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Trastuzumab Side Effects

In Summary

Commonly reported side effects of trastuzumab 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. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to trastuzumab: intravenous powder for solution

Warning

Intravenous route (Powder for Solution)

Trastuzumab can result in subclinical and clinical cardiac failure, with the greatest risk and severity upon concurrent administration with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue trastuzumab in patients receiving adjuvant therapy and withhold trastuzumab for a clinically significant decrease in left ventricular function. Serious and fatal infusion reactions and pulmonary toxicity may occur during or within 24 hours after administration. Discontinue trastuzumab if signs of anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome are noted. Exposure during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception.

Intravenous route (Powder for Solution)

Administration of trastuzumab products can result in subclinical and clinical cardiac failure, with the greatest risk and severity upon concurrent administration with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue trastuzumab-dkst in patients receiving adjuvant therapy and withhold trastuzumab-dkst for a clinically significant decrease in left ventricular function. Serious and fatal infusion reactions and pulmonary toxicity may occur during or within 24 hours after administration. Discontinue trastuzumab-dkst if signs of anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome are noted. Exposure during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception.

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

Less Common

  • Bloody nose
  • cough
  • diarrhea
  • difficult or labored breathing
  • ear congestion or pain
  • fast or irregular heartbeat
  • general feeling of discomfort or illness
  • head congestion
  • hoarseness or other voice changes
  • increased cough
  • joint pain
  • loss of appetite
  • nasal congestion
  • pain or tenderness around the eyes and cheekbones
  • shivering
  • sneezing
  • sweating
  • swelling of the feet or lower legs
  • tightness in the chest
  • trouble with sleeping
  • vomiting

Rare

  • Blue lips and fingernails
  • blurred vision
  • chest pain
  • confusion
  • cough or hoarseness, accompanied by fever or chills
  • faintness or lightheadedness when suddenly getting up from a lying or sitting position
  • itching
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, feet, or sex organs
  • lower back or side pain, accompanied by fever or chills
  • painful or difficult urination, accompanied by fever or chills
  • pale skin
  • redness of the skin

Incidence Not Known

  • Black, tarry stools
  • bloody or cloudy urine
  • sores, ulcers, or white spots in the mouth
  • unusual bleeding or bruising
  • weight gain

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

  • Difficulty in moving
  • metallic taste in the tongue
  • muscle pain or stiffness
  • pain
  • weight loss

Less Common

  • Numbness or tingling of the hands or feet

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 (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]

References

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

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Ogivri (trastuzumab)." Mylan GmbH, Morgantown, WV.

4. "Product Information. Herceptin (trastuzumab)." Genentech, South San Francisco, CA.

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.

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