Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Lorviqua

Lorviqua 25 mg film-coated tablets Lorviqua 100 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 12–13

HOS-140231 · Präparat HOS-098468

12  Respiratory, thoracic and mediastinal disorders Pneumonitisi Common 2.4 0.7 Gastrointestinal disorders Diarrhoea Very common 22.7 1.8 Nausea Very common 17.6 0.9 Constipation Very common 16.8 0.2 Hepatobiliary disorders Alanine aminotransferase increased Very common 14.8 2.0 Aspartate aminotransferase increased Very common 13.9 1.5 Skin and subcutaneous tissue disorders Rashj Very common 14.6 0.2 Renal and urinary disorders Proteinuria Common 3.7 0.4 Musculoskeletal and connective tissue disorders Arthralgia Very common 27.8 0.7 Myalgiak Very common 15.0 0 General disorders and administration site conditions Oedemal Very common 55.4 2.9 Fatiguem Very common 30.7 1.1 Investigations Weight increased Very common 29.8 11 Lipase increased Very common 12.8 6.8 Amylase increased Very common 11.3 2.7 Electrocardiogram PR prolongation Uncommon 0.7 0 Adverse reactions that represent the same medical concept or condition were grouped together and reported as a single adverse reaction in the table above. Terms actually reported in the studies and contributing to the relevant adverse reaction are indicated in parentheses, as listed below. a Hypercholesterolaemia (including blood cholesterol increased, hypercholesterolaemia). b Hypertriglyceridaemia (including blood triglycerides increased, hypertriglyceridaemia). c Mood effects (including affective disorder, affect lability, aggression, agitation, anger, anxiety, bipolar I disorder, depressed mood, depression, depressive symptom, euphoric mood, irritability, mania, mood altered, mood swings, panic attack, personality change, stress). d Psychotic effects (including auditory hallucination, hallucination, visual hallucination). e Cognitive effects (including events from SOC Nervous system disorders: amnesia, cognitive disorder, dementia, disturbance in attention, memory impairment, mental impairment; and also including events from SOC Psychiatric disorders: attention deficit/hyperactivity disorder, confusional state, delirium, disorientation, reading disorder). Within these effects, terms from SOC Nervous system disorders were more frequently reported than terms from SOC Psychiatric disorder. f Peripheral neuropathy (including burning sensation, dysaesthesia, formication, gait disturbance, hypoaesthesia, motor dysfunction, muscular weakness, neuralgia, neuropathy peripheral, neurotoxicity, paraesthesia, peripheral motor neuropathy, peripheral sensory neuropathy, peroneal nerve palsy, sensory disturbance). g Speech effects (dysarthria, slow speech, speech disorder). h Vision disorder (including diplopia, photophobia, photopsia, vision blurred, visual acuity reduced, visual impairment, vitreous floaters). i Pneumonitis (including interstitial lung disease, lung opacity, pneumonitis). j Rash (including dermatitis acneiform, maculopapular rash, pruritic rash, rash). k Myalgia (including musculoskeletal pain, myalgia). l Oedema (including generalised oedema, oedema, oedema peripheral, peripheral swelling, swelling). m Fatigue (including asthenia, fatigue).

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