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Roxithromycin: Side Effects

See also Macrolide antibiotics

Roxithromycin is a macrolide antibiotic with actions and uses similar to those of erythromycin.

Observational studies

In 2917 adults, adverse effects of roxithromycin occurred in 4.1% at a dosage of 150 mg/day. Nausea (1.3%), abdominal pain (1.2%), and diarrhea (0.8%) were the most frequently reported events, whereas rash, vomiting, headache, dizziness, pruritus, urticaria, and constipation were reported only rarely. Treatment had to be withdrawn in 0.9% of the patients because of adverse effects.

In an uncontrolled study in 24 HIV-infected patients, roxithromycin (300 mg bd for 4 weeks) was effective against cryptosporidial diarrhea. The most limiting adverse effects were abdominal pain (two patients), raised hepatic enzymes (two patients), and abdominal pain with raised hepatic enzymes (one patient). Minor symptoms occurred in nine patients.

In 304 infants and children under 14 years adverse effects occurred in 6.9%. Treatment was withdrawn in 10 children (two with vomiting, two diarrhea, and six rashes).

In 480 elderly patients (over 65 years), there were adverse events in 3.1% and treatment was withdrawn in 1.9%. The gastrointestinal tract was most often affected, whereas laboratory changes (increases in bilirubin, aspar-tate transaminase, alanine transaminase, and alkaline phosphatase) were seen in under 0.7%.

Organs and Systems

Cardiovascular

Torsade de pointes has been reported in an 83-year-old man who developed severe prolongation of the QT interval after taking roxithromycin 300 mg/day for 4 days.

Respiratory

Eosinophilic pneumonia of acute onset has been attributed to roxithromycin.

A 21-year-old woman developed a fever of 39°C, a generalized pruritic macular rash, odynophagia, and intense weakness, in conjunction with respiratory difficulties 8 days after starting to take roxithromycin 150 mg bd. Her leukocyte count was 15.4 x 109/1 with 9.8% eosinophiis and an erythrocyte sedimentation rate of 32 mm/hour. Peripheral infiltrates were evident on the chest X-ray and CT scan, with multiple areas of consolidation and an air bronchogram, mainly peripherally distributed. Bronchoalveolar lavage showed 50% eosinophiis. She improved with giucocorticoids and 6 months later was free of respiratory symptoms; a chest X-ray was normal.

Hematologic

In one study lymphopenia or eosinophilia were observed in two of 37 patients. However, this finding could not be confirmed in other studies.

Gastrointestinal

During long-term use of roxithromycin 300 mg/day for 2-66 months in nine patients with chronic diffuse scleros-ing osteomyelitis of the mandible, diarrhea and stomach discomfort occurred in one case and liver dysfunction in another.

Liver

• Cholestatic and hepatocellular liver damage occurred in a previously healthy 20-year-old woman after she took roxithromycin 150 mg bd for 4 days.
• Hepatic failure occurred in a previously healthy 5-year-old boy after he was given roxithromycin 50 mg bd for 5 days. He developed a non-pruritic, non-urticarial, erythematous, maculopapular, generalized rash, and occasional vomiting. Three days later he became jaundiced, and after 8 days underwent liver transplantation.

Skin

Allergic dermatitis with characteristic distribution pattern called “baboon syndrome” has been reported.

A 58-year-old man developed a pruritic skin eruption after he had taken roxithromycin 300 mg/day for 3 days. Large erythematous plaques covered his buttocks. Roxithromycin was immediately withdrawn and following treatment with oral antihistamines and topical corticosteroids the rash resolved within a few days.

Urticarial rashes have been attributed to roxithromycin.

Roxithromycin-induced generalized urticaria and tachycardia with a positive prick test and a cross-reaction to erythromycin and clarithromycin has been reported in a 31-year-old woman.

Angioedema and urticaria occurred in a 22-year-old woman a few hours after a second dose of roxithromycin 150 mg for a sore throat. The lesions subsided within 12 hours of drug withdrawal and there was no relapse after 3 months of follow-up. A skin prick test was positive for roxithromycin (1 mg/ml) and negative for erythromycin and clarithromycin in the same concentrations.

Immunologic

Roxithromycin had an immunomodulatory action on peripheral blood mononuclear cells in patients with psoriasis. The anti-inflammatory activity of roxithromycin is due to reduced production of proinflammatory mediators, cytokines, and co-stimulatory molecules, as has been shown in animal studies.

Drug-Drug Interactions

Antacids

Roxithromycin did not interact with antacids containing hydroxides of aluminium and magnesium.

Carbamazepine

Roxithromycin did not alter the pharmacokinetics of carbamazepine or interact with warfarin, ranitidine, or antacids containing hydroxides of aluminium and magnesium.

Oral contraceptives

Plasma concentrations of oral contraceptive steroids were unchanged when roxithromycin was co-administered.

Ranitidine

Roxithromycin did not interact with ranitidine.

Statins

In an open, randomized, crossover study in 12 healthy volunteers, roxithromycin did not alter the pharmacokinetics of lovastatin in such a way that dosage adjustment of lovastatin should be necessary during co-administration.

Myopathy occurred in a 73-year-old woman taking sim-vastatin 80 mg/day and gemfibrozil 600 mg bd 4 days after she started to take roxithromycin 300 mg/day.

Theophylline

Roxithromycin altered the pharmacokinetics of theophylline, mainly increasing the Cmax, prolonging the half-life, and increasing the renal clearance. However, while these changes were statistically significant, they were considered clinically irrelevant. There was no effect of roxithromycin on trough concentrations of theophylline.

Warfarin

Roxithromycin did not interact with warfarin.

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Therapeutic classes of Roxithromycin:

Anti-Bacterial Agents, Macrolides

Delivery

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