Drugplain

Effexor XR 150 mg/1

VENLAFAXINE HYDROCHLORIDE · CAPSULE, EXTENDED RELEASE · Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

1 Recall on Record
Plain English

Effexor XR is a capsule, extended release containing venlafaxine hydrochloride at 150 mg/1, taken oral. Manufactured by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc..

Key Facts

Brand Name
Effexor XR
Generic Name
VENLAFAXINE HYDROCHLORIDE
NDC Code (Product)
0008-0836
Manufacturer
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Strength
150 mg/1
Dosage Form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
NDA020699
Marketing Start
11/01/1997

Recall History

1 Recall on Record
Class I03/06/2014

Pfizer Us Pharmaceutical Group

Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250 which was identified as a Tikosyn (dofetilide) capsule.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective6,385 reports
nausea6,127 reports
fatigue5,166 reports
headache5,133 reports
depression4,431 reports
dizziness4,382 reports
anxiety4,306 reports
pain3,929 reports
off label use3,520 reports
insomnia3,446 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Effexor XR is indicated in adults for the treatment of: • Major Depressive Disorder (MDD) [see Clinical Studies (14.1) ] • Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2) ] • Social Anxiety Disorder (SAD) [see Clinical Studies (14.3) ] • Panic Disorder (PD) [see Clinical Studies (14.4) ] Effexor XR is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with: • Major Depressive Disorder (MDD) ( 1 ) • Generalized Anxiety Disorder (GAD) ( 1 ) • Social Anxiety Disorder (SAD) ( 1 ) • Panic Disorder (PD) ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Indication Starting Dose Target Dose Maximum Dose MDD ( 2.2 ) 37.5 –75 mg/day 75 mg/day 225 mg/day GAD ( 2.3 ) 37.5 –75 mg/day 75 mg/day 225 mg/day SAD ( 2.4 ) 75 mg/day 75 mg/day 75 mg/day PD ( 2.5 ) 37.5 mg/day 75 mg/day 225 mg/day • Take once daily with food. Capsules should be taken whole; do not divide, crush, chew, or dissolve ( 2.1 ). • When discontinuing treatment, reduce the dose gradually ( 2.10 , 5.7 ). • Renal impairment: reduce the total daily dose by 25% to 50% in patients with renal impairment. Reduce the total daily dose by 50% or more in patients undergoing dialysis or with severe renal impairment ( 2.9 ). • Hepatic impairment: reduce the daily dose by 50% in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment or hepatic cirrhosis, it may be necessary to reduce the dose by more than 50% ( 2.8 ). 2.1 General Administration Information Administer Effexor XR as a single dose with food, either in the morning or in the evening at approximately the same time each day [see Clinical Pharmacology (12.3) ] . Swallow capsules whole with fluid. Do not divide, crush, chew, or place in water. The capsule may a…

Contraindications

4 CONTRAINDICATIONS Effexor XR is contraindicated in patients: • with known hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation [see Adverse Reactions (6.2) ] . • taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of the risk of serotonin syndrome [see Dosage and Administration (2.11) , Warnings and Precautions (5.2) , and Drug Interactions (7.1) ] . • ŸHypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate, or any excipients in the Effexor XR formulation ( 4 ). • Concomitant use of monoaminoxidase inhibitors (MAOIs) or within 14 days of discontinuing an MAOI ( 4 , 5.2 , 7.1 ).

Drug Interactions

7 DRUG INTERACTIONS 7.1 Drugs Having Clinically Important Interactions with Effexor XR Table 15: Clinically Important Drug Interactions with Effexor XR Monoamine Oxidase Inhibitors (MAOI) Clinical Impact The concomitant use of SNRIs, including Effexor XR, with MAOIs increases the risk of serotonin syndrome. Intervention Concomitant use of Effexor XR is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration (2.11) , Contraindications (4) and Warnings and Precautions (5.2) ]. Other Serotonergic Drugs Clinical Impact Concomitant use of Effexor XR with other serotonergic drugs increases the risk of serotonin syndrome. Intervention Monitor for symptoms of serotonin syndrome when Effexor XR is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. If serotonin syndrome occurs, consider discontinuation of Effexor XR and/or concomitant serotonergic drugs [see Dosage and Administration (2.11) and Warnings and Precautions (5.2) ]. Drugs that Interfere with Hemostasis Clinical Impact Concomitant use of Effexor XR with an antiplatelet or anticoagulant drug may potentiate th…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: • Hypersensitivity [see Contraindications (4) ] • Suicidal Thoughts and Behaviors in Adolescents and Young Adults [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) ] • Weight and Height changes in Pediatric Patients [see Warnings and Precautions (5.10) ] • Appetite Changes in Pediatric Patients [see Warnings and Precautions (5.11) ] • Interstitial Lung Disease and Eosinophilic Pneumonia [see Warnings and Precautions (5.12) ] • Sexual Dysfunction [see Warnings and Precautions (5.13) ] Most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo): nausea, somnolence, dry mouth, sw…

Frequently Asked Questions

What is Effexor XR used for?

Effexor XR contains VENLAFAXINE HYDROCHLORIDE. It is a capsule, extended release taken oral. Consult your doctor for specific uses.

Is Effexor XR a controlled substance?

Effexor XR is not classified as a controlled substance by the DEA.

What is the generic name for Effexor XR?

The generic name for Effexor XR is VENLAFAXINE HYDROCHLORIDE. There are 11 other brand versions of VENLAFAXINE HYDROCHLORIDE.

What is the NDC code for Effexor XR 150 mg/1?

The NDC (National Drug Code) for Effexor XR 150 mg/1 is 0008-0836, listed by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc..

Product NDC

0008-0836

Package NDC

0008-0836-21

Other Effexor XR Dosages

Other Venlafaxine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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