Lenalidomide (Revlimid) - Uses, Side Effects, and More

What are the most common side effects of lenalidomide?

The most common side effects of lenalidomide are listed below. Tell your health care provider if you have any of these side effects that bother you.

• Stomach pain, diarrhea, constipation, nausea, and low appetite
• Dizziness, weakness, tiredness, or trouble sleeping
• Low blood cell levels, including low neutrophil levels (neutropenia) and low platelet levels (thrombocytopenia) (see below)
• Fluid retention
• Muscle cramps or spasms
• Back and joint pain
• Infection in the nose or throat, sore throat, cough, fever, or common cold symptoms
• Rash and itching
• Shortness of breath
• Tremor

There may be other side effects of lenalidomide that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of lenalidomide?

While less common, the most serious side effects of lenalidomide are described below, along with what to do if they happen.

Severe Allergic Reactions. Lenalidomide may cause allergic reactions, including a specific type of allergic reaction called DRESS. DRESS stands for drug reaction with eosinophilia and systemic symptoms. It is also sometimes called multiorgan hypersensitivity. This is a reaction that can affect multiple parts of the body, including your liver, kidneys, and heart. Stop taking the medicine and get help right away if you have any of the following symptoms of a serious allergic reaction.

• Breathing problems or wheezing
• Racing heart
• Fever or general ill feeling
• Swollen lymph nodes
• Swelling of the face, lips, mouth, tongue, or throat
• Shortness of breath, trouble swallowing, or throat tightness
• Itching, skin rash, or pale red bumps on the skin called hives
• Nausea or vomiting
• Dizziness, feeling lightheaded, or fainting
• Stomach cramps
• Joint pain
• Dark-colored urine
• Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Low Neutrophil Levels (Neutropenia). Lenalidomide may cause low levels of a type of white blood cell (called neutrophils), which is known as neutropenia. Neutrophils help prevent infection. Having a low level of neutrophils may increase your risk of infection. Make sure to keep all appointments to have your blood cell counts checked, and tell your health care provider right away if you have any of the following symptoms of low neutrophil levels.

• Fever, chills, or sweats
• Tiredness
• Sore throat, cough, or shortness of breath
• Mouth or throat sores
• Swollen lymph nodes

Severely Low Platelet Levels. Lenalidomide can cause you to have a severely low number of platelets in your blood, also called thrombocytopenia. Platelets help form blood clots. Having a low level of platelets may increase your risk of bleeding. Make sure to keep all appointments to have your blood cell counts checked, and tell your health care provider if you have any of the following symptoms of low platelet levels.

• Easy bruising or bleeding
• Bleeding that does not stop
• Nosebleeds

Blood Clots. Lenalidomide may cause blood clots in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism, including a blood clot in the lungs (pulmonary embolism) or deep venous thrombosis (DVT). Stop taking lenalidomide and get emergency help if you have any of the following signs of blood clots.

• Chest pain or pressure
• Fast or abnormal heartbeat
• Trouble breathing
• Pain in your back, jaw, throat, or arm
• Sweating, upset stomach, vomiting, or dizziness
• Sudden weakness on one side of your body
• Sudden and severe headache
• Slurred speech or trouble understanding speech
• Pain, swelling, or tenderness in your arm or leg
• Vision loss
• Bulging eyes
• Double vision

Cancer. Lenalidomide can cause a new cancer to develop or cause a previously treated cancer to recur. These cancers have most often included acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Tell your health care provider about any new symptoms that you may get.

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking lenalidomide. Call your health care provider right away if you have any of the following symptoms of liver damage.

• Nausea or vomiting
• Stomach or belly pain
• Fever
• Weakness or unusual tiredness
• Itching
• Loss of appetite
• Light-colored poop
• Dark-colored urine (pee)
• Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Severe Skin Reactions. Lenalidomide can cause severe skin reactions, called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), that can lead to death if not treated. If you develop a rash, stop lenalidomide and call your health care provider right away. Get emergency help if you have any of the following symptoms of SJS or TEN.

• Painful red or purple skin that looks burned and peels off
• Flat red rash or blisters on your skin, mouth, nose, and genitals
• Red, painful, watery eyes
• Flu-like symptoms, including fever, chills, and muscle aches

Tumor Lysis Syndrome. Lenalidomide can cause a rapid breakdown of cancer cells. This can lead to a condition called tumor lysis syndrome, which can be serious. It is important to drink plenty of water while taking lenalidomide and to keep all appointments for blood tests so your health care provider can see how your body is responding to lenalidomide. Tell your health care provider right away if you have any of the following signs of tumor lysis syndrome while taking lenalidomide.

• Nausea and vomiting
• Weakness
• Swelling or fluid retention
• Shortness of breath
• Muscle cramps
• Seizures

Tumor Flare. Lenalidomide can cause your tumor to grow or your cancer symptoms to worsen, which is called tumor flare. Call your health care provider right away if you have any of the following symptoms of tumor flare.

• Lymph nodes that are sore or swollen
• Pain or swelling at your tumor site
• Chest pain
• Cough
• Trouble breathing

Thyroid Problems. Lenalidomide can affect the function of your thyroid gland, which can lead to low thyroid hormone levels (hypothyroidism) or high thyroid hormone levels (hyperthyroidism). Keep all appointments to have your blood checked. Tell your health care provider if you have any of the following signs of changes in your thyroid hormones.

• Weight gain
• Weight loss
• Feeling cold
• Tiredness that does not go away or continues to worsen
• Constipation
• Feeling nervous, anxious, or cranky
• A swollen thyroid
• Fast or uneven heartbeat or palpitations (pounding in your heart)

Early Death in People With Mantle Cell Lymphoma. In one clinical trial, there was a possible increased risk of experiencing early death in people who were treated with lenalidomide for mantle cell lymphoma. Talk with your health care provider if you have this condition and are considering taking lenalidomide.