Venlafaxine (marketed as Effexor) Information

FDA Alert: 

SSRIs/SNRI/Triptan and Serotonin Syndrome [issued 7/2006]

A life-threatening condition called serotonin syndrome can happen when medicines called selective serotonin/norepinephrine reuptake inhibitors (SNRIs), such as Effexor, and medicines used to treat migraine headaches known as 5-hydroxytryptamine receptor agonists (triptans), are used together...  More about this FDA Alert

This information reflects FDA’s current analysis of data available to FDA concerning these drugs. FDA intends to update this sheet when additional information or analyses become available.

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Effexor Information Antidepressant Use in Children, Adolescents, and Adults (5/2/2007) Healthcare Professional Sheet with FDA Alert  [HTML] [PDF] (7/2006) Prescribing Information (Effexor Label, 2007) Public Health Advisory: Combined Use of 5-Hydroxytryptamine Receptor Agonists (Triptans), Selective Serotonin Reuptake Inhibitors (SSRIs) or Selective Serotonin/Norepinephrine Reuptake Inhibitors (SNRIs) May Result in Life-threatening Serotonin Syndrome (7/2006)

 SSRIs/SNRI/Triptan and Serotonin Syndrome (7/2006)
A life-threatening condition called serotonin syndrome (serious changes in how your brain, muscles and digestive system work due to high levels of serotonin in the body) can happen when medicines called selective serotonin reuptake inhibitors (SSRIs), such as Effexor, and medicines used to treat migraine headaches known as 5-hydroxytryptamine receptor agonists (triptans), are used together. Signs and symptoms of serotonin syndrome include the following:

restlessness diarrhea hallucinations coma loss of coordination nausea

fast heart beat vomiting increased body temperature fast changes in blood pressure overactive reflexes

Serotonin syndrome may be more likely to occur when starting or increasing the dose of an SSRI or a triptan. This information comes from reports sent to FDA and knowledge of how these medicines work. If you take migraine headache medicines, ask your healthcare professional if your medicine is a triptan.

Before you take Effexor and a triptan together, talk to your healthcare professional. If you must take these medicines together, be aware of the possibility of serotonin syndrome, and get medical care right away if you think serotonin syndrome is happening to you.

• Healthcare Professional Sheet with FDA Alert [HTML] [PDF]
• Public Health Advisory: SSRIs/SNRI/Triptan and Serotonin Syndrome (7/2006)

Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.