Amlodipine Side Effects are documented on the FDA prescribing label, and reported separately by patients and doctors to the FDA’s adverse event system. This page sets out what the official record actually says about Amlodipine: what it is approved to treat, what the label warns about, its recall history, and what the reported side effects are — along with what those figures do and do not mean.
- What Amlodipine Is Prescribed For, and Where Amlodipine Side Effects Come From
- Warnings on the Amlodipine Label
- Warnings Beyond the Common Amlodipine Side Effects
- Amlodipine Side Effects Listed on the FDA Label
- Reported Amlodipine Side Effects in the FDA Database
- Who the Label Says Should Take Extra Care
- Amlodipine Recall History
- Is Amlodipine the Subject of Litigation?
- If You Are Worried About Amlodipine Side Effects
- Frequently Asked Questions
- Official Sources
- Related Guides
Before you read on. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first.
What Amlodipine Is Prescribed For, and Where Amlodipine Side Effects Come From
According to the FDA label, mlodipine besylate tablets is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: Hypertension ( 1.1 ) Amlodipine besylate tablets is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. […]
Two separate official sources describe amlodipine side effects. The prescribing label records what was observed in clinical trials, where the drug was compared against a control group. The FDA’s adverse event database records what patients and clinicians have reported since approval, which is a much larger but far less controlled picture. Both appear below, and they answer different questions.
| Active ingredient | Amlodipine Besylate |
| Brand names on this label | Amlodipine Besylate |
| How it is given | oral |
| Boxed warning | See the label for this product |
| Recall records | 39 |
| Label last updated | 2025-04-02 |
Warnings on the Amlodipine Label
The FDA prescribing label carries the full set of warnings and precautions for Amlodipine. Because a medicine can have several approved labels from different manufacturers and formulations, the safest way to see the warnings that apply to the exact product you have is to read the label for that product.
You can look up any product’s current FDA label on DailyMed, the National Library of Medicine’s official label database, using the name on your bottle or box.
Warnings Beyond the Common Amlodipine Side Effects
The label’s warnings and precautions section describes risks the FDA requires prescribers to weigh. For Amlodipine it covers: Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely. ( 5.1 ) Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine particularly in patients with severe obstructive coronary artery disease. ( 5.2 ) Titrate slowly in patients with severe hepatic impairment.
( 5.3 ) 5.1 Hypotension Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. Because of the gradual onset of action, acute hypotension is unlikely. 5.2 Increased Angina or Myocardial Infarction Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of amlodipine besylate tablets, particularly in patients with severe obstructive coronary artery disease. […]
These are the risks the FDA has judged significant enough to state formally, and they sit apart from the routine amlodipine side effects most people ask about. They apply to different patients to very different degrees, which is why the same medicine can be routine for one person and unsuitable for another.
Amlodipine Side Effects Listed on the FDA Label
The label’s adverse reactions section records what was observed in clinical trials: ost 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 Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) 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 was well-tolerated at doses up to 10 mg daily. […]
Trial data is the most reliable source for how common amlodipine side effects are, because the people taking the drug were compared against people who were not. A symptom that appeared just as often in the control group is not caused by the medicine.
Reported Amlodipine Side Effects in the FDA Database
Reported amlodipine side effects — and what these numbers do not mean
The FDA’s adverse event database holds 431,544 reports mentioning Amlodipine, of which 320,689 were classified as serious.
Read those numbers carefully. An adverse event report means somebody told the FDA that something happened to a person taking this medicine. It is not a finding that the medicine caused it. Reports are submitted voluntarily by patients, families, doctors and manufacturers; nobody verifies them; and the same event can be reported more than once.
Report volume tracks how many people take a drug, how new it is, and how much attention it is getting. A widely prescribed medicine will always show more reports than a rarely used one, and reports rise sharply when a drug is in the news or in litigation. A large number here does not mean a drug is dangerous, and a small number does not mean it is safe.
| Most frequently reported | Reports |
|---|---|
| Fatigue | 26,173 |
| Diarrhoea | 22,833 |
| Nausea | 22,605 |
| Dyspnoea | 21,590 |
| Dizziness | 18,373 |
| Headache | 17,066 |
| Pain | 16,308 |
| Asthenia | 14,869 |
Source: FDA Adverse Event Reporting System (FAERS), retrieved July 2026. Non-clinical reporting categories such as “off label use” have been excluded from the list above because they describe how a drug was used, not something that happened to a patient.
Who the Label Says Should Take Extra Care
Contraindications. The label states that Amlodipine should not be used in certain situations: mlodipine besylate tablets are contraindicated in patients with known sensitivity to amlodipine. Known sensitivity to amlodipine ( 4 )
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Interactions with other medicines. o not exceed doses greater than 20 mg daily of simvastatin. (7.2) 7.1 Impact of Other Drugs on Amlodipine CYP3A Inhibitors Co-administration with CYP3A inhibitors (moderate and strong) results in increased systemic exposure to amlodipine and may require dose reduction. Monitor for symptoms of hypotension and edema when amlodipine is co-administered with CYP3A inhibitors to determine the need for dose adjustment [see Clinical Pharmacology (12.3) ] . […]
Older adults. 8.5 Geriatric Use Clinical studies of amlodipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. […]
Your pharmacist can check your full medicine list against this in a couple of minutes, including anything bought over the counter, and that check is free.
Amlodipine Recall History
The FDA enforcement database records 39 recall entries involving Amlodipine products (20 Class II, 19 Class III). A recall almost always concerns specific manufactured batches rather than the medicine itself, and different manufacturers of the same generic drug have separate recall records.
The FDA classifies recalls by how serious the potential consequence is. Class I means a reasonable probability of serious harm or death; Class II means temporary or reversible harm is possible; Class III means the product breaks a regulation but is unlikely to cause harm.
| Date | Class | Recalling firm | Reason |
|---|---|---|---|
| 2026-06-10 | Class II | Ascend Laboratories, LLC | Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications |
| 2025-08-20 | Class II | Ascend Laboratories, LLC | Failed Dissolution Specifications: low dissolution results |
| 2025-08-06 | Class II | Lupin Pharmaceuticals Inc. | Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027 |
| 2023-07-19 | Class III | Lupin Pharmaceuticals Inc. | Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study. |
| 2022-03-09 | Class II | Macleods Pharma Usa Inc | cGMP deviations |
If a batch you have was recalled, the pharmacy that dispensed it is the fastest way to find out and to get a replacement. Do not simply stop taking a prescribed medicine because a recall notice exists — the recall may not affect your batch, and stopping can carry its own risk.
Is Amlodipine the Subject of Litigation?
We are not tracking consolidated federal litigation over Amlodipine. It is a widely prescribed medicine, and the information on this page is drawn from the FDA label and public safety data rather than from any legal claim.
If You Are Worried About Amlodipine Side Effects
Concern about amlodipine side effects is a good reason to have a conversation, and not a reason to act alone. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first. Stopping some medicines abruptly carries risks of its own, and your prescriber can tell you whether that applies to yours.
Write down what you have noticed and when it started before the appointment. Not everything that happens while taking a medicine is one of its amlodipine side effects, and a specific account — what changed, when, and how often — is what lets a clinician tell the difference.
You can also report a side effect directly to the FDA through MedWatch. Reports from patients are part of how safety signals are detected, and filing one takes a few minutes.
Frequently Asked Questions
What are the most commonly reported amlodipine side effects?
In FDA reports, the most frequently mentioned are fatigue, diarrhoea, nausea. The label’s own adverse reactions section, drawn from clinical trials, is the better guide to how common a side effect actually is, because reports to the FDA are not collected in a way that supports rates.
Has Amlodipine been recalled?
There are 39 recall records for Amlodipine products, the most recent dated 2026-06-10. Recalls generally affect specific manufactured batches rather than the medicine as a whole. Your pharmacy can tell you whether a batch you have was affected.
Does Amlodipine have a boxed warning?
A medicine can have several approved labels from different manufacturers, so the reliable answer for the exact product you have is on that product’s label. You can look it up on DailyMed using the name on your packaging.
Do the FDA report numbers tell me how common these amlodipine side effects are?
No. Reports are unverified, anyone can file one, and the total mostly reflects how many people take the medicine and how much attention it is getting. A high count is not evidence of danger, and a low one is not evidence of safety. Clinical trial data on the label is the source that supports rates.
Where can I check amlodipine side effects for the exact product I have?
DailyMed holds the current FDA label for every marketed product, searchable by the name on your packaging. Different manufacturers and formulations of the same medicine can have slightly different labels, so checking the one you actually have is worth the two minutes.
Official Sources
- DailyMed (National Library of Medicine) — the current FDA prescribing label for every product
- FDA Adverse Event Reporting System dashboard — the public report data summarised above
- FDA recalls and safety alerts — current recall notices
- FDA MedWatch — how to report a side effect yourself
Related Guides
Medical and legal disclaimer. This page summarises publicly available FDA data about Amlodipine and is general information, not medical advice, and not legal advice. It is not a substitute for the judgement of a clinician who knows your medical history. Nothing here states that Amlodipine caused any illness or injury in any individual. Adverse event reports are unverified and do not establish causation.
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FDA labels are revised regularly; confirm current information on DailyMed or with your pharmacist. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first.