PlainMeds provides educational information only. This is not medical advice. Always consult your doctor or pharmacist.

ferrous sulfate

Verify with FDA → · CMS NADAC pricing →

Brand names: Feosol, Fer-In-Sol

Iron Supplement OTC

Ferrous sulfate is an iron supplement. It helps increase iron levels in your body.

What it does

This medicine is used to relieve hot flashes that occur with headaches.

Common side effects

Fatigue, Diarrhea, Nausea

Key warnings

There are no boxed warnings for this medication.

How It Works

Ferrous sulfate provides iron, which is needed to make red blood cells. Red blood cells carry oxygen throughout your body. By increasing iron levels, this medicine helps your body function properly.

How to Take It

Adults and children should dissolve 5 pellets under the tongue. Do this 3 times a day when symptoms start. Continue until your symptoms get better, or follow your doctor's directions.

Pregnancy & Breastfeeding

Talk to your doctor before taking this medicine if you are pregnant or breastfeeding. They can help you decide if it is right for you.

Missed Dose

If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store at room temperature away from moisture and heat.

Side Effects (from patient reports)

Based on 24,449 FDA adverse event reports.

Tiredness
3,325
Diarrhea
3,100
Feeling sick to your stomach
2,746
Difficulty breathing
2,724
Death
2,345
Using the medicine for something it is not approved for
2,306
Sudden kidney damage
2,070
Anemia
1,967
Pneumonia
1,944
Headache
1,922

FDA Adverse Event Report Analysis

Detailed analysis of 47,788 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1995–2025.

Total Reports

47,788

Death-Related Reports

5,418

Hospitalization Reports

20,748

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 27,653 (62%)
Male 16,612 (37%)

Age Distribution

0–17 1,588
18–44 5,119
45–64 9,211
65–74 7,760
75+ 9,412

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 FATIGUE 3,325
2 DIARRHOEA 3,100
3 NAUSEA 2,746
4 DYSPNOEA 2,724
5 DEATH 2,345
6 OFF LABEL USE 2,306
7 ACUTE KIDNEY INJURY 2,070
8 ANAEMIA 1,967
9 PNEUMONIA 1,944
10 HEADACHE 1,922
11 ASTHENIA 1,919
12 PAIN 1,891
13 DIZZINESS 1,857
14 VOMITING 1,780
15 FALL 1,771

Reactions in Death Reports

DEATH 2,335
DYSPNOEA 397
ACUTE KIDNEY INJURY 386
PNEUMONIA 361
RENAL FAILURE 304
ANAEMIA 265
GASTROINTESTINAL HAEMORRHAGE 242
FATIGUE 237
SEPSIS 237
CHRONIC KIDNEY DISEASE 232

Reactions in Hospitalization Reports

DYSPNOEA 1,732
PNEUMONIA 1,597
DIARRHOEA 1,396
ACUTE KIDNEY INJURY 1,375
ANAEMIA 1,343
FATIGUE 1,210
FALL 1,203
NAUSEA 1,180
ASTHENIA 1,098
VOMITING 1,028

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

Serious Warnings

There are no boxed warnings for this medication.

Known Drug Interactions

moderate methyldopa

Several studies demonstrate a decrease in the bioavailability of methyldopa when it is ingested with ferrous sulfate or ferrous gluconate. Coadministration of methyldopa with ferrous sulfate or ferrous gluconate is not recommended.

Mechanism: Iron supplements can prevent the body from absorbing the blood pressure medicine correctly. This means the medicine may not work well enough to control your blood pressure.

What to do: It is recommended that you do not take these two medications at the same time. Talk to your doctor about the best way to schedule your doses.

Drug or Drug Class Effect Phosphate Binders (e.g., calcium carbonate, ferrous sulfate, sevelamer, lanthanum) Phosphate binders may bind to levothyroxine. Drug or Drug Class Effect Phosphate Binders (e.g., calcium carbonate, ferrous sulfate, sevelamer, lanthanum) Phosphate binders may bind to levothyroxine.

Mechanism: Ferrous sulfate can stick to levothyroxine in your stomach, which prevents your body from absorbing the thyroid medicine correctly.

What to do: Take these two medications at least four hours apart to make sure your thyroid medicine works as it should.

Common Questions

What is ferrous sulfate used for?
It is used to relieve hot flashes with headaches.
How often should I take this medicine?
Take 5 pellets under the tongue 3 times a day.
Can children take this medicine?
Yes, children can take this medicine at the same dose as adults.
What should I do if my symptoms don't improve?
Talk to your doctor if your symptoms do not get better.
Can I take this medicine with food?
The instructions say to dissolve the pellets under your tongue.
Are there any serious side effects I should watch out for?
This medication does not have any boxed warnings.
Is it safe to take this medicine while pregnant?
Talk to your doctor before taking this medicine if you are pregnant.
What do I do if I miss a dose?
Take it as soon as you remember, unless it is almost time for your next dose.
How should I store this medicine?
Store it at room temperature away from moisture and heat.
Can I take this with other medications?
Ask your doctor or pharmacist if it is safe to take with your other medications.
What are the common side effects of ferrous sulfate?
The most commonly reported side effects of ferrous sulfate include Fatigue, Diarrhea, Nausea, Headache, Pain. Based on 24,449 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does ferrous sulfate interact with other medications?
Yes, ferrous sulfate has 2 known drug interactions. Notable interactions include methyldopa, levothyroxine. Always inform your doctor about all medications you are taking.
What drug class is ferrous sulfate?
ferrous sulfate belongs to the Iron Supplement drug class. It is available over the counter (OTC). This medicine is used to relieve hot flashes that occur with headaches.
Is ferrous sulfate safe during pregnancy?
Talk to your doctor before taking this medicine if you are pregnant or breastfeeding. They can help you decide if it is right for you. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has ferrous sulfate been recalled?
There is 1 recall associated with ferrous sulfate products. CGMP Deviations: Firm went out of business and could no longer continue stability studies. Check the recalls section below for full details and affected products.

Active Recalls

Class II April 26, 2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc.

Related Medications in Iron Supplement

Other drugs grouped near ferrous sulfate — same-class peers and common alternatives.

Compare ferrous sulfate vs ascorbic acid side-by-side →

Medication Guides

Related Health & Safety Data

What the FDA Data Shows for ferrous sulfate

The FDA label for ferrous sulfate (sold under brand names such as Feosol, Fer-In-Sol) classifies it as an over-the-counter product in the Iron Supplement class. This medicine is used to relieve hot flashes that occur with headaches. Official labeling lists 7 commonly reported side effects, including Fatigue, Diarrhea, Nausea.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 24,449 voluntary reports. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.

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 (currently 1 recall record on file), 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).

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: July 21, 2025

All federal data sources used on this page