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Ogivri Side Effects

Generic Name: trastuzumab

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

For the Consumer

Applies to trastuzumab: intravenous powder for solution

Along with its needed effects, trastuzumab (the active ingredient contained in Ogivri) 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
  • Dizziness
  • fever or chills
  • headache
  • muscle aches
  • nausea or vomiting
  • 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
  • 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


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]


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]


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]


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]


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]


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 Ogivri) (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]


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]


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]


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]


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]


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]


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]


Common (1% to 10%): Hepatocellular injury, hepatitis, liver tenderness
Rare (less than 0.1%): Jaundice
Frequency not reported: Hepatic failure[Ref]


Very common (10% or more): Conjunctivitis, lacrimation increased
Common (1% to 10%): Dry eye
Frequency not reported: Papilledema, retinal hemorrhage[Ref]


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]


Very common (10% or more): Depression (up to 20%), insomnia
Common (1% to 10%): Anxiety, thinking abnormal[Ref]


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


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


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

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

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

Some side effects of Ogivri may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.