IODINE: 1,766 Adverse Event Reports & Safety Profile
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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?
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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 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 |
What Is IODINE Used For?
| Indication | Reports |
|---|---|
| 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?
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.