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Effexor XR

Effexor XR(Venlafaxine Hydrochloride Extended-Release) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Effexor XR Side Effects Center

What Is Effexor XR?

Effexor XR (venlafaxine hydrochloride extended-release) is an antidepressant used to treat patients with major depressive disorders such as panic and social disorders. Effexor XR is available as a generic.

What Are Side Effects of Effexor XR?

Common side effects of Effexor XR include:

  • nausea,
  • constipation,
  • insomnia,
  • dizziness,
  • asthenia,
  • drowsiness,
  • dry mouth,
  • nervousness,
  • strange dreams,
  • blurred vision,
  • changes in appetite or weight,
  • decreased sex drive,
  • impotence,
  • difficulty having an orgasm, and
  • increased sweating.

Tell your doctor if you have unlikely but serious side effects of Effexor XR including:

Serious side effects of Effexor XR include clinical worsening of symptoms and suicide risk, especially in younger patients. Tell your doctor if you experience worsening depression or thoughts of suicide while taking Effexor XR.

Dosage for Effexor XR

Effexor XR contains venlafaxine hydrochloride in strengths of 37.5, 75, or 150 mg tablets.

What Drugs, Substances, or Supplements Interact with Effexor XR?

Effexor XR may interact with other medicines that make you sleepy (such as cold or allergy medicines, sedatives, narcotics, sleeping pills, muscle relaxers, and medicines for seizures or anxiety), nonsteroidal anti-inflammatory drugs (NSAIDs), cimetidine, ketoconazole, linezolid, lithium, haloperidol, tramadol, L-tryptophan, warfarin, almotriptan, frovatriptan, sumatriptan, naratriptan, rizatriptan, zolmitriptan, other antidepressants, or other drugs. Tell your doctor all medications and supplements you use. The dose is usually one tablet per day.

Effexor XR During Pregnancy or Breastfeeding

Effexor XR has not been adequately studied in pregnant females; risks of use must be weighed against possible benefits to the mother. Effexor has been detected in breast milk and may cause serious problems for nursing infants. Breastfeeding while using Effexor XR is not recommended. Although there are reports of use of Effexor in pediatric populations, safety and effectiveness has not been established for pediatric patients.

Additional Information

Our Effexor XR Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Effexor XR Consumer Information

Get emergency medical help if you have 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:

  • blurred vision, eye pain or redness, seeing halos around lights;
  • cough, chest tightness, trouble breathing;
  • a seizure (convulsions);
  • unusual bleeding--nosebleeds, bleeding gums, abnormal vaginal bleeding, any bleeding that will not stop;
  • low blood sodium--headache, confusion, problems with thinking or memory, weakness, feeling unsteady; or
  • severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea

Common side effects may include:

  • headache, dizziness, drowsiness, tiredness;
  • feeling anxious, nervous, or jittery;
  • sleep problems, unusual dreams;
  • tremors;
  • fast heartbeats;
  • blurred vision;
  • nausea, vomiting, diarrhea, constipation;
  • changes in weight or appetite;
  • dry mouth, yawning;
  • increased sweating; or
  • sexual problems.

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 Effexor XR (Venlafaxine Hydrochloride Extended-Release)

 

Effexor XR Professional Information

SIDE EFFECTS

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

Clinical Studies Experience

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.

Most Common Adverse Reactions

The most commonly observed adverse reactions in the clinical study database in Effexor XR treated patients in MDD, GAD, SAD, and PD (incidence ≥ 5% and at least twice the rate of placebo) were: nausea (30.0%), somnolence (15.3%), dry mouth (14.8%), sweating (11.4%), abnormal ejaculation (9.9%), anorexia (9.8%), constipation (9.3%), impotence (5.3%) and decreased libido (5.1%).

Adverse Reactions Reported As Reasons For Discontinuation Of Treatment

Combined across short-term, placebo-controlled premarketing studies for all indications, 12% of the 3,558 patients who received Effexor XR (37.5-225 mg) discontinued treatment due to an adverse experience, compared with 4% of the 2,197 placebo-treated patients in those studies.

The most common adverse reactions leading to discontinuation in ≥ 1% of the Effexor XR treated patients in the short-term studies (up to 12 weeks) across indications are shown in Table 7.

Table 7: Incidence (%) of Patients Reporting Adverse Reactions Leading to Discontinuation in Placebo-controlled Clinical Studies (up to 12 Weeks Duration)

Body System
Adverse Reaction		 Effexor XR
n = 3,558		 Placebo
n = 2,197
Body as a whole    
  Asthenia 1.7 0.5
  Headache 1.5 0.8
Digestive system    
  Nausea 4.3 0.4
Nervous system    
  Dizziness 2.2 0.8
  Insomnia 2.1 0.6
  Somnolence 1.7 0.3
Skin and appendages 1.5 0.6
  Sweating 1.0 0.2

Common Adverse Reactions In Placebo-Controlled Studies

The number of patients receiving multiple doses of Effexor XR during the premarketing assessment for each approved indication is shown in Table 8. The conditions and duration of exposure to venlafaxine in all development programs varied greatly, and included (in overlapping categories) open and double-blind studies, uncontrolled and controlled studies, inpatient (Effexor only) and outpatient studies, fixed-dose, and titration studies.

Table 8: Patients Receiving Effexor XR in Premarketing Clinical Studies

Indication Effexor XR
MDD 705a
GAD 1,381
SAD 819
PD 1,314
a In addition, in the premarketing assessment of Effexor, multiple doses were administered to 2,897 patients in studies for
MDD.

The incidences of common adverse reactions (those that occurred in ≥ 2% of Effexor XR treated patients [357 MDD patients, 1,381 GAD patients, 819 SAD patients, and 1,001 PD patients] and more frequently than placebo) in Effexor XR treated patients in short-term, placebo-controlled, fixed-and flexible-dose clinical studies (doses 37.5 to 225 mg per day) are shown in Table 9.

The adverse reaction profile did not differ substantially between the different patient populations.

Table 9: Common Adverse Reactions: Percentage of Patients Reporting Adverse Reactions (≥ 2% and > placebo) in Placebo-controlled Studies (up to 12 Weeks Duration) across All Indications

Body System
Adverse Reaction		 Effexor XR
n = 3,558		 Placebo
n = 2,197
Body as a whole    
  Asthenia 12.6 7.8
Cardiovascular system    
  Hypertension 3.4 2.6
  Palpitation 2.2 2.0
  Vasodilatation 3.7 1.9
Digestive system    
  Anorexia 9.8 2.6
  Constipation 9.3 3.4
  Diarrhea 7.7 7.2
  Dry mouth 14.8 5.3
  Nausea 30.0 11.8
  Vomiting 4.3 2.7
Nervous system    
  Abnormal dreams 2.9 1.4
  Dizziness 15.8 9.5
  Insomnia 17.8 9.5
  Libido decreased 5.1 1.6
  Nervousness 7.1 5.0
  Paresthesia 2.4 1.4
  Somnolence 15.3 7.5
  Tremor 4.7 1.6
Respiratory system    
  Yawn 3.7 0.2
Skin and appendages    
  Sweating (including night sweats) 11.4 2.9
Special senses    
  Abnormal vision 4.2 1.6
Urogenital system    
  Abnormal ejaculation/orgasm (men)a 9.9 0.5
  Anorgasmia (men)a 3.6 0.1
  Anorgasmia (women)b 2.0 0.2
  Impotence (men)a 5.3 1.0
a Percentages based on the number of men (Effexor XR, n = 1,440; placebo, n = 923)
b Percentages based on the number of women (Effexor XR, n = 2,118; placebo, n = 1,274)

Other Adverse Reactions Observed In Clinical Studies

Body as a whole - Photosensitivity reaction, chills

Cardiovascular system - Postural hypotension, syncope, hypotension, tachycardia

Digestive system - Gastrointestinal hemorrhage [see WARNINGS AND PRECAUTIONS], bruxism

Hemic/Lymphatic system - Ecchymosis [see WARNINGS AND PRECAUTIONS]

Metabolic/Nutritional - Hypercholesterolemia, weight gain [see WARNINGS AND PRECAUTIONS], weight loss [see WARNINGS AND PRECAUTIONS]

Nervous system - Seizures [see WARNINGS AND PRECAUTIONS], manic reaction [see WARNINGS AND PRECAUTIONS], agitation, confusion, akathisia, hallucinations, hypertonia, myoclonus, depersonalization, apathy

Skin and appendages - Urticaria, pruritus, rash, alopecia

Special senses - Mydriasis, abnormality of accommodation, tinnitus, taste perversion

Urogenital system - Urinary retention, urination impaired, urinary incontinence, urinary frequency increased, menstrual disorders associated with increased bleeding or increased irregular bleeding (e.g., menorrhagia, metrorrhagia)

Vital Sign Changes

In placebo-controlled premarketing studies, there were increases in mean blood pressure (see Table 10). Across most indications, a dose-related increase in mean supine systolic and diastolic blood pressure was evident in patients treated with Effexor XRs. Across all clinical studies in MDD, GAD, SAD and PD, 1.4% of patients in the Effexor XR groups experienced an increase in SDBP of ≥15 mm Hg along with a blood pressure ≥ 105 mm Hg, compared to 0.9% of patients in the placebo groups. Similarly, 1% of patients in the Effexor XR groups experienced an increase in SSBP of ≥ 20 mm Hg with a blood pressure ≥ 180 mm Hg, compared to 0.3% of patients in the placebo groups.

Table 10: Final On-therapy Mean Changes From Baseline in Supine Systolic (SSBP) and Diastolic (SDBP) Blood Pressure (mm Hg) in Placebo-controlled Studies

Indication
  (Duration)		 Effexor XR Placebo
≤ 75 mg per day > 75 mg per day  
SSBP SDBP SSBP SDBP SSBP SDBP
MDD            
  (8-12 weeks) -0.28 0.37 2.93 3.56 -1.08 -0.10
GAD            
  (8 weeks) -0.28 0.02 2.40 1.68 -1.26 -0.92
  (6 months) 1.27 -0.69 2.06 1.28 -1.29 -0.74
SAD            
  (12 weeks) -0.29 -1.26 1.18 1.34 -1.96 -1.22
  (6 months) -0.98 -0.49 2.51 1.96 -1.84 -0.65
PD            
  (10-12 weeks) -1.15 0.97 -0.36 0.16 -1.29 -0.99

Effexor XR treatment was associated with sustained hypertension (defined as treatment-emergent Supine Diastolic Blood Pressure [SDBP] ≥ 90 mm Hg and ≥ 10 mm Hg above baseline for three consecutive on-therapy visits (see Table 11). An insufficient number of patients received mean doses of Effexor XR over 300 mg per day in clinical studies to fully evaluate the incidence of sustained increases in blood pressure at these higher doses.

Table 11: Sustained Elevations in SDBP in Effexor XR Premarketing Studies

Indication Dose Range (mg per day) Incidence (%)
MDD 75-375 19/705 (3)
GAD 37.5-225 5/1011 (0.5)
SAD 75-225 5/771 (0.6)
PD 75-225 9/973 (0.9)

Effexor XR was associated with mean increases in pulse rate compared with placebo in premarketing placebo-controlled studies (see Table 12) [see WARNINGS AND PRECAUTIONS].

Table 12: Approximate Mean Final On-therapy Increase in Pulse Rate (beats/min) in Effexor XR Premarketing Placebo-controlled Studies (up to 12 Weeks Duration)

Indication (Duration) Effexor XR Placebo
MDD    
  (12 weeks) 2 1
GAD    
  (8 weeks) 2 < 1
SAD    
  (12 weeks) 3 1
PD    
  (12 weeks) 1 < 1

Laboratory Changes

Serum Cholesterol

Effexor XR was associated with mean final increases in serum cholesterol concentrations compared with mean final decreases for placebo in premarketing MDD, GAD, SAD and PD clinical studies (Table 13).

Table 13: Mean Final On-therapy Changes in Cholesterol Concentrations (mg/dL) in Effexor XR Premarketing Studies

Indication (Duration) Effexor XR Placebo
MDD    
  (12 weeks) +1.5 -7.4
GAD    
  (8 weeks) +1.0 -4.9
  (6 months) +2.3 -7.7
SAD    
  (12 weeks) +7.9 -2.9
  (6 months) +5.6 -4.2
PD    
  (12 weeks) 5.8 -3.7

Effexor XR (venlafaxine hydrochloride) extended-release capsules treatment for up to 12 weeks in premarketing placebo-controlled trials for major depressive disorder was associated with a mean final on-therapy increase in serum cholesterol concentration of approximately 1.5 mg/dL compared with a mean final decrease of 7.4 mg/dL for placebo. Effexor XR treatment for up to 8 weeks and up to 6 months in premarketing placebo-controlled GAD trials was associated with mean final on-therapy increases in serum cholesterol concentration of approximately 1.0 mg/dL and 2.3 mg/dL, respectively while placebo subjects experienced mean final decreases of 4.9 mg/dL and 7.7 mg/dL, respectively. Effexor XR treatment for up to 12 weeks and up to 6 months in premarketing placebo-controlled Social Anxiety Disorder trials was associated with mean final on-therapy increases in serum cholesterol concentration of approximately 7.9 mg/dL and 5.6 mg/dL, respectively, compared with mean final decreases of 2.9 and 4.2 mg/dL, respectively, for placebo. Effexor XR treatment for up to 12 weeks in premarketing placebo-controlled panic disorder trials was associated with mean final on-therapy increases in serum cholesterol concentration of approximately 5.8 mg/dL compared with a mean final decrease of 3.7 mg/dL for placebo.

Patients treated with Effexor (immediate release) for at least 3 months in placebo-controlled 12-month extension trials had a mean final on-therapy increase in total cholesterol of 9.1 mg/dL compared with a decrease of 7.1 mg/dL among placebo-treated patients. This increase was duration dependent over the study period and tended to be greater with higher doses. Clinically relevant increases in serum cholesterol, defined as 1) a final on-therapy increase in serum cholesterol ≥50 mg/dL from baseline and to a value ≥261 mg/dL, or 2) an average on-therapy increase in serum cholesterol ≥50 mg/dL from baseline and to a value ≥261 mg/dL, were recorded in 5.3% of venlafaxine-treated patients and 0.0% of placebo-treated patients.

Serum Triglycerides

Effexor XR was associated with mean final on-therapy increases in fasting serum triglycerides compared with placebo in premarketing clinical studies of SAD and PD up to 12 weeks (pooled data) and 6 months duration (Table 14).

Table 14: Mean Final On-therapy Increases in Triglyceride Concentrations (mg/dL) in Effexor XR Premarketing Studies

Indication (Duration) Effexor XR Placebo
SAD 8.2 0.4
  (12 weeks)    
SAD 11.8 1.8
  (6 months)    
PD 5.9 0.9
  (12 weeks)    
PD 9.3 0.3
  (6 months)    

Pediatric Patients

In general, the adverse reaction profile of venlafaxine (in placebo-controlled clinical studies) in children and adolescents (ages 6 to 17) was similar to that seen for adults. As with adults, decreased appetite, weight loss, increased blood pressure, and increased serum cholesterol were observed [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

In pediatric clinical studies, the adverse reaction, suicidal ideation, was observed.

Particularly, the following adverse reactions were observed in pediatric patients: abdominal pain, agitation, dyspepsia, ecchymosis, epistaxis, and myalgia.

Adverse Reactions Identified During Postapproval Use

The following adverse reactions have been identified during postapproval use of Effexor XR. 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:

Body as a whole - Anaphylaxis, angioedema

Cardiovascular system - QT prolongation, ventricular fibrillation, ventricular tachycardia (including torsade de pointes)

Digestive system - Pancreatitis

Hemic/Lymphatic system - Mucous membrane bleeding [see WARNINGS AND PRECAUTIONS], blood dyscrasias (including agranulocytosis, aplastic anemia, neutropenia and pancytopenia), prolonged bleeding time, thrombocytopenia

Metabolic/Nutritional - Hyponatremia [see WARNINGS AND PRECAUTIONS], Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion [see WARNINGS AND PRECAUTIONS], abnormal liver function tests, hepatitis, prolactin increased

Musculoskeletal - Rhabdomyolysis

Nervous system - Neuroleptic Malignant Syndrome (NMS) [see WARNINGS AND PRECAUTIONS], serotonergic syndrome [see WARNINGS AND PRECAUTIONS], delirium, extrapyramidal reactions (including dystonia and dyskinesia), impaired coordination and balance, tardive dyskinesia

Respiratory system - Dyspnea, interstitial lung disease, pulmonary eosinophilia [see WARNINGS AND PRECAUTIONS]

Skin and appendages - Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme

Special senses - Angle-closure glaucoma [see WARNINGS AND PRECAUTIONS]

Read the entire FDA prescribing information for Effexor XR (Venlafaxine Hydrochloride Extended-Release)

&Copy; Effexor XR Patient Information is supplied by Cerner Multum, Inc. and Effexor XR Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.