Certolizumab Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 24, 2023.

Applies to certolizumab: subcutaneous powder for solution, subcutaneous solution.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Certolizumab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

While you are being treated with certolizumab, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Certolizumab may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Check with your doctor right away if you have symptoms of liver problems, such as yellow skin or eyes, dark brown-colored urine, right-sided stomach pain, fever, or severe tiredness.

This medicine may cause other unwanted effects that may not occur until months or years after this medicine is used. A small number of people (including children and teenagers) who have used this type of medicine have developed certain types of cancer (eg, lymphoma, leukemia, skin cancer). Some patients developed a rare type of cancer called lymphoma. Talk with your doctor if you have unusual bleeding, bruising, or weakness, swollen lymph nodes in the neck, underarms, or groin, or unexplained weight loss. Also, check with your doctor right away if your skin has red, scaly patches, or raised bumps that are filled with pus.

Check with your doctor right away if you have more than one of these symptoms: chest pain, decreased urine output, dilated neck veins, extreme fatigue, irregular breathing, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, tightness in the chest, trouble breathing, or weight gain. These may be symptoms of a heart condition called congestive heart failure.

Certolizumab may cause serious allergic reactions. Check with your doctor right away if you have a rash, itching, dizziness, fainting, or lightheadedness, swelling of the face, throat, legs, or feet, or troubled breathing after you use the medicine.

Some people using this medicine developed lupus-like symptoms. Make sure your doctor knows if you start having chest pain, joint pain, or a rash on your cheeks or arms that is sensitive to the sun.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of certolizumab

Along with its needed effects, certolizumab 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 immediately if any of the following side effects occur while taking certolizumab:

Other side effects of certolizumab

Some side effects of certolizumab 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:

For healthcare professionals

Applies to certolizumab: subcutaneous kit.

General adverse events

The most commonly reported side effects were upper respiratory infection (18%), urinary tract infection (18%), and rash (9%)^[Ref]

Cardiovascular

• Common (1% to 10%): Hypertension
• Uncommon (0.1% to 1%): Cardiomyopathies (including heart failure), ischemic coronary artery disorders, arrhythmias (including atrial fibrillation), palpitations, hypercoagulation (including thrombophlebitis, pulmonary embolism), edema (including peripheral, facial), ecchymoses (including hematoma, petechiae)
• Frequency not reported: Angina pectoris, myocardial infarction, pericardial effusion, stroke
• Rare (less than 0.1%): Pericarditis, atrioventricular block, cerebrovascular accident, arteriosclerosis, Raynaud's phenomenon, livedo reticularis, telangiectasia
• Postmarketing reports: Systemic vasculitis^[Ref]

Respiratory

• Common (1% to 10%): Upper respiratory tract infection, nasopharyngitis, pharyngitis, acute bronchitis, pneumonia, inflammation
• Uncommon (0.1% to 1%): Asthma, pleural effusion, respiratory tract congestion, lower respiratory tract infection, oropharyngeal dryness, cough
• Rare (less than 0.1%): Interstitial lung disease, pneumonitis^[Ref]

Dermatologic

• Common (1% to 10%): Rash
• Uncommon (0.1% to 1%): Alopecia, new onset or worsening of psoriasis (including palmoplantar pustular psoriasis) and related conditions, dermatitis and eczema, sweat gland disorder, skin ulcer, photosensitivity, acne, skin discoloration, dry skin, nail and nail bed disorders skin injuries
• Rare (less than 0.1%): Skin exfoliation and desquamation, bullous conditions, hair texture disorder
• Frequency not reported: Cellulitis, erythema nodosum, urticaria, pruritus
• Postmarketing reports: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infections, pyelonephritis
• Uncommon (0.1% to 1%): Menstrual cycle and uterine bleeding disorders (including amenorrhea), breast disorders, hematuria, bladder symptoms, urethral symptoms
• Rare (less than 0.1%): Sexual dysfunction^[Ref]

Hematologic

• Common (1% to 10%): Eosinophilic disorders, leukopenia (including neutropenia, lymphopenia)
• Uncommon (0.1% to 1%): Anemia, lymphadenopathy, thrombocytopenia, thrombocytosis, blood alkaline phosphatase increased, coagulation time prolonged
• Rare (less than 0.1%): Pancytopenia, splenomegaly, erythrocytosis, white blood cell morphology abnormal, ancytopenia (including aplastic anemia), erythrocytosis
• Frequency not reported: Thrombophilia, hemorrhage, hypercoagulation, hematoma, blood uric acid increased, blood bilirubin increased^[Ref]

Hepatic

• Common (1% to 10%): Hepatitis (including hepatic enzyme increased)
• Uncommon (0.1% to 1%): Hepatopathy (including cirrhosis), cholestasis
• Rare (less than 0.1%): Reactivation of hepatitis B virus (HBV), including fatalities
• Frequency not reported: Elevated liver enzymes^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Drug hypersensitivity (including anaphylactic shock), allergic disorders, auto-antibody positive, angioedema, allergic dermatitis, dizziness (postural), dyspnea, hot flush, hypotension, (vasovagal) syncope, autoantibody positive^[Ref]

Ocular

• Common (1% to 10%): Conjunctivitis
• Uncommon (0.1% to 1%): Visual disorder (including decreased vision), eye and eyelid inflammation, lacrimation disorder, optic neuritis
• Frequency not reported: Retinal hemorrhage, uveitis^[Ref]

Oncologic

• Uncommon (0.1% to 1%): Blood and lymphatic system malignancies (including lymphoma and leukemia), solid organ tumors, non-melanoma skin cancers, pre-cancerous lesions (including oral leukoplakia, melanocytic nevus), benign tumors, cysts (including skin papilloma)
• Rare (less than 0.1%): Gastrointestinal tumors, melanoma
• Frequency not reported: Merkel cell carcinoma^[Ref]

Psychiatric

• Uncommon (0.1% to 1%): Anxiety, mood disorders (including associated symptoms), restlessness
• Rare (less than 0.1%): Suicide attempt, delirium, mental impairment, bipolar disorder^[Ref]

Renal

• Uncommon (0.1% to 1%): Renal impairment
• Rare (less than 0.1%): Nephropathy (including nephritis)^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain, arthralgia, muscle spasms, pain in extremity
• Uncommon (0.1% to 1%): Muscle disorders, blood creatine phosphokinase increased^[Ref]

Gastrointestinal

• Common (1% to 10%): Abdominal pain (including upper abdominal pain), diarrhea, dyspepsia, gastritis, nausea
• Uncommon (0.1% to 1%): Ascites, gastrointestinal infections, abdominal distension, gastrointestinal fistula, odynophagia, oropharyngeal dryness, hypermotility, splenomegaly, pancreatitis, dental infections, gastrointestinal ulceration and perforation, gastrointestinal tract inflammation (any site), stomatitis
• Rare (less than 0.1%): Gastrointestinal stenosis, gastrointestinal obstruction^[Ref]

Nervous system

• Common (1% to 10%): Headaches (including migraine), sensory abnormalities
• Uncommon (0.1% to 1%): Peripheral neuropathies, dizziness, tremor, vertigo, acoustic neuritis, trigeminal neuralgia, Raynaud's phenomenon, cranial nerve inflammation, cranial nerve impairment, dysesthesia, paresthesia
• Rare (less than 0.1%): Seizure, exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis, and with peripheral demyelinating disease, including Guillain-Barre syndrome^[Ref]

Other

• Common (1% to 10%): Pyrexia, fatigue, pain (any site), asthenia, pruritus (any site)
• Uncommon (0.1% to 1%): Tinnitus, vertigo, chills, altered temperature perception, night sweats, flushing, impaired healing, malaise, ear infections
• Rare (less than 0.1%): Fistula (any site)^[Ref]

Local

• Uncommon (0.1% to 1%): Injection site reactions (erythema, itching, hematoma, pain, swelling, bruising)^[Ref]

Metabolic

• Uncommon (0.1% to 1%): Electrolyte imbalance, dyslipidemia, appetite disorders, weight change, electrolyte imbalance, increased alkaline phosphatase levels
• Rare (less than 0.1%): Hemosiderosis^[Ref]

Endocrine

• Rare (less than 0.1%): Thyroid disorders^[Ref]

Immunologic

• Uncommon (0.1% to 1%): Vasculitides, lupus erythematosus
• Rare (less than 0.1%): Angioneurotic edema, sarcoidosis, serum sickness, panniculitis (including erythema nodosum)
• Rare (less than 0.1%): Opportunistic infections, sepsis, tuberculosis, and fungal infections (candidiasis, histoplasmosis, pneumocystosis)
• Frequency not reported: Viral infections (herpes, papillomavirus, influenza), pneumonia, tuberculosis, cellulitis, pyelonephritis bacterial and viral infections, positive ANA titers^[Ref]

See also:

Frequently asked questions

• What are the new drugs for rheumatoid arthritis (RA)?

Further information

Certolizumab 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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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