Note: This document contains side effect information about golimumab. Some dosage forms listed on this page may not apply to the brand name Simponi Aria.
Summary
Common side effects of Simponi Aria include: infection. Other side effects include: malignant neoplasm. Continue reading for a comprehensive list of adverse effects.
Applies to golimumab: solution.
Warning
Intravenous route (Solution)
Serious Infections and MalignancySerious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as histoplasmosis), and other opportunistic infections have occurred in patients receiving golimumab.Discontinue golimumab if a patient develops a serious infection or sepsis.Perform test for latent TB; if positive, start treatment for TB prior to starting golimumab.Monitor all patients for active TB during treatment, even if initial latent TB test is negative.Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which golimumab is a member.
Subcutaneous route (Solution)
Serious Infections and MalignancySerious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as histoplasmosis), and other opportunistic infections have occurred in patients receiving golimumab.Discontinue golimumab if a patient develops a serious infection or sepsis.Perform test for latent TB; if positive, start treatment for TB prior to starting golimumab.Monitor all patients for active TB during treatment, even if initial latent TB test is negative.Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which golimumab is a member.
Serious side effects of Simponi Aria
Along with its needed effects, golimumab (the active ingredient contained in Simponi Aria) 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 golimumab:
More common
- Body aches or pain
- chills
- cough
- difficulty with breathing
- ear congestion
- fever
- headache
- loss of voice
- muscle aches
- sneezing
- sore throat
- stuffy or runny nose
- trouble breathing
- unusual tiredness or weakness
Less common
- Blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- cough with mucus
- diarrhea
- dizziness
- general feeling of discomfort or illness
- hoarseness
- joint pain
- loss of appetite
- nasal congestion
- nausea
- nervousness
- pain or tenderness around the eyes and cheekbones
- painful cold sores or blisters on the lips
- pounding in the ears
- shivering
- slow or fast heartbeat
- sweating
- tender, swollen glands in the neck
- tightness in the chest
- trouble with sleeping
- trouble with swallowing
- voice changes
- vomiting
Rare
- Bone pain
- frequent or painful urination
- redness, soreness, or itching of the skin
- severe stomach pain
- sores, welts, or blisters
- yellow eyes or skin
Incidence not known
- Hives, skin rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red, scaling, or crusted skin
- swelling of the face, throat, or tongue
Other side effects of Simponi Aria
Some side effects of golimumab 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:
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
- burning or stinging of the skin
- difficulty having a bowel movement
For Healthcare Professionals
Applies to golimumab: intravenous solution, subcutaneous solution.
General
The most common side effects were upper respiratory tract infection, sepsis, increased ALT, increased AST, tuberculosis, and anemia. The most serious side effects were serious infections and malignancies.[Ref]
Respiratory
Very common (10% or more): Upper respiratory tract infections (nasopharyngitis, pharyngitis, laryngitis, and rhinitis) (up to 16%)
Common (1% to 10%): Bronchitis, sinusitis
Uncommon (0.1% to 1%): Lower respiratory tract infection (e.g., pneumonia), asthma and related symptoms (such as wheezing and bronchial hyperactivity), interstitial lung disease
Rare (less than 0.1%): Tuberculosis[Ref]
Oncologic
Uncommon (0.1% to 1%): Neoplasms (e.g., skin cancer, squamous cell carcinoma, melanocytic nevus)
Rare (less than 0.1%): Lymphoma, leukemia, melanoma[Ref]
Other
Common (1% to 10%): Pyrexia, asthenia
Rare (less than 0.1%): Impaired healing[Ref]
Cardiovascular
Common (1% to 10%): Hypertension
Uncommon (0.1% to 1%): Congestive heart failure (new onset or worsening), arrhythmia, ischemic coronary artery disorders, thrombosis (e.g., deep venous and aortic), Raynaud's phenomenon, flushing, chest discomfort
Rare (less than 0.1%): Vasculitis (systemic)[Ref]
Nervous system
Common (1% to 10%): Dizziness, headache
Uncommon (0.1% to 1%): Demyelinating disorders (central and peripheral), balance disorders, dysgeusia, paresthesia[Ref]
Hepatic
Common (1% to 10%): Increased ALT and AST
Uncommon (0.1% to 1%): Cholelithiasis, hepatic disorders
Rare (less than 0.1%): Hepatitis B reactivation[Ref]
Hematologic
Common (1% to 10%): Anemia
Uncommon (0.1% to 1%): Leucopenia, thrombocytopenia, pancytopenia
Frequency not reported: Aplastic anemia[Ref]
Immunologic
Common (1% to 10%): Bacterial infections (such as cellulitis), viral infections (such as influenza and herpes), superficial fungal infections, autoantibody positive
Uncommon (0.1% to 1%): Septic shock, sepsis, opportunistic infections (e.g., invasive fungal infections [histoplasmosis, coccidioidomycosis, pneumocytosis], bacterial, atypical mycobacterial infection and protozoal), abscess
Rare (less than 0.1%): Sarcoidosis
Postmarketing reports: Autoimmune lupus-like syndrome[Ref]
Local
Common (1% to 10%): Injection site reactions (e.g., injection site erythema, urticaria, induration, pain, bruising, irritation, paresthesia)[Ref]
Dermatologic
Common (1% to 10%): Pruritus, rash
Uncommon (0.1% to 1%): Psoriasis (new onset or worsening of preexisting psoriasis, palmar/plantar and pustular), urticaria, vasculitis (cutaneous), alopecia, dermatitis
Rare (less than 0.1%): Skin exfoliation[Ref]
Hypersensitivity
Common (1% to 10%): Allergic reactions (bronchospasm, urticaria)
Rare (less than 0.1%): Serious systemic hypersensitivity reactions (including anaphylactic reaction)[Ref]
Endocrine
Uncommon (0.1% to 1%): Hypothyroidism, hyperthyroidism, goiter[Ref]
Gastrointestinal
Common (1% to 10%): Constipation, dyspepsia, gastrointestinal and abdominal pain, nausea
Uncommon (0.1% to 1%): Gastrointestinal inflammatory disorders (e.g., gastritis and colitis), gastroesophageal reflux disease, stomatitis[Ref]
Genitourinary
Uncommon (0.1% to 1%): Breast disorders, menstrual disorders, bladder disorders[Ref]
Metabolic
Uncommon (0.1% to 1%): Increased blood glucose, increased lipids[Ref]
Musculoskeletal
Uncommon (0.1% to 1%): Bacterial arthritis, bone fractures
Rare (less than 0.1%): Infective bursitis, lupus-like syndrome[Ref]
Ocular
Uncommon (0.1% to 1%): Blurred vision, decreased visual acuity, conjunctivitis, eye allergy (e.g., pruritus, irritation)[Ref]
Psychiatric
Uncommon (0.1% to 1%): Depression, insomnia[Ref]
Renal
Uncommon (0.1% to 1%): Renal disorders
Rare (less than 0.1%): Pyelonephritis[Ref]
