From the FDA Drug Label
Adverse reactions reported in ≥2% of patients in placebo-controlled clinical studies and at a rate greater than placebo are shown in Table 2. These studies had a treatment duration of up to 12 weeks Table 2: Adverse Reactions Reported in ≥2% of Patients Treated with Rosuvastatin and > Placebo in Placebo-Controlled Trials Adverse Reactions | Placebo N=382% | Rosuvastatin 5 mg N=291% | Rosuvastatin 10 mg N=283% | Rosuvastatin 20 mg N=64% | Rosuvastatin 40 mg N=106% | Total Rosuvastatin 5 mg to 40 mg N=744% Headache | 5.0 | 5.5 | 4.9 | 3.1 | 8.5 | 5.5
In the METEOR study, patients were treated with rosuvastatin 40 mg (n=700) or placebo (n=281) with a mean treatment duration of 1. 7 years. Adverse reactions reported in ≥2% of patients and at a rate greater than placebo are shown in Table 3. Table 3: Adverse Reactions Reported in ≥ 2% of Patients Treated with Rosuvastatin and > Placebo in the METEOR Trial Adverse Reactions | Placebo N=281% | Rosuvastatin 40 mg N=700% Headache | 5.3 | 6.4
Yes, statins (HMG-CoA reductase inhibitors), such as rosuvastatin, can cause headaches.
- The frequency of headaches in patients treated with rosuvastatin was reported to be around 5.5% in placebo-controlled trials, which is slightly higher than the frequency in the placebo group (5.0%) 1.
- In the METEOR study, the frequency of headaches was 6.4% in patients treated with rosuvastatin 40 mg, compared to 5.3% in the placebo group 1.
- Similar results were also reported in other studies, including the JUPITER trial 1.
From the Research
Statins may actually have a preventive effect on headaches, particularly migraine-type headaches, rather than causing them, as evidenced by the most recent and highest quality study. According to the study published in 2022 2, atorvastatin significantly improved the frequency of headache and quality of life (QOL) in patients with migraine over 24 weeks compared with placebo. This suggests that statins could be a potential treatment option for migraine prophylaxis.
The potential benefits of statins in headache prevention are thought to be related to their anti-inflammatory and vasodilatory endothelial effects, as well as their ability to reduce cardiovascular risk factors that may contribute to headache development. Some studies have also suggested that statins may have a positive effect on migraine headaches, particularly in patients with high serum vitamin D levels 3.
While some patients may experience headaches as a side effect of statin therapy, the evidence suggests that this is not a common occurrence, and that the benefits of statin therapy may outweigh the risks for many patients. In fact, a 2023 review of statin side effects found that headaches were not a commonly reported adverse effect, and that the majority of side effects were related to muscle pain and liver enzyme elevations 4.
Key points to consider:
- Statins may have a preventive effect on migraine-type headaches
- Atorvastatin has been shown to improve headache frequency and QOL in patients with migraine
- Statins may have anti-inflammatory and vasodilatory effects that contribute to headache prevention
- Headaches are not a commonly reported side effect of statin therapy
- The benefits of statin therapy may outweigh the risks for many patients, particularly those with high cardiovascular risk.