Applies to remdesivir: intravenous powder for solution, intravenous solution.

Serious side effects of Remdesivir

Along with its needed effects, remdesivir 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 remdesivir:

More common

• Back pain
• chest tightness
• chills
• cough
• dark-colored urine
• difficulty swallowing
• fast heartbeat
• fever
• flushing
• headache
• hives, itching
• light-colored stools
• nausea and vomiting
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• stomach pain, continuing
• trouble breathing
• unusual tiredness or weakness
• yellow eyes or skin

Less common

• Seizures
• skin rash

Other side effects of Remdesivir

Some side effects of remdesivir 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

• Bleeding, blistering, burning, coldness, discoloration of 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

For Healthcare Professionals

Applies to remdesivir: intravenous powder for injection, intravenous solution.

General

The most common side effect in healthy subjects was increased transaminases. The most common side effects in patients with coronavirus disease 2019 (COVID-19) were nausea, increased AST, and increased ALT.^[Ref]

Cardiovascular

Sinus bradycardia generally normalized within 4 days after the last dose of this drug without additional intervention.

Uncommon (0.1% to 1%): Decreased heart rate

Postmarketing reports: Sinus bradycardia

Dermatologic

Common (1% to 10%): Rash

Frequency not reported: Angioedema

Gastrointestinal

Common (1% to 10%): Nausea

Genitourinary

Frequency not reported: Proteinuria, glycosuria

Hematologic

Very common (10% or more): Decreased hemoglobin (up to 15%), decreased lymphocytes (up to 11%), prolonged prothrombin time

Frequency not reported: Prolonged INR, prolonged activated partial thromboplastin time, decreased WBC

In a clinical study of patients with COVID-19, the incidence of prolonged prothrombin time or INR (mostly grades 1 to 2) was higher with this drug compared to placebo; no difference was observed in the incidence of bleeding events between the 2 groups.

Hepatic

In studies in healthy subjects, increases in ALT, AST, or both in those who received this drug were grade 1 (10%) or grade 2 (4%). In a clinical study of patients with COVID-19, any grade (at least 1.25 times the upper limit of normal [1.25 x ULN]) laboratory abnormalities of increased AST and increased ALT were reported in 33% and 32% of patients, respectively, receiving this drug compared with 44% and 43% of patients, respectively, receiving placebo; at least grade 3 (at least 5 x ULN) laboratory abnormalities of increased AST and increased ALT were reported in 6% and 3% of patients, respectively, receiving this drug compared with 8% and 6% of patients, respectively, receiving placebo. In a clinical trial in hospitalized patients with severe COVID-19 receiving this drug for 5 or 10 days, any grade laboratory abnormalities of increased AST and increased ALT were reported in 40% and 42% of patients, respectively; at least grade 3 laboratory abnormalities of increased AST and increased ALT were both reported in 7% of patients. In a clinical trial in hospitalized patients with moderate COVID-19 receiving this drug for 5 or 10 days compared to standard of care, any grade laboratory abnormalities of increased AST and increased ALT occurred in 32% and 33% of patients, respectively, receiving this drug and 33% and 39% of patients, respectively, receiving standard of care; at least grade 3 laboratory abnormalities of increased AST and increased ALT occurred in 2% and 3% of patients, respectively, receiving this drug and 6% and 8%, respectively, receiving standard of care.

Very common (10% or more): Increased transaminases, increased ALT, increased AST

Common (1% to 10%): Increased aminotransferase levels (including ALT, AST, or both), increased bilirubin

Uncommon (0.1% to 1%): Increased hepatic enzyme, hypertransaminasemia, increased liver function tests

Frequency not reported: Hyperbilirubinemia, increased direct bilirubin

Hypersensitivity

Rare (0.01% to 0.1%): Hypersensitivity

Frequency not reported: Anaphylaxis, anaphylactic shock

Postmarketing reports: Anaphylactic reaction, hypersensitivity

Local

Uncommon (0.1% to 1%): Injection site erythema

Frequency not reported: Administration site extravasation

Metabolic

Very common (10% or more): Increased glucose (up to 12%)

Nervous system

Common (1% to 10%): Headache

Uncommon (0.1% to 1%): Seizure

Frequency not reported: Generalized seizure

Other

Uncommon (0.1% to 1%): Infusion-related reactions, increased blood alkaline phosphatase

Frequency not reported: Decreased potassium

Renal

Very common (10% or more): Decreased CrCl (based on Cockcroft-Gault formula; up to 19%), decreased estimated glomerular filtration rate (eGFR; up to 18%), increased creatinine (up to 15%)

Uncommon (0.1% to 1%): Decreased GFR, acute kidney injury