(desvenlafaxine succinate)

Prescribing Information
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6 ADVERSE REACTIONS

6 ADVERSE REACTIONS

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

•
Hypersensitivity [see Contraindications (4)]
•
Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients [see Warnings and Precautions (5.1)]
•
Serotonin Syndrome [see Warnings and Precautions (5.2)]
•
Elevated Blood Pressure [see Warnings and Precautions (5.3)]
•
Increased Risk of Bleeding [see Warnings and Precautions (5.4)]
•
Angle Closure Glaucoma [see Warnings and Precautions (5.5)]
•
Activation of Mania/Hypomania [see Warnings and Precautions (5.6)]
•
Discontinuation Syndrome [see Warnings and Precautions (5.7)]
•
Seizure [see Warnings and Precautions (5.8)]
•
Hyponatremia [see Warnings and Precautions (5.9)]
•
Interstitial Lung Disease and Eosinophilic Pneumonia [see Warnings and Precautions (5.10)]
•
Sexual Dysfunction [see Warnings and Precautions (5.11)]

6.1 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
PRISTIQ
System Organ Class
Preferred Term		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

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) [see Warnings and Precautions (5.11)].

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

PRISTIQ

Placebo
(n=239)

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

PRISTIQ

Placebo
(n=397)

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*
PRISTIQ
Placebo50 mg100 mg200 mg400 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
PRISTIQ
Placebo50 mg100 mg200 mg400 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
PRISTIQ
Placebo50 mg100 mg200 mg400 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 GroupProportion 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).

6.2 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

Respiratory, thoracic and mediastinal disorders - Anosmia, hyposmia

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.

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LAB-0539-16.0

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

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