What the label lists and what reports show
Fluvastatin side effects
Fluvastatin's FDA label: “The most common adverse reactions that led to treatment discontinuation and occurred at an incidence greater than placebo were: transaminase increased (0.8%), upper abdominal pain (0.3%), dyspepsia (0.3%), fatigue (0.2%) and diarrhea (0.2%).” FAERS holds 7,505 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is myalgia (882 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the fluvastatin FDA label on DailyMed (effective April 21, 2025, Teva Pharmaceuticals USA, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of fluvastatin capsules?When taking fluvastatin capsules, some patients may develop serious side effects, including: muscle problems. Call your health care professional right away if you experience unexplained muscle pain, tenderness, or weakness especially with fever. This may be an early sign of a rare muscle problem that could lead to serious kidney problems. The risk of muscle problems is greater in people who are 65 years of age or older, or who already have thyroid or kidney problems. The chance of muscle problems may be increased if you are taking certain other medicines with fluvastatin capsules. If you have muscle problems that do not go away even after your health care professional has advised you to stop taking fluvastatin capsules, notify your health care professional. Your health care professional may do further tests to diagnose the cause of your muscle problems. liver problems. […]
Source: FDA drug label, Teva Pharmaceuticals USA, Inc., effective April 21, 2025 (SPL set aad8b373-0aec-4efb-8e61-3d8114b31127), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions that led to treatment discontinuation and occurred at an incidence greater than placebo were: transaminase increased (0.8%), upper abdominal pain (0.3%), dyspepsia (0.3%), fatigue (0.2%) and diarrhea (0.2%).
Table 2: Clinical Adverse Events Reported in ≥ 2% in Patients Treated With Fluvastatin Sodium and at an Incidence Greater Than Placebo in the Trial Regardless of Causality (% of Patients)
| Reaction | Fluvastatin Capsules 40 mg b.i.d. N = 822 (%) | Placebo N = 818 (%) |
|---|---|---|
| Atrial fibrillation | 2.4 | 2.0 |
| Abdominal pain upper | 6.3 | 4.5 |
| Fatigue | 4.7 | 3.8 |
| Bronchitis | 2.3 | 2.0 |
| Arthralgia | 2.1 | 1.8 |
| Dizziness | 3.9 | 3.5 |
| Dyspnea exertional | 2.8 | 2.4 |
| Hypertension | 5.8 | 4.2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are discussed in greater detail in other sections of the label: Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis) [ see Warnings and Precautions ( 5.1 ) ]. Liver Enzyme Abnormalities [ see Warnings and Precautions ( 5.3 ) ]. Most frequent adverse reactions (rate ≥ 2% and > placebo) are: headache, dyspepsia, myalgia, abdominal pain and nausea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience in Adult Patients Because clinical studies on fluvastatin capsules are conducted in varying study populations and study designs, the frequency of adverse reactions observed in the clinical studies of fluvastatin capsules cannot be directly compared with that in the clinical studies of other statins and may not reflect the frequency of adverse reactions observed in clinical practice. In the fluvastatin capsules placebo-controlled clinical trials database of 2326 patients treated with fluvastatin capsules 1 (age range 18 to 75 years, 44% women, 94% Caucasians, 4% Blacks, 2% other ethnicities) with a median treatment duration of 24 weeks, 3.4% of patients on fluvastatin capsules and 2.3% patients on placebo discontinued due to adverse reactions regardless of causality.
Source: FDA drug label, Teva Pharmaceuticals USA, Inc., effective April 21, 2025 (SPL set aad8b373-0aec-4efb-8e61-3d8114b31127), via openFDA; the full label on DailyMed
What do FAERS reports show?
7,505 reports list fluvastatin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 889 are coded as a death and 3,248 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 16 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Fluvastatin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions