Simponi Aria Side Effects

Generic name: golimumab

Medically reviewed by Drugs.com. Last updated on Jun 9, 2024.

Note: This document provides detailed information about Simponi Aria Side Effects associated with golimumab. Some dosage forms listed on this page may not apply specifically to the brand name Simponi Aria.

Applies to golimumab: solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (solution)

Serious Infections and Malignancy. Serious 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 Malignancy. Serious 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 side effects

• 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 side effects

• 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 side effects

• 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 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
• burning or stinging of the skin
• difficulty having a bowel movement

For healthcare professionals

Applies to golimumab: intravenous solution, subcutaneous solution.

General adverse events

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]

Frequently asked questions

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

Further information

Simponi Aria 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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