Is cough a side effect of atorvastatin?

Is Cough a Side Effect of Atorvastatin?

Cough is not a recognized side effect of atorvastatin based on FDA labeling and clinical trial data, though isolated case reports exist. The FDA prescribing information for atorvastatin lists multiple adverse effects including muscle pain, gastrointestinal upset, and elevated liver enzymes, but does not include cough as a documented side effect. 1

Evidence from Clinical Trials and Guidelines

Bronchiectasis Studies

• In a randomized controlled trial of 60 patients with bronchiectasis, atorvastatin 80 mg daily for 6 months actually improved cough (measured by Leicester Cough Questionnaire) compared to placebo, though it was associated with increased adverse events overall (33% vs 10%, p=0.02). 2
• The adverse events leading to withdrawal in the atorvastatin group included headache, diarrhea, and liver function abnormalities—not cough. 2
• The British Thoracic Society guidelines specifically note that statins showed "improved cough, but an increase in adverse events" in bronchiectasis patients, indicating cough was a therapeutic outcome rather than a side effect. 2

FDA-Approved Safety Profile

The FDA prescribing information for atorvastatin lists the following adverse effects but does not include cough: 1

• Muscle pain, tenderness, and weakness (myopathy)
• Gastrointestinal upset
• Elevated liver transaminases
• Rare cases of rhabdomyolysis

Published Clinical Experience

• Multiple comprehensive reviews of atorvastatin's pharmacology and adverse effects from 1997-2001 consistently report gastrointestinal disturbances, elevated liver enzymes, and myalgia as the primary adverse effects, with no mention of cough. 3, 4, 5, 6
• One isolated case report from 2012 described chronic cough associated with simvastatin and fluvastatin (different statins), noting this was only the second such case in the literature. 7

Clinical Implications

If a patient on atorvastatin develops cough, investigate alternative causes first:

1. ACE inhibitor use (if taking concomitant antihypertensives)—the most common pharmaceutical cause of chronic dry cough, occurring in 5-35% of patients 8, 9

2. Cardiac causes—pulmonary edema from heart failure can present with cough 9

3. Gastroesophageal reflux disease—especially in older, overweight patients with diabetes 9

4. Primary respiratory conditions—asthma, post-nasal drip, or other pulmonary pathology 2

Important Caveats

• The 2022 ACC Expert Consensus on nonstatin therapies does not list cough among the adverse effects of any statin, including atorvastatin. 2
• While one case report suggests a possible association with statins broadly, this represents extremely rare, isolated observations rather than an established class effect. 7
• Do not discontinue atorvastatin for cough without first ruling out other common causes, as the cardiovascular benefits of statin therapy are well-established and cough is not a recognized adverse effect. 1, 3, 4, 5, 6