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Otezla · 4.8 · Hypersensitivity reactions are uncommonly observed (see section 4.3).
Eintrag öffnenOtezla · 4.8 · Insomnia Common Depression Psychiatric disorders Suicidal ideation and behaviour Uncommon Anxiety Mood altered
Eintrag öffnenOtezla · 4.8 · Paediatric patients The safety of apremilast was assessed in a 52-week clinical trial in paediatric patients 6
Eintrag öffnenOtezla · 4.8 · Patients with hepatic impairment The safety of apremilast was not evaluated in PsA, PSOR or BD patients with h
Eintrag öffnenOtezla · 4.8 · Patients with renal impairment In the PsA, PSOR or BD clinical studies, the safety profile observed in patient
Eintrag öffnenOtezla · 4.8 · Please see additional warning in section 4.4 for patients who are underweight at beginning of treatment.
Eintrag öffnenOtezla · 4.8 · Psychiatric disorders In clinical studies and post-marketing experience, uncommon cases of suicidal ideation a
Eintrag öffnenOtezla · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenOtezla · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenOtezla · 4.8 · Special populations
Eintrag öffnenOtezla · 4.8 · Summary of the safety profile
Eintrag öffnenOtezla · 4.8 · System Organ Class Frequency Adverse reaction
Eintrag öffnenOtezla · 4.8 · Table 3. Summary of adverse reactions in psoriatic arthritis (PsA), psoriasis (PSOR) and Behçet’s disease (BD)
Eintrag öffnenOtezla · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenOtezla · 4.8 · The adverse drug reactions were determined based on data from the apremilast clinical development programme an
Eintrag öffnenOtezla · 4.8 · The adverse reactions observed in adult patients treated with apremilast are listed below by system organ clas
Eintrag öffnenOtezla · 4.8 · The gastrointestinal adverse reactions generally occurred within the first 2 weeks of treatment and usually re
Eintrag öffnenOtezla · 4.8 · The most commonly reported adverse drug reactions with apremilast in adults with BD are diarrhoea (41.3%), nau
Eintrag öffnenOtezla · 4.8 · The most commonly reported adverse reactions with apremilast in adults with PsA and PSOR are gastrointestinal
Eintrag öffnenOtezla · 4.8 · Very common Upper respiratory tract infectiona Infections and Bronchitis infestations Common Nasopharyngitis*
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