Cimzia Side Effects
Generic Name: certolizumab
Note: This page contains information about the side effects of certolizumab. Some of the dosage forms included on this document may not apply to the brand name Cimzia.
Not all side effects for Cimzia 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 certolizumab: subcutaneous powder for solution, subcutaneous solution
In addition to its needed effects, some unwanted effects may be caused by certolizumab (the active ingredient contained in Cimzia). In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking certolizumab:More common
- Bladder pain
- bloody or cloudy urine
- body aches or pain
- cough or hoarseness
- difficult, burning, or painful urination
- difficulty with breathing
- ear congestion
- frequent urge to urinate
- loss of voice
- lower back or side pain
- nasal congestion
- runny nose
- sore throat
- unusual tiredness or weakness
- 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
- colds or flu-like symptoms
- frequent urination
- pain in the ankles or knees
- pain in the arms 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
- Blurred vision
- coughing or spitting up blood
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- feeling of warmth
- general feeling of discomfort, illness, or weakness
- inflammation of the joints
- joint pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- muscle aches
- night sweats
- redness of the face, neck, arms, and occasionally, upper chest
- skin rash
- sudden high fever or low-grade fever for months
- swelling of the lymph glands
- 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
Some of the side effects that can occur with certolizumab 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
- Difficulty with moving
- muscle pain or stiffness
For Healthcare Professionals
Applies to certolizumab: subcutaneous kit
During clinical trials, the most serious side effects were serious infections, malignancies, and heart failure. The most common side effects occurring in greater than or equal to 8% of all patient populations combined were upper respiratory infections (18%), rash (9%), and urinary tract infections (8%).
During controlled studies with Crohn's disease, the most common side effects with a higher incidence than placebo and occurring in greater than or equal to 5% of patients were infections (38% certolizumab (the active ingredient contained in Cimzia) 30% placebo), upper respiratory infections (20% certolizumab, 13% placebo), urinary tract infections (7% certolizumab, 6% placebo), and arthralgia (6% certolizumab, 4% placebo). The proportion of patients with Crohn's disease who stopped treatment due to side effects during controlled clinical studies was 8% for certolizumab and 7% for placebo. The most common side effects leading to certolizumab discontinuation (for at least 2 patients and with a higher incidence than placebo) were abdominal pain (0.4% certolizumab, 0.2% placebo), diarrhea (0.4% certolizumab, 0% placebo), and intestinal obstruction (0.4% certolizumab, 0% placebo).
The proportion of patients with rheumatoid arthritis who stopped treatment due to side effects during controlled clinical studies was 5% for certolizumab and 2.5% for placebo. The most common side effects leading to certolizumab discontinuation were tuberculosis infections (0.5%); and pyrexia, urticaria, pneumonia, and rash (0.3%).
The overall rate of tuberculosis (pulmonary, miliary, lymphatic, and peritoneal) is approximately 0.61 per 100 patient-years across all indications. The majority of cases occurred in countries with high endemic rates of tuberculosis. No cases of tuberculosis (0/980) were reported in the US or Canada across all indications.
During clinical studies in Crohn's disease, the development of positive ANA titers was reported in 4% of patients treated with certolizumab (the active ingredient contained in Cimzia) and 2% of patients treated with placebo.
One of 1,564 Crohn's disease patients and 4 of 2,367 rheumatoid arthritis patients treated with certolizumab developed symptoms of a lupus-like syndrome.
Immunologic side effects have included infections (up to 38%), upper respiratory infections (e.g., nasopharyngitis, laryngitis, viral infections), urinary tract infections (e.g., bladder infection, bacteriuria, cystitis), herpes infections, lower respiratory tract infections, and alopecia totalis. Serious infections observed during controlled clinical studies included bacterial and viral infections, pneumonia, tuberculosis, cellulitis, and pyelonephritis. During clinical studies, development of positive ANA titers, symptoms of a lupus-like syndrome, and rare cases of opportunistic infections were reported. Development of antibodies to certolizumab has been reported. The following side effects were reported in antibody-positive Crohn's disease patients (N = 100) at an incidence at least 3% higher compared to antibody-negative patients (N = 1,242): abdominal pain, arthralgia, peripheral edema, erythema nodosum, injection site erythema, injection site pain, pain in extremity, and upper respiratory tract infection. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, or parasitic organisms (including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, and tuberculosis) have been reported with TNF blockers. Postmarketing reports of sarcoidosis have been received.
Cardiovascular side effects have included hypertension (5%), angina pectoris, arrhythmias, atrial fibrillation, cardiac failure (new or worsening), hypertensive heart disease, myocardial infarction, myocardial ischemia, pericardial effusion, pericarditis, stroke, transient ischemic attack, thrombophlebitis, and vasculitis. Systemic vasculitis has been reported with TNF blockers during postmarketing experience.
During rheumatoid arthritis studies, cases of new or worsening heart failure were reported with certolizumab use.
Respiratory side effects have included upper respiratory infections (up to 20%), upper respiratory tract infections (6%), nasopharyngitis (5%), pharyngitis (3%), acute bronchitis (3%), pneumonia, and lower respiratory tract infections.
Dermatologic side effects have included rash (up to 9%), cellulitis, dermatitis, erythema nodosum, and urticaria. Psoriasis-like skin lesions have been associated with TNF blockers. Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and new or worsening psoriasis (all subtypes including pustular and palmoplantar) have been reported with TNF blockers during postmarketing experience.
Genitourinary side effects have included urinary tract infections (up to 8%), pyelonephritis, and menstrual disorder.
Hematologic side effects have included anemia, leukopenia, lymphadenopathy, pancytopenia, and thrombophilia. Rare cases of pancytopenia (including aplastic anemia) have been reported with TNF blockers.
Hepatic side effects have included elevated liver enzymes and hepatitis.
Hypersensitivity side effects have been reported rarely. These have included angioedema, allergic dermatitis, dizziness (postural), dyspnea, hot flush, hypotension, injection site reactions, malaise, pyrexia, rash, serum sickness, and (vasovagal) syncope.
Ocular side effects have included optic neuritis, retinal hemorrhage, and uveitis.
Oncologic side effects have included malignancies; however, the overall incidence was similar for certolizumab-treated and control patients. For some TNF blockers, more cases of malignancies were reported in patients receiving those TNF blockers compared to control patients. Leukemia and hepatosplenic T-cell lymphoma have been reported with TNF blockers during postmarketing experience.
Psychiatric side effects have included anxiety, bipolar disorder, and suicide attempt.
Renal side effects have included nephrotic syndrome and renal failure.
Musculoskeletal side effects have included arthralgia (up to 6%).
Gastrointestinal side effects have included abdominal pain, diarrhea, and intestinal obstruction.
Nervous system side effects have included headache (5%). Rare cases of neurological disorders (including seizure disorder, optic neuritis, and peripheral neuropathy) have been reported. Use of TNF blockers has been associated with rare reports of new onset or 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.
Other side effects have included back pain (4%), pyrexia (3%), and fatigue (3%). Hepatitis B virus reactivation has been reported.
Local side effects have included bleeding and injection site reactions.
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