What the label lists and what reports show
Atorvastatin side effects
Atorvastatin's FDA label: “Most common adverse reactions (incidence ≥5%) are nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection ( 6.1 ).” FAERS holds 245,894 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 fatigue (14,251 reports).
- Generic listed
Check it at the source: the atorvastatin FDA label on DailyMed (effective April 15, 2024, Viatris Specialty LLC); 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 LIPITOR?LIPITOR may cause serious side effects including: • Muscle pain, tenderness and weakness (myopathy). Muscle problems, including muscle breakdown, can be serious in some people and, rarely, cause kidney damage that can lead to death. Tell your healthcare provider right away if you have: o unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or feel more tired than usual while you take LIPITOR. o muscle problems that do not go away after your healthcare provider has told you to stop taking LIPITOR. Your healthcare provider may do further tests to diagnose the cause of your muscle problems. […]
Source: FDA drug label, NDA020702 (Upjohn), as published by Viatris Specialty LLC, effective April 15, 2024 (SPL set a60cc18b-0631-4cf0-b021-9f52224ece65), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥5%) are nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection ( 6.1 ).
Table 1: Adverse Reactions Occurring in ≥ 2% in Patients LIPITOR-Treated with any Dose and Greater than Placebo
| Adverse Reaction | % Placebo N=7,311 | % 10 mg N=3,908 | % 20 mg N=188 | % 40 mg N=604 | % 80 mg N=4,055 | % Any dose N=8,755 |
|---|---|---|---|---|---|---|
| Nasopharyngitis | 8.2 | 12.9 | 5.3 | 7.0 | 4.2 | 8.3 |
| Arthralgia | 6.5 | 8.9 | 11.7 | 10.6 | 4.3 | 6.9 |
| Diarrhea | 6.3 | 7.3 | 6.4 | 14.1 | 5.2 | 6.8 |
| Pain in extremity | 5.9 | 8.5 | 3.7 | 9.3 | 3.1 | 6.0 |
| Urinary tract infection | 5.6 | 6.9 | 6.4 | 8.0 | 4.1 | 5.7 |
| Dyspepsia | 4.3 | 5.9 | 3.2 | 6.0 | 3.3 | 4.7 |
| Nausea | 3.5 | 3.7 | 3.7 | 7.1 | 3.8 | 4.0 |
| Musculoskeletal pain | 3.6 | 5.2 | 3.2 | 5.1 | 2.3 | 3.8 |
| Muscle spasms | 3.0 | 4.6 | 4.8 | 5.1 | 2.4 | 3.6 |
| Myalgia | 3.1 | 3.6 | 5.9 | 8.4 | 2.7 | 3.5 |
| Insomnia | 2.9 | 2.8 | 1.1 | 5.3 | 2.8 | 3.0 |
| Pharyngolaryngeal pain | 2.1 | 3.9 | 1.6 | 2.8 | 0.7 | 2.3 |
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 important adverse reactions are described below and elsewhere in the labeling: • Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1) ] • Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2) ] • Hepatic Dysfunction [see Warnings and Precautions (5.3) ] • Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4) ] Most common adverse reactions (incidence ≥5%) are nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In the LIPITOR placebo-controlled clinical trial database of 16,066 patients (8755 LIPITOR vs. 7,311 placebo; …
Source: FDA drug label, NDA020702 (Upjohn), as published by Viatris Specialty LLC, effective April 15, 2024 (SPL set a60cc18b-0631-4cf0-b021-9f52224ece65), via openFDA; the full label on DailyMed
What do FAERS reports show?
245,894 reports list atorvastatin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 18,672 are coded as a death and 70,054 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 20 reactions below, 11 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?
- Atorvastatin: 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