Note: This document contains side effect information about trastuzumab. Some dosage forms listed on this page may not apply to the brand name Herceptin.

Summary

Common side effects of Herceptin include: febrile neutropenia, infection, asthenia, dizziness, fever, headache, nausea, pain, skin rash, vomiting, abdominal pain, back pain, diarrhea, flu-like symptoms, insomnia, neutropenia, pharyngitis, rhinitis, chills, and anorexia. Other side effects include: urinary tract infection, anemia, arthralgia, depression, edema, ostealgia, paresthesia, sinusitis, and tachycardia. Continue reading for a comprehensive list of adverse effects.

Applies to trastuzumab: intravenous powder for solution.

Serious side effects of Herceptin

Along with its needed effects, trastuzumab (the active ingredient contained in Herceptin) 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 trastuzumab:

More common

• Black, tarry stools
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody urine
• body aches or pain
• chest pain
• chills
• cough
• decreased frequency or amount of urine
• diarrhea
• difficulty in breathing
• dilated neck veins
• dry mouth
• dryness or soreness of the throat
• ear congestion
• extreme tiredness or weakness
• fever
• general feeling of discomfort or illness
• headache
• hoarseness
• increased blood pressure
• increased cough
• increased thirst
• irregular breathing
• irregular heartbeat
• joint pain
• loss of appetite
• loss of voice
• lower back or side pain
• mood changes
• muscle pain or cramps
• nausea
• numbness or tingling in the hands, feet, or lips
• pain or tenderness around the eyes and cheekbones
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• rapid weight gain
• seizures
• shivering
• sneezing
• sore throat
• stuffy or runny nose
• sweating
• tender, swollen glands in the neck
• tightness in the chest
• trouble in swallowing
• trouble sleeping
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• voice changes
• vomiting

Less common

• Bladder pain
• blindness or vision changes
• blurred vision
• burning of the face or mouth
• burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
• cloudy urine
• clumsiness or unsteadiness
• dizziness
• fast, pounding, or irregular heartbeat or pulse
• frequent urge to urinate
• nervousness
• nosebleed
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• pounding in the ears
• slow heartbeat
• weakness in the hands or feet

Rare

• Decreased ability to exercise
• fainting
• hives, itching, skin rash
• irritation
• joint stiffness or swelling
• neck tenderness or swelling
• redness of the skin

Other side effects of Herceptin

Some side effects of trastuzumab 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

• Back pain
• bone pain
• change in or loss of taste
• cracked lips
• depression
• difficulty in moving
• lack or loss of strength
• stomach pain
• swelling or inflammation of the mouth
• trouble sleeping
• weight decreased

Less common

• Belching
• heartburn
• indigestion
• muscle spasm
• stabbing pain
• stomach discomfort or upset
• upper stomach pain

For Healthcare Professionals

Applies to trastuzumab: intravenous powder for injection.

General

The most common adverse events were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, stomatitis, weight loss, thrombocytopenia, mucosal inflammation, nasopharyngitis, dysgeusia, and myalgia.^[Ref]

Hematologic

Very common (10% or more): Neutropenia (78%), leukopenia (52%), anemia (36%), febrile neutropenia (23%), thrombocytopenia (16%)

Frequency not reported: Hypoprothrombinemia^[Ref]

Cardiovascular

Very common (10% or more): LVEF decrease (44%), congestive heart failure (28%), cardiomyopathy (15%), peripheral edema (10%), tachycardia (10%)

Common (1% to 10%): Hypertension, hypotension, asymptomatic cardiac dysfunction, ejection fraction decreased, palpitation, cardiac arrhythmia, cardiac failure, heart beat irregular, cardiac flutter, lymphedema, hot flush, thrombotic adverse event, supraventricular tachyarrhythmia, vasodilation

Uncommon (0.1% to 1%): Ventricular dysfunction, pericardial effusion

Frequency not reported: Cardiogenic shock, pericarditis, bradycardia, gallop rhythm present, S3 gallop^[Ref]

Hypersensitivity

Very common (10% or more): Infusion-related reactions (54%)

Common (1% to 10%): Hypersensitivity, allergic reaction

Frequency not reported: Anaphylactic reaction, anaphylactic shock^[Ref]

Respiratory

Very common (10% or more): Cough (43%), dyspnea (42%), rhinitis (22%), Grade 2 to 5 pulmonary toxicity (14%), nasopharyngitis (13%), wheezing, epistaxis, rhinorrhea

Common (1% to 10%): Pharyngolaryngeal pain, sinusitis, epistaxis, upper respiratory infection, rhinitis, asthma, lung disorder, pleural effusion

Uncommon (0.1% to 1%): Pulmonary infiltrates, pulmonary hypertension, interstitial pneumonitis

Frequency not reported: Pulmonary insufficiency, pulmonary fibrosis, respiratory distress, respiratory failure, lung infiltration, acute pulmonary edema, acute respiratory distress syndrome, bronchospasm, hypoxia, oxygen saturation decreased, laryngeal edema, pulmonary edema, orthopnea

Postmarketing reports: Bronchospasm, hypoxia, pleural effusions, non-cardiogenic pulmonary edema^[Ref]

Immunologic

Very common (10% or more): Infection (47%), herpes simplex (38%), antibody to trastuzumab (the active ingredient contained in Herceptin) (15%), flu syndrome (12%)

Common (1% to 10%): Neutropenic sepsis, postoperative wound infection, herpes zoster

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

Renal

Very common (10% or more): Renal impairment/failure (18%)

Common (1% to 10%): Grade 3 or 4 renal failure, renal disorder, hyperbilirubinemia

Frequency not reported: Glomerulonephritis membranous, glomerulonephropathy, renal failure

Postmarketing reports: Nephrotic syndrome with pathological evidence of glomerulopathy^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (76%), vomiting (53%), diarrhea (45%), abdominal pain (34%), stomatitis (24%), anorexia (14%)

Common (1% to 10%): Constipation, dyspepsia, dysphagia, lip swelling, pancreatitis, hemorrhoids, dry mouth^[Ref]

Nervous system

Very common (10% or more): Headache (44%), asthenia (42%), fatigue (35%), insomnia (29%), dizziness (24%), paresthesia (23%), peripheral neuritis (23%), neuropathy (13%), dysgeusia (10%), dizziness (13%), tremor, hypoesthesia

Common (1% to 10%): Hypertonia, somnolence, ataxia

Rare (less than 0.1%): Paresis

Frequency not reported: Brain edema^[Ref]

Dermatologic

Very common (10% or more): Rash (38%), nail changes (12%), acne (11%), rash/desquamation (11%), erythema, swelling face, palmar-plantar erythrodysesthesia syndrome, alopecia

Common (1% to 10%): Pruritus, dry skin, ecchymosis, hyperhidrosis, maculopapular rash, onychoclasis, dermatitis, contusion, skin infection, erysipelas, cellulitis

Uncommon (0.1% to 1%): Urticaria

Frequency not reported: Angioedema^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (37%), back pain (34%), bone pain (24%), muscle tightness, myalgia

Common (1% to 10%): Muscle spasm, neck pain, pain in extremity, arthritis^[Ref]

Metabolic

Very common (10% or more): Anorexia (31%), hypokalemia (28%), weight loss (23%)

Frequency not reported: Hyperkalemia

Postmarketing reports: Volume overload^[Ref]

Other

Very common (10% or more): Asthenia (62%), pain (61%), fever (56%), chills (41%), accidental injury (13%)

Common (1% to 10%): Malaise

Uncommon (0.1% to 1%): Deafness

Rare (less than 0.1%): Sudden death

Postmarketing reports: Oligohydramnios or oligohydramnios sequence (including pulmonary hypoplasia, skeletal abnormalities, and neonatal death)^[Ref]

Hepatic

Common (1% to 10%): Hepatocellular injury, hepatitis, liver tenderness

Rare (less than 0.1%): Jaundice

Frequency not reported: Hepatic failure^[Ref]

Ocular

Very common (10% or more): Conjunctivitis, lacrimation increased

Common (1% to 10%): Dry eye

Frequency not reported: Papilledema, retinal hemorrhage^[Ref]

Genitourinary

Common (1% to 10%): Breast inflammation/mastitis, urinary tract infection, cystitis^[Ref]

Psychiatric

Very common (10% or more): Depression (20%), insomnia (14%)

Common (1% to 10%): Anxiety, thinking abnormal

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

Endocrine

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

Oncologic

Frequency not reported: Malignant neoplasm progression, neoplasm progression^[Ref]