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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

IODINE: 1,766 Adverse Event Reports & Safety Profile

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1,766
Total FAERS Reports
318 (18.0%)
Deaths Reported
388
Hospitalizations
1,766
As Primary/Secondary Suspect
210
Life-Threatening
177
Disabilities
Topco Associates LLC
Manufacturer

Route: TOPICAL · Manufacturer: Topco Associates LLC · HUMAN OTC DRUG · FDA Label: Available

First Report: 1968 · Latest Report: 20250529

What Are the Most Common IODINE Side Effects?

#1 Most Reported
Drug hypersensitivity
987 reports (55.9%)
#2 Most Reported
Nausea
266 reports (15.1%)
#3 Most Reported
Dyspnoea
259 reports (14.7%)

All IODINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug hypersensitivity 987 55.9% 49 72
Nausea 266 15.1% 190 97
Dyspnoea 259 14.7% 165 110
Fatigue 245 13.9% 185 90
Diarrhoea 229 13.0% 168 76
Arthralgia 225 12.7% 168 76
Headache 205 11.6% 146 92
Pruritus 201 11.4% 164 54
Vomiting 196 11.1% 150 76
Pyrexia 179 10.1% 136 76
Fall 177 10.0% 130 59
Dizziness 176 10.0% 154 44
Abdominal pain 169 9.6% 139 36
Malaise 167 9.5% 126 69
Decreased appetite 158 9.0% 138 58
Abdominal pain upper 153 8.7% 146 48
Pain 152 8.6% 84 118
Insomnia 151 8.6% 137 23
Rash 151 8.6% 100 95
Tachycardia 151 8.6% 143 12

Who Reports IODINE Side Effects? Age & Gender Data

Gender: 79.6% female, 20.4% male. Average age: 60.0 years. Most reports from: US. View detailed demographics →

Is IODINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2004 1 0 0
2006 11 0 10
2008 2 0 0
2009 4 0 3
2010 1 0 1
2011 2 0 0
2012 3 0 1
2013 12 0 1
2014 11 0 7
2015 19 1 10
2016 17 0 7
2017 27 1 12
2018 35 0 23
2019 23 1 7
2020 17 0 4
2021 19 1 5
2022 21 0 7
2023 20 1 10
2024 13 2 3
2025 2 0 1

View full timeline →

What Is IODINE Used For?

IndicationReports
Product used for unknown indication 615
Computerised tomogram 26
Thyrotoxic crisis 20
Rheumatoid arthritis 16
Goitre 11
Psoriatic arthropathy 11
Scan with contrast 11
Foetal exposure during pregnancy 9
Contrast media allergy 8
Hepatic cancer 8

IODINE vs Alternatives: Which Is Safer?

IODINE vs IODINE\IOFLUPANE I-123 IODINE vs IODIXANOL IODINE vs IOHEXOL IODINE vs IOMEPROL IODINE vs IOPAMIDOL IODINE vs IOPROMIDE IODINE vs IOVERSOL IODINE vs IOXILAN IODINE vs IPATASERTIB IODINE vs IPILIMUMAB

Official FDA Label for IODINE

Official prescribing information from the FDA-approved drug label.

Drug Description

DESCRIPTION Iodine 5g, potassium iodide 10g, in enough purified water to make 100 ml.

FDA Approved Uses (Indications)

INDICATIONS Strong Iodine Solution, containing 5 percent of iodine and 10 percent of potassium iodide, is employed in the prophylaxis of simple and colloid goiters and in the treatment of exophthalmic goiter. It can be used alone as a preoperative preparation but is now most commonly used concomitantly with propylthiouracil and other antithyroid drugs. When used with these drugs, Strong Iodine Solution produces involution of the hyperplastic gland thus making a less triable and vascular gland for thyroidectomy. In addition, it has an additive antithyroid action that helps make the patient enthyroid faster than if the antithyroid drugs were used alone.

Dosage & Administration

DOSAGE Strong Iodine Solution is for oral use only. The usual dosage of Strong Iodine Solution is 2 to 6 drops (0.1 to 0.3 ml) three times daily taken in water after meals for two or three weeks prior to operation. In thyroid crisis the dosage is 1 ml three times a day.

Contraindications

CONTRAINDICATIONS The use of iodides may be contraindicated in patients with tuberculosis because it is believed they may cause a breakdown of healing lesions. The use of iodides is contraindicated in patients with iododerma, laryngeal edema, and swelling of salivary glands or increased salivation upon previous exposure to iodides.

Strong Iodine

Solution is ineffective in the treatment of postoperative thyroid crisis.

Known Adverse Reactions

ADVERSE REACTION Walgreen Pharmacist Recommended Our Pharmacists recommend the Walgreens brand. Distributed by: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015 100% satisfaction guaranteed walgreens.com 1-800-925-4733 2021 Walgreen Co.

Warnings

Warnings and Storage: Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms. Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place. *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED. This product is not intended to diagnose, treat, cure, or prevent any disease.

Precautions

PRECAUTIONS Iodine therapy does not completely control the manifestations of hyperthyroidism and after a variable period of time, the beneficial effects wear off. With continued administration of the drug, the hyperthyroidism may return in its initial intensity or become even more severe than it was at first. Measurements of the protein-bound iodine or of the uptake of radioiodine are rendered useless if iodine is given.

Active Ingredient

Iodium 15C, HPUS The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

Inactive Ingredients

INACTIVE INGREDIENTS Active: As Above; Inactive: ENA 50% v/v and Purified Water q.s.