Olysio Side Effects
Generic Name: simeprevir
Note: This document contains side effect information about simeprevir. Some of the dosage forms listed on this page may not apply to the brand name Olysio.
Some side effects of Olysio may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to simeprevir: oral capsule
Along with its needed effects, simeprevir (the active ingredient contained in Olysio) 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 simeprevir: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 side effects of simeprevir 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
- Difficulty with moving
- joint pain
- muscle aching or cramping
- muscle pains or stiffness
- 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.
More about Olysio (simeprevir)
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