eyesight (such as blurred vision and trouble focusing)
o
increase in blood pressure
•
Seizures (convulsions).
•
Low sodium levels in your blood (hyponatremia). Low sodium levels can happen during treatment with PRISTIQ. Low sodium levels in your blood may be serious and may cause death. Signs and Symptoms of low sodium levels in your blood may include:
•
headache
•
difficulty concentrating
•
memory changes
•
confusion
•
weakness and unsteadiness on your feet which can lead to falls
 
In severe or more sudden cases, signs and symptoms include:
•
hallucinations (seeing or hearing things that are not real)
•
fainting
•
seizures
•
coma
•
Lung problems. Some people who have taken the medicine venlafaxine which is the same kind of medicine as the medicine in PRISTIQ have had lung problems. Symptoms of lung problems include difficulty breathing, cough, or chest discomfort. Tell your healthcare provider right away if you have any of these symptoms.
•
Sexual Problems (dysfunction). Taking serotonin and norepinephrine reuptake inhibitors (SNRIs), including PRISTIQ, may cause sexual problems.
Symptoms in males may include:
o
Delayed ejaculation or inability to have an ejaculation
o
Decreased sex drive
o
Problems getting or keeping an erection
 
Symptoms in females may include:
o
Decreased sex drive
o
Delayed orgasm or inability to have an orgasm
 
Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with PRISTIQ. There may be treatments your healthcare provider can suggest.

The most common side effects of PRISTIQ include:

•
nausea
•
problems sleeping
•
constipation
•
decreased appetite
•
sexual function problems
•
dizziness
•
sweating
•
feeling sleepy
•
anxiety

These are not all the possible side effects of PRISTIQ.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store PRISTIQ?

•
Store PRISTIQ at room temperature between 68°F to 77°F (20°C to 25°C).
•
Keep PRISTIQ and all medicines out of the reach of children.

General Information about the safe and effective use of PRISTIQ
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take PRISTIQ for a condition for which it was not prescribed. Do not give PRISTIQ to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about PRISTIQ that is written for healthcare professionals.

What are the ingredients in PRISTIQ?
Active ingredient: desvenlafaxine
Inactive ingredients:

•
25 mg tablet: hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides.
•
50 mg tablet: hypromellose, microcrystalline cellulose, talc, magnesium stearate and film coating, which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, and iron oxides.
•
100 mg tablet: hypromellose, microcrystalline cellulose, talc, magnesium stearate, a film coating which consists of polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, iron oxide and FD&C yellow #6.

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

logo

LAB-0539-16.0

For more information, go to www.pristiq.com or call 1-888-PRISTIQ (774-7847).

Additional Resources

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine or vaccine.

Speak with a Pfizer Medical Information Professional regarding your Pfizer medicine or vaccine inquiry.

Available 9AM-5PM ET Monday to Friday; excluding holidays.

 

Submit a medical question for a Pfizer medicine or a vaccine. 

The submission will be reviewed during our standard business hours.

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this medication, click the link below to submit your information: 
Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.