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Pembrolizumab Side Effects

In Summary

More frequently reported side effects include: hyperthyroidism. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to pembrolizumab: intravenous powder for solution, intravenous solution

As well as its needed effects, pembrolizumab may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking pembrolizumab, check with your doctor or nurse immediately:

More common:
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • body aches or pain
  • chills
  • constipation
  • cough
  • depressed mood
  • difficulty with breathing
  • difficulty with moving
  • dry skin and hair
  • ear congestion
  • feeling cold
  • fever
  • hair loss
  • headache
  • hoarseness or husky voice
  • loss of voice
  • muscle cramps, pain, and stiffness
  • pain in the joints
  • pale skin
  • rapid weight gain
  • runny or stuffy nose
  • slowed heartbeat
  • sneezing
  • sore throat
  • tingling of the hands or feet
  • trouble breathing
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
Less common:
  • Chest pain
  • general feeling of discomfort or illness
  • nervousness
  • pain
  • sensitivity to heat
  • stomach cramps
  • sweating
  • tenderness
  • thickening of bronchial secretions
  • trouble sleeping
  • watery or bloody diarrhea
  • weight loss
Rare
  • Back, leg, or stomach pains
  • bleeding gums
  • blurred vision or other change in vision
  • cracks in the skin
  • darkened urine
  • difficulty with moving
  • drowsiness
  • eye pain
  • fast heartbeat
  • general body swelling
  • general tiredness and weakness
  • indigestion
  • light-colored stools
  • loss of appetite
  • loss of heat from the body
  • nausea or vomiting
  • nosebleeds
  • pain, swelling, or redness in the joints
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • red, swollen skin
  • redness of the eye
  • scaly skin
  • seizures
  • sensitivity of the eye to light
  • sore throat
  • tearing
  • upper right abdominal or stomach pain
  • yellow eyes and skin

Minor Side Effects

Some pembrolizumab side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Decreased appetite
  • diarrhea
  • dizziness
  • headache
  • rash

For Healthcare Professionals

Applies to pembrolizumab: intravenous powder for injection, intravenous solution

Cardiovascular

Very common (10% or more): Peripheral edema (up to 17%)[Ref]

Dermatologic

Very common (10% or more): Pruritus (up to 30%), rash (up to 29%), vitiligo (up to 11%)
Uncommon (0.1% to 1%): Exfoliative dermatitis[Ref]

Endocrine

Very common (10% or more): Hyperglycemia (up to 40%), hypertriglyceridemia (up to 25%)
Common (1% to 10%): Hypothyroidism, hyperthyroidism
Uncommon (0.1% to 1%): Hypophysitis, adrenal insufficiency[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 30%), constipation (up to 21%), diarrhea (up to 20%), vomiting (up to 16%), abdominal pain (up to 12%)
Common (1% to 10%): Colitis
Uncommon (0.1% to 1%): Pancreatitis[Ref]

Hematologic

Very common (10% or more): Anemia (up to 55%), immune-mediated hemolytic anemia[Ref]

Hepatic

Very common (10% or more): Hypoalbuminemia (up to 34%), increased aspartate aminotransferase (up to 24%)
Uncommon (0.1% to 1%): Hepatitis[Ref]

Metabolic

Very common (10% or more): Hyponatremia (up to 35%), decreased appetite (up to 26%), hypocalcemia (up to 24%)[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 20%), pain in extremity (up to 18%), myalgia (up to 14%), back pain (up to 12%)
Uncommon (0.1% to 1%): Arthritis, myositis, myasthenic syndrome, rhabdomyolysis[Ref]

Nervous system

Very common (10% or more): Headache (up to 16%), dizziness (up to 11%)
Uncommon (0.1% to 1%): Partial seizures[Ref]

Ocular

Uncommon (0.1% to 1%): Uveitis, optic neuritis[Ref]

Other

Very common (10% or more): Fatigue (up to 47%), chills (up to 14%), pyrexia (up to 11%), sepsis (up to 10%)[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 14%)[Ref]

Renal

Uncommon (0.1% to 1%): Nephritis, renal failure[Ref]

Respiratory

Very common (10% or more): Cough (up to 30%), dyspnea (up to 18%), upper respiratory tract infection (up to 11%)
Common (1% to 10%): Pneumonitis[Ref]

References

1. "Product Information. Keytruda (pembrolizumab)." Merck & Company Inc, Whitehouse Station, NJ.

2. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

It is possible that some side effects of pembrolizumab may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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