Nonsteroidal Anti-inflammatory Drug · Brand: Sound Body Ibuprofen, Ibuprofen Minis + 141 more
Ibuprofen Side Effects: Common, Serious & FDA Warnings
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FDA-Approved For
Quick answer
Based on 279,000+ FDA adverse event reports, the most-reported ibuprofen reactions include pain, fatigue, and nausea. FDA reports 5 active Class II recalls of ibuprofen, primarily for failed dissolution specifications. 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.
| Reaction | Reports | % of total |
|---|---|---|
| Pain | 19,279 | 6.9% |
| Fatigue | 18,495 | 6.6% |
| Nausea | 17,968 | 6.4% |
| Headache | 16,347 | 5.8% |
| Arthralgia | 13,263 | 4.7% |
| Dyspnoea | 12,938 | 4.6% |
| Vomiting | 12,850 | 4.6% |
| Diarrhoea | 12,545 | 4.5% |
| Dizziness | 11,268 | 4.0% |
| Rash | 10,996 | 3.9% |
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 flag | Reports | % of total |
|---|---|---|
| Serious reports (any flag) | — | — |
| Hospitalization | — | — |
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.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2026-03-25 | Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product. STRIDES PHARMA INC | Class II | 89592 bottles | Ongoing |
| 2024-11-27 | Failed Tablet/Capsule Specifications Dr. Reddy's Laboratories, Inc. | Class III | 3416 botttles | Ongoing |
| 2024-09-04 | Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. Dr. Reddy's Laboratories, Inc. | Class II | 14940 bottles | Ongoing |
| 2024-09-04 | Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. Dr. Reddy's Laboratories, Inc. | Class II | 31,802 bottles | Ongoing |
| 2024-09-04 | Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit. Dr. Reddy's Laboratories, Inc. | Class II | 103,298 bottles | Ongoing |
Show 15 closed recalls (2018 to 2022)
Includes resolved and terminated recalls matched to ibuprofen. Most recent first.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2022-06-15 | cGMP deviations: Temperature abuse Mckesson Medical-Surgical Inc. Corporate Office | Class II | 1 carton/100 blisters per carton | Terminated |
| 2021-06-02 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. | Class II | 345 CARTONS | Terminated |
| 2020-11-11 | Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups. Aurobindo Pharma USA Inc. | Class III | 7440 bottles | Terminated |
| 2020-04-01 | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. Glaxosmithkline Consumer Healthcare Holdings | Class II | 151,056 bottles | Terminated |
| 2020-04-01 | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel. Glaxosmithkline Consumer Healthcare Holdings | Class II | 446,628 bottles | Terminated |
| 2019-11-06 | Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing. Taro Pharmaceuticals U.S.A., Inc. | Class II | 5,190 bottles | Terminated |
| 2019-11-06 | Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing. Taro Pharmaceuticals U.S.A., Inc. | Class II | 182,986 bottles | Terminated |
| 2019-11-06 | Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing. Taro Pharmaceuticals U.S.A., Inc. | Class II | 639,325 bottles | Terminated |
| 2019-11-06 | Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing. Taro Pharmaceuticals U.S.A., Inc. | Class II | 138,886 bottles | Terminated |
| 2018-09-05 | Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters. Pfizer Global Supply | Class II | 17,136 bottles | Terminated |
| 2018-05-02 | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Time-Cap Laboratories, Inc. | Class II | N/A | Terminated |
| 2018-05-02 | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Time-Cap Laboratories, Inc. | Class II | N/A | Terminated |
| 2018-05-02 | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Time-Cap Laboratories, Inc. | Class II | N/A | Terminated |
| 2018-05-02 | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Time-Cap Laboratories, Inc. | Class II | N/A | Terminated |
| 2018-05-02 | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. Time-Cap Laboratories, Inc. | Class II | N/A | Terminated |
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.
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.
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
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 active and closed recalls on record in the FDA enforcement database. Reasons are dominated by contamination or foreign material, CGMP deviations, and mislabeling. See the recalls table on this page for current counts, firm names, dates, and lot quantities.
What are ibuprofen's current ongoing recalls about?
Active ibuprofen recalls are listed in the recalls table above with their class, reason, firm, and affected lots. The dominant reason across these recalls is contamination or foreign material. For lot numbers, distribution patterns, and the FDA enforcement record for any individual recall, follow the verify-on-FDA link from each row.
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.
| Source | Endpoint | Refresh |
|---|---|---|
| FAERS reactions | openFDA /drug/event.json count API. Aggregated per drug per reaction term; we do not store individual reports. | Daily |
| Recalls | openFDA /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 |
| Shortages | FDA Drug Shortages list. | Daily |
| Boxed warnings & label sections | openFDA /drug/label.json. Labels are stable; monthly cadence is sufficient. | Monthly |
| Condition categories | Synonym-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.