Applies to peramivir: intravenous solution, solution iv (infusion).

Serious side effects of Peramivir

Along with its needed effects, peramivir 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 peramivir:

Less common

• Cloudy urine
• fever

Incidence not known

• Blistering, peeling, or loosening of the skin
• chills
• confusion as to time, place, or person
• cough
• cracks in the skin
• diarrhea
• difficulty swallowing
• dizziness
• fast heartbeat
• hives, itching, skin rash
• holding false beliefs that cannot be changed by fact
• joint or muscle pain
• loss of heat from the body
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red, irritated eyes
• red, swollen skin
• red skin lesions, often with a purple center
• scaly skin
• seeing, hearing, or feeling things that are not there
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• tightness in the chest
• trouble breathing
• unusual excitement, nervousness, or restlessness
• unusual tiredness or weakness

Other side effects of Peramivir

Some side effects of peramivir 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:

Less common

• Blurred vision
• constipation
• difficulty having a bowel movement
• headache
• nervousness
• pounding in the ears
• redness of the eardrum
• slow or fast heartbeat
• trouble sleeping
• vomiting

For Healthcare Professionals

Applies to peramivir: intravenous solution.

Hematologic

Decreased neutrophil count (less than 1 x 10[9]/L) was reported in 8% of patients.^[Ref]

Common (1% to 10%): Decreased neutrophil count^[Ref]

Gastrointestinal

Vomiting was reported in 3% of pediatric patients; this side effect was not reported in adults.^[Ref]

Common (1% to 10%): Diarrhea, constipation

Frequency not reported: Vomiting, nausea, upper abdominal pain, abdominal discomfort, gastritis^[Ref]

Metabolic

Elevated serum glucose (greater than 160 mg/dL) was reported in 5% of patients.^[Ref]

Common (1% to 10%): Elevated serum glucose

Frequency not reported: Decreased appetite, decreased blood glucose, increased blood uric acid^[Ref]

Musculoskeletal

Common (1% to 10%): Elevated creatine phosphokinase

Frequency not reported: Arthralgia^[Ref]

Elevated creatine phosphokinase (at least 6 times the upper limit of normal [6 x ULN]) was reported in 4% of patients.^[Ref]

Hepatic

Common (1% to 10%): Increased ALT, increased AST

Frequency not reported: Elevated liver enzymes, increased GGT, liver disorder^[Ref]

Increased ALT (greater than 2.5 x ULN) was reported in 3% of patients.

Elevated liver enzymes have been reported in healthy subjects and patients with influenza-like illness using this drug.^[Ref]

Psychiatric

Delirium and abnormal behavior leading to injury have been reported during postmarketing experience in influenza patients using this drug. These side effects were primarily reported in pediatric patients, often with abrupt onset and rapid resolution; the contribution of this drug to such events has not been established.^[Ref]

Common (1% to 10%): Insomnia

Frequency not reported: Psychomotor hyperactivity

Postmarketing reports: Delirium, abnormal behavior/abnormal behavior leading to injury, hallucinations^[Ref]

Cardiovascular

Common (1% to 10%): Hypertension

Frequency not reported: ECG QT prolonged^[Ref]

Dermatologic

Rare (0.01% to 0.1%): Serious skin reactions (including erythema multiforme)

Frequency not reported: Dermatitis, drug eruption, eczema, urticaria, toxic epidermal necrolysis, pruritus

Postmarketing reports: Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis, rash^[Ref]

Other

Fever and tympanic membrane erythema were reported in 2% (each) of pediatric patients; these side effects were not reported in adults.^[Ref]

Frequency not reported: Fever/pyrexia, tympanic membrane erythema/hyperemia, increased blood lactate dehydrogenase, decreased blood albumin, increased blood chloride, decreased blood lactate dehydrogenase, increased blood potassium, increased blood sodium, increased total protein, chest discomfort, fatigue^[Ref]

Hypersensitivity

Frequency not reported: Anaphylactic shock

Postmarketing reports: Anaphylaxis, anaphylactic/anaphylactoid reactions^[Ref]

Genitourinary

Frequency not reported: Proteinuria, blood present in urine, urobilin present in urine, increased urine ketone body^[Ref]

Proteinuria (by dipstick analysis) was reported in 3% of pediatric patients; this side effect was not reported in adults.^[Ref]

Renal

Frequency not reported: Increased blood urea, increased blood creatinine, acute renal failure, renal failure, prerenal failure, renal disorder, anuria, nephritis, acute kidney injury, renal impairment^[Ref]

Nervous system

Frequency not reported: Hypoesthesia, paresthesia

Ocular

Frequency not reported: Blurred vision^[Ref]

Local

Frequency not reported: Injection site rash^[Ref]