Skip to main content
SpringerLink
Log in

Side Effects of Ofloxacin in Clinical Trials and in Postmarketing Surveillance

  • Section 6: The Safety Profile of Ofloxacin and Drug Interaction Studies
  • Published:
Drugs Aims and scope Submit manuscript

Summary

Data derived from clinical trials of ofloxacin in 15,962 patients show that the incidence rate of adverse drug events was 4.27 per 100 patients. Symptoms were generally mild and related to the gastrointestinal tract, nervous system or hypersensitivity reactions in rank order. On the other hand, spontaneous reports obtained during postmarketing surveillance involving 1.5 million patients showed that the most frequent adverse drug events were related to the nervous system; next in order of frequency were hypersensitivity reactions and gastrointestinal symptoms. A comparison of the data obtained from clinical trials and postmarketing surveillance revealed no change in the favourable overall benefit:risk ratio of ofloxacin. Possible reasons for the different patterns of adverse drug events are discussed.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  • Dette GA, Knothe H. Die Nebenwirkungen der heterocyclischen Carbonsäuren (Gyrasehemmer) am Zentralnervensystem. Fortschritte in der Antimikrobiellen und Antineoplastischen Chemotherapie, in press.

  • Hori S, Shimada J, Saito A, Miyahara T, Kurioka S, Matsuda M. Effect of new quinolones on gamma-aminobutyric acid receptor binding. 25th Interscience Conference on Antimicrobial Agents and Chemotherapy, Minneapolis, Minnesota, September 29–October 2, Abstract No. 396, 1985.

  • Inman WHW. Under-reporting of adverse drug reactions, British Medical Journal 290: 1355, 1985.

    Google Scholar 

  • Karcn FE, Lasagna L. Adverse drug reactions. Journal of the American Medical Association 234: 1236–1241, 1975.

    Article  Google Scholar 

  • Ricci S, Del Favero A, Longo VG. Central nervous system side-effects of anti-infectious drugs. Drugs of Today 22: 283–300, 1983.

    Google Scholar 

  • Turner WM. The food and drug administration algorithm. Drug Information Journal 18: 259–266, 1984.

    PubMed  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Klinische Forschung, Hoechst AG, H 840, D 6230, Frankfurt am Main, 80, Germany

    Günther Jüngst & Rüdiger Mohr

Authors
  1. Günther Jüngst
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Rüdiger Mohr
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

About this article

Cite this article

Jüngst, G., Mohr, R. Side Effects of Ofloxacin in Clinical Trials and in Postmarketing Surveillance. Drugs 34 (Suppl 1), 144–149 (1987). https://doi.org/10.2165/00003495-198700341-00031

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/00003495-198700341-00031

Keywords

Search

Navigation