What the label lists and what reports show
Levamlodipine side effects
Levamlodipine's FDA label: “Most common adverse reactions to amlodipine is edema which occurred in a dose related manner.” FAERS holds 122 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 diarrhoea (12 reports).
- No generic listed
Check it at the source: the levamlodipine FDA label on DailyMed (effective December 11, 2024, CSPC Ouyi Pharmaceutical Co. Ltd); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions 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 | Amlodipine (%) (N=1,730) | Placebo (%) (N=1,250) |
|---|---|---|
| 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 reactions 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, call CSPC Ouyi Pharmaceutical Co., Ltd at 1-877-436-7220 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. Amlodipine has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with amlodipine besylate was well-tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with amlodipine were of mild or moderate severity. In controlled clinical trials directly comparing amlodipine besylate (N = 1730) at doses up to 10 mg to placebo (N = 1250), discontinuation of amlodipine besylate 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, CSPC Ouyi Pharmaceutical Co. Ltd, effective December 11, 2024 (SPL set c3cca66e-348a-43e8-8f96-e995104dae3d), via openFDA; the full label on DailyMed
What do FAERS reports show?
122 reports list levamlodipine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 13 are coded as a death and 73 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, 10 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.
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?
- Levamlodipine: 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