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This page presents data from the FDA Adverse Event Reporting System (FAERS) and the FDA-approved drug label. A report submitted to FAERS does not prove a drug caused the reported event. Always consult a healthcare provider about medications.

Cold-eeze Cold Remedy (zinc gluconate)

Last updated: June 21, 2026
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Cold-eeze Cold Remedy is the brand name for zinc gluconate. According to the FDA-approved label, reduces the duration of the common cold reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness. FAERS contains 25,222 submissions naming this drug from 2004 through 2026; the top three reactions cited are fatigue, pain, and diarrhoea.

Most-Reported Reactions

Counts of the reactions most often cited in FAERS submissions that named Cold-eeze Cold Remedy. Inclusion here does not establish causation - submitters describe what was observed, not what was confirmed. One submission can list several reactions, so the totals exceed the report count.

FATIGUE 2,700 (10.7%) PAIN 1,947 (7.7%) DIARRHOEA 1,927 (7.6%) NAUSEA 1,922 (7.6%) HEADACHE 1,833 (7.3%) OFF LABEL USE 1,827 (7.2%) DRUG INEFFECTIVE 1,544 (6.1%) DYSPNOEA 1,479 (5.9%) ARTHRALGIA 1,345 (5.3%) DIZZINESS 1,332 (5.3%) ASTHENIA 1,275 (5.1%) FALL 1,261 (5.0%) CONSTIPATION 1,124 (4.5%) RASH 1,091 (4.3%) VOMITING 1,007 (4.0%)

Patient Demographics

Patient sex and age across the FAERS submissions that named Cold-eeze Cold Remedy. Percentages here are computed only from submissions where these fields were filled in - many leave them blank.

By Sex

Female Male Unknown

By Age Group

0-17 18-44 45-64 65+

Severity Outcomes

Severity flags recorded across the 25,222 FAERS submissions that named Cold-eeze Cold Remedy. Each bar shows the count of those reports carrying that flag. A single case can carry more than one (a hospitalization that became life-threatening, for example), so these bars are independent rates - they don't sum to 100%. Inclusion of a case under any flag does not establish that the drug caused the outcome.

DEATH 1,521 (6.0%) HOSPITALIZATION 6,373 (25.3%) LIFE-THREATENING 1,067 (4.2%) DISABLING 1,237 (4.9%)

Submissions Per Quarter

Quarterly count of FAERS submissions that named Cold-eeze Cold Remedy. Ups and downs on this chart can track prescribing volume, news cycles, or shifts in how reports get filed, rather than the drug becoming safer or more dangerous.

2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026

From the FDA-Approved Label

Excerpts from the official FDA-approved prescribing information for Cold-eeze Cold Remedy. This is the authoritative source on indications, warnings, and known adverse reactions.

Indications

reduces the duration of the common cold reduces the severity of cold symptoms: cough, sore throat, nasal congestion, post nasal drip and/or hoarseness

Warnings

Do not use for treatment of influenza or allergies. This product is intended only to reduce the duration of the common cold and its symptoms. Ask a doctor or pharmacist before use if you are taking minocycline, doxycycline, tetracycline or are on Coumadin (warfarin) therapy. Zinc treatment may inhibit the absorption of these medicines. When using this product do not take on an empty stomach (to avoid possible minor stomach upset) Stop use and ask your doctor if symptoms persist more than 7 days If pregnant or breastfeeding , ask a healthcare professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

FDA label effective date: 2026-05-01

Disclaimer

AdverseEvent.ai is not affiliated with the FDA. Adverse-event counts come from the FDA Adverse Event Reporting System (FAERS). Drug labels come from the FDA drug label dataset. A report submitted to FAERS does not prove a drug caused the reported event — always consult a healthcare provider about medications. This site is for informational purposes only and is not medical advice.