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
Rare
  • 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

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 (up to 78%), leukopenia (up to 52%), anemia (up to 36%), febrile neutropenia (up to 23%), thrombocytopenia (16%), leukopenia (10.5%)
Frequency not reported: Hypoprothrombinemia[Ref]

Cardiovascular

Very common (10% or more): LVEF decrease (up to 44.3%), congestive heart failure (up to 28%), tachycardia (up to 10%), blood pressure decreased, blood pressure increased, heart beat irregular, palpitation, cardiac flutter, ejection fraction decreased, lymphedema, hot flush
Common (1% to 10%): Asymptomatic cardiac dysfunction, hypertension, thrombotic adverse event, palpitations, cardiac arrhythmias, supraventricular tachyarrhythmia, cardiomyopathy, hypotension, vasodilation
Uncommon (0.1% to 1%): Cardiac failure, cardiac disorder, 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 (up to 54%)
Common (1% to 10%): Hypersensitivity, allergic reaction
Frequency not reported: Anaphylactic reaction, anaphylactic shock[Ref]

Respiratory

Very common (10% or more): Cough increased (up to 43%), dyspnea (up to 42%), rhinitis (up to 22%), Grade 2 to 5 pulmonary toxicity (14.3%), wheezing, epistaxis, rhinorrhea, oropharyngeal pain, cough
Common (1% to 10%): Upper respiratory infection, rhinitis, pharyngolaryngeal pain, asthma, lung disorder, pleural effusion
Uncommon (0.1% to 1%): Pneumonitis, 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 (up to 47%), herpes simplex (up to 38%), pharyngitis (up to 30%), sinusitis (up to 21%), upper respiratory tract infections (19%), urinary tract infection (up to 18%), antibody to trastuzumab (the active ingredient contained in Herceptin) (up to 14.6%), nasopharyngitis (13%), flu syndrome (up to 12%)
Common (1% to 10%): Nasopharyngitis, influenza, urinary tract infection, neutropenic sepsis, cystitis, herpes zoster, influenza, skin infection, rhinitis, erysipelas, cellulitis, pneumonia, post-operative wound infection
Uncommon (0.1% to 1%): Sepsis[Ref]

Renal

Postmarketing reports of pathological evidence of glomerulopathy included membranous glomerulonephritis, focal glomerulosclerosis, and fibrillary glomerulonephritis. Complications included volume overload and congestive heart failure.[Ref]

Very common (10% or more): Renal failure and impairment (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 (up to 76%), vomiting (up to 53%), diarrhea (up to 45%), abdominal pain (up to 34%), stomatitis (24%), nausea and vomiting (18%), lip swelling, pancreatitis, constipation, dyspepsia
Common (1% to 10%): Dysphagia, upper abdominal pain, hemorrhoids, dry mouth[Ref]

Nervous system

Very common (10% or more): Headache (up to 44%), fatigue (35%), insomnia (up to 29%), dizziness (up to 24%), paresthesia (up to 23%), peripheral neuritis (up to 23%), neuropathy (up to 13%), dysgeusia (10%), tremor, hypoesthesia
Common (1% to 10%): Peripheral neuropathy, hypertonia, somnolence, ataxia
Rare (less than 0.1%): Paresis
Frequency not reported: Brain edema[Ref]

Dermatologic

Very common (10% or more): Rash (up to 38%), nail changes (11.5%), acne (up to 11%), rash/desquamation (10.9%), erythema, swelling face, palmar-plantar erythrodysesthesia syndrome, nail disorder, alopecia, nail toxicity
Common (1% to 10%): Pruritus, dry skin, ecchymosis, hyperhidrosis, maculopapular rash, onychoclasis, dermatitis, contusion
Uncommon (0.1% to 1%): Urticaria
Frequency not reported: Angioedema[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 37%), back pain (up to 34%), bone pain (up to 24%), muscle tightness, myalgia
Common (1% to 10%): Muscle spasm, neck pain, pain in extremity, arthritis[Ref]

Metabolic

Very common (10% or more): Anorexia (up to 31%) hypokalemia (28%), weight decrease (23%), weight increased, decreased appetite
Frequency not reported: Hyperkalemia
Postmarketing reports: Volume overload[Ref]

Other

Very common (10% or more): Asthenia (up to 62%), pain (up to 61%), fever (up to 56%), chills (up to 41%), peripheral edema (up to 22%), hot flashes (17.1%), accidental injury (up to 13%), mucosal inflammation (13%), edema (11%), chest pain, influenza-like symptoms
Common (1% to 10%): Edema peripheral, asthenia, malaise
Uncommon (0.1% to 1%): Deafness
Rare (less than 0.1%): Sudden 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

Oligohydramnios sequence included pulmonary hypoplasia, skeletal abnormalities, and neonatal death.[Ref]

Common (1% to 10%): Breast inflammation/mastitis
Postmarketing reports: Oligohydramnios or oligohydramnios sequence[Ref]

Psychiatric

Very common (10% or more): Depression (up to 20%), insomnia
Common (1% to 10%): Anxiety, thinking abnormal[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. "Australian Product Information." O 0

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

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

4. Cathomas R, Goldhirsch A, von Moos R "Drug-induced immune thrombocytopenia." N Engl J Med 357 (2007): 1870-1; author reply 1871

5. Perez EA, Rodeheffer R "Clinical cardiac tolerability of trastuzumab." J Clin Oncol 22 (2004): 322-9

6. Keefe DL "Trastuzumab-associated cardiotoxicity." Cancer 95 (2002): 1592-600

7. Seidman A, Hudis C, Pierri MK, et al. "Cardiac dysfunction in the trastuzumab clinical trials experience." J Clin Oncol 20 (2002): 1215-21

8. Pansegrau GK, Grant DR, Norris B, Gelmon KA "Trastuzumab-associated peripheral vascular toxicity." J Clin Oncol 25 (2007): 1438-40

9. Behr TM, Behe M, Wormann B "Trastuzumab and breast cancer." N Engl J Med 345 (2001): 995-6

10. Srinivasan S, Parsa V, Liu CY, Fontana JA "Trastuzumab-induced hepatotoxicity." Ann Pharmacother 42 (2008): 1497-501

11. Montagna E, Cancello G, D'Agostino D, et al. "Central nervous system metastases in a cohort of metastatic breast cancer patients treated with trastuzumab." Cancer Chemother Pharmacol 63 (2008): 275-80

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