FDA Drug Safety Communication: Updated information about the drug interaction between linezolid (Zyvox) and serotonergic psychiatric medications

This update is in follow-up to the FDA Drug Safety Communication posted on 7/26/2011: Serious CNS reactions possible when linezolid is given to patients taking certain psychiatric medications.

Safety Announcement

[10/20/2011] The U.S. Food and Drug Administration (FDA) is updating the public on the potential drug interaction between linezolid and serotonergic psychiatric medications.

FDA is providing additional information about the reports of serotonin syndrome. Not all serotonergic psychiatric drugs have an equal capacity to cause serotonin syndrome with linezolid. Most cases from the FDA's Adverse Event Reporting System (AERS) of serotonin syndrome with linezolid occurred in patients taking specific serotonergic psychiatric drugs, namely a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI) (see section I). It is unclear at this time whether linezolid administration in patients receiving other psychiatric drugs with lesser degrees of serotonergic activity poses a comparable risk (see section II).

FDA will update the public when new information is available.

I. Serotonergic psychiatric drugs implicated in the AERS cases of serotonin syndrome with linezolid

Selective Serotonin Reuptake Inhibitors (SSRIs)

 Generic NameFound in Brand Names 
paroxetinePaxil, Paxil CR
fluvoxamineLuvox, Luvox CR
fluoxetineProzac, Symbyax
vilazodone1  Viibryd

1Although the FDA has not received cases of serotonin syndrome to date involving vilazodone, the pharmacology of this drug places it in the SSRI category and suggests that it possesses a risk comparable to that of the SSRIs.

Serotonin Norepinephrine Reuptake Inhibitors (SNRIs)


Generic NameFound in Brand Names     
venlafaxineEffexor, Effexor XR


II. Other psychiatric drugs with varying degress of serotonergic activity for which the risk of serotonin syndrome with linezolid is unclear

Tricyclic Antidepressants (TCAs)


Generic NameFound in Brand Names    
clomipramine              Anafranil
amitriptylineAmitid, Amitril, Elavil, Endep, Etrafon,        
Limbitrol, Triavil
desipramineNorpramin, Pertofrane
imipramineTofranil, Tofranil PM, Janimine,
Pramine, Presamine
nortriptylinePamelor, Aventyl hydrochloride
doxepinSinequan, Zonalon, Silenor
trimipramine                    Surmontil


Monoamine Oxidase Inhibitors (MAOIs)


Generic NameFound in Brand Names
isocarboxazid           Marplan                                            
transdermal selegilineEmsam


Other Psychiatric Medications


Generic NameFound in Brand Names
amoxapine                     Asendin
trazodoneDesyrel, Oleptro, Trialodine
bupropionWellbutrin, Wellbutrin SR, Wellbutrin XL,
mirtazapineRemeron, Remeron Soltab



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