Dostarlimab Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 8, 2023.

Applies to dostarlimab: intravenous solution.

Serious side effects of Dostarlimab

Along with its needed effects, dostarlimab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking dostarlimab:

More common

• Bladder pain
• bloating
• bloody or cloudy urine
• blurred vision or changes in vision
• confusion
• constipation
• dark urine
• darkening of the skin
• depression
• difficult, burning, or painful urination
• difficulty in moving
• dry skin and hair
• eye pain, redness
• fainting
• fast heartbeat
• feeling cold
• frequent urge to urinate
• hair loss
• headache
• hoarseness or husky voice
• indigestion
• irritability
• loss of appetite
• lower back or side pain
• muscle cramps and stiffness
• nausea
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• seizures
• sensitivity of the eye to light
• slow heartbeat
• sore tongue
• stiff neck
• swollen joints
• tearing
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• weight gain
• yellow eyes and skin

Less common

• Agitation
• chest pain or tightness
• chills
• coma
• cough
• cough producing mucus
• decreased urine output
• diarrhea
• dizziness
• fever
• general feeling of discomfort or illness
• hostility
• lethargy
• muscle twitching
• nervousness
• rapid weight gain
• sensitivity to heat
• stomach cramps, tenderness, or pain
• stupor
• sweating
• swelling of the face, feet, lower legs, ankles, or hands
• thickening of bronchial secretions
• trouble sleeping
• watery or bloody diarrhea
• weight loss

Rare

• Anxiety
• back or leg pain
• black, tarry stools
• bleeding gums
• blood in the stools
• blue or pale skin
• blurred vision
• burning, tingling, numbness, or pain in the hands, arms, feet, or legs
• burning feeling in the chest or stomach
• change in vision
• chest pain, possibly moving to the left arm, neck, or shoulder
• drowsiness
• dry mouth
• eye pain
• general body swelling
• inability to move the arms and legs
• indigestion
• joint pain
• light-colored stools
• lightheadedness
• loss of consciousness
• loss of strength or energy
• muscle aches, pain, tenderness, or weakness
• nosebleeds
• numbness or tingling in the fingers, face, or feet
• partial or slight paralysis
• pinpoint red spots on the skin
• rapid, shallow breathing
• redness of the eye
• sensation of pins and needles
• sensitivity of the eye to light
• severe headache
• skin rash, redness, soreness, or itching
• sores, welting, or blisters
• stabbing pain
• stiff neck or back
• stomach discomfort or upset
• sudden numbness and weakness in the arms and legs
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tearing
• upper right abdominal or stomach pain

Incidence not known

• Blistering, peeling, or loosening of the skin
• cracks in the skin
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased thirst
• increased urination
• loss of heat from the body
• red irritated eyes
• red skin lesions, often with a purple center
• red, swollen skin
• scaly skin
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips

For Healthcare Professionals

Applies to dostarlimab: intravenous solution.

General

-The most frequently observed adverse reactions (occurring in 20% or more) were fatigue/asthenia, anemia, rash, nausea, diarrhea, constipation, and vomiting.

-The most common Grade 3 or 4 laboratory abnormalities (seen in 2% or more of patients) were decreased lymphocytes, decreased sodium, increased alanine aminotransferase, increased creatinine, decreased neutrophils, decreased albumin, and increased alkaline phosphatase.^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Myocarditis^[Ref]

Dermatologic

Very common (10% or more): Rash (rash, rash maculo-papular, rash pruritic, erythema, and pemphigoid; up to 21%), pruritus (up to 19%)^[Ref]

Endocrine

Very common (10% or more): Hypothyroidism (up to 11%)

Common (1% to 10%): Hyperthyroidism, adrenal insufficiency

Uncommon (0.1% to 1%): Hypophysitis, thyroiditis^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 32%), diarrhea (up to 29%), constipation (up to 23%), vomiting (up to 23%), abdominal pain (up to 15.1%)

Common (1% to 10%): Colitis, pancreatitis, gastritis

Uncommon (0.1% to 1%): Esophagitis

Frequency not reported: Enterocolitis, hemorrhage, acute pancreatitis^[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (up to 19%)^[Ref]

Hematologic

Very common (10% or more): Anemia (anemia, decreased hemoglobin, iron deficiency, and iron deficiency anemia; up to 35%), decreased lymphocytes (up to 46%), decreased leukocytes (up to 21%), decreased neutrophils (up to 17%)

Uncommon (0.1% to 1%): Autoimmune hemolytic anemia^[Ref]

Hepatic

Very common (10% or more): Hypoalbuminemia (up to 36%), increased transaminases (increased alanine aminotransferase, increased aspartate aminotransferase, increased transaminases, and hypertransaminasemia; up to 13%), increased alkaline phosphatase (up to 31%), increased aspartate aminotransferase (up to 31%), increased alanine aminotransferase (up to 25%), increased total bilirubin (up to 7%)

Uncommon (0.1% to 1%): Hepatitis

Frequency not reported: Hepatocellular injury^[Ref]

Metabolic

Very common (10% or more): Decreased appetite (up to 15%), hyponatremia (up to 29%), hypomagnesemia (up to 28%), hypokalemia (up to 22%), hypercalcemia (up to 8%), hyperkalemia (up to 14%)

Common (1% to 10%): Hypermagnesemia, hypercalcemia

Uncommon (0.1% to 1%): Type 1 diabetes mellitus, diabetic ketoacidosis^[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (up to 10%), arthralgia (up to 16.6%), back pain (up to 12.3%)

Uncommon (0.1% to 1%): Immune-mediated arthritis, polymyalgia rheumatica, myositis^[Ref]

Nervous system

Uncommon (0.1% to 1%): Myasthenia gravis, myasthenic syndrome, encephalitis^[Ref]

Ocular

Uncommon (0.1% to 1%): Uveitis

Frequency not reported: Iridocyclitis^[Ref]

Other

Very common (10% or more): Fatigue (fatigue and asthenia; up to 49%), pyrexia (up to 13%)

Common (1% to 10%): Chills, infusion-related reaction, sepsis

Uncommon (0.1% to 1%): Systemic inflammatory response syndrome^[Ref]

Renal

Very common (10% or more): Increased creatinine (up to 33%)

Common (1% to 10%): Acute kidney injury

Uncommon (0.1% to 1%): Nephritis

Frequency not reported: Tubulointerstitial nephritis^[Ref]

Respiratory

Very common (10% or more): Cough (up to 15%), dyspnea (up to 12.5%)

Common (1% to 10%): Pneumonitis

Frequency not reported: Interstitial lung disease^[Ref]

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer