1986
DOI: 10.1007/bf01661311
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Safety of ofloxacin — adverse drug reactions reported during phase-II studies in europe and in Japan

Abstract: During phase-II studies monitored by Hoechst AG (Germany) and Daiichi (Japan) and phase-III/IV studies of Hoechst AG 577 adverse drug reactions were recorded among 13,717 patients treated with ofloxacin. Treatment was stopped in about 40% of the patients with adverse drug reactions. Most of the adverse reactions concerned the gastrointestinal tract. 124 adverse reactions concerned the central nervous system, mostly headache and sleep disturbances (n = 84). For the rare occurrences of other symptoms of the cent… Show more

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Cited by 33 publications
(14 citation statements)
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“…Mild eye disorders, such as corneal opacity, abnormal vision, retroocular pain, dizziness, lightheadedness, blurred vision, and photophobia, have been reported as ADRs of ciprofloxacin, enoxacin, pefloxacin, norfloxacin, and ofloxacin (Arcieri et al, 1989;Blomer et al, 1986;Chysky et al, 1991;Corraddo et al, 1987;Halkin, 1988;Sawada et al, 1991;Schacht et al, 1988;Young, 1985). The incidence of these symptoms, however, was very low, and no serious ophthalmic toxicity has been reported (Rapp et al, 1990).…”
Section: Phototoxicitymentioning
confidence: 97%
“…Mild eye disorders, such as corneal opacity, abnormal vision, retroocular pain, dizziness, lightheadedness, blurred vision, and photophobia, have been reported as ADRs of ciprofloxacin, enoxacin, pefloxacin, norfloxacin, and ofloxacin (Arcieri et al, 1989;Blomer et al, 1986;Chysky et al, 1991;Corraddo et al, 1987;Halkin, 1988;Sawada et al, 1991;Schacht et al, 1988;Young, 1985). The incidence of these symptoms, however, was very low, and no serious ophthalmic toxicity has been reported (Rapp et al, 1990).…”
Section: Phototoxicitymentioning
confidence: 97%
“…Rarely, hives or angioedema have been reported (3,4,20 Drug-Drug Interactions. Adverse interactions of quinolones with other drugs include those with theophylline and, possibly, non-steroidal anti-inflammatory drugs already discussed.…”
Section: Adverse Effectsmentioning
confidence: 98%
“…No bone toxicities were identified in either group. In adults receiving quinolones, arthritis, arthralgia and tenosynovitis have been uncommon and reversible adverse effects (1,3,5,20,(45)(46)(47)(48). For norfloxacin, four cases of reversible joint swelling and tendonitis have been reported, with recurrence occurring in two patients upon rechallenge (45, 49).…”
Section: Adverse Effectsmentioning
confidence: 99%
“…Fluorhinolonski antibitik, levofloxacin ima izveštaje o izazivanju akutnog delirijuma [25]. Slični navodi postoje i kod olfoksacina [26].…”
Section: Antiinfektivni Lekoviunclassified