Desvenlafaxine Side Effects

Some side effects of desvenlafaxine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to desvenlafaxine: oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking desvenlafaxine: 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:

• 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;

• headache, slurred speech, severe weakness, muscle cramps, feeling unsteady, fainting, shallow breathing (breathing may stop);

• 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.

Common side effects may include:

• dizziness, drowsiness, anxiety;

• increased sweating;

• mild nausea, loss of 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.

For Healthcare Professionals

Applies to desvenlafaxine: oral tablet extended release

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.

Bruxism has also been reported.

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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