Important Safety Information

WARNING: Risk to unborn babies, low blood counts, and blood clots

Before you begin taking REVLIMID, you must read and agree to all of the instructions in the REVLIMID REMS® program (formerly known as the RevAssist® program).

REVLIMID may cause serious side effects including:

Possible birth defects (deformed babies) or death of an unborn baby. Females who are pregnant or who plan to become pregnant must not take REVLIMID.

REVLIMID is similar to the medicine thalidomide (THALOMID®). We know thalidomide can cause severe life-threatening birth defects. REVLIMID has not been tested in pregnant females. REVLIMID has harmed unborn animals in animal testing.

In females of childbearing potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment.

Females must not get pregnant:

  • for at least 4 weeks before starting REVLIMID
  • while taking REVLIMID
  • during any breaks (interruptions) in your treatment with REVLIMID
  • for at least 4 weeks after stopping REVLIMID

If you become pregnant while taking REVLIMID, stop taking it right away and call your healthcare provider.

REVLIMID causes low white blood cells (neutropenia) and low platelets (thrombocytopenia) in most patients.

REVLIMID causes a higher chance for blood clots in your veins (deep vein thrombosis), lungs (pulmonary embolism), and arteries (heart attack or stroke).

Risk to Unborn Babies

REVLIMID may cause serious birth defects or death of an unborn baby. Do not get pregnant while taking REVLIMID.

Females who can become pregnant


Females and Males

Low white blood cells (neutropenia) and low platelets (thrombocytopenia)

Blood clots

Other serious side effects

Common side effects

Drug interactions

Other important information about REVLIMID

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.