What the label lists and what reports show
Amlodipine and atorvastatin side effects
Amlodipine and atorvastatin's FDA label: “Most common adverse reaction to amlodipine is edema which occurred in a dose related manner ( 6.1 ).” FAERS holds 4,158 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 dizziness (184 reports).
- Generic listed
Check it at the source: the amlodipine and atorvastatin FDA label on DailyMed (effective May 23, 2025, Alembic Pharmaceuticals Limited); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible side effects of amlodipine and atorvastatin tablets?Amlodipine and atorvastatin tablets can 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: unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or feel more tired than usual while you take amlodipine and atorvastatin tablets. muscle problems that do not go away after your healthcare provider has told you to stop taking amlodipine and atorvastatin tablets. Your healthcare provider may do further tests to diagnose the cause of your muscle problems. […]
Source: FDA drug label, Alembic Pharmaceuticals Limited, effective May 23, 2025 (SPL set ecab983e-6ed8-4440-b7b4-7ac4bf39b26c), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reaction to amlodipine is edema which occurred in a dose related manner ( 6.1 ).
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
This table is printed in the Caduet label published by Pfizer Laboratories Div Pfizer Inc of June 25, 2026; the label quoted above does not print one.
| Adverse Reaction | % Placebo N=7311 | % 10 mg N=3908 | % 20 mg N=188 | % 40 mg N=604 | % 80 mg N=4055 | % Any dose N=8755 |
|---|---|---|---|---|---|---|
| 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 (5.6)] Most common adverse reaction to amlodipine is edema which occurred in a dose related manner ( 6.1 ). Most common adverse reactions (incidence ≥ 5%) are nasopharyngitis, arthralgia, diarrhea, pain in extremity, and urinary tract infection to atorvastatin ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact 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. Amlodipine and Atorvastatin Amlodipine and atorvastatin has been evaluated for safety in 1,092 patients in double-blind placebo-controlled studies treated for co-morbid hypertension and dyslipidemia. In general, treatment with amlodipine and atorvastatin was well tolerated. For the most part, adverse reactions have been mild or moderate in severity. …
Source: FDA drug label, Alembic Pharmaceuticals Limited, effective May 23, 2025 (SPL set ecab983e-6ed8-4440-b7b4-7ac4bf39b26c), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,158 reports list amlodipine and atorvastatin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 386 are coded as a death and 1,100 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 22 reactions below, 14 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?
- Amlodipine and 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