Trastuzumab Side Effects

Medically reviewed by Drugs.com. Last updated on Mar 30, 2024.

Applies to trastuzumab: intravenous powder for solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (powder for solution)

Cardiomyopathy. Administration of trastuzumab products can result in subclinical and clinical cardiac failure.

The incidence and severity were highest in patients receiving trastuzumab with anthracycline-containing chemotherapy regimens.

Evaluate left ventricular function in all patients prior to and during treatment with trastuzumab-dttb.

Discontinue trastuzumab-dttb treatment in patients receiving adjuvant therapy and withhold trastuzumab-dttb in patients with metastatic disease for clinically significant decrease in left ventricular function.Infusion Reactions, Pulmonary Toxicity. Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity.

Symptoms usually occur during or within 24 hours of administration.

Interrupt trastuzumab-dttb infusion for dyspnea or clinically significant hypotension.

Monitor patients until symptoms completely resolve.

Discontinue trastuzumab-dttb for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.Embryo-Fetal Toxicity. Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.

Advise patients of these risks and the need for effective contraception.

Serious side effects of trastuzumab

Along with its needed effects, trastuzumab 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 side effects

• 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 side effects

• 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 side effects

• 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 trastuzumab

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 side effects

• 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 side effects

• 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 adverse events

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 (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]

Frequently asked questions

• How long can you stay on Herceptin and Perjeta?
• What happens after Herceptin treatment?
• How long can I stay on Herceptin?
• What is TDM1 chemotherapy?
• What are biologic drugs and how do they work?
• What biosimilars have been approved in the United States?
• What is Herceptin? Is Herceptin a chemo drug? How does it work?
• How long does Herceptin stay in your body?
• How do Herceptin (trastuzumab) and Perjeta (pertuzumab) work together?

Further information

Trastuzumab side effects can vary depending on the individual. 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