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VENLAFAXINE
VENLAFAXINE is a drug. It is currently FDA-approved (first approved 1993).
Venlafaxine is a small molecule inhibitor of the sodium-dependent serotonin transporter, classified as an antidepressant. It has been studied for various conditions, including depression, anxiety disorder, chronic low back pain, and cardiovascular diseases, often in combination with other treatments or interventions.
At a glance
| Generic name | VENLAFAXINE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1993 |
Approved indications
Boxed warnings
- Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of venlafaxine tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Venlafaxine tablets are not approved for use in pediatric patients (see WARNINGS: Clinical Worsening and Suicide Risk , PRECAUTIONS: Information for Patients , and PRECAUTIONS: Pediatric Use ).
Common side effects
- Nausea
- Somnolence
- Dry mouth
- Sweating
- Abnormal ejaculation
- Anorexia
- Constipation
- Impotence
- Decreased libido
- Asthenia
- Hypertension
- Palpitation
Key clinical trials
- Venlafaxine as Adjunct Therapy in Rheumatoid Arthritis (PHASE2)
- The Analgesic Efficacy and Safety of Venlafaxine for Prevention of Postherpetic Neuralgia in Patients With Acute Herpes Zoster (NA)
- A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats
- Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
- The Efficacy and Safety of Short Term S-ketamine Infusion as an Adjunctive Therapy in Patients With Fibromyalgia (NA)
- The Analgesic Efficacy and Safety of Desvenlafaxine in Patients With Herpes Zoster (NA)
- Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure (PHASE3)
- Desvenlafaxine for Preventive Treatment of Frequent Episodic Tension-type Headache (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- VENLAFAXINE CI brief — competitive landscape report
- VENLAFAXINE updates RSS · CI watch RSS
Frequently asked questions about VENLAFAXINE
What is VENLAFAXINE?
When was VENLAFAXINE approved?
What development phase is VENLAFAXINE in?
What are the side effects of VENLAFAXINE?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing