Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · GONAL-f

GONAL-f 1050 IU/1.75 mL powder and solvent for solution for injection · Abschnitt 4.8 · PDF-Seite 9

HOS-084402 · Präparat HOS-083015

Respiratory, thoracic and mediastinal disorders Very rare: Exacerbation or aggravation of asthma

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · GONAL-f

GONAL-f 150 IU/0.24 mL solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 21

HOS-084426 · Präparat HOS-083015

Respiratory, thoracic and mediastinal disorders Very rare: Exacerbation or aggravation of asthma

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · GONAL-f

GONAL-f 300 IU/0.48 mL solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 33

HOS-084449 · Präparat HOS-083015

Respiratory, thoracic and mediastinal disorders Very rare: Exacerbation or aggravation of asthma

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · GONAL-f

GONAL-f 450 IU/0.72 mL solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 45

HOS-084472 · Präparat HOS-083015

Respiratory, thoracic and mediastinal disorders Very rare: Exacerbation or aggravation of asthma

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · GONAL-f

GONAL-f 900 IU/1.44 mL solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 57

HOS-084495 · Präparat HOS-083015

Respiratory, thoracic and mediastinal disorders Very rare: Exacerbation or aggravation of asthma

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Caelyx pegylated liposomal

Caelyx pegylated liposomal 2 mg/ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 11–12

HOS-085575 · Präparat HOS-083155

11  Cardiotoxicity Rare Ventricular arrhythmia Bundle branch block right Conduction disorder Atrioventricular block Cyanosis Vascular disorders Common Hypertension Hypotension Flushing Uncommon Pulmonary embolism Infusion site necrosis (including soft tissue necrosis and skin necrosis) Phlebitis Orthostatic hypotension Rare Thrombophlebitis Venous thrombosis Vasodilatation Respiratory, thoracic Common Dyspnoea and mediastinal Dyspnoea exertional disorders Epistaxis Cough Uncommon Asthma Chest discomfort Rare Throat tightness Not Known Interstitial lung disease Gastrointestinal Very common Stomatitis disorders Nausea Vomiting Diarrhoea Constipation Common Gastritis Aphthous stomatitis Mouth ulceration Dyspepsia Dysphagia Oesophagitis Abdominal pain Abdominal pain upper Oral pain Dry mouth Uncommon Flatulence Gingivitis Rare Glossitis Lip ulceration Skin and subcutaneous Very common Palmar plantar erythrodysaesthesia tissue disorders syndromea Rash (including erythematous, maculo-papular, and papular) Alopecia Common Skin exfoliation Blister Dry skin Erythema Pruritus

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Bondronat

Bondronat 2 mg concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 7

HOS-085643 · Präparat HOS-083171

System Organ Common Uncommon Rare Very rare Not known Class Infections and Infection Cystitis, vaginitis, infestations oral candidiasis Neoplasms Benign skin benign, neoplasm malignant and unspecified Blood and Anaemia, blood lymphatic dyscrasia system disorders Immune system Hypersensitivit Asthma disorders y†, exacerbation bronchospasm† , angioedema†, anaphylactic reaction/shock† ** Endocrine Parathyroid disorders disorder Metabolism and Hypocalcaemia** Hypophosphataemia nutrition disorders Psychiatric Sleep disorder, disorders anxiety, affection lability Nervous system Headache, Cerebrovascular disorders dizziness, disorder, nerve root dysgeusia (taste lesion, amnesia, perversion) migraine, neuralgia, hypertonia, hyperaestesia, paraesthesia circumoral, parosmia Eye disorders Cataract Ocular inflammation†** Ear and Deafness labyrinth disorders Cardiac Bundle branch Myocardial disorders block ischaemia, cardiovascular disorder, palpitations Respiratory, Pharyngitis Lung oedema, thoracic, and stridor mediastinal disorders

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Bondronat

Bondronat 50 mg film-coated tablets. · Abschnitt 4.8 · PDF-Seite 20

HOS-085667 · Präparat HOS-083171

System Organ Common Uncommon Rare Very rare Not known Class Blood and Anaemia lymphatic system disorders Immune system Hypersensitivity†, Asthma disorders bronchospasm†, exacerbation angioedema†, Anaphylactic reaction/shock†** Metabolism and Hypocalcaemia** nutrition disorders Nervous system Paraesthesia, disorders dysgeusia (taste perversion) Eye disorders Ocular inflammation†** Gastrointestinal Oesophagitis, Haemorrage, disorders abdominal pain, duodenal dyspepsia, nausea ulcer, gastritis, dysphagia, dry mouth Skin and Pruritus Stevens-Johnson subcutaneous Syndrome†, tissue disorders Erythema Multiforme†, Dermatitis Bullous† Musculoskeletal Atypical Osteonecrosis of Atypical and connective subtrochanteric jaw†** fractures of tissue disorders and diaphyseal Osteonecrosis of long bones femoral the external other than the fractures† auditory canal femur (bisphosphonate class adverse reaction)† Renal and Azotaemia urinary (uraemia) disorders General Asthenia Chest pain, disorders and influenza-like administration site conditions illness, malaise, pain Investigations Blood parathyroid hormone increased **See further information below †Identified in post-marketing experience.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Bondronat

Bondronat 6 mg concentrate for solution for infusion. · Abschnitt 4.8 · PDF-Seite 32

HOS-085682 · Präparat HOS-083171

System Organ Common Uncommon Rare Very rare Not known Class Infections and Infection Cystitis, vaginitis, infestations oral candidiasis Neoplasms Benign skin benign, neoplasm malignant and unspecified Blood and Anaemia, blood lymphatic dyscrasia system disorders Immune system Hypersensitivit Asthma disorders y†, exacerbation bronchospasm† , angioedema†, anaphylactic reaction/shock† ** Endocrine Parathyroid disorders disorder Metabolism and Hypocalcaemia** Hypophosphataemia nutrition disorders Psychiatric Sleep disorder, disorders anxiety, affection lability Nervous system Headache, Cerebrovascular disorders dizziness, disorder, nerve root dysgeusia (taste lesion, amnesia, perversion) migraine, neuralgia, hypertonia, hyperaestesia, paraesthesia circumoral, parosmia Eye disorders Cataract Ocular inflammation†** Ear and Deafness labyrinth disorders Cardiac Bundle branch Myocardial disorders block ischaemia, cardiovascular disorder, palpitations Respiratory, Pharyngitis Lung oedema, thoracic, and stridor mediastinal disorders

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Norvir

Norvir 100 mg powder for oral suspension · Abschnitt 4.5 · PDF-Seite 13

HOS-086205 · Präparat HOS-083284

Antiasthmatic Theophylline1 3 mg/kg q8h 500 q12h ↓ 43% ↓ 32% An increased dose of theophylline may be required when co-administered with ritonavir, due to induction of CYP1A2.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): theophylline (HOS-085910)

Wechselwirkungen · Norvir

Norvir 100 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 45

HOS-086414 · Präparat HOS-083284

Antiasthmatic Theophylline1 3 mg/kg q8h 500 q12h ↓ 43% ↓ 32% An increased dose of theophyline may be required when co-administered with ritonavir, due to induction of CYP1A2.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · MabThera

MabThera 100 mg concentrate for solution for infusion MabThera 500 mg concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 17

HOS-087544 · Präparat HOS-083527

Vascular hypertension, vasculitis disorders orthostatic (predominately hypotension, cutaneous), hypotension leukocytoclastic vasculitis Respiratory, bronchospasm5, asthma, interstitial lung respiratory lung infiltration thoracic and respiratory bronchiolitis disease8 failure5 mediastinal disease, obliterans, disorders chest pain, lung disorder, dyspnoea, hypoxia increased cough, rhinitis Gastrointestinal nausea vomiting, abdominal gastro-intestinal disorders diarrhoea, enlargement perforation8 abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation Skin and pruritus, urticaria, severe bullous subcutaneous rash, sweating, skin reactions, tissue disorders +alopecia night sweats, Stevens-Johnson +skin disorder syndrome, toxic epidermal necrolysis (Lyell’s syndrome)8 Musculoskeletal hypertonia, and connective myalgia, tissue disorders arthralgia, back pain, neck pain, pain Renal and renal failure5 urinary disorders

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · MabThera

MabThera 1400 mg solution for subcutaneous injection · Abschnitt 4.8 · PDF-Seite 65

HOS-087688 · Präparat HOS-083527

Vascular hypertension, vasculitis disorders orthostatic (predominately hypotension, cutaneous), hypotension leukocytoclastic vasculitis Respiratory, bronchospasm5, asthma, interstitial lung respiratory lung infiltration thoracic and respiratory bronchiolitis disease8 failure5 mediastinal disease, obliterans, disorders chest pain, lung disorder, dyspnoea, hypoxia increased cough, rhinitis

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · MabThera

MabThera 1600 mg solution for subcutaneous injection · Abschnitt 4.8 · PDF-Seite 90

HOS-087746 · Präparat HOS-083527

Vascular hypertension, vasculitis disorders orthostatic (predominately hypotension, cutaneous), hypotension leukocytoclastic vasculitis Respiratory, bronchospasm5, asthma, interstitial respiratory lung infiltration thoracic and respiratory bronchiolitis lung disease8 failure 5 mediastinal disease, obliterans, disorders chest pain, lung disorder, dyspnoea, hypoxia increased cough, rhinitis Gastrointestinal nausea vomiting, abdominal gastro-intestinal disorders diarrhoea, enlargement perforation8 abdominal pain, dysphagia, stomatitis, constipation, dyspepsia, anorexia, throat irritation Skin and pruritis, urticaria, severe bullous skin subcutaneous rash, sweating, reactions, tissue disorders +alopecia night sweats, Stevens-Johnson +skin disorder Syndrome, toxic epidermal necrolysis (Lyell’s Syndrome)8

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Synagis

Synagis 50 mg/0.5 ml solution for injection Synagis 100 mg/1 ml solution for injection · Abschnitt 4.8 · PDF-Seite 5

HOS-090201 · Präparat HOS-084025

In an observational, post-marketing, database study, a small increase in the frequency of asthma was observed among preterm palivizumab recipients; however, the causal relationship is uncertain.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Azopt

AZOPT 10 mg/ml eye drops, suspension · Abschnitt 4.8 · PDF-Seite 6

HOS-090580 · Präparat HOS-084087

System Organ Classification MedDRA Preferred Term (v.15.1) Infections and infestations Uncommon: nasopharyngitis, pharyngitis, sinusitis Not Known: rhinitis Blood and lymphatic system Uncommon: red blood cell count decreased, blood chloride disorders increased Immune system disorders Not Known: hypersensitivity Metabolism and nutrition disorders Not known: decreased appetite Psychiatric disorders Uncommon: apathy, depression, depressed mood, libido decreased, nightmare, nervousness Rare: insomnia Nervous system disorders Uncommon: motor dysfunction, amnesia, dizziness, paraesthesia, headache Rare: memory impairment, somnolence Not Known: tremor, hypoaesthesia, ageusia Eye disorders Common: blurred vision, eye irritation, eye pain, foreign body sensation in eyes, ocular hyperaemia Uncommon: corneal erosion, keratitis, punctate keratitis, keratopathy, deposit eye, corneal staining, corneal epithelium defect, corneal epithelium disorder, blepharitis, eye pruritus, conjunctivitis, eye swelling, meibomianitis, glare, photophobiadry eye, allergic conjunctivitis, pterygium, scleral pigmentation, asthenopia, ocular discomfort, abnormal sensation in eye, keratoconjunctivitis sicca, subconjunctival cyst, conjunctival hyperaemia, eyelids pruritus, eye discharge, eyelid margin crusting, lacrimation increased Rare: corneal oedema, diplopia, visual acuity reduced, photopsia, hypoaesthesia eye, periorbital oedema, intraocular pressure increased, optic nerve cup/disc ratio increased Not Known: corneal disorder, visual disturbance, eye allergy, madarosis, eyelid disorder, erythema of eyelid Ear and labyrinth disorders Rare: tinnitus Not Known: vertigo Cardiac disorders Uncommon: cardio-respiratory distress, bradycardia, palpitations Rare: angina pectoris, heart rate irregular Not Known: arrhythmia, tachycardia, hypertension, blood pressure increased, blood pressure decreased, heart rate increased Respiratory, thoracic and Uncommon: dyspnoea, epistaxis, oropharyngeal pain, mediastinal disorders pharyngolaryngeal pain, throat irritation, upper airway cough syndrome, rhinorrhoea, sneezing Rare: bronchial hyperreactivity, upper respiratory tract congestion, sinus congestion, nasal congestion, cough, nasal dryness Not Known: asthma

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Herceptin

Herceptin 150 mg powder for concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 11–12

HOS-090921 · Präparat HOS-084155

11 System organ class Adverse reaction Frequency Thrombocytopenia Very common Hypoprothrombinaemia Not known Immune thrombocytopenia Not known Immune system disorders Hypersensitivity Common + Anaphylactic reaction Rare + Anaphylactic shock Rare Metabolism and nutrition Weight decreased/Weight loss Very common disorders Anorexia Very common Tumour lysis syndrome Not known Hyperkalaemia Not known Psychiatric disorders Insomnia Very common Anxiety Common Depression Common 1 Nervous system disorders Tremor Very common Dizziness Very common Headache Very common Paraesthesia Very common Dysgeusia Very common Peripheral neuropathy Common Hypertonia Common Somnolence Common Eye disorders Conjunctivitis Very common Lacrimation increased Very common Dry eye Common Papilloedema Not known Retinal haemorrhage Not known Ear and labyrinth Deafness Uncommon disorders 1 Cardiac disorders Blood pressure decreased Very common 1 Blood pressure increased Very common 1 Heart beat irregular Very common 1 Cardiac flutter Very common Ejection fraction decreased* Very common + Cardiac failure (congestive) Common +1 Supraventricular tachyarrhythmia Common Cardiomyopathy Common 1 Palpitation Common Pericardial effusion Uncommon Cardiogenic shock Not known Gallop rhythm present Not known Vascular disorders Hot flush Very common +1 Hypotension Common Vasodilatation Common + Respiratory, thoracic and Dyspnoea Very common mediastinal disorders Cough Very common Epistaxis Very common Rhinorrhoea Very common + Pneumonia Common Asthma Common Lung disorder Common + Pleural effusion Common +1 Wheezing Uncommon Pneumonitis Uncommon

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Herceptin

Herceptin 600 mg solution for injection in vial · Abschnitt 4.8 · PDF-Seite 42–43

HOS-090970 · Präparat HOS-084155

42 System organ class Adverse reaction Frequency Blood and lymphatic Anaemia Very common system disorders Neutropenia Very common White blood cell count Very common decreased/leukopenia Thrombocytopenia Very common Hypoprothrombinaemia Not known Immune thrombocytopenia Not known Immune system disorders Hypersensitivity Common + Anaphylactic reaction Rare + Anaphylactic shock Rare Metabolism and nutrition Weight decreased/Weight loss Very common disorders Anorexia Very common Tumour lysis syndrome Not known Hyperkalaemia Not known Psychiatric disorders Insomnia Very common Anxiety Common Depression Common 1 Nervous system disorders Tremor Very common Dizziness Very common Headache Very common Paraesthesia Very common Dysgeusia Very common Peripheral neuropathy Common Hypertonia Common Somnolence Common Eye disorders Conjunctivitis Very common Lacrimation increased Very common Dry eye Common Papilloedema Not known Retinal haemorrhage Not known Ear and labyrinth disorders Deafness Uncommon 1 Cardiac disorders Blood pressure decreased Very common 1 Blood pressure increased Very common 1 Heart beat irregular Very common 1 Cardiac flutter Very common Ejection fraction decreased* Very common + Cardiac failure (congestive) Common +1 Supraventricular tachyarrhythmia Common Cardiomyopathy Common 1 Palpitation Common Pericardial effusion Uncommon Cardiogenic shock Not known Gallop rhythm present Not known Vascular disorders Hot flush Very common +1 Hypotension Common Vasodilatation Common + Respiratory, thoracic and Dyspnoea Very common mediastinal disorders Cough Very common Epistaxis Very common Rhinorrhoea Very common + Pneumonia Common Asthma Common Lung disorder Common

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Xeloda

Xeloda 150 mg film-coated tablets. Xeloda 500 mg film-coated tablets. · Abschnitt 4.8 · PDF-Seite 13–14

HOS-091444 · Präparat HOS-084311

13 Body System Very Common Uncommon Rare/Very Rare Common (Post-Marketing All grades Severe and/or Life- Experience) All grades threatening (grade 3-4) or considered medically relevant Ear and - - Vertigo, Ear pain labyrinth disorders Cardiac - - Angina unstable, Ventricular fibrillation disorders Angina pectoris, (rare), QT Myocardial prolongation (rare), ischaemia/infarction, Torsade de pointes Atrial fibrillation, (rare), Bradycardia Arrhythmia, (rare), Vasospasm Tachycardia, Sinus (rare) tachycardia, Palpitations Vascular - Thrombophlebitis Deep vein thrombosis, disorders Hypertension, Petechiae, Hypotension, Hot flush, Peripheral coldness Respiratory, - Dyspnoea, Pulmonary embolism, thoracic and Epistaxis, Cough, Pneumothorax, mediastinal Rhinorrhoea Haemoptysis, Asthma, disorders Dyspnoea exertional Gastrointestin Diarrhoea, Gastrointestinal Intestinal obstruction, al disorders Vomiting, haemorrhage, Ascites, Enteritis, Nausea, Constipation, Gastritis, Dysphagia, Stomatitis, Upper abdominal Abdominal pain lower, Abdominal pain, Dyspepsia, Oesophagitis, pain Flatulence, Abdominal Dry mouth discomfort, Gastrooesophageal reflux disease, Colitis, Blood in stool Hepatobiliary - Hyperbilirubinem Jaundice Hepatic failure (rare), disorders ia, Liver function Cholestatic hepatitis test abnormalities (rare) Skin and Palmar-plantar Rash, Alopecia, Blister, Skin ulcer, Cutaneous lupus subcutaneous erythro- Erythema, Dry Rash, Urticaria, erythematosus (rare), tissue dysaesthesia skin, Pruritus, Photosensitivity Severe skin reactions disorders syndrome** Skin hyper- reaction, Palmar such as Stevens- pigmentation, erythema, Swelling Johnson Syndrome Rash macular, face, Purpura, and toxic Epidermal Skin Radiation recall Necrolysis (very rare) desquamation, syndrome (see section 4.4.) Dermatitis, Pigmentation disorder, Nail disorder

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Travatan

TRAVATAN 40 micrograms/mL eye drops, solution · Abschnitt 4.8 · PDF-Seite 5–6

HOS-109703 · Präparat HOS-093237

5  Common iris hyperpigmentation, eye pain, ocular discomfort, dry eye, eye pruritus, eye irritation Uncommon corneal erosion, uveitis, iritis, anterior chamber inflammation, keratitis, punctate keratitis, photophobia, eye discharge , blepharitis, erythema of eyelid, periorbital oedema, eyelids pruritus, visual acuity reduced, vision blurred, lacrimation increased, conjunctivitis, ectropion, cataract, eyelid margin crusting, growth of eyelashes Rare iridocyclitis, ophthalmic herpes simplex, eye inflammation, photopsia, eczema eyelids, conjunctival oedema, halo vision, conjunctival follicles, hypoaesthesia eye, trichiasis, meibomianitis, anterior chamber pigmentation, mydriasis, asthenopia, eyelash hyperpigmentation, eyelash thickening Not known macular oedema, lid sulcus deepened Ear and labyrinth disorders Not known vertigo, tinnitus Cardiac disorders Uncommon palpitations Rare heart rate irregular, heart rate decreased Not known chest pain, bradycardia, tachycardia, arrhythmia Vascular disorders Rare blood pressure diastolic decreased, blood pressure systolic increased, hypotension, hypertension Respiratory, thoracic Uncommon cough, nasal congestion, throat irritation and mediastinal Rare dyspnoea, asthma, respiratory disorder, disorders oropharyngeal pain, dysphonia, rhinitis allergic, nasal dryness Not known asthma aggravated, epistaxis Gastrointestinal disorders Rare peptic ulcer reactivated, gastrointestinal disorder, constipation, dry mouth Not known diarrhoea, abdominal pain, nausea, vomiting Skin and subcutaneous Uncommon skin hyperpigmentation (periocular), skin tissue disorders discolouration, hair texture abnormal, hypertrichosis Rare dermatitis allergic, dermatitis contact, erythema, rash, hair colour changes, madarosis Not known pruritus, hair growth abnormal Musculoskeletal and Rare musculoskeletal pain, arthralgia connective tissue disorders

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.