Ein Paarvergleich findet Originalpassagen, die den anderen Wirkstoff wörtlich nennen. Aussagen gelten für das jeweilige Präparat und seine Formulierung. Klassenbegriffe und abweichende Synonyme können fehlen. Kein Treffer bedeutet nicht, dass keine Wechselwirkung besteht.
RxNorm 05-Oct-2026 · geprüft 2026-10-25 · 1009 Präparate · 54812 Quellenpassagen · 148 strukturierte Aussagen. Automatisch aktualisiert, ohne menschliche Freigabe.
Nebenwirkungen · Olanzapine Teva
Olanzapine Teva 2.5 mg film-coated tablets Olanzapine Teva 5 mg film-coated tablets Olanzapine Teva 7.5 mg film-coated tablets Olanzapine Teva 10 mg film-coated tablets Olanzapine Teva 15 mg film-coated tablets Olanzapine Teva 20 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 8
HOS-209074 · Präparat HOS-154237
Tabulated list of adverse reactions
The following table lists the adverse reactions and laboratory investigations observed from
spontaneous reporting and in clinical trials. Within each frequency grouping, adverse reactions are
presented in order of decreasing seriousness. The frequency terms listed are defined as follows: Very
common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
<1/1,000), very rare (<1/10,000), not known (cannot be estimated from the data available).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-05-12T13:49:00Z · SHA-256 4c6933e864732db54f617a6615c3605a1299041a617de136aab779c18c8dbbe1 · Passage 860e53c6a4a27254a86f13bc9918ac649901e204771afc1b2a018b8fb5bb4f5f · Zeichen 719–1231 im Abschnitt
Nebenwirkungen · Olanzapine Teva
Olanzapine Teva 2.5 mg film-coated tablets Olanzapine Teva 5 mg film-coated tablets Olanzapine Teva 7.5 mg film-coated tablets Olanzapine Teva 10 mg film-coated tablets Olanzapine Teva 15 mg film-coated tablets Olanzapine Teva 20 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 8
HOS-209075 · Präparat HOS-154237
Very common Common Uncommon Rare Not known
Blood and the lymphatic system disorders
Eosinophilia Thrombocytopeni
Leukopenia10 a11
Neutropenia10
Immune system disorders
Hypersensitivity11
Metabolism and nutrition disorders
Weight gain1 Elevated Development or Hypothermia12
cholesterol exacerbation of
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-05-12T13:49:00Z · SHA-256 4c6933e864732db54f617a6615c3605a1299041a617de136aab779c18c8dbbe1 · Passage 1721d0ceea94b11fd30db8aefd3163da95098922bb54833c6d96204d864e39cd · Zeichen 1233–1794 im Abschnitt
Nebenwirkungen · Olanzapine Teva
Olanzapine Teva 2.5 mg film-coated tablets Olanzapine Teva 5 mg film-coated tablets Olanzapine Teva 7.5 mg film-coated tablets Olanzapine Teva 10 mg film-coated tablets Olanzapine Teva 15 mg film-coated tablets Olanzapine Teva 20 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 8–10
HOS-209076 · Präparat HOS-154237
8
levels2,3 diabetes
Elevated glucose occasionally
levels4 associated with
Elevated ketoacidosis or
triglyceride coma, including
levels2,5 some fatal cases
Glucosuria (see section 4.4)11
Increased appetite
Nervous system disorders
Somnolence Dizziness Seizures where in Neuroleptic
Akathisia6 most cases a malignant
Parkinsonism6 history of seizures syndrome (see
Dyskinesia6 or risk factors for section 4.4)12
seizures were Discontinuation
reported11 symptoms7,12
Dystonia
(including
oculogyration)11
Tardive
dyskinesia11
Amnesia9
Dysarthria
Stuttering11
Restless legs
syndrome11
Cardiac disorders
Bradycardia Ventricular
QTc prolongation tachycardia/fibrill
(see section 4.4) ation, sudden
death (see
section 4.4)11
Vascular disorders
Orthostatic Thromboembolis
hypotension10 m (including
pulmonary
embolism and
deep vein
thrombosis) (see
section 4.4)
Respiratory, thoracic and mediastinal disorders
Epistaxis9
Gastrointestinal disorders
Mild, transient Abdominal Pancreatitis11
anticholinergic distension9
effects including Salivary
constipation and hypersecretion11
dry mouth
Hepatobiliary disorders
Transient, Hepatitis
asymptomatic (including
elevations of hepatocellular,
hepatic cholestatic or
aminotransferases mixed liver
(ALT, AST), injury)11
especially in early
treatment (see
section 4.4)
9
Skin and subcutaneous tissue disorders
Rash Photosensitivity Drug Reaction
reaction with Eosinophilia
Alopecia and Systemic
Symptoms
(DRESS)
Musculoskeletal and connective tissue disorders
Arthralgia9 Rhabdomyolysis11
Renal and urinary disorders
Urinary
incontinence
Urinary retention
Urinary
hesitation11
Pregnancy, puerperium and perinatal conditions
Drug withdrawal
syndrome
neonatal (see
section 4.6)
Reproductive system and breast disorders
Erectile Amenorrhea Priapism12
dysfunction in Breast
males enlargement
Decreased libido Galactorrhea in
in males and females
females Gynaecomastia/br
east enlargement
in males
General disorders and administration site conditions
Asthenia
Fatigue
Oedema
Pyrexia10
Investigations
Elevated plasma Increased alkaline Increased total
prolactin levels8 phosphatase10 bilirubin
High creatine
phosphokinase11
High Gamma
Glutamyltransfera
se10
High uric acid10
1
Clinically significant weight gain was observed across all baseline Body Mass Index (BMI)
categories. Following short term treatment (median duration 47 days), weight gain ≥7% of baseline
body weight was very common (22.2%), ≥15% was common (4.2%) and ≥25% was uncommon
(0.8%). Patients gaining ≥7%, ≥15% and ≥25% of their baseline body weight with long-term
exposure (at least 48 weeks) were very common (64.4%, 31.7% and 12.3% respectively).
2
Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were
greater in patients without evidence of lipid dysregulation at baseline.
3
Observed for fasting normal levels at baseline (<5.17 mmol/l) which increased to high
(≥6.2 mmol/l). Changes in total fasting cholesterol levels from borderline at baseline
(≥5.17-<6.2 mmol/l) to high (≥6.2 mmol/l) were very common.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-05-12T13:49:00Z · SHA-256 4c6933e864732db54f617a6615c3605a1299041a617de136aab779c18c8dbbe1 · Passage c31539c793fd6314b6997b1129c011e60ec75e8f1d0602443c84d9bc327ac25e · Zeichen 1848–8258 im Abschnitt
Nebenwirkungen · Olanzapine Teva
Olanzapine Teva 2.5 mg film-coated tablets Olanzapine Teva 5 mg film-coated tablets Olanzapine Teva 7.5 mg film-coated tablets Olanzapine Teva 10 mg film-coated tablets Olanzapine Teva 15 mg film-coated tablets Olanzapine Teva 20 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 10–11
HOS-209077 · Präparat HOS-154237
10
4
Observed for fasting normal levels at baseline (<5.56 mmol/l) which increased to high (≥7 mmol/l).
Changes in fasting glucose from borderline at baseline (≥5.56-<7 mmol/l) to high (≥7 mmol/l) were
very common.
5
Observed for fasting normal levels at baseline (<1.69 mmol/l) which increased to high
(≥2.26 mmol/l). Changes in fasting triglycerides from borderline at baseline
(≥1.69 mmol/l-<2.26 mmol/l) to high (≥2.26 mmol/l) were very common.
6
In clinical trials, the incidence of Parkinsonism and dystonia in olanzapine-treated patients was
numerically higher, but not statistically significantly different from placebo. Olanzapine-treated
patients had a lower incidence of Parkinsonism, akathisia and dystonia compared with titrated
doses of haloperidol. In the absence of detailed information on the pre-existing history of
individual acute and tardive extrapyramidal movement disorders, it cannot be concluded at present
that olanzapine produces less tardive dyskinesia and/or other tardive extrapyramidal syndromes.
7
Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been
reported when olanzapine is stopped abruptly.
8
In clinical trials of up to 12 weeks, plasma prolactin concentrations exceeded the upper limit of
normal range in approximately 30% of olanzapine treated patients with normal baseline prolactin
value. In the majority of these patients the elevations were generally mild, and remained below two
times the upper limit of normal range.
9
Adverse event identified from clinical trials in the Olanzapine Integrated Database.
10
As assessed by measured values from clinical trials in the Olanzapine Integrated Database.
11
Adverse event identified from spontaneous post-marketing reporting with frequency determined
utilising the Olanzapine Integrated Database.
12
Adverse event identified from spontaneous post-marketing reporting with frequency estimated at
the upper limit of the 95% confidence interval utilising the Olanzapine Integrated Database.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-05-12T13:49:00Z · SHA-256 4c6933e864732db54f617a6615c3605a1299041a617de136aab779c18c8dbbe1 · Passage 61641cf89eca50ede327e675889c9f3b68fc012375baee39fa5c5a52fb2e0918 · Zeichen 8313–10448 im Abschnitt
Nebenwirkungen · Olanzapine Teva
Olanzapine Teva 2.5 mg film-coated tablets Olanzapine Teva 5 mg film-coated tablets Olanzapine Teva 7.5 mg film-coated tablets Olanzapine Teva 10 mg film-coated tablets Olanzapine Teva 15 mg film-coated tablets Olanzapine Teva 20 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 11
HOS-209078 · Präparat HOS-154237
Long-term exposure (at least 48 weeks)
The proportion of patients who had adverse, clinically significant changes in weight gain, glucose,
total/LDL/HDL cholesterol or triglycerides increased over time. In adult patients who completed
9-12 months of therapy, the rate of increase in mean blood glucose slowed after approximately
6 months.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-05-12T13:49:00Z · SHA-256 4c6933e864732db54f617a6615c3605a1299041a617de136aab779c18c8dbbe1 · Passage 4375aec2673d97fa741427ed501b30f102f260845435acfd0edb35591a81f370 · Zeichen 10450–10788 im Abschnitt
Nebenwirkungen · Olanzapine Teva
Olanzapine Teva 2.5 mg film-coated tablets Olanzapine Teva 5 mg film-coated tablets Olanzapine Teva 7.5 mg film-coated tablets Olanzapine Teva 10 mg film-coated tablets Olanzapine Teva 15 mg film-coated tablets Olanzapine Teva 20 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 11
HOS-209079 · Präparat HOS-154237
Additional information on special populations
In clinical trials in elderly patients with dementia, olanzapine treatment was associated with a higher
incidence of death and cerebrovascular adverse reactions compared to placebo (see section 4.4). Very
common adverse reactions associated with the use of olanzapine in this patient group were abnormal
gait and falls. Pneumonia, increased body temperature, lethargy, erythema, visual hallucinations and
urinary incontinence were observed commonly.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-05-12T13:49:00Z · SHA-256 4c6933e864732db54f617a6615c3605a1299041a617de136aab779c18c8dbbe1 · Passage d3ff8afa7e22632a9df18c9bb93097910e8ce26cdfeb9f04479f98815a6175b4 · Zeichen 10790–11285 im Abschnitt
Nebenwirkungen · Olanzapine Teva
Olanzapine Teva 2.5 mg film-coated tablets Olanzapine Teva 5 mg film-coated tablets Olanzapine Teva 7.5 mg film-coated tablets Olanzapine Teva 10 mg film-coated tablets Olanzapine Teva 15 mg film-coated tablets Olanzapine Teva 20 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 11
HOS-209080 · Präparat HOS-154237
In clinical trials in patients with drug-induced (dopamine agonist) psychosis associated with
Parkinson’s disease, worsening of Parkinsonian symptomatology and hallucinations were reported
very commonly and more frequently than with placebo.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-05-12T13:49:00Z · SHA-256 4c6933e864732db54f617a6615c3605a1299041a617de136aab779c18c8dbbe1 · Passage c29040ea7fa8697b2fb783bf69a1db1963559b0ed961ec03969ed7a0a9388588 · Zeichen 11287–11528 im Abschnitt
Nebenwirkungen · Olanzapine Teva
Olanzapine Teva 2.5 mg film-coated tablets Olanzapine Teva 5 mg film-coated tablets Olanzapine Teva 7.5 mg film-coated tablets Olanzapine Teva 10 mg film-coated tablets Olanzapine Teva 15 mg film-coated tablets Olanzapine Teva 20 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 11
HOS-209081 · Präparat HOS-154237
In one clinical trial in patients with bipolar mania, valproate combination therapy with olanzapine
resulted in an incidence of neutropenia of 4.1%; a potential contributing factor could be high plasma
valproate levels. Olanzapine administered with lithium or valproate resulted in increased levels
(≥10%) of tremor, dry mouth, increased appetite, and weight gain. Speech disorder was also reported
commonly. During treatment with olanzapine in combination with lithium or divalproex, an increase
of ≥7% from baseline body weight occurred in 17.4% of patients during acute treatment (up to
6 weeks). Long-term olanzapine treatment (up to 12 months) for recurrence prevention in patients with
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-05-12T13:49:00Z · SHA-256 4c6933e864732db54f617a6615c3605a1299041a617de136aab779c18c8dbbe1 · Passage 45f84d6facafc59018953eeddb2fae395efd5b8946d9f368d5378a1569f6dfe2 · Zeichen 11530–12221 im Abschnitt
Nebenwirkungen · Olanzapine Teva
Olanzapine Teva 2.5 mg film-coated tablets Olanzapine Teva 5 mg film-coated tablets Olanzapine Teva 7.5 mg film-coated tablets Olanzapine Teva 10 mg film-coated tablets Olanzapine Teva 15 mg film-coated tablets Olanzapine Teva 20 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 11–12
HOS-209082 · Präparat HOS-154237
11
bipolar disorder was associated with an increase of ≥7% from baseline body weight in 39.9% of
patients.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-05-12T13:49:00Z · SHA-256 4c6933e864732db54f617a6615c3605a1299041a617de136aab779c18c8dbbe1 · Passage 5eb1425a4683012aac1d21f6ab3e3530912414d3c9f6117b80a49307561c3b00 · Zeichen 12275–12382 im Abschnitt
Nebenwirkungen · Olanzapine Teva
Olanzapine Teva 2.5 mg film-coated tablets Olanzapine Teva 5 mg film-coated tablets Olanzapine Teva 7.5 mg film-coated tablets Olanzapine Teva 10 mg film-coated tablets Olanzapine Teva 15 mg film-coated tablets Olanzapine Teva 20 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 12
HOS-209083 · Präparat HOS-154237
Paediatric population
Olanzapine is not indicated for the treatment of children and adolescent patients below 18 years.
Although no clinical studies designed to compare adolescents to adults have been conducted, data
from the adolescent trials were compared to those of the adult trials.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-05-12T13:49:00Z · SHA-256 4c6933e864732db54f617a6615c3605a1299041a617de136aab779c18c8dbbe1 · Passage b9284543c0b616de6873ed17f4f74ff9f9eda1fc88049c9ecc0d528057af12c9 · Zeichen 12384–12671 im Abschnitt
Nebenwirkungen · Olanzapine Teva
Olanzapine Teva 2.5 mg film-coated tablets Olanzapine Teva 5 mg film-coated tablets Olanzapine Teva 7.5 mg film-coated tablets Olanzapine Teva 10 mg film-coated tablets Olanzapine Teva 15 mg film-coated tablets Olanzapine Teva 20 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 12
HOS-209084 · Präparat HOS-154237
The following table summarises the adverse reactions reported with a greater frequency in adolescent
patients (aged 13-17 years) than in adult patients or adverse reactions only identified during short-term
clinical trials in adolescent patients. Clinically significant weight gain (≥7%) appears to occur more
frequently in the adolescent population compared to adults with comparable exposures. The magnitude
of weight gain and the proportion of adolescent patients who had clinically significant weight gain
were greater with long-term exposure (at least 24 weeks) than with short-term exposure.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Nebenwirkungen · Olanzapine Teva
Olanzapine Teva 2.5 mg film-coated tablets Olanzapine Teva 5 mg film-coated tablets Olanzapine Teva 7.5 mg film-coated tablets Olanzapine Teva 10 mg film-coated tablets Olanzapine Teva 15 mg film-coated tablets Olanzapine Teva 20 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 12
HOS-209085 · Präparat HOS-154237
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
The frequency terms listed are defined as follows: Very common (≥1/10), common (≥1/100 to <1/10).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-05-12T13:49:00Z · SHA-256 4c6933e864732db54f617a6615c3605a1299041a617de136aab779c18c8dbbe1 · Passage e1fcaaaa173730aff198da7151f14acc0bae9252d999ad50a1551a274436c2bd · Zeichen 13272–13469 im Abschnitt
Nebenwirkungen · Olanzapine Teva
Olanzapine Teva 2.5 mg film-coated tablets Olanzapine Teva 5 mg film-coated tablets Olanzapine Teva 7.5 mg film-coated tablets Olanzapine Teva 10 mg film-coated tablets Olanzapine Teva 15 mg film-coated tablets Olanzapine Teva 20 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 12
HOS-209086 · Präparat HOS-154237
Metabolism and nutrition disorders
Very common: Weight gain13, elevated triglyceride levels14, increased appetite.
Common: Elevated cholesterol levels15
Nervous system disorders
Very common: Sedation (including: hypersomnia, lethargy, somnolence).
Gastrointestinal disorders
Common: Dry mouth
Hepatobiliary disorders
Very common: Elevations of hepatic aminotransferases (ALT/AST; see section 4.4).
Investigations
Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels16.
13
Following short term treatment (median duration 22 days), weight gain ≥7% of baseline body
weight (kg) was very common (40.6%), ≥15% of baseline body weight was common (7.1%) and
≥25% was common (2.5%). With long-term exposure (at least 24 weeks), 89.4% gained ≥7%,
55.3%gained ≥15% and 29.1% gained ≥25% of their baseline body weight.
14
Observed for fasting normal levels at baseline (<1.016 mmol/l) which increased to high
(≥1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline
(≥ 1.016 mmol/l-<1.467 mmol/l) to high (≥1.467 mmol/l).
15
Changes in total fasting cholesterol levels from normal at baseline (<4.39 mmol/l) to high
(≥5.17 mmol/l) were observed commonly. Changes in total fasting cholesterol levels from
borderline at baseline (≥4.39-<5.17 mmol/l) to high (≥5.17 mmol/l) were very common.
16
Elevated plasma prolactin levels were reported in 47.4% of adolescent patients.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-05-12T13:49:00Z · SHA-256 4c6933e864732db54f617a6615c3605a1299041a617de136aab779c18c8dbbe1 · Passage 9ae3dc0d25bb2708f4dc72546932294015236fd47fbf5a52c337ada87ded5ee5 · Zeichen 13471–14956 im Abschnitt
Nebenwirkungen · Olanzapine Teva
Olanzapine Teva 2.5 mg film-coated tablets Olanzapine Teva 5 mg film-coated tablets Olanzapine Teva 7.5 mg film-coated tablets Olanzapine Teva 10 mg film-coated tablets Olanzapine Teva 15 mg film-coated tablets Olanzapine Teva 20 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 12
HOS-209087 · Präparat HOS-154237
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
professionals are asked to report any suspected adverse reactions via the national reporting system
listed in Appendix V.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-05-12T13:49:00Z · SHA-256 4c6933e864732db54f617a6615c3605a1299041a617de136aab779c18c8dbbe1 · Passage 42f7144177697b690f59b1bda795c3fd216297691cf296a2e1269a137feab3cd · Zeichen 14958–15313 im Abschnitt
Nebenwirkungen · Olanzapine Teva
Olanzapine Teva 5 mg orodispersible tablets Olanzapine Teva 10 mg orodispersible tablets Olanzapine Teva 15 mg orodispersible tablets Olanzapine Teva 20 mg orodispersible tablets · Abschnitt 4.8 · PDF-Seite 26
HOS-209097 · Präparat HOS-154237
Summary of the safety profile
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2025-05-12T13:49:00Z · SHA-256 4c6933e864732db54f617a6615c3605a1299041a617de136aab779c18c8dbbe1 · Passage d55a523b6a19085dba8d780d613791739571d7f51eec366b153cafd8949337ee · Zeichen 0–29 im Abschnitt
Nebenwirkungen · Olanzapine Teva
Olanzapine Teva 5 mg orodispersible tablets Olanzapine Teva 10 mg orodispersible tablets Olanzapine Teva 15 mg orodispersible tablets Olanzapine Teva 20 mg orodispersible tablets · Abschnitt 4.8 · PDF-Seite 26
HOS-209098 · Präparat HOS-154237
Adults
The most frequently (seen in ≥1% of patients ) reported adverse reactions associated with the use of
olanzapine in clinical trials were somnolence, weight gain, eosinophilia, elevated prolactin,
cholesterol, glucose and triglyceride levels (see section 4.4), glucosuria, increased appetite, dizziness,
akathisia, parkinsonism, leukopenia, neutropenia (see section 4.4), dyskinesia, orthostatic hypotension,
anticholinergic effects, transient asymptomatic elevations of hepatic aminotransferases (see
section 4.4), rash, asthenia, fatigue, pyrexia, arthralgia, increased alkaline phosphatase, high gamma
glutamyltransferase, high uric acid, high creatine phosphokinase and oedema.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
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Nebenwirkungen · Olanzapine Teva
Olanzapine Teva 5 mg orodispersible tablets Olanzapine Teva 10 mg orodispersible tablets Olanzapine Teva 15 mg orodispersible tablets Olanzapine Teva 20 mg orodispersible tablets · Abschnitt 4.8 · PDF-Seite 26
HOS-209099 · Präparat HOS-154237
Tabulated list of adverse reactions
The following table lists the adverse reactions and laboratory investigations observed from
spontaneous reporting and in clinical trials. Within each frequency grouping, adverse reactions are
presented in order of decreasing seriousness. The frequency terms listed are defined as follows: Very
common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
<1/1,000), very rare (<1/10,000), not known (cannot be estimated from the data available).
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-05-12T13:49:00Z · SHA-256 4c6933e864732db54f617a6615c3605a1299041a617de136aab779c18c8dbbe1 · Passage 860e53c6a4a27254a86f13bc9918ac649901e204771afc1b2a018b8fb5bb4f5f · Zeichen 719–1231 im Abschnitt
Nebenwirkungen · Olanzapine Teva
Olanzapine Teva 5 mg orodispersible tablets Olanzapine Teva 10 mg orodispersible tablets Olanzapine Teva 15 mg orodispersible tablets Olanzapine Teva 20 mg orodispersible tablets · Abschnitt 4.8 · PDF-Seite 26
HOS-209100 · Präparat HOS-154237
Very common Common Uncommon Rare Not known
Blood and the lymphatic system disorders
Eosinophilia Thrombocytopeni
Leukopenia10 a11
Neutropenia10
Immune system disorders
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
Vollständigen Kontext in der EMA-Fachinformation lesen →Quellennachweis
Version 2025-05-12T13:49:00Z · SHA-256 4c6933e864732db54f617a6615c3605a1299041a617de136aab779c18c8dbbe1 · Passage 8f0b74fcdb5d32194d219b0ef62b1d21bfe2e7afe0d791d7263a5c49875b80ab · Zeichen 1233–1572 im Abschnitt
Nebenwirkungen · Olanzapine Teva
Olanzapine Teva 5 mg orodispersible tablets Olanzapine Teva 10 mg orodispersible tablets Olanzapine Teva 15 mg orodispersible tablets Olanzapine Teva 20 mg orodispersible tablets · Abschnitt 4.8 · PDF-Seite 26–27
HOS-209101 · Präparat HOS-154237
26
Hypersensitivity11
Metabolism and nutrition disorders
Weight gain1 Elevated Development or Hypothermia12
cholesterol exacerbation of
levels2,3 diabetes
Elevated glucose occasionally
levels4 associated with
Elevated ketoacidosis or
triglyceride coma, including
levels2,5 some fatal cases
Glucosuria (see section 4.4)11
Increased appetite
Nervous system disorders
Somnolence Dizziness Seizures where in Neuroleptic
Akathisia6 most cases a malignant
Parkinsonism6 history of seizures syndrome (see
Dyskinesia6 or risk factors for section 4.4)12
seizures were Discontinuation
reported11 symptoms7,12
Dystonia
(including
oculogyration)11
Tardive
dyskinesia11
Amnesia9
Dysarthria
Stuttering11
Restless legs
syndrome11
Cardiac disorders
Bradycardia Ventricular
QTc prolongation tachycardia/fibrill
(see section 4.4) ation, sudden
death (see
section 4.4)11
Vascular disorders
Orthostatic Thromboembolis
hypotension10 m (including
pulmonary
embolism and
deep vein
thrombosis) (see
section 4.4)
Respiratory, thoracic and mediastinal disorders
Epistaxis9
Gastrointestinal disorders
Mild, transient Abdominal Pancreatitis11
anticholinergic distension9
effects including Salivary
constipation and hypersecretion11
dry mouth
Hepatobiliary disorders
Transient, Hepatitis
asymptomatic (including
elevations of hepatocellular,
hepatic cholestatic or
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2025-05-12T13:49:00Z · SHA-256 4c6933e864732db54f617a6615c3605a1299041a617de136aab779c18c8dbbe1 · Passage ee67e423472127ee66aaf39fd5d2ea422357909255b2b82d0402db4167354aff · Zeichen 1625–4718 im Abschnitt
Nebenwirkungen · Olanzapine Teva
Olanzapine Teva 5 mg orodispersible tablets Olanzapine Teva 10 mg orodispersible tablets Olanzapine Teva 15 mg orodispersible tablets Olanzapine Teva 20 mg orodispersible tablets · Abschnitt 4.8 · PDF-Seite 27–28
HOS-209102 · Präparat HOS-154237
27
aminotransferases mixed liver
(ALT, AST), injury)11
especially in early
treatment (see
section 4.4)
Skin and subcutaneous tissue disorders
Rash Photosensitivity Drug Reaction
reaction with Eosinophilia
Alopecia and Systemic
Symptoms
(DRESS)
Musculoskeletal and connective tissue disorders
Arthralgia9 Rhabdomyolysis11
Renal and urinary disorders
Urinary
incontinence
Urinary retention
Urinary
hesitation11
Pregnancy, puerperium and perinatal conditions
Drug withdrawal
syndrome
neonatal (see
section 4.6)
Reproductive system and breast disorders
Erectile Amenorrhea Priapism12
dysfunction in Breast
males enlargement
Decreased libido Galactorrhea in
in males and females
females Gynaecomastia/br
east enlargement
in males
General disorders and administration site conditions
Asthenia
Fatigue
Oedema
Pyrexia10
Investigations
Elevated plasma Increased alkaline Increased total
8
prolactin levels phosphatase10 bilirubin
High creatine
phosphokinase11
High Gamma
Glutamyltransfera
se10
High uric acid10
1
Clinically significant weight gain was observed across all baseline Body Mass Index (BMI)
categories. Following short term treatment (median duration 47 days), weight gain ≥7% of baseline
body weight was very common (22.2%), ≥15% was common (4.2%) and ≥25% was uncommon
(0.8%). Patients gaining ≥7%, ≥15% and ≥25% of their baseline body weight with long-term
exposure (at least 48 weeks) were very common (64.4%, 31.7% and 12.3% respectively).
2
Mean increases in fasting lipid values (total cholesterol, LDL cholesterol, and triglycerides) were
greater in patients without evidence of lipid dysregulation at baseline.
Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.
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Version 2025-05-12T13:49:00Z · SHA-256 4c6933e864732db54f617a6615c3605a1299041a617de136aab779c18c8dbbe1 · Passage 217ff4b10eb944bd9fd705112db981c8a00dec0a7f1a8797811ce0b8b59da12b · Zeichen 4767–8009 im Abschnitt
This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.