Olysio Side Effects

Generic Name: simeprevir

Note: This page contains side effects data for the generic drug simeprevir. It is possible that some of the dosage forms included below may not apply to the brand name Olysio.

It is possible that some side effects of Olysio may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to simeprevir: oral capsule

As well as its needed effects, simeprevir (the active ingredient contained in Olysio) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking simeprevir, check with your doctor immediately:

More common
  • Blistering, crusting, irritation, itching, or reddening of the skin
  • cracked, dry, or scaly skin
  • difficult or labored breathing
  • increased sensitivity of the skin to sunlight
  • rash with flat lesions or small raised lesions on the skin
  • rash, itching skin
  • redness or other discoloration of the skin
  • severe sunburn
  • tightness in the chest

Some simeprevir side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Difficulty with moving
  • joint pain
  • muscle aching or cramping
  • muscle pains or stiffness
  • nausea
  • swollen joints

For Healthcare Professionals

Applies to simeprevir: oral capsule

General

In clinical trials, most side effects reported during 12 weeks therapy with this drug in combination with peginterferon alfa and ribavirin were Grade 1 to 2 in severity. Grade 3 or 4 side effects were reported in 3.1% to 23% of subjects using this drug with peginterferon alfa and ribavirin and in 0.5% to 25% using placebo with peginterferon alfa and ribavirin. Serious side effects were reported in 0.3% to 2% of subjects using this drug with peginterferon alfa and ribavirin and in 0% to 3% using placebo with peginterferon alfa and ribavirin. During the first 12 weeks of therapy, the most common side effects were nausea, rash, pruritus, dyspnea, increased blood bilirubin, and photosensitivity reaction. This drug was discontinued due to side effects in 0.9% to 2% of subjects using this drug with peginterferon alfa and ribavirin.

Dermatologic

Very common (10% or more): Rash (including photosensitivity; term includes rash, erythema, eczema, maculopapular rash, macular rash, dermatitis, papular rash, skin exfoliation, pruritic rash, erythematous rash, urticaria, generalized rash, drug eruption, allergic dermatitis, dermatosis, vasculitic rash, toxic skin eruption, exfoliative rash, generalized erythema, dermatitis exfoliative, cutaneous vasculitis, photosensitivity reaction, polymorphic light eruption, solar dermatitis, photodermatosis, sunburn; up to 28%), pruritus (term includes pruritus, generalized pruritus; up to 22%)
Common (1% to 10%): Photosensitivity reaction

Fifty-six percent (56%) of rash events occurred in the first 4 weeks; 42% in the first 2 weeks. Most rash and pruritus events were of mild or moderate severity. Severe rash was reported in up to 1% of subjects. This drug was discontinued due to rash in up to 1% of subjects. The frequencies of rash and photosensitivity reactions were higher in subjects with higher simeprevir exposures.

Rash was reported in 15% of patients using this drug with sofosbuvir and ribavirin and 4% using this drug with sofosbuvir. Pruritus was reported in 11% of patients using this drug with sofosbuvir.

All trial subjects were directed to use sun protection measures. Most photosensitivity reactions were of mild or moderate severity. Two subjects had photosensitivity reactions that required hospitalization.

Photosensitivity reactions were reported in 7% of patients using this drug with sofosbuvir and 6% using this drug with sofosbuvir and ribavirin.

Metabolic

Grade 1 and 2 alkaline phosphatase elevations were reported in 3.3% and 0.1% of patients, respectively.

Common (1% to 10%): Increased alkaline phosphatase

Gastrointestinal

Nausea was reported in 17% of patients using this drug with sofosbuvir.

Very common (10% or more): Nausea (up to 22%)
Common (1% to 10%): Constipation

Musculoskeletal

Very common (10% or more): Myalgia (16%)

Respiratory

All dyspnea events were of mild or moderate severity. Sixty-one percent (61%) of dyspnea events occurred in the first 4 weeks. In patients older than 45 years, dyspnea was reported in 16.4% of patients using this drug compared to 9.1% using placebo with peginterferon alfa and ribavirin.

Very common (10% or more): Dyspnea (term includes dyspnea, exertional dyspnea; 12%)

Hematologic

Very common (10% or more): Anemia (up to 11%)

Anemia was reported in 11% of patients using this drug with sofosbuvir and ribavirin and 0% using this drug with sofosbuvir.

A higher incidence of anemia was reported in patients with advanced fibrosis.

Hepatic

Grade 1, 2, 3, and 4 hyperbilirubinemia were reported in 27%, 18.3%, 4.1%, and 0.4% of patients, respectively. Bilirubin elevations were mostly mild to moderate in severity, and included elevation of both direct and indirect bilirubin. Bilirubin elevations occurred soon after therapy started, peaked by the second week, and reversed quickly after this drug was stopped. In general, bilirubin elevations were not associated with liver transaminase elevations.

Increased bilirubin was reported in 0% of patients using this drug with sofosbuvir and 9% using this drug with sofosbuvir and ribavirin.

A higher incidence of increased bilirubin levels was reported with increased simeprevir (the active ingredient contained in Olysio) plasma exposure (e.g., in patients with severe liver dysfunction).

Very common (10% or more): Hyperbilirubinemia (up to 27%)
Common (1% to 10%): Increased blood bilirubin

Nervous system

Very common (10% or more): Headache (21%)

Headache was reported in 21% of patients using this drug with sofosbuvir.

Other

Fatigue was reported in 25% of patients using this drug with sofosbuvir.

Very common (10% or more): Fatigue (25%)

Psychiatric

Very common (10% or more): Insomnia (14%)

Insomnia was reported in 14% of patients using this drug with sofosbuvir.

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