Simponi Side Effects

Generic Name: golimumab

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

Some side effects of Simponi may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to golimumab: solution

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
  • unusual tiredness or weakness
Less common
  • Blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • congestion
  • cough with mucus
  • diarrhea
  • dizziness
  • general feeling of discomfort or illness
  • hoarseness
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • nervousness
  • pain or tenderness around the eyes and cheekbones
  • painful cold sores or blisters on the lips
  • pounding in the ears
  • shivering
  • shortness of breath or troubled breathing
  • slow or fast heartbeat
  • sweating
  • tender, swollen glands in the neck
  • tightness of the chest or wheezing
  • trouble with sleeping
  • trouble with swallowing
  • voice changes
  • vomiting
  • Bone pain
  • frequent or painful urination
  • pain and inflammation at the joints
  • redness, soreness, or itching skin
  • severe abdominal or stomach pain
  • sores, welting, or blisters
  • yellow eyes or skin
Incidence not known
  • Hives
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red, scaling, or crusted skin
  • skin rash
  • swelling of the face, throat, or tongue

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 (stool)

For Healthcare Professionals

Applies to golimumab: intravenous solution, subcutaneous solution


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.


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


Uncommon (0.1% to 1%): Neoplasms (e.g., skin cancer, squamous cell carcinoma, melanocytic nevus)
Rare (less than 0.1%): Lymphoma, leukemia, melanoma


Common (1% to 10%): Pyrexia, asthenia
Rare (less than 0.1%): Impaired healing


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)

Nervous system

Common (1% to 10%): Dizziness, headache
Uncommon (0.1% to 1%): Demyelinating disorders (central and peripheral), balance disorders, dysgeusia, paresthesia


Common (1% to 10%): Increased ALT and AST
Uncommon (0.1% to 1%): Cholelithiasis, hepatic disorders
Rare (less than 0.1%): Hepatitis B reactivation


Common (1% to 10%): Anemia
Uncommon (0.1% to 1%): Leucopenia, thrombocytopenia, pancytopenia
Frequency not reported: Aplastic anemia


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


Common (1% to 10%): Injection site reactions (e.g., injection site erythema, urticaria, induration, pain, bruising, irritation, paresthesia)


Common (1% to 10%): Pruritus, rash
Uncommon (0.1% to 1%): Psoriasis (new onset or worsening of pre-existing psoriasis, palmar/plantar and pustular), urticaria, vasculitis (cutaneous), alopecia, dermatitis
Rare (less than 0.1%): Skin exfoliation


Common (1% to 10%): Allergic reactions (bronchospasm, urticaria)
Rare (less than 0.1%): Serious systemic hypersensitivity reactions (including anaphylactic reaction)


Uncommon (0.1% to 1%): Hypothyroidism, hyperthyroidism, goiter


Common (1% to 10%): Constipation, dyspepsia, gastrointestinal and abdominal pain, nausea
Uncommon (0.1% to 1%): Gastrointestinal inflammatory disorders (e.g., gastritis and colitis), gastro-esophageal reflux disease, stomatitis


Uncommon (0.1% to 1%): Breast disorders, menstrual disorders, bladder disorders


Uncommon (0.1% to 1%): Increased blood glucose, increased lipids


Uncommon (0.1% to 1%): Bacterial arthritis, bone fractures
Rare (less than 0.1%): Infective bursitis, lupus-like syndrome


Uncommon (0.1% to 1%): Blurred vision, decreased visual acuity, conjunctivitis, eye allergy (e.g., pruritus, irritation)


Uncommon (0.1% to 1%): Depression, insomnia


Uncommon (0.1% to 1%): Renal disorders
Rare (less than 0.1%): Pyelonephritis

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