From the Guidelines
The risk of tendon rupture with the use of Cipro (ciprofloxacin) is estimated to be around 0.015-0.02%, or approximately 15 to 20 per 100,000 treated patients 1.
Key Factors Influencing Risk
- Age: Advanced age is a significant risk factor, with the risk increasing in patients over 60 years old 1.
- Steroid therapy: Patients taking corticosteroids are also at higher risk of tendon rupture 1.
- Underlying diseases: Certain conditions, such as hypercholesterolemia, gout, rheumatoid arthritis, end-stage renal disease/dialysis, and renal transplantation, increase the risk of tendon rupture 1.
Precautions
- Patients taking Cipro should be advised to stop treatment and contact their doctor immediately if they experience any tendon pain or swelling.
- The risk of tendon rupture may increase with higher doses and longer durations of treatment, particularly beyond 20 days, although this is not explicitly stated in the provided evidence, it is a general precaution for fluoroquinolone antibiotics.
- It is essential to weigh the benefits and risks of Cipro treatment, especially in patients with underlying risk factors, and to consider alternative treatment options when possible.
From the FDA Drug Label
ADVERSE REACTIONS Adverse Reactions in Adult Patients: During clinical investigations with oral and parenteral ciprofloxacin, 49,038 patients received courses of the drug. The most frequently reported drug related events, from clinical trials of all formulations, all dosages, all drug-therapy durations, and for all indications of ciprofloxacin therapy were nausea (2.5%), diarrhea (1.6%), liver function tests abnormal (1. 3%), vomiting (1%), and rash (1%). Additional medically important events that occurred in less than 1% of ciprofloxacin patients are listed below SKIN/HYPERSENSITIVITY: allergic reaction, pruritus, urticaria, photosensitivity/phototoxicity reaction, flushing, fever, chills, angioedema, edema of the face, neck, lips, conjunctivae or hands, cutaneous candidiasis, hyperpigmentation, erythema nodosum, sweating SPECIAL SENSES: blurred vision, disturbed vision (change in color perception, overbrightness of lights), decreased visual acuity, diplopia, eye pain, tinnitus, hearing loss, bad taste, chromatopsia An adolescent female discontinued ciprofloxacin for wrist pain that developed during treatment. An MRI performed 4 weeks later showed a tear in the right ulnar fibrocartilage.
The FDA drug label does not provide a specific percentage risk of tendon rupture with the use of Cipro (ciprofloxacin) [ 2 ].
From the Research
Tendon Rupture Risk with Ciprofloxacin
- The risk of tendon rupture associated with ciprofloxacin use is a known side effect, with various studies reporting on its occurrence 3, 4, 5, 6, 7.
- A study published in the British Journal of Clinical Pharmacology estimated the excess risk of tendon rupture due to current ciprofloxacin use to be low, at 3.73 per 10,000 person-years 3.
- The same study found that the risk of tendon rupture was higher among women, patients aged 60+, and those with concomitant corticosteroid use 3.
- Another study published in Expert Opinion on Drug Safety reported 606 cases of tendon rupture associated with ciprofloxacin use, with a mean age of affected individuals being 59.6 years 4.
- The study also found that corticosteroids were administered concomitantly with ciprofloxacin in 21.2% of cases, highlighting the increased risk of tendon rupture with combined use 4.
- Case reports have also been published, detailing instances of bilateral Achilles tendon ruptures associated with ciprofloxacin use, often in the presence of other risk factors such as advanced age, corticosteroid use, and renal failure 6, 7.
- The exact percentage risk of tendon rupture with ciprofloxacin use is not explicitly stated in the available evidence, but it is clear that the risk is increased, particularly in certain patient populations and with concomitant corticosteroid use 3, 4, 5, 6, 7.