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


In clinical trials, most side effects reported during 12 weeks therapy with simeprevir (the active ingredient contained in Olysio) combination therapy (simeprevir, peginterferon alfa, and ribavirin) were Grade 1 to 2 in severity. Grade 3 or 4 side effects were reported in 23% of subjects using simeprevir combination therapy and in 25% using placebo with peginterferon alfa and ribavirin. Serious side effects were reported with simeprevir combination therapy (2%) and with placebo, peginterferon alfa, and ribavirin (3%). Simeprevir or placebo was discontinued due to side effects in 2% and 1% of subjects using simeprevir combination therapy and subjects using placebo with peginterferon alfa and ribavirin, respectively.


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

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.

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; 28%), pruritus (term includes pruritus, generalized pruritus; 22%)
Common (1% to 10%): Photosensitivity (5%)


Very common (10% or more): Hyperbilirubinemia (Grade 1: 27%; Grade 2: 18%)
Common (1% to 10%): Hyperbilirubinemia (Grade 3: 4%), increased alkaline phosphatase (Grade 1: 3%)
Uncommon (0.1% to 1%): Hyperbilirubinemia (Grade 4: less than 1%), increased alkaline phosphatase (Grade 2: less than 1%)

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 simeprevir was stopped. In general, bilirubin elevations were not associated with liver transaminase elevations.


Very common (10% or more): Nausea (22%)


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


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

All dyspnea events were of mild or moderate severity. Sixty-one percent (61%) of dyspnea events occurred in the first 4 weeks.

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