Lisinopril 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 Lisinopril: 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 Lisinopril Is Prescribed For, and Where Lisinopril Side Effects Come From
- The FDA Boxed Warning on Lisinopril
- Warnings Beyond the Common Lisinopril Side Effects
- Lisinopril Side Effects Listed on the FDA Label
- Reported Lisinopril Side Effects in the FDA Database
- Who the Label Says Should Take Extra Care
- Lisinopril Recall History
- Is Lisinopril the Subject of Litigation?
- If You Are Worried About Lisinopril 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 Lisinopril Is Prescribed For, and Where Lisinopril Side Effects Come From
According to the FDA label, isinopril tablet USP is an angiotensin converting enzyme (ACE) inhibitor indicated for: Treatment of hypertension in adults and pediatric patients 6 years of age and older ( 1.1 ) Adjunct therapy for heart failure ( 1.2 ) Treatment of Acute Myocardial Infarction ( 1.3 ) 1.1 Hypertension Lisinopril tablet USP is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure.
Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. […]
Two separate official sources describe lisinopril 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 | Lisinopril |
| Brand names on this label | Lisinopril |
| How it is given | oral |
| Boxed warning | Yes – see below |
| Recall records | 15 |
| Label last updated | 2023-08-18 |
The FDA Boxed Warning on Lisinopril
This medicine carries a boxed warning
WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue lisinopril as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 ) WARNING: FETAL TOXICITY When pregnancy is detected, discontinue lisinopril as soon as possible [see WARNINGS AND PRECAUTIONS ( 5.1 )] . Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see WARNINGS AND PRECAUTIONS ( 5.1 )] .
A boxed warning is the most serious warning the FDA requires on a prescription label. It does not mean the medicine should not be used. It means there is a specific risk serious enough that the FDA requires it to appear at the very top of the prescribing information, so that prescribers weigh it deliberately for each patient.
Prescribers see this warning every time they consult the label. If it concerns you, it is a reasonable thing to raise at your next appointment and ask how it applies to your own situation.
Warnings Beyond the Common Lisinopril Side Effects
The label’s warnings and precautions section describes risks the FDA requires prescribers to weigh. For Lisinopril it covers: ngioedema: Discontinue lisinopril, provide appropriate therapy and monitor until resolved ( 5.2 ) Renal impairment: Monitor renal function periodically ( 5.3 ) Hypotension: Patients with other heart or renal diseases have increased risk, monitor blood pressure after initiation ( 5.4) Hyperkalemia: Monitor serum potassium periodically ( 5.5 ) Cholestatic jaundice and hepatic failure: Monitor for jaundice or signs of liver failure ( 5.6 ) 5.1 Fetal Toxicity Lisinopril can cause fetal harm when administered to a pregnant woman.
Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue lisinopril as soon as possible [see USE IN SPECIFIC POPULATIONS ( 8.1 )] . […]
These are the risks the FDA has judged significant enough to state formally, and they sit apart from the routine lisinopril 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.
Lisinopril Side Effects Listed on the FDA Label
The label’s adverse reactions section records what was observed in clinical trials: ommon adverse reactions (events 2% greater than placebo) by use: Hypertension: headache, dizziness and cough ( 6.1 ) Heart Failure: hypotension and chest pain ( 6.1 ) Acute Myocardial Infarction: hypotension ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 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 studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Hypertension In clinical trials in patients with hypertension treated with lisinopril, 5.7% of patients on lisinopril discontinued with adverse reactions. […]
Trial data is the most reliable source for how common lisinopril 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 Lisinopril Side Effects in the FDA Database
Reported lisinopril side effects — and what these numbers do not mean
The FDA’s adverse event database holds 310,216 reports mentioning Lisinopril, of which 189,208 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.
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| Most frequently reported | Reports |
|---|---|
| Fatigue | 20,203 |
| Nausea | 18,867 |
| Diarrhoea | 17,559 |
| Dyspnoea | 14,212 |
| Pain | 13,886 |
| Dizziness | 13,791 |
| Headache | 13,186 |
| Vomiting | 11,151 |
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 Lisinopril should not be used in certain situations: ngioedema or a history of hereditary or idiopathic angioedema ( 4 ) Hypersensitivity ( 4 ) Co-administration of aliskiren with lisinopril in patients with diabetes ( 4 , 7.4 ) Lisinopril is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer Lisinopril tablet USP within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor [see WARNINGS and PRECAUTIONS ( 5.2 )]. […]
Interactions with other medicines. iuretics: Excessive drop in blood pressure ( 7.1 ) NSAIDS: Increased risk of renal impairment and loss of antihypertensive efficacy ( 7.3 ) Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension and hyperkalemia ( 7.4 ) Lithium: Symptoms of lithium toxicity ( 7.5 ) Gold: Nitritoid reactions have been reported ( 7.6 ) Concomitant mTOR inhibitor or neprilysin inhibitor use may increase angioedema risk ( 7.7 , 7.8 ) 7.1 Diuretics Initiation of lisinopril in […]
Older adults. 8.5 Geriatric Use No dosage adjustment with lisinopril is necessary in elderly patients. In a clinical study of lisinopril in patients with myocardial infarctions (GISSI-3 Trial) 4,413 (47%) were 65 and over, while 1,656 (18%) were 75 and over. In this study, 4.8 % of patients aged 75 years and older discontinued lisinopril treatment because of renal dysfunction vs. 1.3% of patients younger than 75 years. […]
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.
Lisinopril Recall History
The FDA enforcement database records 15 recall entries involving Lisinopril products (10 Class II, 5 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 |
|---|---|---|---|
| 2025-07-23 | Class II | Lupin Pharmaceuticals Inc. | Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg h |
| 2024-11-27 | Class II | Evaric Pharmaceuticals Inc. | Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet. |
| 2024-01-03 | Class II | CARDINAL HEALTHCARE | CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. |
| 2023-11-29 | Class III | NCS Healthcare of Kentucky Inc | Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots |
| 2022-09-21 | Class II | Lupin Pharmaceuticals Inc. | Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet. |
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 Lisinopril the Subject of Litigation?
We are not tracking consolidated federal litigation over Lisinopril. 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 Lisinopril Side Effects
Concern about lisinopril 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 lisinopril 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 lisinopril side effects?
In FDA reports, the most frequently mentioned are fatigue, nausea, diarrhoea. 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 Lisinopril been recalled?
There are 15 recall records for Lisinopril products, the most recent dated 2025-07-23. 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 Lisinopril have a boxed warning?
Yes. The boxed warning is reproduced above. It is the most serious warning the FDA requires, and it exists so that prescribers weigh a specific risk for each patient rather than overlooking it.
Do the FDA report numbers tell me how common these lisinopril 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 lisinopril 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 Lisinopril 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 Lisinopril 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.