Fosinopril
Fosinopril is an ACE inhibitor used to treat high blood pressure and heart failure.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 11 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Fosinopril can seriously harm or kill an unborn baby. If you discover you are pregnant while taking this medication, stop it as soon as possible and contact your doctor right away. Drugs that work on the renin-angiotensin system — the system fosinopril targets — have been shown to cause fetal injury and death, especially when used during the second and third trimesters of pregnancy. The risks include poor fetal kidney function, too little amniotic fluid, abnormal bone development, and in severe cases, death of the baby. This is not a theoretical risk — it is a serious, documented danger.
📖 Fosinopril: Patient Information Guide
A plain-language walkthrough of Fosinopril — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Fosinopril is an oral ACE inhibitor approved for the following conditions:
- High blood pressure (hypertension) — Fosinopril Sodium tablets can be used alone or combined with a thiazide diuretic when additional blood pressure lowering is needed
- Heart failure — Fosinopril Sodium tablets are used as add-on therapy alongside diuretics, with or without digitalis, to help manage symptoms and improve exercise tolerance
⚙️How it works▾
Fosinopril is a prodrug — after you swallow it, your body converts it into the active form, fosinoprilat. Fosinoprilat blocks ACE (angiotensin-converting enzyme), which normally helps produce angiotensin II, a chemical that tightens blood vessels and raises blood pressure. By blocking this process, fosinopril allows blood vessels to relax, lowers blood pressure, and also reduces the amount of aldosterone (a hormone that causes the body to retain salt and water). In heart failure, this dual effect reduces both the pressure the heart pumps against (afterload) and the volume it must handle (preload), easing its overall workload.
Because fosinopril is cleared through both the liver and kidneys, it can generally be used at standard doses even in patients with significant kidney disease — an advantage compared with some other ACE inhibitors. However, ACE inhibitors as a class tend to have a smaller blood-pressure-lowering effect in Black patients compared to non-Black patients.
💊How it's taken▾
Fosinopril Sodium tablets are taken by mouth, typically once a day. Food may slow absorption slightly but does not reduce the total amount absorbed, so it can be taken with or without food. For heart failure, patients are usually observed closely after the first dose for signs of low blood pressure.
- If you are on a diuretic (water pill), your doctor may adjust or pause it before starting fosinopril to reduce the chance of a blood pressure drop
- Do not use potassium supplements or potassium-containing salt substitutes unless your doctor directs you to — they can raise potassium to unsafe levels
- Never stop taking fosinopril on your own; always check with your prescriber first
🤒Side effects — in detail▾
Most side effects with fosinopril are mild and temporary, but there are a few important ones to know about:
- Dry, nagging cough — a well-known ACE inhibitor side effect; talk to your doctor if it becomes bothersome
- Dizziness or lightheadedness — especially when standing up quickly (orthostatic hypotension)
- Nausea or vomiting
- Diarrhea
- Fatigue or weakness
- Headache
- Elevated potassium levels (hyperkalemia) — may cause muscle weakness or heart rhythm changes
Seek emergency care immediately for sudden swelling of the face, lips, tongue, or throat (angioedema) — this is rare but can be life-threatening. Also contact your doctor right away if you develop yellowing of the skin or eyes, significant drop in urination, or signs of low blood pressure such as fainting.
⚠️Warnings & precautions▾
- Fetal toxicity (most critical): Fosinopril can cause fetal injury or death, especially in the second and third trimesters. Stop the medication as soon as pregnancy is detected and contact your doctor immediately.
- Angioedema (severe swelling): Rare but potentially fatal swelling of the face, tongue, throat, or intestines can occur. Throat swelling is a medical emergency. Black patients and those taking mTOR inhibitors (e.g., temsirolimus) are at higher risk.
- Low blood pressure (hypotension): Most likely in patients who are dehydrated, on high-dose diuretics, have low sodium, or have heart failure. The first dose requires close monitoring in heart failure patients.
- Kidney function changes: Fosinopril can worsen kidney function, particularly in people with heart failure or severe kidney disease. Blood and urine tests may be needed regularly.
- High potassium (hyperkalemia): Risk increases when combined with potassium supplements, potassium-sparing diuretics, or salt substitutes containing potassium.
- Liver failure: Rarely reported with ACE inhibitors. Stop fosinopril and seek care if jaundice or markedly abnormal liver tests develop.
- Blood count changes: Rare risk of low white blood cell counts (agranulocytosis), particularly in patients with kidney disease or connective-tissue diseases such as lupus.
🔀What it interacts with▾
Fosinopril can interact with several medications and substances — tell your doctor and pharmacist about everything you take:
- Potassium supplements, potassium-sparing diuretics, or potassium-containing salt substitutes — can raise potassium to dangerous levels when combined with fosinopril
- Diuretics (water pills) — increase the risk of a blood pressure drop, especially with the first dose of fosinopril
- Lithium — fosinopril can raise lithium blood levels, increasing the risk of lithium toxicity; frequent monitoring is needed
- Antacids (aluminum/magnesium-based) — may reduce fosinopril absorption; separate doses by at least 2 hours
- NSAIDs (ibuprofen, naproxen) and COX-2 inhibitors — can blunt fosinopril's blood-pressure effect and may impair kidney function, especially in older or dehydrated patients
- Injectable gold (sodium aurothiomalate) — rarely causes flushing, nausea, and low blood pressure when combined with ACE inhibitors
- mTOR inhibitors (e.g., temsirolimus) — increase the risk of angioedema (dangerous swelling)
- Aliskiren — must not be combined with fosinopril in patients with diabetes; avoid in those with kidney disease due to risk of low blood pressure, high potassium, and kidney failure
- Other ACE inhibitors or angiotensin receptor blockers (ARBs) — combining two drugs that block the same system raises risk of low blood pressure, high potassium, and kidney damage
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Pregnancy: Do not take fosinopril if you are pregnant. Stop immediately and contact your doctor if you become pregnant while taking it — the drug can seriously harm the baby.
- Prior angioedema with any ACE inhibitor: You must not take fosinopril if you have had dangerous swelling reactions with any ACE inhibitor.
- Hypersensitivity: Do not take fosinopril if you are allergic to it or any other ACE inhibitor.
- Diabetes + aliskiren use: Do not combine fosinopril with aliskiren if you have diabetes.
- Kidney disease: Fosinopril can be used in kidney impairment at standard doses due to its dual liver/kidney elimination route, but kidney function and potassium should be monitored.
- Liver disease: Fosinopril clearance is reduced in patients with liver cirrhosis; your doctor may adjust monitoring or dosing.
- Collagen-vascular diseases (e.g., lupus, scleroderma): Higher risk of blood count problems; white blood cell monitoring may be needed.
- Black patients: ACE inhibitors tend to lower blood pressure less effectively and carry a higher rate of angioedema in this population — discuss all options with your prescriber.
- Children under 50 kg: An appropriate tablet strength is not available for children weighing less than 50 kg.
- Older adults: Side effect rates in patients 65 and older were similar to younger patients in clinical trials, but close monitoring is still appropriate.
- Dialysis patients: Fosinopril is not well removed by dialysis; anaphylactoid (severe allergic-like) reactions have been reported with certain high-flux dialysis membranes.
🚑If you take too much▾
The most likely effect of taking too much fosinopril is a significant drop in blood pressure (hypotension), which can cause dizziness, fainting, or weakness. Fosinopril is not well removed by dialysis, so standard supportive care — such as intravenous fluids to restore blood pressure — is the primary approach. If you suspect an overdose, seek emergency medical help immediately.
📡Pharmacodynamics — effects in the body▾
Fosinopril begins to significantly suppress ACE activity within 2 hours of a dose. A single dose of fosinopril suppresses the ACE enzyme by 90% or more for up to 12 hours, and meaningful suppression (over 85%) is still measurable at 24 hours — helping explain why once-daily dosing is effective for most patients. In the blood, fosinopril also causes small increases in potassium levels over time, which is worth monitoring, especially in patients on other medications that raise potassium.
🔬Pharmacokinetics — how your body processes it▾
After swallowing a fosinopril tablet, the drug is absorbed through the upper small intestine — food may slow this slightly but does not reduce how much is absorbed overall. The body converts fosinopril into its active form (fosinoprilat) within hours, with peak blood levels reached in about 3 hours. Fosinoprilat is cleared about equally by the liver and kidneys — a dual elimination pathway that is unusual among ACE inhibitors and means that even patients with severe kidney disease typically do not require dose adjustments. The effective half-life (how long the drug stays active) is roughly 11 to 14 hours in most patients.
📦How to store it▾
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Protect from moisture by keeping bottle tightly closed.
📄 Written from Fosinopril’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Fosinopril
166 supplements and herbal products have documented interactions with Fosinopril in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 6
- Moderate · 136
- Minor · 24
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Fosinopril has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Fosinopril — the kind of thing our pharmacy team would talk through with you at the counter.
What is fosinopril actually used for? ▾
I keep hearing that ACE inhibitors cause a cough. Is that true with fosinopril? ▾
What should I watch out for and call someone about right away? ▾
Can I take fosinopril if I'm pregnant or trying to get pregnant? ▾
Are there foods or other medicines I need to be careful with? ▾
I have kidney disease — is it safe for me to take fosinopril? ▾
Is Fosinopril available over the counter? ▾
When was Fosinopril first available? ▾
Who makes Fosinopril? ▾
💬 Answers drafted from Fosinopril’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Fosinopril comes
Fosinopril is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Fosinopril Sodium tablets are used to treat high blood pressure (hypertension), alone or with a diuretic
- Fosinopril Sodium tablets are used to help manage heart failure, added to standard therapy including diuretics with or without digitalis
- Fosinopril Sodium tablets are taken by mouth once daily, with or without food
- Fosinopril Sodium tablets should be taken at about the same time each day; follow your prescriber's guidance on timing and dose adjustments
- If you are also taking an antacid, separate it from Fosinopril Sodium by at least 2 hours to avoid reducing absorption
- Do not stop taking Fosinopril Sodium tablets without talking to your doctor first
📊 Fosinopril across the U.S. market
How Fosinopril appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Fosinopril is used
A general measure of how commonly Fosinopril is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Fosinopril is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Fosinopril prescribed? Of the 1,597 medications we measure, Fosinopril ranks #1,067 by Medicaid prescriptions — more than 33% of them.
Utilization by Fosinopril product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
fosinopril sodium 40 MG Oral Tablet Most dispensed
Summed across the 2 of 30 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 857187
fosinopril sodium 20 MG Oral Tablet
Summed across the 2 of 28 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 857183
fosinopril sodium 10 MG Oral Tablet
Summed across the 2 of 32 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 857169
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Fosinopril, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 6 of 90 listed Fosinopril NDCs with Medicaid activity.
🔍 Compare Fosinopril products
A representative set of FDA-listed product records for Fosinopril — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 10 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 40 mg | Oral | A-S Medication Solutions × 3 listings | ANDA | View NDC → |
| 10 mg | — | Aurobindo Pharma Limited | DRUG FOR FURTHER PROCESSING | View NDC → |
| 10 mg | Oral | Aurobindo Pharma Limited × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | Aurobindo Pharma Limited × 2 listings | ANDA | View NDC → |
| 20 mg | — | Aurobindo Pharma Limited | DRUG FOR FURTHER PROCESSING | View NDC → |
| 40 mg | Oral | Aurobindo Pharma Limited × 2 listings | ANDA | View NDC → |
| 40 mg | — | Aurobindo Pharma Limited | DRUG FOR FURTHER PROCESSING | View NDC → |
| 20 mg | Oral | AvPAK | ANDA | Find on DailyMed ↗ |
| 40 mg | Oral | AvPAK | ANDA | Find on DailyMed ↗ |
| 10 mg | Oral | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | Bryant Ranch Prepack × 4 listings | ANDA | View NDC → |
| 40 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 10 mg | Oral | Chartwell RX, LLC × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | Chartwell RX, LLC × 2 listings | ANDA | View NDC → |
| 40 mg | Oral | Chartwell RX, LLC × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | Cipla USA Inc. × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | Cipla USA Inc. × 2 listings | ANDA | View NDC → |
| 40 mg | Oral | Cipla USA Inc. × 2 listings | ANDA | View NDC → |
| 40 mg | Oral | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Find on DailyMed ↗ |
| 10 mg | Oral | Exelan Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | Exelan Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 40 mg | Oral | Exelan Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 20 mg | Oral | Preferred Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 40 mg | Oral | Rising Pharma Holdings, Inc. | ANDA | View NDC → |
| 20 mg | Oral | Solco Healthcare LLC × 2 listings | ANDA | View NDC → |
| 40 mg | Oral | Solco Healthcare LLC × 2 listings | ANDA | View NDC → |
| 💊Bulk drug substance | ||||
| 50 kg/50 kg | — | Aurobindo Pharma Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Hetero Drugs Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Zhejiang Huahai Pharmaceutical Co., Ltd. | BULK INGREDIENT | View NDC → |
Showing 53 of 53 products — FDA National Drug Code Directory. See every product, package size and price: browse all 53 Fosinopril NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Fosinopril — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Fosinopril in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Fosinopril went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 50166 1 dose form · 3 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 372274In current FDA listingsClinical drug / strength (SCD) sodium 10 MGRxCUI 857169sodium 20 MGRxCUI 857183sodium 40 MGRxCUI 857187
Look up RxCUI 50166 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Fosinopril is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Fosinopril belongs to the Angiotensin Converting Enzyme Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 11 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Cipla USA Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.