Applies to ramucirumab: intravenous solution.

Serious side effects of Ramucirumab

Along with its needed effects, ramucirumab 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 ramucirumab:

More common

• Back pain or spasms
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain
• chills
• cloudy urine
• confusion
• cough
• coughing up blood
• decreased urine output
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, slow, pounding, or irregular heartbeat or pulse
• feeling of warmth
• feeling unusually cold
• fever
• headache
• increased thirst
• lower back or side pain
• muscle pain or cramps
• nausea
• nervousness
• nosebleeds
• painful or difficult urination
• pounding in the ears
• redness of the face, neck, arms, and occasionally, upper chest
• seizures
• shakiness in the legs, arms, hands, or feet
• shivering
• sweating
• swelling of the face, hands, ankles, feet, or lower legs
• trembling or shaking of the hands or feet
• trouble breathing
• unusual tiredness or weakness
• vomiting

Less common

• Bleeding gums
• difficulty swallowing
• dizziness
• inability to speak
• increased menstrual flow or vaginal bleeding
• loss of consciousness
• low blood pressure or pulse
• pain in the chest, groin, or legs, especially calves of the legs
• pain or discomfort in the arms, jaw, back, or neck
• pale skin
• paralysis
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• severe constipation
• severe headaches of sudden onset
• severe numbness, especially on one side of the face or body
• slurred speech
• sore throat
• stomach pain, cramping, or burning
• sudden loss of coordination
• sudden onset of slurred speech
• sudden vision changes
• sweating
• temporary blindness
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• vomiting of material that looks like coffee grounds, severe and continuing

Incidence not known

• Full feeling and pain in the upper abdomen
• nausea
• sudden weakness in the arms or legs
• sudden, severe chest pain

Other side effects of Ramucirumab

Some side effects of ramucirumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Cracked lips
• diarrhea
• hair loss or thinning
• swelling or inflammation of the mouth

For Healthcare Professionals

Applies to ramucirumab: intravenous solution.

Gastrointestinal

Very common (10% or more): Diarrhea (32%), abdominal pain (29%), stomatitis (20%), mucosal inflammation, GI hemorrhage events (e.g., hemorrhage, diarrhea hemorrhage, gastric hemorrhage, hematemesis, hematochezia, hemorrhoidal hemorrhage, Mallory-Weiss syndrome, melaena, esophageal hemorrhage, rectal hemorrhage, upper GI hemorrhage) (10%)

Common (1% to 10%): Intestinal obstruction

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

Immunologic

Common (1% to 10%): Anti-ramucirumab antibodies

Uncommon (0.1% to 1%): Infusion related reactions, sepsis^[Ref]

Dermatologic

Common (1% to 10%): Rash, Palmar-plantar erythrodysesthesia syndrome^[Ref]

Hematologic

Very common (10% or more): Neutropenia (54%), leukopenia (34%), thrombocytopenia (13%)^[Ref]

Nervous system

Common (1% to 10%): Headache

Rare (less than 0.1%): Reversible Posterior Leukoencephalopathy Syndrome (RPLS), hepatic encephalopathy^[Ref]

Renal

Very common (10% or more): Proteinuria (17%)^[Ref]

Cardiovascular

Very common (10% or more): Peripheral edema (25%), hypertension (25%)

Common (1% to 10%): Arterial thromboembolic events^[Ref]

Metabolic

Very common (10% or more): Hypoalbuminemia (11%)

Common (1% to 10%): Hyponatremia, hypokalemia, hypoalbuminemia^[Ref]

Other

Very common (10% or more): Fatigue/asthenia (57%), peripheral edema^[Ref]

Respiratory

Very common (10% or more): Epistaxis (31%)^[Ref]

Local

Common (1% to 10%): Infusion-related reactions^[Ref]

Genitourinary

Very common (10% or more): Proteinuria^[Ref]