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fosinopril

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Brand names: Monopril

ACE Inhibitor Rx

Fosinopril is a medicine that lowers blood pressure. It can also help manage heart failure.

Drug Pricing (NADAC)

Generic Price

$0.15/unit

Generic Available

Yes (6 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

Fosinopril is used to treat high blood pressure.

Common side effects

Cough, Dizziness, Nausea

Key warnings

Fosinopril can harm your unborn baby, even causing death.

How It Works

Fosinopril belongs to a class of drugs called ACE inhibitors. It works by blocking a substance in your body that tightens blood vessels. This helps your blood vessels relax and lowers your blood pressure.

How to Take It

For high blood pressure, the usual starting dose for adults is 10 mg once a day. Your doctor may change your dose based on how your blood pressure responds. Some people may need up to 80 mg per day. For heart failure, the usual starting dose is 10 mg once a day.

Pregnancy & Breastfeeding

Do not take fosinopril if you are pregnant. It can cause serious harm or death to your unborn baby. Talk to your doctor about other blood pressure medicines if you are breastfeeding.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store fosinopril at room temperature, away from moisture and heat.

Side Effects (from patient reports)

Based on 1,897 FDA adverse event reports.

Tiredness
239
Diarrhea
232
Difficulty breathing
210
Feeling sick to your stomach
205
Medicine not working
182
Feeling lightheaded
180
Sudden kidney damage
176
Weakness
170
Kidney failure
160
Low blood pressure
143

FDA Adverse Event Report Analysis

Detailed analysis of 4,213 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.

Total Reports

4,213

Death-Related Reports

398

Hospitalization Reports

1,936

Top Indication

Hypertension

Gender Distribution

Female 1,635 (41%)
Male 2,371 (59%)

Age Distribution

0–17 29
18–44 160
45–64 1,035
65–74 947
75+ 927

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 FATIGUE 239
2 DIARRHOEA 232
3 DYSPNOEA 210
4 NAUSEA 204
5 DRUG INEFFECTIVE 182
6 DIZZINESS 179
7 ACUTE KIDNEY INJURY 176
8 ASTHENIA 170
9 RENAL FAILURE 160
10 HYPOTENSION 142
11 PAIN 142
12 HEADACHE 141
13 MYOCARDIAL INFARCTION 131
14 VOMITING 131
15 DRUG INTERACTION 129

Reactions in Death Reports

DEATH 95
COMPLETED SUICIDE 43
RENAL FAILURE 43
PNEUMONIA 31
CARDIAC FAILURE CONGESTIVE 27
HYPOTENSION 27
FATIGUE 26
MYOCARDIAL INFARCTION 26
SEPSIS 26
DYSPNOEA 23

Reactions in Hospitalization Reports

DYSPNOEA 140
ASTHENIA 120
ACUTE KIDNEY INJURY 119
RENAL FAILURE ACUTE 117
HYPOTENSION 106
BRADYCARDIA 103
CARDIAC FAILURE CONGESTIVE 100
MYOCARDIAL INFARCTION 100
DIARRHOEA 97
NAUSEA 90

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Fosinopril can harm your unborn baby, even causing death. Stop taking fosinopril as soon as you know you are pregnant.

Known Drug Interactions

Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Do not co-administer aliskiren with fosinopril in patients with diabetes. Avoid concomitant use of aliskiren with fosinopril in patients with renal impairment (GFR<60 mL/min/1.73 m 2 ).

Mechanism: Both drugs affect the same system that controls blood pressure and kidney function. Using them together increases the risk of very low blood pressure, high potassium levels, and kidney failure.

What to do: Avoid this combination, and do not use these drugs together if you have diabetes or kidney disease.

moderate lithium

Lithium Increased serum lithium levels and symptoms of lithium toxicity have been reported in patients receiving ACE inhibitors during therapy with lithium. These drugs should be coadministered with caution, and frequent monitoring of serum lithium levels is recommended. If a diuretic is also used, the risk of lithium toxicity may be increased.

Mechanism: Fosinopril can make it harder for your body to get rid of lithium, causing it to build up to toxic levels in your blood.

What to do: Your doctor should frequently monitor your lithium blood levels if you take these medications together.

In separate single or multiple dose pharmacokinetic interaction studies with chlorthalidone, nifedipine, propranolol, hydrochlorothiazide, cimetidine, metoclopramide, propantheline, digoxin, and warfarin, the bioavailability of fosinoprilat was not altered by coadministration of fosinopril with any one of these drugs.

Mechanism: Studies show that taking these two medications together does not change how much of the medicine is absorbed into your bloodstream.

What to do: No special changes or precautions are usually needed when taking these two drugs at the same time.

minor aspirin

In a study with concomitant administration of aspirin and fosinopril sodium, the bioavailability of unbound fosinoprilat was not altered.

Mechanism: Taking aspirin at the same time as fosinopril does not change the amount of active medicine available for your body to use.

What to do: You can typically take these medications together without needing to adjust your dosage.

In separate single or multiple dose pharmacokinetic interaction studies with chlorthalidone, nifedipine, propranolol, hydrochlorothiazide, cimetidine, metoclopramide, propantheline, digoxin, and warfarin, the bioavailability of fosinoprilat was not altered by coadministration of fosinopril with any one of these drugs.

Mechanism: These two drugs do not interfere with each other's levels in the body when they are taken together.

What to do: No dosage adjustments are generally required when using this combination of medications.

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Common Questions

Can I take fosinopril with food?
You can take fosinopril with or without food.
What should I do if I feel dizzy after taking fosinopril?
Lie down until the dizziness passes. Talk to your doctor if dizziness continues.
Can I take potassium supplements while taking fosinopril?
Talk to your doctor before taking potassium supplements or salt substitutes. Fosinopril can increase your potassium levels.
How long will I need to take fosinopril?
Your doctor will determine how long you need to take fosinopril. Continue taking it as prescribed, even if you feel well.
Can fosinopril cause a cough?
Yes, a cough is a common side effect of fosinopril. Talk to your doctor if the cough becomes bothersome.
Can I drink alcohol while taking fosinopril?
Talk to your doctor about drinking alcohol while taking fosinopril. Alcohol can lower your blood pressure and may increase the risk of side effects.
What if I have diabetes?
If you have diabetes, you should not take fosinopril with aliskiren.
Will this medicine affect my ability to drive?
Fosinopril may cause dizziness. Be careful driving or operating machinery until you know how it affects you.
Can I stop taking this medicine if my blood pressure is normal?
Do not stop taking fosinopril without talking to your doctor first. Your blood pressure may increase if you stop taking it suddenly.
What strengths does this medication come in?
Fosinopril comes in 10 mg, 20 mg, and 40 mg tablets.
What are the common side effects of fosinopril?
The most commonly reported side effects of fosinopril include Cough, Dizziness, Nausea, Vomiting. Based on 1,897 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does fosinopril interact with other medications?
Yes, fosinopril has 12 known drug interactions. Notable interactions include aliskiren, lithium, hydrochlorothiazide. Always inform your doctor about all medications you are taking.
What drug class is fosinopril?
fosinopril belongs to the ACE Inhibitor drug class. It requires a prescription (Rx). Fosinopril is used to treat high blood pressure.
Is fosinopril safe during pregnancy?
Do not take fosinopril if you are pregnant. It can cause serious harm or death to your unborn baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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Related Health & Safety Data

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What the FDA Data Shows for fosinopril

The FDA label for fosinopril (sold under brand names such as Monopril) classifies it as a prescription-only medication in the ACE Inhibitor class. Fosinopril is used to treat high blood pressure. Official labeling lists 4 commonly reported side effects, including Cough, Dizziness, Nausea.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 1,897 voluntary reports. The database also lists 12 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.15.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: October 25, 2021

All federal data sources used on this page