Pristiq Side Effects

Please note - some side effects for Pristiq may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Pristiq - for the Consumer

Pristiq Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Pristiq Extended-Release Tablets:

Constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; fatigue; flushing; headache; increased sweating; loss of appetite; nausea; stomach upset; trouble sleeping; vomiting; yawning.

Seek medical attention right away if any of these SEVERE side effects occur when using Pristiq Extended-Release Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); behavior changes; blood in the stools; blurred vision; chest pain or discomfort; confusion; decreased concentration; decreased coordination; decreased urination; enlarged pupils; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; memory problems; new or worsening agitation, anxiety, panic attacks, aggressiveness, impulsiveness, irritability, hostility, restlessness, or inability to sit still; new or worsening mental or mood changes; red, swollen, blistered, or peeling skin; seizures; severe or persistent cough; severe or persistent headache, dizziness, or stomach pain; severe or persistent trouble sleeping; shortness of breath; significant weight loss; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual weakness; worsening of depression.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Pristiq Side Effects - for the Professional

Pristiq

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

• Hypersensitivity [see Contraindications (4.1)]
• Effects on blood pressure [see Warnings and Precautions (5.3)]
• Abnormal bleeding [see Warnings and Precautions (5.4)]
• Mydriasis [see Warnings and Precautions (5.5)]
• Hypomania and mania [see Warnings and Precautions (5.6)]
• Serum cholesterol and triglyceride elevation [see Warnings and Precautions (5.8)]
• Seizure [see Warnings and Precautions (5.11)]

Clinical Studies Experience

The most commonly observed adverse reactions in Pristiq treated MDD patients in short-term 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.

Adverse reactions reported as reasons for discontinuation of treatment

Combined across 8-week placebo-controlled pre-marketing studies for major depressive disorder, 12% of the 1,834 patients who received Pristiq (50-400 mg) discontinued treatment due to an adverse event, compared with 3% of the 1,116 placebo-treated patients in those studies. At the recommended dose of 50 mg, the discontinuation rate due to an adverse event 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 event was 8.7%.

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

Patient exposure

Pristiq was evaluated for safety in 3,292 patients diagnosed with major depressive disorder who participated in multiple-dose pre-marketing studies, representing 1,289 patient-years of exposure. Among these 3,292 Pristiq treated patients, 1,834 patients were exposed to Pristiq in 8-week, placebo-controlled studies at doses ranging from 50 to 400 mg/day. Out of the 1,834 patients, 687 Pristiq treated patients continued into a 10-month open-label study. Of the total 3,292 patients exposed to at least one dose of Pristiq, 1,070 were exposed to Pristiq for 6 months, representing 842 patient-years of exposure, and 274 were exposed for one year, representing 241 patient-years of exposure.

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

Common adverse reactions in placebo-controlled MDD studies

Table 3 shows the incidence of common adverse reactions that occurred in ≥ 2% of Pristiq treated MDD patients at any dose in the 8-week, placebo-controlled, fixed dose, pre-marketing clinical studies. In general, the adverse reactions were most frequent in the first week of treatment.

Table 3: Common Adverse Reactions: Percentage of Patients (≥ 2% in any Fixed-Dose Group) in MDD 8‑Week Placebo-Controlled Studiesa

	Percentage of Patients Reporting Reaction
		Pristiq
System Organ Class Preferred Term	Placebo	50 mg	100 mg	200 mg	400 mg
Cardiac disorders
Palpitations	2	1	3	2	3
Tachycardia	1	1	<1	1	2
Blood pressure    increased	1	1	1	2	2
Gastrointestinal disorders
Nausea	10	22	26	36	41
Dry mouth	9	11	17	21	25
Diarrhea	9	11	9	7	5
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
Asthenia	1	1	2	1	1
Metabolism and nutrition disorders
Decreased    appetite	2	5	8	10	10
Weight decreased	1	2	1	1	2
Nervous system disorders
Dizziness	5	13	10	15	16
Somnolence	4	4	9	12	12
Headache	23	20	22	29	25
Tremor	2	2	3	9	9
Paraesthesia	1	2	2	1	3
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
Irritability	1	2	2	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
Rash	<1	1	1	2	<1
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
a: Percentage based on the number of patients (placebo, n = 636; Pristiq 50 mg, n = 317; Pristiq 100 mg, n = 424; Pristiq 200 mg, n = 307; Pristiq 400 mg, n = 317).

Sexual function adverse reactions

Table 4 shows the incidence of sexual function adverse reactions that occurred in ≥ 2% of Pristiq treated MDD patients in any fixed-dose group (8-week, placebo-controlled, fixed and flexible-dose, pre-marketing clinical studies).

Table 4: Sexual Function Disorders: Adverse Reactions (≥ 2% in Mena or Womenb in any Pristiq Group) During the On-Therapy Period

		Pristiq
System Organ Class Preferred Term	Placebo	50 mg	100 mg	200 mg	400 mg
a: Percentage based on the number of men (placebo, n = 239; Pristiq 50 mg, n = 108; Pristiq 100 mg, n = 157; Pristiq 200 mg, n = 131; Pristiq 400 mg, n = 154). b: Percentage based on the number of women (placebo, n = 397; Pristiq 50 mg, n = 209; Pristiq 100 mg, n = 267; Pristiq 200 mg, n = 176; Pristiq 400 mg, n = 163).
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
Women only
Anorgasmia	0	1	1	0	3

Other adverse reactions observed in pre-marketing clinical studies

Other infrequent adverse reactions, not described elsewhere in section 6.1, occurring at an incidence of < 2% in MDD patients treated with Pristiq were:

Immune system disorders – Hypersensitivity.

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

Nervous system disorders – Convulsion, syncope, extrapyramidal disorder.

Musculoskeletal and connective tissue disorders – Musculoskeletal stiffness.

Psychiatric disorders – Depersonalization, hypomania, bruxism.

Respiratory, thoracic and mediastinal disorders – Epistaxis.

Vascular disorders – Orthostatic hypotension.

In clinical studies, there were uncommon reports of ischemic cardiac adverse events, 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 [see Warnings and Precautions (5.7)].

Discontinuation events

Adverse events reported in association with abrupt discontinuation, dose reduction or tapering of treatment in MDD clinical studies at a rate of ≥ 5% include: dizziness, nausea, headache, irritability, insomnia, diarrhea, anxiety, abnormal dreams, fatigue, and hyperhidrosis. In general, discontinuation events occurred more frequently with longer duration of therapy [see Dosage and Administration (2.4) and Warnings and Precautions (5.9)].

Laboratory, ECG and vital sign changes observed in MDD clinical studies

The following changes were observed in placebo-controlled, short-term, pre-marketing 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 [see Warnings and Precautions (5.8)].

The percentage of patients who exceeded a predetermined threshold value is shown in Table 5.

Table 5: Incidence (%) of Patients With Lipid Abnormalities of Potential Clinical Significance*

		Pristiq
	Placebo	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 fixed-dose controlled studies. This proteinuria was not associated with increases in BUN or creatinine and was generally transient.

Table 6: Incidence (%) of Patients with Proteinuria in the Fixed-dose Clinical Studies

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

ECG changes

Electrocardiograms were obtained from 1,492 Pristiq treated patients with major depressive disorder and 984 placebo-treated patients in clinical studies lasting up to 8 weeks. No clinically relevant differences were observed between Pristiq treated and placebo-treated patients for QT, QTc, PR, and QRS intervals. In a thorough QTc study with prospectively determined criteria, desvenlafaxine did not cause QT prolongation. No difference was observed between placebo and desvenlafaxine treatments for the QRS interval.

Vital sign changes

Table 7 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 7: Mean Changes in Vital Signs at Final on Therapy for All Short-term, Fixed-dose Controlled Studies

		Pristiq
	Placebo	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

At the final on-therapy assessment in the 6-month, double-blind, placebo-controlled phase of a long-term study in patients who had responded to Pristiq during the initial 12-week, open-label phase, there was no statistical difference in mean weight change between Pristiq and placebo-treated patients.

Orthostatic hypotension

In the short-term, placebo-controlled clinical studies with doses of 50-400 mg, systolic orthostatic hypotension (decrease ≥ 30 mm Hg from supine to standing position) occurred more frequently in patients ≥ 65 years of age receiving Pristiq (8.0%, 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).

Adverse Reactions Identified During Post-Approval Use

The following adverse reaction has been identified during post-approval use of Pristiq. Because post-approval 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 – Angioedema.

Adverse Reactions Reported With Other SNRIs

Although the following are not considered adverse reactions for Pristiq, they are adverse reactions for other SNRIs and may also occur with Pristiq: gastrointestinal bleeding, hallucinations, photosensitivity reactions and severe cutaneous reactions (such as Stevens-Johnson Syndrome, toxic epidermal necrolysis, and/or erythema multiforme).

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Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects including nausea (up to 41%), dry mouth (up to 25%), diarrhea (up to 11%), constipation (up to 14%), and vomiting (up to 9%) have been reported. Postmarketing reports have included decreased appetite.

Nervous system

Nervous system side effects including headache (up to 29%), dizziness (up to 16%), somnolence (up to 12%), tremor (up to 9%), paraesthesia (up to 3%), dysgeusia (up to 2%), and disturbance in attention (up to 2%) have been reported. Convulsion, syncope, and extrapyramidal disorders have been reported infrequently. Postmarketing reports have included anxiety, insomnia and vertigo.

Dermatologic

Dermatologic side effects including hyperhidrosis (up to 21%), rash (up to 2%), and angioedema have been reported. Severe cutaneous reactions (such as Stevens-Johnson Syndrome, toxic epidermal necrolysis, and/or erythema multiforme) have been reported with other SNRIs.

Psychiatric

Psychiatric side effects including insomnia (up to 15%), anxiety (up to 5%), abnormal dreams (up to 4%), nervousness (up to 2%), and irritability (up to 2%) have been reported. Depersonalization and hypomania have been reported infrequently.

General

General side effects including fatigue (up to 11%), chills (up to 4%), feeling jittery (up to 3%), and asthenia (up to 2%) have been reported.

Genitourinary

Genitourinary side effects including urinary hesitation (up to 2%) have been reported. Effects found in men only have included erectile dysfunction (up to 11%), anorgasmia (up to 8%), delayed ejaculation (up to 7%), decreased libido (up to 6%), ejaculation disorder (up to 5%), abnormal orgasm (up to 3%), ejaculation failure (up to 2%), and sexual dysfunction (up to 2%). Effects found in women only have included anorgasmia (up to 3%).

Metabolic

Metabolic side effects including decreased appetite (up to 10%) and decreased weight (up to 2%) have been reported. Increased total cholesterol (up to 10%), increased LDL cholesterol (up to 2%), fasting triglycerides greater than or equal to 327 mg/dl (up to 6%), and proteinuria greater than or equal to trace, have been reported in the fixed dose controlled studies.

Proteinuria was not associated with increases in BUN or creatinine and was generally transient.

Ocular

Ocular side effects including mydriasis (up to 6%) and blurred vision (up to 4%) have been reported.

Cardiovascular

Cardiovascular side effects including palpitations (up to 3%), tachycardia (up to 2%), hot flushes (up to 2%), and increased blood pressure (up to 2%) have been reported. Orthostatic hypotension has been reported infrequently. In clinical studies, there were uncommon reports of ischemic cardiac adverse events, including myocardial ischemia, myocardial infarction, and coronary occlusion requiring revascularization; these patients had multiple underlying cardiac risk factors.

Respiratory

Respiratory side effects including yawning (up to 4%) have been reported. Epistaxis has been reported infrequently.

Other

Other side effects including tinnitus (up to 2%) have been reported.

Adverse events reported in association with abrupt discontinuation, dose reduction, or tapering of treatment clinical studies on patients with major depressive disorder at a rate of greater than or equal to 5% include: dizziness, nausea, headache, irritability, insomnia, diarrhea, anxiety, abnormal dreams, fatigue, and hyperhidrosis.

In general, discontinuation events occurred more frequently with longer duration of therapy.

Immunologic

Immunologic side effects including hypersensitivity have been reported infrequently.

Hepatic

Hepatic side effects including abnormal liver function tests have been reported infrequently.

Endocrine

Endocrine side effects including increased blood prolactin levels have been reported infrequently.

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