Avsola Side Effects

Generic name: infliximab

Medically reviewed by Philip Thornton, DipPharm. Last updated on Dec 31, 2024.

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

Applies to infliximab: powder for solution.

Other dosage forms:

• intravenous powder for solution

Precautions

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Infliximab-dyyb may cause an infusion reaction while you are receiving it or right after the infusion ends. Check with your doctor or nurse right away if you have chest pain, fever, chills, itching, hives, rash, dizziness, fainting, lightheadedness, headache, joint pain, difficulty with swallowing, shortness of breath, trouble breathing, or swelling of the face, tongue, and throat.

Your body's ability to fight an infection may be reduced while you are using infliximab-dyyb. It is very important that you call your doctor at the first sign of any infection. Check with your doctor right away if you have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.

You will need to have a skin test for tuberculosis before you start receiving this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

A small number of people (including children and teenagers) who have used this medicine have developed certain types of cancer. This is more common in patients who have lung diseases (eg, COPD) or are heavy smokers, and in psoriasis patients who have had phototherapy treatment for a long time. Phototherapy treatment is ultraviolet light or sunlight combined with oral medicine to make your skin sensitive to light. Some teenagers and young adults with Crohn disease or ulcerative colitis also developed a rare type of cancer called hepatosplenic T-cell lymphoma. Talk with your doctor if you have unusual bleeding, bruising, or weakness, swollen lymph nodes in the neck, underarms, or groin, unexplained weight loss, or red, scaly patches, or raised bumps with pus on the skin.

Receiving this medicine may increase your risk of getting skin cancer (eg, melanoma, Merkel cell carcinoma) or cervical cancer. If you have any changes or growths on your skin, abnormal vaginal bleeding or pelvic pain, check with your doctor right away.

It is important to have your heart checked closely if you receive infliximab-dyyb. Call your doctor right away if you have difficulty breathing, swelling in the ankles and feet, or a sudden weight gain.

This medicine may increase your chance of having a lupus-like syndrome or a liver disease called autoimmune hepatitis. Check with your doctor right away if you have dark brown-colored urine, fever or chills, a general feeling of discomfort, illness, or weakness, joint pain, light-colored stools, nausea and vomiting, a rash on the cheeks or arms that is worse in the sun, severe tiredness, upper right stomach pain, or yellow eyes and skin.

While you are being treated with infliximab-dyyb, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given with infliximab-dyyb. Your child's vaccinations must be current before receiving infliximab-dyyb. Talk to your child's doctor if you have any questions about this.

If you have a baby while receiving infliximab-dyyb, make sure the baby's doctor knows that you were receiving this medicine. You will need to wait a few months before giving certain vaccines to your baby. Talk to the baby's doctor if you have questions.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes abatacept (Orencia®), anakinra (Kineret®), tocilizumab (Actemra®), or other medicines called biologics that are used to treat the same conditions as infliximab-dyyb. Using these medicines together with infliximab-dyyb may increase your chance of having serious unwanted effects.

Serious side effects of Avsola

Along with its needed effects, infliximab (the active ingredient contained in Avsola) 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 or nurse immediately if any of the following side effects occur while taking infliximab:

Other side effects of Avsola

Some side effects of infliximab 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:

For healthcare professionals

Applies to infliximab: intravenous powder for injection, subcutaneous kit.

General adverse events

One of the most-common reasons for discontinuation of treatment was infusion-related reactions (e.g., dyspnea, flushing, headache, rash)^[Ref]

Immunologic

• Very common (10% or more): Viral infection (e.g., influenza, herpes virus infection)
• Common (1% to 10%): Bacterial infections (e.g., sepsis, cellulitis, abscess), moniliasis
• Uncommon (0.1% to 1%): Tuberculosis, fungal infections (e.g., candidiasis), vaginitis
• Rare (less than 0.1%): Meningitis, opportunistic infections (such as invasive fungal infections [pneumocystosis, histoplasmosis, aspergillosis, coccidioidomycosis, cryptococcosis, blastomycosis], bacterial infections [atypical mycobacterial, listeriosis, salmonellosis], and viral infections [cytomegalovirus]), parasitic infections, hepatitis B reactivation^[Ref]

Respiratory

• Very common (10% or more): Upper respiratory tract infection (32%), sinusitis (14%), pharyngitis (12%), cough (12%), bronchitis (10%)
• Common (1% to 10%): Lower respiratory tract infection (e.g., pneumonia), dyspnea, epistaxis
• Uncommon (0.1% to 1%): Pulmonary edema, bronchospasm, pleurisy, pleural effusion
• Rare (less than 0.1%): Interstitial lung disease (including rapidly progressive disease, lung fibrosis, pneumonitis), adult respiratory distress syndrome
• Frequency not reported: Respiratory insufficiency, pulmonary embolism, shortness of breath^[Ref]

Other

• Common (1% to 10%): Hot flush, flushing, fatigue, fever, chills
• Uncommon (0.1% to 1%): Impaired healing, autoantibody positive
• Rare (less than 0.1%): Granulomatous lesion, complement factor abnormal^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Anaphylactic reaction, lupus-like syndrome, serum sickness or serum sickness-like reaction
• Rare (less than 0.1%): Anaphylactic shock, vasculitis, sarcoid-like reaction
• Frequency not reported: Facial, hand, or lip edema, sore throat^[Ref]

Nervous system

• Very common (10% or more): Headache (18%)
• Common (1% to 10%): Vertigo, dizziness, hypoesthesia, paresthesia
• Uncommon (0.1% to 1%): Seizure, neuropathy
• Rare (less than 0.1%): Transverse myelitis, central nervous system demyelinating disorders (multiple sclerosis-like disease and optic neuritis), peripheral demyelinating disorders (such as Guillain-Barre syndrome, chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy), rheumatoid vasculitis, systemic vasculitis
• Frequency not reported: Dysesthesia, meningitis, brain infarction, neuritis, peripheral neuropathy, Miller Fisher syndrome^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (21%), abdominal pain (12%), diarrhea (12%), dyspepsia (10%)
• Common (1% to 10%): Gastrointestinal hemorrhage, gastroesophageal reflux, constipation, vomiting
• Uncommon (0.1% to 1%): Intestinal perforation, intestinal stenosis, diverticulitis, pancreatitis, cheilitis
• Frequency not reported: Abdominal hernia, abscess, intestinal obstruction, proctalgia, ileus, abdominal hernia, abscess, intestinal obstruction, peritonitis, proctalgia^[Ref]

Cardiovascular

• Common (1% to 10%): Tachycardia, palpitation, chest pain
• Uncommon (0.1% to 1%): Cardiac failure (new onset or worsening), arrhythmia, syncope, bradycardia, peripheral ischemia
• Rare (0.01% to 0.1%): Cyanosis, pericardial effusion, circulatory failure, vasospasm
• Very rare (less than 0.01%): Heart block
• Frequency not reported: Myocardial ischemia/myocardial infarction occurring during or within 2 hours of infusion^[Ref]

Dermatologic

• Very common (10% or more): Rash (10%)
• Common (1% to 10%): Ecchymosis, new onset or worsening psoriasis including pustular psoriasis (primarily palms and soles), urticaria, pruritus, hyperhidrosis, dry skin, fungal dermatitis, alopecia
• Uncommon (0.1% to 1%): Bullous eruption, onychomycosis, rosacea, skin papilloma, hyperkeratosis, abnormal skin pigmentation, cellulitis, eczema/seborrhea, furunculosis, verruca
• Rare (0.01% to 0.1%): Petechia, granulomatous lesion
• Very rare (less than 0.01%): Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, necrotizing fasciitis, bullous skin lesions, aggressive cutaneous T-cell lymphomas
• Postmarketing reports: Worsening of symptoms of dermatomyositis, lichenoid reactions^[Ref]

Oncologic

• Rare (less than 0.1%): Lymphoma, non-Hodgkin's lymphoma, Hodgkin's disease, leukemia, melanoma
• Very rare (0.01% to 0.01%): Breast cancer, colorectal cancer
• Frequency not reported: Hepatosplenic T-cell lymphoma (primarily in adolescents and young adults with Crohn's disease and ulcerative colitis), Merkel cell carcinoma
• Frequency not reported: Nonmelanoma skin cancer, neoplasms (basal cell and breast)^[Ref]

Hepatic

• Common (1% to 10%): Hepatic function abnormal, transaminases increased
• Uncommon (0.1% to 1%): Hepatitis, hepatocellular damage, cholecystitis, cholelithiasis
• Rare (less than 0.1%): Autoimmune hepatitis, jaundice
• Frequency not reported: Liver failure, autoimmune hepatitis, biliary pain, cytomegalovirus^[Ref]

Hematologic

• Common (1% to 10%): Neutropenia, leucopenia, lymphadenopathy
• Uncommon (0.1% to 1%): Thrombocytopenia, lymphopenia, lymphocytosis, thrombophlebitis, hematoma, pyelonephritis
• Rare (less than 0.1%): Agranulocytosis, thrombotic thrombocytopenic purpura, pancytopenia, hemolytic anemia, idiopathic thrombocytopenic purpura,
• Frequency not reported: Aplastic anemia, splenic infarction, splenomegaly^[Ref]

Musculoskeletal

• Common (1% to 10%): Arthralgia, myalgia, back pain
• Uncommon (0.1% to 1%): Tendon injury
• Frequency not reported: Intervertebral disk herniation, infective arthritis, swelling of fingers, paresthesia in the forearm region^[Ref]

Renal

• Common (1% to 10%): Kidney infarction (less than 2%)
• Uncommon (0.1% to 1%): Renal calculus, renal failure
• Very rare (less than 0.01%): IgA nephropathy, pyelonephritis^[Ref]

Metabolic

• Uncommon (0.1% to 1%): Dehydration
• Frequency not reported: Extra-high levels of VLDL-triglycerides^[Ref]

Local

• Very common (10% or more): Injection site reaction (e.g., erythema, pruritus, rash, mild to moderate pain) (27%)^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infection, moniliasis
• Frequency not reported: Menstrual irregularity, herpes simplex, endometritis, dysuria, urethral obstruction^[Ref]

Ocular

• Common (1% to 10%): Conjunctivitis
• Uncommon (0.1% to 1%): Keratitis, periorbital edema, hordeolum
• Rare (0.01% to 0.1%): Endophthalmitis
• Very rare (less than 0.01%): Retrobulbar optic neuritis of the left eye, orbital cellulitis, third nerve palsy, transient visual loss associated with infliximab (the active ingredient contained in Avsola) administration (during or within 2 hours of infusion)
• Frequency not reported: Transient visual loss occurring during or within 2 hours of infusion^[Ref]

Psychiatric

• Common (1% to 10%): Depression, insomnia
• Uncommon (0.1% to 1%): Amnesia, agitation, confusion, somnolence, nervousness
• Rare (less than 0.1%): Apathy
• Frequency not reported: Suicide attempt^[Ref]

See also:

Frequently asked questions

• What are the new drugs for rheumatoid arthritis (RA)?
• What are biosimilar drugs and how do they compare to biologics?
• What are the new drugs for plaque psoriasis?
• What biosimilars have been approved in the United States?
• What causes Plaque Psoriasis?
• What is the mechanism of action of infliximab?
• What is the difference between Inflectra and Remicade?
• What is the difference between Renflexis and Remicade?

Further information

Avsola 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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer