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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
  • chills
  • cough or hoarseness
  • difficult, burning, or painful urination
  • difficulty with breathing
  • ear congestion
  • fever
  • frequent urge to urinate
  • headache
  • loss of voice
  • lower back or side pain
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness
Less common
  • 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
Rare
  • 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
  • inflammation of the joints
  • itching
  • joint pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • muscle aches
  • nausea
  • night sweats
  • redness of the face, neck, arms, and occasionally, upper chest
  • skin rash
  • 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

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
Less common
  • Vomiting

For Healthcare Professionals

Applies to certolizumab: subcutaneous kit

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]

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]

General

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

References

1. "Product Information. Cimzia (certolizumab)." UCB Pharma Inc, Smyrna, GA.

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

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. "Certolizumab (Cimzia) for Crohn's disease." Med Lett Drugs Ther 50 (2008): 81-2

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