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Sylatron Side Effects

Generic name: peginterferon alfa-2b

Medically reviewed by Drugs.com. Last updated on Mar 30, 2024.

Note: This document provides detailed information about Sylatron.

Applies to peginterferon alfa-2b: subcutaneous kit Side Effects associated with peginterferon alfa-2b. Some dosage forms listed on this page may not apply specifically to the brand name Sylatron.

Applies to peginterferon alfa-2b: subcutaneous kit.

Important warnings This medicine can cause some serious health issues

  • Alpha interferons may cause mental health problems or make them worse.

    Suicide or suicidal thoughts, thoughts of hurting others, depression, forceful actions, hallucinations, and other mood or behavior problems have happened during treatment and within 6 months after the last dose.

    Relapse of drug addiction has also happened.

    Alpha interferons may also cause or make infections, blood flow problems, or autoimmune diseases worse.

    Sometimes, these may be deadly.

    If you think you have any of these health problems, call your doctor right away. Side effects such as high or low blood pressure, a fast or abnormal heartbeat, chest pain or pressure, trouble breathing, heart attacks, and strokes have happened.

    Closely read the part in this leaflet which lists when to call your doctor.

    Many times, but not every time, these side effects get better after stopping this drug.

Serious side effects of Sylatron

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Other side effects of Sylatron

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

For healthcare professionals

Applies to peginterferon alfa-2b: subcutaneous kit, subcutaneous powder for injection.

General

Nearly all study patients experienced at least 1 side effect. The most common side effects associated with the product used for the treatment of chronic hepatitis C (CHC), with or without ribavirin, have included headache, myalgia, fatigue/asthenia, injection site inflammation/reaction, emotional lability/irritability, nausea, rigors, and fevers. Chills, insomnia, anemia, alopecia, anorexia, weight loss, and rash were also reported very commonly with peginterferon alfa-2b (the active ingredient contained in Sylatron) ribavirin. Serious side effects associated with this drug (with or without ribavirin) have been reported in about 12% of subjects during clinical trials. The most common serious side effects associated with peginterferon alfa-2b/ribavirin were depression and suicidal ideation in less than 1% of subjects. The most common fatal side effects associated with this combination were cardiac arrest, suicidal ideation, and suicide attempt in less than 1% of subjects. In most cases, side effects resolved upon discontinuation of therapy. During clinical trials, 10% to 15% of CHC patients discontinued therapy due to side effects.

The most common side effects associated with the product used for adjuvant treatment of melanoma have included fatigue, increased ALT, increased AST, pyrexia, headache, anorexia, myalgia, nausea, chills, and injection site reaction. The most common serious side effects were fatigue, increased ALT, increased AST, and pyrexia. During a clinical trial, 33% of melanoma patients discontinued therapy due to side effects.[Ref]

Hematologic

CHC Patients:

Melanoma Patients:

Decreased neutrophil counts (alone: 70%; with ribavirin: 85%), anemia (with ribavirin: up to 35%), neutropenia (alone: 6%; with ribavirin: up to 31%), thrombocytopenia (alone: 7%; with ribavirin: 5%), and leukopenia (alone: less than 1%; with ribavirin: up to 10%) have been reported in CHC patients.

WHO grade 3 (21%) and WHO grade 4 (7%) neutropenia and hemoglobin levels below 100 g/L (up to 14%) were reported with peginterferon alfa-2b (the active ingredient contained in Sylatron) ribavirin.

Granulocytopenia (less than 0.75 x 10[9]/L) was reported in 4% and 7% of patients using 0.5 and 1 mcg/kg of peginterferon alfa-2b, respectively. Thrombocytopenia (less than 70 x 10[9]/L) was reported in 1% and 3% of patients using 0.5 and 1 mcg/kg of peginterferon alfa-2b, respectively.

Neutropenia, thrombocytopenia, and anemia occurred more often in hepatitis C virus (HCV)/HIV-coinfected patients. Neutropenia (26%), decreased absolute neutrophil count levels (less than 500 cells/mm3: 4%), decreased platelets (less than 50,000/mm3: 4%), anemia (hemoglobin less than 9.4 g/dL: 12%), and decreased CD4 lymphocytes (8%) were reported in HCV/HIV-coinfected patients receiving peginterferon alfa-2b/ribavirin.

Anemia (all grades: 6%; grade 3/4: less than 1%) has been reported in melanoma patients.

A 48-year-old patient with multiple myeloma experienced severe bone marrow hypoplasia coincident with peginterferon alfa-2b therapy. The patient was taking oral thalidomide for several months prior to adding peginterferon alfa-2b to her regimen; she developed a severe bone marrow hypoplasia while using both drugs. Since she used thalidomide previously and this agent was never stopped, it would appear the peginterferon alfa-2b was responsible for the myelosuppression; however, a possible interaction between thalidomide and interferon alfa-2b cannot be ruled out.[Ref]

Nervous system

CHC Patients:

Melanoma Patients:

Headache (alone: 56%; with ribavirin: up to 62%), dizziness (alone: 12%; with ribavirin: up to 21%), and taste perversion (alone: less than 1%; with ribavirin: 9%) have been reported in CHC patients.

Paresthesia was reported in 5% of HCV/HIV-coinfected patients receiving peginterferon alfa-2b (the active ingredient contained in Sylatron) ribavirin.

Vertigo, migraine headache, paresthesia, hearing impairment, hearing loss, encephalopathy, and peripheral neuropathy have also been reported during postmarketing experience.

Headache (all grades: 70%; grade 3/4: 4%), dysgeusia (all grades: 38%), dizziness (all grades: 35%; grade 3/4: 2%), olfactory nerve disorder (all grades: 23%), and paresthesia (all grades: 21%; grade 3/4: less than 1%) have been reported in melanoma patients.[Ref]

Psychiatric

CHC Patients:

Melanoma Patients:

Anxiety/emotional lability/irritability (alone: 28%; with ribavirin: up to 47%), insomnia (alone: 23%; with ribavirin: up to 41%), depression (alone: 29%; with ribavirin: up to 31%), impaired concentration (alone: 10%; with ribavirin: 17%), agitation (alone: 2%; with ribavirin: 8%), and nervousness (alone: 4%; with ribavirin: 6%) have been reported in CHC patients.

Life-threatening or fatal neuropsychiatric events have been reported in CHC patients with and without a previous psychiatric disorder.

Psychosis and hallucinations have been reported in patients treated with alpha interferons.

Psychoses, hallucinations, and bipolar disorders have also been reported during postmarketing experience.

Depression (all grades: 59%; grade 3/4: 7%) has been reported in melanoma patients.[Ref]

Other

CHC Patients:

Melanoma Patients:

Fatigue/asthenia (alone: 52%; with ribavirin: up to 68%), rigors (alone: 23%; with ribavirin: 48%), fever (alone: 22%; with ribavirin: up to 46%), chills (with ribavirin: up to 39%), weight decrease (alone: 11%; with ribavirin: up to 29%), unspecified pain (with ribavirin: up to 13%), right upper quadrant pain (alone: 8%; with ribavirin: 12%), viral infections (alone: 11%; with ribavirin: 12%), malaise (alone: 7%; with ribavirin: 4%), chest pain (alone: 6%; with ribavirin: 8%), flushing (alone: 6%; with ribavirin: 4%), and fungal infections (alone: less than 1%; with ribavirin: 6%) have been reported in CHC patients.

Influenza-like symptoms may decrease in severity as treatment continues.

Bacterial infection (including sepsis) has also been reported during postmarketing experience.

Fatigue (all grades: 94%; grade 3/4: 16%), pyrexia (all grades: 75%; grade 3/4: 4%), chills (all grades: 63%; grade 3/4: 1%), and decreased weight (all grades: 11%; grade 3/4: less than 1%) have been reported in melanoma patients.[Ref]

Musculoskeletal

CHC Patients:

Melanoma Patients:

Myalgia (alone: 54%; with ribavirin: up to 56%), arthralgia (alone: 23%; with ribavirin: up to 34%), and musculoskeletal pain (alone: 28%; with ribavirin: 21%) have been reported in CHC patients.

Pain in limb (6%) and back pain (5%) were reported in HCV/HIV-coinfected patients receiving peginterferon alfa-2b (the active ingredient contained in Sylatron) ribavirin.

A small number of patients developed mild to moderate gout.

Rhabdomyolysis, myositis, and rheumatoid arthritis have also been reported during postmarketing experience.

Myalgia (all grades: 68%; grade 3/4: 4%) and arthralgia (all grades: 51%; grade 3/4: 3%) have been reported in melanoma patients.[Ref]

Local

CHC Patients:

Melanoma Patients:

Injection site inflammation/reaction (including bruise, itchiness, irritation; alone: 47%; with ribavirin: up to 75%) has been reported in CHC patients.

Injection site reaction (all grades: 62%; grade 3/4: 1.8%) has been reported in melanoma patients.[Ref]

Gastrointestinal

CHC Patients:

Melanoma Patients:

Nausea (alone: 26%; with ribavirin: up to 43%), diarrhea (alone: 18%; with ribavirin: up to 22%), abdominal pain (alone: 15%; with ribavirin: up to 13%), vomiting (alone: 7%; with ribavirin: up to 14%), dry mouth (alone: 6%; with ribavirin: 12%), dyspepsia (alone: 6%; with ribavirin: 9%), and constipation (alone: 1%; with ribavirin: 5%) have been reported in CHC patients.

Oral candidiasis (14%), increased blood amylase (6%), and increased lipase (6%) were reported in HCV/HIV-coinfected patients receiving peginterferon alfa-2b/ribavirin.

Both fatal and nonfatal ulcerative or hemorrhagic/ischemic colitis have been reported within the first 3 months of alpha interferon therapy. Pancreatitis, fatal and nonfatal, has also been reported with the use of alpha interferon therapy.

Pancreatitis has also been reported during postmarketing experience.

Nausea (all grades: 64%; grade 3/4: 3%), diarrhea (all grades: 37%; grade 3/4: 1%), and vomiting (all grades: 26%; grade 3/4: 1%) have been reported in melanoma patients.[Ref]

Metabolic

CHC Patients:

Melanoma Patients:

Hyperbilirubinemia (10% to 14%) and hyperuricemia (33% to 38%), in association with hemolysis, have been reported during combination therapy trials using peginterferon alfa-2b (the active ingredient contained in Sylatron) ribavirin.

Anorexia (alone: 20%; with ribavirin: up to 32%) has been reported in CHC patients.

Decreased appetite (8%) and increased blood lactic acid (5%) were reported in HCV/HIV-coinfected patients receiving peginterferon alfa-2b/ribavirin.

A 48-year-old man experienced sudden onset of diabetic ketoacidosis 7 months after the start of treatment for hepatitis C.

Elevated triglyceride levels have been associated with interferon alphas.

Dehydration, hypertriglyceridemia, and diabetic ketoacidosis have also been reported during postmarketing experience.

Anorexia (all grades: 69%; grade 3/4: 3%) and increased blood alkaline phosphatase (all grades: 23%) have been reported in melanoma patients.[Ref]

Dermatologic

CHC Patients:

Melanoma Patients:

Alopecia (alone: 22%; with ribavirin: up to 36%), rash (alone: 6%; with ribavirin: up to 34%), pruritus (alone: 12%; with ribavirin: up to 29%), dry skin (alone: 11%; with ribavirin: up to 24%), and increased sweating (alone: 6%; with ribavirin: 11%) have been reported in CHC patients.

Acquired lipodystrophy was reported in 13% of HCV/HIV-coinfected patients receiving peginterferon alfa-2b (the active ingredient contained in Sylatron) ribavirin.

Urticaria and cutaneous desquamation of all of the patient's body except his face have been reported in a 41-year-old man with chronic hepatitis C infection after 3 months of combination antiviral therapy with peginterferon alfa-2b/ribavirin. Initially, ribavirin was stopped and topical corticosteroid therapy started without significant improvement. Two weeks later peginterferon alfa-2b was discontinued and significant improvement (decrease in cutaneous lesions) was observed during the following week. Rechallenge with interferon alfa-2b confirmed the development of systemic cutaneous lesions and pruritus.

Erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, urticaria, and psoriasis have also been reported during postmarketing experience.

Exfoliative rash (all grades: 36%; grade 3/4: 1%) and alopecia (all grades: 34%) have been reported in melanoma patients.[Ref]

Respiratory

CHC Patients:

Melanoma Patients:

Dyspnea (alone: 4%; with ribavirin: up to 26%), coughing (alone: 8%; with ribavirin: up to 23%), pharyngitis (alone: 10%; with ribavirin: 12%), sinusitis (alone: 7%; with ribavirin: 6%), and rhinitis (alone: 2%; with ribavirin: 8%) have been reported in CHC patients.

Rhinitis was reported in 5% of HCV/HIV-coinfected patients receiving peginterferon alfa-2b (the active ingredient contained in Sylatron) ribavirin.

Pulmonary infiltrates, pneumonitis, and pneumonia (sometimes fatal) have been reported with the use of peginterferon alfa-2b or alpha interferon therapy in general.

Dyspnea, pulmonary infiltrates, pneumonia, and bronchiolitis obliterans have also been reported during postmarketing experience.

Dyspnea (all grades: 6%; grade 3/4: 1%) and cough (all grades: 5%; grade 3/4: less than 1%) have been reported in melanoma patients.[Ref]

Hepatic

CHC Patients:

Melanoma Patients:

Hyperbilirubinemia (10% to 14%) and hyperuricemia (33% to 38%), in association with hemolysis, have been reported during combination therapy trials using peginterferon alfa-2b/ribavirin.

Hepatomegaly (alone: 6%; with ribavirin: 4%) has been reported in CHC patients.

Increased GGT (9%) and cytolytic hepatitis (6%) were reported in HCV/HIV-coinfected patients receiving peginterferon alfa-2b/ribavirin. Hepatic decompensation (including fatalities) and cirrhosis were reported in a study in HCV/HIV coinfection.

Increased risks of hepatic decompensation and death have been reported in patients with cirrhosis.

Increased ALT or AST (all grades: 77%; grade 3/4: 11%) and increased GGT (all grades: 8%; grade 3/4: 4%) have been reported in melanoma patients.[Ref]

Cardiovascular

CHC Patients:

Melanoma Patients:

Palpitations, cardiomyopathy, hypertension, and hypotension have also been reported during postmarketing experience.[Ref]

Endocrine

CHC Patients:

Melanoma Patients:

Hypothyroidism (with or without ribavirin: 5%) and hyperthyroidism (with or without ribavirin: 3%) have been reported in CHC patients.

TSH abnormalities, with and without clinical manifestations, have been associated with interferon therapies.[Ref]

Ocular

CHC Patients:

Melanoma Patients:

Conjunctivitis (alone: 4%; with ribavirin: 4%) and blurred vision (alone: 2%; with ribavirin: 5%) have been reported in CHC patients.

Retinal and ocular changes induced or aggravated by treatment with this or other alpha interferons have included decreased or loss of vision, retinopathy including macular edema, retinal hemorrhages and cotton wool spots, retinal artery or vein thrombosis, optic neuritis, papilledema, and serous retinal detachment.[Ref]

Genitourinary

CHC Patients:

Melanoma Patients:

Menstrual disorder (alone: 4%; with ribavirin: 7%) has been reported in CHC patients.

Proteinuria (all grades: 7%) has been reported in melanoma patients.

Immunologic

CHC Patients:

Autoimmune thrombocytopenia has been reported 4 weeks after the start of treatment for hepatitis C.

A case report of Hashimoto encephalopathy has been associated with the use of peginterferon alfa-2b/ribavirin for chronic hepatitis C infection in a 36-year-old woman with a 10-year history of autoimmune thyroiditis. After discontinuation of the drugs, corticosteroid therapy was started and the patient experienced full recovery.

Sarcoidosis has also been reported during postmarketing experience.[Ref]

Hypersensitivity

CHC Patients:

Serious acute hypersensitivity reactions have been reported rarely with the use of alpha interferon therapy.[Ref]

Renal

CHC Patients:

Renal insufficiency, renal failure, and interstitial nephritis have also been reported during postmarketing experience.[Ref]

References

1. (2001) "Product Information. PEG-Intron (peginterferon alfa-2b)." Schering Corporation

2. Bagheri H, Fouladi A, Barange K, et al. (2004) "Follow-up of adverse drug reactions from peginterferon alfa-2b-ribavirin therapy." Pharmacotherapy, 24, p. 1546-1553

3. Cerner Multum, Inc. "Australian Product Information."

4. Peck-Radosavljevic M, Wichlas M, Homoncik-Kraml M, et al. (2002) "Rapid suppression of hematopoiesis by standard or pegylated interferon-alpha." Gastroenterology, 123, p. 141-51

5. Gomez-Rangel JD, Ruiz-Delgado GJ, Ruiz-Arguelles GJ (2003) "Pegylated-interferon induced severe bone marrow hypoplasia in a patient with multiple myeloma receiving thalidomide." Am J Hematol, 74, p. 290-1

6. Espinosa M, Arenas MD, Aumente MD, et al. (2007) "Anemia associated with pegylated interferon-alpha2a and alpha2b therapy in hemodialysis patients." Clin Nephrol, 67, p. 366-73

7. Simon-Talero M, Buti M, Esteban R (2012) "Severe anaemia related to oseltamivir during treatment of chronic hepatitis C: a new drug interaction?" J Viral Hepat, 19 Suppl 1, p. 14-7

8. (2015) "Product Information. Sylatron (peginterferon alfa-2b)." Schering-Plough Corporation

9. Cerner Multum, Inc. "UK Summary of Product Characteristics."

10. Udina M, Castellvi P, Moreno-Espana J, et al. (2012) "Interferon-induced depression in chronic hepatitis C: a systematic review and meta-analysis." J Clin Psychiatry, 73, p. 1128-38

11. Gallelli L, Ferraro M, Mauro GF, De Sarro G (2004) "Generalized exfoliative dermatitis induced by interferon alfa." Ann Pharmacother, 38, p. 2173-4

12. Dalmau J, Pimentel CL, Puig L, Peramiquel L, Roe E, Alomar A (2005) "Cutaneous necrosis after injection of polyethylene glycol-modified interferon alfa." J Am Acad Dermatol, 53, p. 62-6

13. Jabr FI, Ordinario MM (2003) "Sudden onset of diabetic ketoacidosis during pegylated interferon alfa therapy." Am J Med, 115, p. 158-9

14. Sevastianos VA, Deutsch M, Dourakis SP, Manesis EK (2003) "Pegylated interferon-2b-associated autoimmune thrombocytopenia in a patient with chronic hepatitis C." Am J Gastroenterol, 98, p. 706-7

15. Deutsch M, Koskinas J, Tzannos K, et al. (2005) "Hashimoto encephalopathy with pegylated interferon alfa-2b and ribavirin." Ann Pharmacother, 39, p. 1745-8

16. Monsuez JJ, Carcelain G, Charniot JC, et al. (2008) "T cells subtypes in a patient with interferon-alpha induced sarcoidosis." Am J Med Sci, 337, p. 60-2

17. Vispo E, Maida I, Moreno A, Barreiro P, Soriano V (2008) "Autoimmune hepatitis induced by pegylated interferon in an HIV-infected patient with chronic hepatitis C." J Antimicrob Chemother, 62, p. 1470-2

Further information

Sylatron 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.