Certolizumab Side Effects

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

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

Important warnings This medicine can cause some serious health issues

Subcutaneous route (powder for solution; solution)

Serious Infections-Patients treated with certolizumab pegol are at increased risk for developing serious infections that may lead to hospitalization or death.

Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.Certolizumab pegol should be discontinued if a patient develops a serious infection or sepsis.Reported infections include:Active tuberculosis, including reactivation of latent tuberculosis.

Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease.

Patients should be tested for latent tuberculosis before certolizumab pegol use and during therapy.

Treatment for latent infection should be initiated prior to certolizumab pegol use.Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis.

Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized disease.

Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection.

Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.The risks and benefits of treatment with certolizumab pegol should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with certolizumab pegol, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.Malignancy-Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which certolizumab pegol is a member. certolizumab pegol is not indicated for use in pediatric patients.

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:

More common side effects

• bladder pain
• bloody or cloudy urine
• body aches or pain
• chills
• cough
• difficult, burning, or painful urination
• difficulty with breathing
• ear congestion
• fever
• frequent urge to urinate
• headache
• hoarseness
• loss of voice
• lower back or side pain
• nasal congestion
• runny nose
• sneezing
• sore throat
• unusual tiredness or weakness

Less common side effects

• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• bloating or swelling of the face, arms, hands, lower legs, or feet
• chest pain
• frequent urination
• pain in the arms, ankles, knees, or legs
• painful, red lumps under the skin, mostly on the legs
• rapid weight gain
• stomach pain
• tingling of the hands or feet
• tightness in the chest
• unusual weight gain or loss

Rare side effects

• blurred vision
• confusion
• coughing or spitting up blood
• diarrhea
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• feeling of warmth
• general feeling of discomfort, illness, or weakness
• itching, skin rash
• joint pain or swelling
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• loss of appetite
• muscle aches
• nausea
• night sweats
• redness of the face, neck, arms, and occasionally, upper chest
• sudden high fever or low-grade fever for months
• sweating
• swelling of the lymph glands
• weakness

Incidence not known

• blistering, peeling, or loosening of the skin
• red skin lesions, often with a purple center
• red, irritated eyes
• red, scaling, or crusted skin
• sores, ulcers, or white spots in the mouth or on the lips

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:

More common side effects

• difficulty with moving
• muscle pain or stiffness

Less common side effects

• vomiting

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]

Frequently asked questions

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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.

Some side effects may not be reported. You may report them to the FDA.

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