Infliximab Side Effects

Medically reviewed by Drugs.com. Last updated on Mar 31, 2024.

Applies to infliximab: intravenous powder for solution.

Other dosage forms:

• powder for solution

Important Warnings This medicine can cause some serious health issues

Intravenous route (Powder for Solution)

Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens.

Discontinue infliximab if a patient develops a serious infection.

Perform test for latent TB; if positive, start treatment for TB prior to starting infliximab.

Monitor all patients for active TB during treatment, even if initial latent TB test is negative.

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab.

Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab.

Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis.

The majority of infliximab cases were reported in patients with Crohn’s disease or ulcerative colitis, most of whom were adolescent or young adult males.

Intravenous route (Powder for Solution)

Warning: Serious Infections and Malignancy Serious Infections Patients treated with infliximab products are at increased risk for developing serious infections that may lead to hospitalization or death.

Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Infliximab-dyyb should be discontinued if a patient develops a serious infection or sepsis.Reported infections include: 1) Active tuberculosis, including reactivation of latent tuberculosis.

Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease.

Patients should be tested for latent tuberculosis before infliximab-dyyb use and during therapy.

Treatment for latent infection should be initiated prior to Infliximab-dyyb use.

Active tuberculosis, including reactivation of latent tuberculosis.

Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease.

Patients should be tested for latent tuberculosis before infliximab-dyyb use and during therapy.

Treatment for latent infection should be initiated prior to Infliximab-dyyb use. 2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis.

Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease.

Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection.

Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. 3) Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.The risks and benefits of treatment with infliximab-dyyb should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with infliximab-dyyb, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.Malignancy Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including infliximab products.Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including infliximab products.

These cases have had a very aggressive disease course and have been fatal.

Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis.

The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in adolescent and young adult males.

Intravenous route (Powder for Solution)

Increased risk of serious infections leading to hospitalization or death, including TB, bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens.

Discontinue infliximab-abda if a patient develops a serious infection.

Perform test for latent TB; if positive, start treatment for TB prior to starting infliximab-abda.

Monitor all patients for active TB during treatment, even if initial latent TB test is negative.

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab.

Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab products.

Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis.

The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis, most of whom were adolescent or young adult males.

Intravenous route (Powder for Solution)

Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens.

Discontinue infliximab-qbtx if a patient develops a serious infection.

Perform test for latent TB; if positive, start treatment for TB prior to starting infliximab-qbtx.

Monitor all patients for active TB during treatment, even if initial latent TB test is negative.

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab products.

Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab products.

Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis.

The majority of cases were reported in patients with Crohn disease or ulcerative colitis, most of whom were adolescent or young adult males.

Intravenous route (Powder for Solution)

Increased risk of serious infections leading to hospitalization or death, including TB, bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens.

Discontinue infliximab-axxq if a patient develops a serious infection.

Perform test for latent TB; if positive, start treatment for TB prior to starting infliximab-axxq.

Monitor all patients for active TB during treatment, even if initial latent TB test is negative.

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab.

Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab products.

Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis.

The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis, most of whom were adolescent or young adult males.

Serious side effects of infliximab

Along with its needed effects, infliximab 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:

More common

• black, tarry stools
• bladder pain
• bloody or cloudy urine
• blurred vision
• body aches or pain
• chest pain
• chills
• cough
• cough producing mucus
• difficult, burning, or painful urination
• difficulty breathing
• dizziness
• dryness or soreness of the throat
• ear congestion
• fever
• frequent urge to urinate
• headache
• hoarseness
• hives, itching, or rash
• loss of voice
• lower back or side pain
• muscle pain
• nervousness
• pain or swelling in the arms or legs
• pain or tenderness around the eyes and cheekbones
• painful or difficult urination
• pale skin
• pounding in the ears
• runny or stuffy nose
• slow or fast heartbeat
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain
• tender, swollen glands in the neck
• tightness in the chest
• trouble breathing
• trouble swallowing
• unusual bleeding or bruising
• unusual tiredness or weakness
• voice changes

Rare

• bleeding gums
• blood in the stool
• blue lips and fingernails
• changes in skin color or tenderness of the foot or leg
• chest discomfort
• confusion
• coughing that sometimes produces a pink frothy sputum
• dark urine
• decreased urination
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fast or noisy breathing
• feeling of discomfort
• general feeling of illness
• general tiredness and weakness
• high fever
• hives
• increased sweating
• irregular or pounding heartbeat
• light-colored stools
• muscle aches
• nausea
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid, shallow breathing
• swelling of the joints
• sunken eyes
• thirst
• upper right abdominal or stomach pain
• vomiting
• unusual weight loss
• wrinkled skin
• yellow skin and eyes

Incidence not known

• back pain, sudden and severe
• blistering, peeling, loosening of the skin
• bloody nose
• burning, tingling, numbness or pain in the hands, arms, feet, or legs
• change in mental status
• clay-colored stools
• dark or bloody urine
• diarrhea
• difficulty with speaking
• dilated neck veins
• double vision
• heavier menstrual periods
• inability to move the arms, legs, or facial muscles
• inability to speak
• loss of appetite
• muscle weakness, sudden and progressing
• red, irritated eyes
• red skin lesions, often with a purple center
• seizures
• sensation of pins and needles
• slow or irregular breathing
• slow speech
• stabbing pain
• temporary vision loss
• vomiting of blood

Other side effects of infliximab

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:

More common

• belching
• difficulty in moving
• feeling of warmth
• heartburn
• indigestion
• muscle stiffness
• redness of the face, neck, arms, and occasionally, upper chest

Less common

• constipation, severe

For Healthcare Professionals

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

General

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 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]

Frequently asked questions

• What are the new drugs for rheumatoid arthritis (RA)?
• What is the mechanism of action of infliximab?
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• What is the difference between Renflexis and Remicade?
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• How many biosimilars have been approved in the United States?
• What is the difference between Ixifi and Remicade?

Further information

Infliximab 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.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer