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Nonsteroidal Anti-inflammatory Drug · Brand: Sound Body Ibuprofen, Ibuprofen Minis + 141 more

Ibuprofen Side Effects: Common, Serious & FDA Warnings

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Based on 279,000+ FDA adverse event reports, the most-reported ibuprofen reactions include pain, fatigue, and nausea. No active recalls are on record. The FDA-approved label does not carry a boxed warning.

For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.

Common Side Effects of Ibuprofen

The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for ibuprofen. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.

ReactionReports% of total
Pain19,2776.9%
Fatigue18,4926.6%
Nausea17,9656.4%
Headache16,3455.8%
Arthralgia13,2624.7%
Dyspnoea12,9344.6%
Vomiting12,8474.6%
Diarrhoea12,5444.5%
Dizziness11,2674.0%
Rash10,9943.9%
Source: FDA FAERS·Updated ·n=279,637+·verify on FDA →·Methodology

Serious Outcomes and FDA Warnings

FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.

Outcome flagReports
Serious reports (any flag)176,147
Hospitalization84,072

Ibuprofen Recalls

FDA enforcement actions matched to ibuprofen via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.

No recalls are on record for this drug in the FDA enforcement database.

Source: FDA Drug Enforcement Reports·Updated ·Refreshes every 6 hours·verify on FDA →
Show 1 closed recall (2021 to 2021)

Includes resolved and terminated recalls matched to ibuprofen. Most recent first.

DateReasonClassQuantityStatus
2021-06-02CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cardinal Health Inc.
Class II345 CARTONSTerminated

Ibuprofen Shortages

FDA-listed shortages of ibuprofen products. Strength and dosage-form level detail.

No active or recent shortages of ibuprofen are listed. We refresh this view daily.
Source: FDA Drug Shortages·Updated

Is Ibuprofen Safe?

Ibuprofen is FDA-approved and the label does not carry a boxed warning.

As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.

Source: DailyMed (ibuprofen label)·Updated

FDA-Approved Indications

Ibuprofen is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.

Uses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis temporarily reduces fever
Source: DailyMed (ibuprofen label)·Updated ·Section 1 (Indications and Usage)

Frequently Asked Questions

What are the most-reported side effects of ibuprofen?
Pain, fatigue, and nausea are among the most-reported reactions in FDA FAERS data for ibuprofen. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.
Is ibuprofen the same as Sound Body Ibuprofen?
Ibuprofen is the generic name; Sound Body Ibuprofen is a brand name for the same active ingredient. Other brand names include Ibuprofen Minis, Proprinal, Ibuprofen Mini, Childrens Ibuprofen Oral Suspension, Junior Strength Advil, Children'S Advil, Ibuprofen Childrens, Leader Childrens Ibuprofen, Care One Ibuprofen Childrens, Equate Ibuprofen, Childrens Ibuprofen, Signature Care Childrens Ibuprofen, Topcare Childrens Ibuprofen, Rexall Ibuprofen, Dg Health Ibuprofen, Equate Ibuprofen Childrens, Good Neighbor Pharmacy Childrens Ibuprofen, Profen Ib Childrens, Equaline Ibuprofen Childrens, Basic Care Childrens Ibuprofen, Good Sense Ibuprofen Childrens, Up And Up Ibuprofen, Care One Ibuprofen, Leader Ibuprofen, Equaline Ibuprofen, Good Sense Ibuprofen, Good Neighbor Pharmacy Ibuprofen Childrens, Profen Ib, Good Neighbor Pharmacy Ibuprofen, Up And Up Childrens Ibuprofen, Dg Health Childrens Ibuprofen, Children'S Ibuprofen, Infants Ibuprofen, Topcare Ibuprofen, Basic Care Ibuprofen, Foster And Thrive Ibuprofen, Concentrated Ibuprofen Infants, Ibuprofen Infants Drops, Infants Advil, Infant'S Advil, Pediatric Advil, Caldolor, Ibuprofen Pain Releiver/ Fever Reducer, Infants Dye Free Ibuprofen, Profen Ib Infants, Signature Care Infants Ibuprofen, Basic Care Infants Ibuprofen, Ibuprofen Infants, Up And Up Dye Free Infants Concentrated Ibuprofen, Good Sense Ibuprofen Infants, Parents Choice Infants Ibuprofen, Leader Infants Ibuprofen, Topcare Infants Ibuprofen, Good Sense Infants Ibuprofen, Foster And Thrive Infants Ibuprofen, Dye-Free Pain Relief, Ibuprofen Migraine, Dye-Free Ibuprofen, Pain Relief, Dolex Flex, Ibuprofen Mini Dye Free Advil, Migraine Relief, Motrin Ib, Motrin Ib Migraine, Amazon Basic Care Ibuprofen, Childrens Flanax Oral, Dye Free Ibuprofen, Ibuprofen Dye Free, Pain Relief Ibuprofen, Ibuprofen Dye-Free, Ibuprofen Immediate Release, Advil, Dye Free Childrens Ibuprofen, Childrens Ibuprofen Bubblegum, Childrens Ibuprofen Fruit, Childrens Ibuprofen Blue Raspberry, Childrens Ibuprofen Grape, Infants Motrin, Motrin Infants, Children'S Motrin, Medique Iprin, Medi-First Ibuprofen, Medi-First Plus Ibuprofen, Dover Addaprin, Green Guard Ibupro Relief, Uline Ibuprofen, Henry Schein Ibuprofen, Ibuprofen Thompson, Physicians Care Ibuprofen, Unishield Ibuprofen, Circle K Ibuprofen, Medique At Home Iprin, Direct Safety Ibuprofen, Ibu, Ibuprofen (Nsaid) Pain Releiver/ Fever Reducer, Cvs Ibuprofen, Flex-Prin, Ibuprofen Fast Relief Medicine For Pain, Cabinet Pain Reliever And Fever Reducer, Xpect Ibuprofen, Green Guard Ibuprofen Relief, Lil Drug Store Ibuprofen, Ibuwin Forte, Careall Ibuprofen, Fast Pain Relief, Advil Menstrual Pain, Childrens Ibuprofen Oral Suspension, Dye Free, Childrens Ibuprofen Oral Suspension Dye Free, Kosher Meds, Kosher Meds Dye-Free Ibuprofen, Ibuprofen Oral, Childrens Ibuprofen Oral Suspension Original Berry Flavor, Childrens Ibuprofen Oral Suspension, Bubble Gum, Pediacare Childrens Ibuprofen Berry, Dolex Children, Good Sense Childrens Ibuprofen, Foster And Thrive Childrens Ibuprofen Ib, Equaline Childrens Ibuprofen, Careone Childrens Ibuprofen, Childrens Motrin, Ibuprofen Pain Reliever/Fever Reducer, Ibuprofen Ib, Assured Ibuprofen, Betr Pain Relief, Berkley And Jensen Ibuprofen, Careone Ibuprofen, Betr Remedies Ibuprofen, Kirkland Signature Ibuprofen, Counteract Ib, Goodnow Pain Relief, Signature Care Ibuprofen, Childrens Advil, Children'S Advil-Flavored, Kirkland Signature Ibuprofen Ib, Motrin Ib, Travel Basix, Motrin Ib, Cvp Health, Aerotab Ibuprofen, Ibuprofen Ca, Valumeds Ibuprofen, Advil Liqui-Gels, Advil Migraine, and Advil Migraine Liqui-Gels. The active ingredient is identical; formulation and inactive ingredients may vary by manufacturer.
Has ibuprofen been recalled?
Yes. Ibuprofen has closed recalls on record in the FDA enforcement database; no recalls are currently active. Reasons are dominated by CGMP deviations. See the recalls table on this page for dates, firm names, and lot quantities.
What do FDA recall classes mean?
Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.

Data Sources & Methodology

How each section of this page is sourced, and how often the data is refreshed.

SourceEndpointRefresh
FAERS reactionsopenFDA /drug/event.json count API. Aggregated per drug per reaction term; we do not store individual reports.Daily
RecallsopenFDA /drug/enforcement.json. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here.6 hours
ShortagesFDA Drug Shortages list.Daily
Boxed warnings & label sectionsopenFDA /drug/label.json. Labels are stable; monthly cadence is sufficient.Monthly
Condition categoriesSynonym-mapped from drug_labels.indications. Methodology at /methodology/.Per-drug

What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.

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