Note: This document contains side effect information about golimumab. Some dosage forms listed on this page may not apply to the brand name Simponi.

Summary

Common side effects of Simponi include: infection. Other side effects include: malignant neoplasm. Continue reading for a comprehensive list of adverse effects.

Applies to golimumab: solution.

Serious side effects of Simponi

Along with its needed effects, golimumab (the active ingredient contained in Simponi) 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

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]