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Besremi Side Effects

Generic name: ropeginterferon alfa-2b

Medically reviewed by Last updated on Nov 16, 2023.

Note: This document contains side effect information about ropeginterferon alfa-2b. Some dosage forms listed on this page may not apply to the brand name Besremi.

Applies to ropeginterferon alfa-2b: subcutaneous solution.


Subcutaneous route (Solution)

Risk of Serious DisordersInterferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy.

Serious side effects of Besremi

Along with its needed effects, ropeginterferon alfa-2b (the active ingredient contained in Besremi) 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 immediately if any of the following side effects occur while taking ropeginterferon alfa-2b:

More common

Less common


Incidence not known

Other side effects of Besremi

Some side effects of ropeginterferon alfa-2b 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

For Healthcare Professionals

Applies to ropeginterferon alfa-2b: subcutaneous solution.


The more commonly reported adverse reactions have included leukopenia, thrombocytopenia, influenza-like illness, arthralgia, fatigue, pruritus, nasopharyngitis, and musculoskeletal pain.[Ref]


Very common (10% or more): Leukopenia (18%), neutropenia (16%), thrombocytopenia (12%)


Very common (10% or more): Depression (20%), sleep disorder (20%)

Common (1% to 10%): Serious neuropsychiatric reactions

Frequency not reported: Depression, depressive symptoms, depressed mood, listlessness

In the clinical development program (n=178), depression, depressive symptoms, depressed mood, and listlessness occurred in 17 patients; 3.4% of the patients recovered with temporary drug interruption and 2.8% stopped treatment.


Common (1% to 10%): Hyperthyroidism, hypothyroidism, autoimmune thyroiditis/thyroiditis

In the clinical development program, Hyperthyroidism was reported in 8 patients (4.5%), hypothyroidism in 7 patients (3.9%), and autoimmune thyroiditis/thyroiditis occurred in 5 patients (2.8%).


Very common (10% or more): Edema (16%), hypertension (16%)

Frequency not reported: Atrial fibrillation


Very common (10% or more): Diarrhea (33%), nausea (28%), abdominal pain (20%)

Common (1% to 10%): Pancreatitis


Very common (10% or more): Nasopharyngitis (43%), upper respiratory tract infection (27%)

Frequency not reported: Pulmonary toxicity


Very common (10% or more): Influenza-like illness (59%)


Very common (10% or more): Arthralgia (47%), musculoskeletal pain (41%), muscle spasms (16%)


Common (1% to 10%): Cataract, dry eye

Frequency not reported: Ophthalmologic toxicity


Very common (10% or more): Transaminase elevations (16%)


Very common (10% or more): Decreased appetite (18%)

Common (1% to 10%): Hyperlipidemia/hypertriglyceridemia/dyslipidemia


Very common (10% or more): Pruritus (45%), hyperhidrosis (29%), alopecia (16%), rash (16%)

Frequency not reported: Dermatologic toxicity


Very common (10% or more): Urinary tract infection (16%)


Frequency not reported: Hypersensitivity reactions

Nervous system

Very common (10% or more): Headache (39%), dizziness (22%)


Very common (10% or more): Local administration site reactions (26%)


In clinical trials, less than 1% of patients experienced renal impairment or toxic nephropathy.

Frequency not reported: Renal impairment, toxic nephropathy


1. Product Information. BESREMi (ropeginterferon alfa-2b). PharmaEssentia USA Corp. 2021.

Further information

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.