Simponi Side Effects

Generic Name: golimumab

Note: This page contains side effects data for the generic drug golimumab. It is possible that some of the dosage forms included below may not apply to the brand name Simponi.

It is possible that some side effects of Simponi may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to golimumab: solution

As well as its needed effects, golimumab (the active ingredient contained in Simponi) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking golimumab, check with your doctor immediately:

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
Rare
  • 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 golimumab side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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

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[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 pre-existing 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), gastro-esophageal 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]

References

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

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

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

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