unerwünschte Arzneimittelwirkung

English translation: adverse drug reaction

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German term or phrase:	unerwünschte Arzneimittelwirkung
English translation:	adverse drug reaction

05:02 Nov 26, 2015

The asker opted for community grading. The question was closed on 2015-11-30 04:54:09 based on peer agreement (or, if there were too few peer comments, asker preference.)

German to English translations [PRO]
Medical - Medical: Health Care / medication side effects

German term or phrase: unerwünschte Arzneimittelwirkung

I usually don't translate from German, but a German acronym has crept into my Italian document (I assume it's from Switzerland) and I need to make sure I translate this correctly:

"Da notare che nella monografia del [name of drug] non è descritta distonia come *UAW* (anzi viene riportato che: Akute Dystonie ist keine nachgewiesene Nebenwirkung einer [name of drug]-Behandlung)."

For those who don't read Italian, here's the first part in English:

"Note that dystonia is not described as a *UAW* in the [name of drug] monograph (in fact it is reported that: Akute Dystonie ist keine nachgewiesene Nebenwirkung einer [name of drug]-Behandlung).

UAW = unerwünschte Arzneimittelwirkung

Also meine Frage ist, wie soll ich "unerwünschte Arzneimittelwirkung" übersetzen?

Some online sites translate this as "adverse drug reaction" but in a Summary of Product Characteristics there is always a section called "undesirable effects" and to me this looks closer to these German words.

Which is the correct meaning?

Vielen Dank für eure Hilfe!

Joseph Tein KudoZ activity Questions: 1487 (7 open) (1 without valid answers) (120 closed without grading) Answers: 724 United States
Local time: 07:53

adverse drug reaction

Explanation:
"Adverse drug reaction" is a standard phrase in English, particularly in the US, and for what it's worth it includes 'drug' for 'Arzneimittel', which "Undesirable effects" does not.
I would use 'adverse drug reaction'. See:
"Adverse drug reactions: definitions, diagnosis, and management."
http://www.ncbi.nlm.nih.gov/pubmed/11072960

and many other examples on the Net.

Selected response from:

David Tracey, PhD
Local time: 16:53

Grading comment

Thanks again.
4 KudoZ points were awarded for this answer

Summary of answers provided

4 +15

adverse drug reaction

David Tracey, PhD

4 +1

undesirable effects

Erzsébet Czopyk

Discussion entries: 1

Answers

14 mins confidence:

peer agreement (net): +15

adverse drug reaction

David Tracey, PhD
Local time: 16:53
Specializes in field
Native speaker of:

English
PRO pts in category: 42

Grading comment

Thanks again.

Notes to answerer

Asker: Hi David, thank you very much. I understand "Arzneimittel" ... I was being pulled between the two possible meanings because the other version has the word "undesirable" which corresponds to the "unerwünschte" term.

Peer comments on this answer (and responses from the answerer)

agree

H. C. Centner

2 mins

-> Many thanks, Collette.

agree

philgoddard

5 mins

-> Many thanks again, Phil.

agree

Edith Kelly

7 mins

-> Many thanks, Edith.

agree

BrigitteHilgner: I'm translating from English/US-American into German and frequently clients use just simply "adverse effect". ("Adverse" is definitely the standard term, as far as I can see.)

1 hr

-> Thank you kindly, Brigitte.

agree

Ramey Rieger (X)

2 hrs

-> Many thanks, Ramey.

agree

Marga Shaw

2 hrs

-> Thank you, Marga.

agree

barbarameyer

3 hrs

-> Many thanks, Barbara.

agree

Donald Jacobson

3 hrs

-> Thanks, Don!

agree

Susanne Schiewe

3 hrs

-> Many thanks, Susanne.

agree

Melanie Maiwald-Meylahn

3 hrs

-> Thank you, Melanie.

agree

Jacek Konopka

7 hrs

-> Many thanks, Jacek.

agree

Gergely Glázer: I work with clinical trials, this is a common phrase. Also supported by Eur-Lex (for what it's worth).

8 hrs

-> Thank you, Greg.

agree

Lirka: yes, or "drug-related adverse reaction/event"

10 hrs

-> Many thanks, lirka.

agree

analytical (X)

1 day 4 hrs

-> Thank you, analytical.

agree

Siegfried Armbruster: ADR

1 day 8 hrs

-> Hi Siegfried, many thanks...

15 mins confidence:

peer agreement (net): +1

undesirable effects

Explanation:
Adverse drug reaction used generally:

Adverse drug reaction - Wikipedia, the free encyclopedia
https://en.wikipedia.org/wiki/Adverse_drug_reaction
An adverse drug reaction (ADR) is an injury caused by taking a medication. ADRs may occur following a single dose or prolonged administration of a drug or ...
‎Classification - ‎Mechanisms - ‎Assessing causality - ‎Monitoring bodies

Adverse Drug Reactions - The Merck Manuals
www.merckmanuals.com › ... › Clinical Pharmacology
Adverse drug reaction (ADR, or adverse drug effect) is a broad term referring to unwanted, uncomfortable, or dangerous effects that a drug may have. ADRs can ...

http://www.adrreports.eu/en/
On this website you can view data on suspected side-effects also known as suspected adverse drug reactions for authorised medicines in the European Economic Area (EEA).

Adverse drug reactions - The Lancet
www.thelancet.com/pdfs/.../PIIS0140673600027999.pd...
WHO's definition of an adverse drug reaction, which has been in use for about 30 years, is “a response to a drug that is noxious and unintended and occurs at ...

Drug Interactions & Labeling > Preventable Adverse Drug ...
www.fda.gov/Drugs/.../ucm110632.htm
Welcome to the Adverse Drug Reaction (ADR) learning module. The module will begin with a presentation of a case that was published in 1990. This case ...

BUT undesirable effects is an official EMEA term:

Section 4.8: Undesirable effects - European Medicines Agency
www.ema.europa.eu/docs/en.../WC500137021.pdf
An agency of the European Union. Section 4.8: Undesirable effects. SmPC training presentation. Note: for full information refer to the European Commission's ...

CTPA - Serious Undesirable Effects (SUEs)
www.ctpa.org.uk/content.aspx?pageid=461
Article 2 of the Regulation provides definitions of both undesirable effects and serious undesirable effects. Undesirable Effect means. 'an adverse reaction for ...

For unerwünschte Arzneimittelwirkung I definitely suggest to use "undesirable (drug) effects"

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Note added at 16 mins (2015-11-26 05:18:55 GMT)
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As your document comes from EU , I suggest to follow the EU-terminology, and refer to EMEA

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Note added at 1 day2 hrs (2015-11-27 07:11:05 GMT)
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@Joseph: you asked for a translation, which is corresponsds to German. I know (I have my experience) that in some language pairs, even if you put the utmost careful research, with many links, with explanation, you will never get a single agree just beacuse no one will supoort a non-native speaker. We use adverse drug reaction in leaflets but the official EMEA term is undesirable effects which we shall use in SmPCs, PILs and other official documents. I am just sad not because of lost points or whatever just for the time. Maybe I shall refrain from answering your questions.

Erzsébet Czopyk
Hungary
Local time: 16:53
Specializes in field
Native speaker of:

Hungarian

Notes to answerer

Asker: Hello Erzsébet. Thank you again for your research and comments, and for this suggestion. Since THIRTEEN colleagues (at least one of them is a German-speaking doctor) agreed with the other answer, that is the one that I must choose!

Asker: Hi Erzsébet. See my new comment in the Discussion section above.

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English translation: adverse drug reaction

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