Side Effects of Rituximab

Common Side Effects

Rituximab has been studied thoroughly in clinical trials. In some of these studies, the side effects that occurred in a group of people who were given rituximab were documented and then compared to the problems that occurred in a similar group of people given a placebo (in this case, an injection with no active ingredient).
 
As a result, it was possible to see what side effects occurred, how often they appeared, and how they compared to the group given the placebo. In some studies (such as cancer studies), it would have been unethical to use a placebo; in these cases, placebos were not used.
 
Some of the studies treated people with just rituximab, while other studies combined rituximab with other medications, such as methotrexate or chemotherapy medications. To help distinguish between the side effects caused by rituximab and the side effects probably caused by the other medications, the following information was taken only from studies that used rituximab alone, without combining it with other medications.
 
The most common side effects of rituximab that were reported in clinical trials included:
 
  • Fever -- in up to 53 percent of people
  • Low lymphocytes (a type of white blood cell) -- up to 48 percent
  • Chills -- up to 33 percent
  • Infections -- up to 31 percent
  • General weakness -- up to 26 percent
  • Nausea -- up to 23 percent
  • Headaches -- up to 19 percent
  • Diarrhea -- up to 17 percent
  • Muscle spasms -- up to 17 percent
  • Anemia -- up to 16 percent
  • Swelling (water retention) in the hands or feet -- up to 16 percent 
  • Night sweats -- up to 15 percent
  • Rash -- up to 15 percent.
     
Other common reactions (seen in 5 to 14 percent of people) included:
 
  • Abdominal pain (stomach pain)
  • Back pain
  • General pain
  • Throat irritation
  • Flushing
  • Low white blood cells
  • Low blood platelets
  • Low neutrophils (a certain type of white blood cell)  
  • Itching
  • Hives
  • Cough
  • Runny or stuffy nose
  • Difficulty breathing
  • Wheezing
  • Sinus infections
  • High blood sugar
  • Increased LDL cholesterol ("bad" cholesterol)
  • Vomiting
  • Muscle pain
  • Joint pain
  • High blood pressure (hypertension) or low blood pressure (hypotension)

 

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