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Last update: March 2019

Common adverse reactions of patients treated with Praluent (table 1):

  • local injection site reactions (most were transient and of mild intensity)
  • upper respiratory tract signs and symptoms
  • pruritus (typically mild and transient)

Table 1: Adverse events reported in patients treated with Praluent1

System organ class Common
(≥1/100 to <1/10)
(≥1/10,000 to <1/1,000)
Not Known
Immune system disorders
Hypersensitivity vasculitis

Respiratory, thoracic and mediastinal disorder Upper respiratory tract signs and symptoms*

Skin and subcutaneous tissue disorders Pruritus Urticaria
Eczema nummular

General disorders and administration site conditions Injection site reactions**
Flu-like illness
* Including mainly oropharyngeal pain, rhinorrhoea, sneezing
** Including erythema/redness, itching, swelling, pain/tenderness

General allergic reactions were reported more frequently in the Praluent group (8.1% of patients) than in the control group (7.0% of patients), mainly due to the incidence of pruritus.

Most common adverse reactions leading to treatment discontinuation in patients treated with Praluent were local injection site reactions1

  • Local injection site reactions including erythema/redness, itching, swelling and pain/tenderness were reported in 6.1% of patients treated with Praluent versus 4.1% in the control group (receiving placebo injections).1
  • The discontinuation rate due to local injection site reactions was comparable between Praluent and placebo (0.2% in the Praluent group verses 0.3% in the control group).