From the Guidelines
Statins can cause several adverse effects, including muscle-related symptoms, liver problems, cognitive effects, digestive issues, increased blood sugar levels, and peripheral neuropathy, but the benefits of statins in reducing cardiovascular events typically outweigh these risks for most patients with appropriate indications.
Common Adverse Effects of Statins
- Muscle-related symptoms: muscle pain, tenderness, or weakness (myalgia) affects approximately 5-10% of patients 1
- Liver problems: elevated liver enzymes without symptoms, though rarely patients experience fatigue, abdominal pain, or jaundice 1
- Cognitive effects: memory problems or confusion have been reported 1
- Digestive issues: nausea, constipation, or diarrhea 1
- Increased blood sugar levels: potentially leading to diabetes, particularly in predisposed individuals 1
- Peripheral neuropathy: numbness, tingling, or burning sensations in extremities 1
Management of Adverse Effects
- For patients with statin-associated side effects, it is recommended that CK be measured in the case of severe symptoms and in the presence of objective muscle weakness 1
- An asymptomatic increase in transaminases (>3 times upper limit of normal) is an infrequent statin-associated side effect that often resolves with dose reduction or rechallenge with alternative statins 1
- A management strategy of statin discontinuation until symptoms improve, followed by rechallenge with a reduced dose, alternative agent, or alternative dosing regimen while monitoring for recurrent symptoms is recommended 1
- In patients at increased ASCVD risk, the goal should be to treat with the guideline-recommended maximally tolerated statin dose 1
From the FDA Drug Label
Adverse reactions (regardless of causality) occurring in ≥5% of patients treated with pravastatin in these studies are identified in Table 2: Table 2: Adverse Reactions in ≥5% of Patients Treated with Pravastatin 40 mg and at an Incidence Greater than Placebo in Long-Term Placebo-Controlled Trials Placebo (N=10,719) % of patients Pravastatin (N=10,764) % of patients Musculoskeletal Pain 24.4 24. 9 Upper Respiratory Tract Infection 20.2 21.2 Musculoskeletal Traumatism 9.6 10.2 Chest Pain 9.8 10.0 Influenza 9.0 9.2 Fatigue 7.8 8.4 Cough 7.4 8.2 Dizziness 6.6 7.3 Rash (including dermatitis) 7.1 7.2 Sinus Abnormality 6.7 7.0 Muscle Cramp 4.6 5. 1
The symptoms of adverse effects of statins include:
- Musculoskeletal Pain
- Upper Respiratory Tract Infection
- Musculoskeletal Traumatism
- Chest Pain
- Influenza
- Fatigue
- Cough
- Dizziness
- Rash
- Sinus Abnormality
- Muscle Cramp 2
From the Research
Symptoms of Adverse Effects of Statins
The symptoms of adverse effects of statins include:
- Muscle symptoms, such as myopathy and rhabdomyolysis, which are the most frequent side effects of statins 3, 4, 5
- Elevation in liver enzymes, which can lead to hepatotoxicity 3, 4, 6, 7
- New-onset diabetes mellitus 3
- Peripheral neuropathy 4
- Impaired myocardial contractility 4
- Autoimmune diseases 4
- Coenzyme Q deficiency, which can result in mitochondrial electron transport and antioxidant protection impairment 4
Mechanisms of Adverse Effects
The mechanisms of adverse effects of statins include:
- Impaired protein prenylation due to depletion of isoprenoids 4
- Deficiency of coenzyme Q involved in mitochondrial electron transport and antioxidant protection 4
- Abnormal protein glycosylation due to dolichol shortage 4
- Deficiency of selenoproteins 4
Management of Adverse Effects
The management of adverse effects of statins includes:
- Identifying patients with true statin-associated side effects (SASE) 3
- Proactive utilization of available diagnostic tests to rule out alternate etiologies mimicking adverse effects 3
- Timely intervention with modified statin or non-statins in patients with true SASE 3
- Reduction of dose or exchange of statin may be beneficial in some patients 5
- Careful clinical judgment may be necessary in certain cases to manage potential side effects on an individual basis 5