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Golimumab Side Effects

In Summary

Commonly reported side effects of golimumab include: infection. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to golimumab: solution

In addition to its needed effects, some unwanted effects may be caused by golimumab. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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

Minor Side Effects

Some of the side effects that can occur with golimumab 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:

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.[Ref]


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]


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


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


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]


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]


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


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]


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


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]


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


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


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[Ref]


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


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


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


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


Uncommon (0.1% to 1%): Depression, insomnia[Ref]


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


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

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

3. "Product Information. Simponi (golimumab)." Centocor Inc, Malvern, PA.

Not all side effects for golimumab may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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