What the label lists and what reports show
Amlodipine side effects
Amlodipine's FDA label: “Most common adverse reaction to amlodipine is edema which occurred in a dose related manner.” FAERS holds 409,186 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 (25,352 reports).
- Generic listed
Check it at the source: the amlodipine FDA label on DailyMed (effective February 15, 2023, 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 NORVASC?NORVASC may cause the following side effects. Most side effects are mild or moderate: • swelling of your legs or ankles • tiredness, extreme sleepiness • stomach pain, nausea • dizziness • flushing (hot or warm feeling in your face) • arrhythmia (irregular heartbeat) • heart palpitations (very fast heartbeat) • muscle rigidity, tremor and/or abnormal muscle movement It is rare, but when you first start taking NORVASC or increase your dose, you may have a heart attack or your angina may get worse. If that happens, call your doctor right away or go directly to a hospital emergency room. Tell your doctor if you are concerned about any side effects you experience. These are not all the possible side effects of NORVASC . For a complete list, ask your doctor or pharmacist. How do I store NORVASC? Keep NORVASC away from children. Store NORVASC Tablets at room temperature (between 59° and 86°F). […]
Source: FDA drug label, Viatris Specialty LLC, effective February 15, 2023 (SPL set 7367289c-b0b0-466a-83e2-558e2985c29f), 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.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | NORVASC (%) (N=1730) | Placebo (%) (N=1250) |
|---|---|---|
| Fatigue | 4.5 | 2.8 |
| Nausea | 2.9 | 1.9 |
| Abdominal Pain | 1.6 | 0.3 |
| Somnolence | 1.4 | 0.6 |
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, continuedMost common adverse reaction to amlodipine is edema which occurred in a dose related manner. Other adverse experiences not dose related but reported with an incidence >1.0% are fatigue, nausea, abdominal pain, and somnolence. ( 6 ) 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, 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. NORVASC has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with NORVASC was well‑tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with NORVASC were of mild or moderate severity. In controlled clinical trials directly comparing NORVASC (N=1730) at doses up to 10 mg to placebo (N=1250), discontinuation of NORVASC because of adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). The most commonly reported side effects more frequent than placebo are reflected in the table below.
Source: FDA drug label, Viatris Specialty LLC, effective February 15, 2023 (SPL set 7367289c-b0b0-466a-83e2-558e2985c29f), via openFDA; the full label on DailyMed
What do FAERS reports show?
409,186 reports list amlodipine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 42,260 are coded as a death and 159,402 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 21 reactions below, 12 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: 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