Herceptin Side Effects

Generic Name: trastuzumab

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

Not all side effects for Herceptin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to trastuzumab: intravenous powder for solution

In addition to its needed effects, some unwanted effects may be caused by trastuzumab (the active ingredient contained in Herceptin). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking trastuzumab, check with your doctor or nurse immediately:

More common
  • Dizziness
  • fever or chills
  • headache
  • muscle aches
  • nausea or vomiting
  • shortness of breath
  • skin rash
  • sore throat
  • stuffy or runny nose
  • unusual tiredness or weakness
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
  • wheezing
  • Blue lips and fingernails
  • blurred vision
  • chest pain
  • confusion
  • cough or hoarseness, accompanied by fever or chills
  • faintness or lightheadedness when getting up suddenly from a lying or sitting position suddenly
  • 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
  • trouble with breathing
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 of the side effects that can occur with trastuzumab may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Pain
Less common
  • Numbness or tingling of the hands or feet

For Healthcare Professionals

Applies to trastuzumab: intravenous powder for injection


Cardiovascular side effects including congestive heart failure (7%), tachycardia (5%), angioedema, asymptomatic drops in LVEF, and elevated blood pressure have been reported. Trastuzumab (the active ingredient contained in Herceptin) has also been associated with an increased risk of asymptomatic decreases in ejection fraction and a case report of peripheral vascular toxicity.

A randomized, Phase III trial that was conducted in 2043 women with operable, HER2 overexpressing breast cancer demonstrated a significant increase in cardiotoxicity in patients who were randomized to the trastuzumab-containing arm as compared to patients who received chemotherapy alone. Preliminary analysis of safety data revealed a statistically significant increase in the 3 year cumulative incidence of New York Heart Association Class III and IV congestive heart failure and cardiac death observed in patients who received the trastuzumab-containing regimen (4.1%) compared with control (0.8%). There were no cardiac deaths observed in patients who received the trastuzumab-containing regimen and one cardiac death was observed in the control arm. Final analysis of the cardiac safety data collected in these studies is ongoing.

The infusion of trastuzumab should be interrupted for patients experiencing clinically significant hypotension. Discontinuation of therapy should be strongly considered for patients who develop angioedema.

Trastuzumab is associated with an increased risk of cardiac dysfunction which is greatest in patients receiving concurrent anthracyclines.


General side effects including pain (47%), asthenia (42%), fever (36%), chills (32%), headache (26%), abdominal pain (22%), back pain (22%), infection (20%), flu syndrome (10%), and accidental injury (6%) have been reported.


Gastrointestinal side effects including nausea (33%), diarrhea (25%), vomiting (23%), anorexia (14%), and nausea with vomiting (8%) have been reported.


Adverse reactions requiring interruption or discontinuation of trastuzumab (the active ingredient contained in Herceptin) treatment include pulmonary toxicity. The infusion of trastuzumab should be interrupted for patients experiencing dyspnea. Discontinuation of therapy should be strongly considered for patients who develop acute respiratory distress syndrome.

Respiratory side effects including adult respiratory distress syndrome have been reported. Fifteen patients have been reported to have experienced pulmonary and other adverse events which lead to fatalities. Increased cough (26%), dyspnea (22%), rhinitis (14%), pharyngitis (12%), and sinusitis (9%) have also been reported.


Patients should be monitored closely until signs and symptoms of the hypersensitivity reaction completely resolve. Discontinuation of therapy should be strongly considered for patients who develop anaphylaxis.

Hypersensitivity side effects including fatal anaphylaxis have been reported. There have been sixty-two postmarketing reports of serious adverse events related to the use of trastuzumab. These events have been hypersensitivity, infusion, and/or pulmonary reactions.


Local side effects including infusion reactions (some of which had fatal outcomes) have been reported.


Dermatologic side effects including rash (18%), herpes simplex (2%), and acne (2%) have been reported.

Nervous system

Nervous system side effects including insomnia (14%), dizziness (13%), paresthesia (9%), depression (6%), peripheral neuritis (2%), and neuropathy (1%) have been reported.


Metabolic side effects including peripheral edema (10%) and edema (8%) have been reported.


Musculoskeletal side effects including bone pain (7%) and arthralgia (6%) have been reported.


Genitourinary side effects including urinary tract infection (5%) have been reported.


Hematologic side effects including anemia (4%), leukopenia (3%), neutropenia, and febrile neutropenia have been reported. A case of thrombocytopenia has also been reported.

Deaths due to sepsis in patients with severe neutropenia have been reported in patients receiving trastuzumab and myelosuppressive chemotherapy.


Oncologic side effects including central nervous system metastases have been reported.


Hepatic side effects including a case of hepatotoxicity have been reported.

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