Lugol's Solution
Lugol's solution is an iodine-potassium iodide solution; human studies mainly examine it preoperatively in Graves' disease and thyroid surgery.
We evaluated 154 human studies on Lugol's solution, including 11 randomised controlled trials and 2 meta-analyses or systematic reviews; the controlled studies include 6,593 participants in total. As of 3 October 2026.
1. What Is Lugol's Solution? Occurrence, Origin and Forms
Lugol's solution is an aqueous solution of elemental iodine and potassium iodide, classically with 5% iodine and 10% potassium iodide; weaker dilutions are also in use. Closely related is the saturated solution of potassium iodide (SSKI). Both supply iodine in amounts far above the daily requirement from food.
The solution itself does not occur in nature. Its component iodine comes from seawater, seaweed, iodine-rich brines and the mother liquor of Chilean saltpetre production.
It is made by dissolving iodine in a potassium iodide solution. The potassium iodide makes the otherwise barely water-soluble iodine soluble.
Forms and Preparations Studied
- Lugol's solution at classic strength and in dilutions
- Saturated solution of potassium iodide (SSKI) and high-dose potassium iodide
- Potassium iodide tablets to protect the thyroid from radiation
- Molecular iodine (I2) and iodine in the milligram range, for example for breast complaints
Not covered on this page:
- Iodised salt and iodine supplements in the microgram range, for example in pregnancy or iodine deficiency → Iodine
- Povidone-iodine and other iodine disinfectants
- Lugol's solution as a stain in endoscopy, colposcopy or dentistry
- Radioiodine therapy (iodine-131) as a treatment in its own right, and iodinated contrast media
- Potassium iodide as an enhancer of photodynamic therapy
2. What Does Lugol's Solution Do? Results by Area
| Area | Result in controlled studies | Strength of evidence | Studies | Participants |
|---|---|---|---|---|
| Hyperthyroidism and Graves' disease | mostly improved | moderate | 0 meta-analyses · 9 controlled · 59 other | 112 |
| Preparation for thyroid surgery | mixed | moderate | 0 meta-analyses · 7 controlled · 34 other | 121 |
| Breast tissue and breast pain | mostly improved | moderate | 0 meta-analyses · 2 controlled · 2 other | 111 |
| Thyroid protection from radiation | mixed | unclear | 1 meta-analyses · 1 controlled · 7 other | 27 |
| Infections | mostly no difference | unclear | 1 meta-analyses · 1 controlled · 23 other | 0 |
| Other outcomes | mixed | low | 0 meta-analyses · 9 controlled · 34 other | 6,222 |
How to read the table: counted are human studies whose results concern the area. “High” means at least one meta-analysis and two controlled studies showing improvement, or at least three controlled studies of which three quarters show improvement, with at least 300 participants in total. “Moderate” means at least two controlled studies showing improvement, as a majority, or one meta-analysis alongside controlled studies. “Low” means one controlled study showing improvement. Where an area has no controlled study, the strength of evidence is at most “low” (result “reviews only” or “observational data only”). Everything else is “unclear”. A study counts as showing improvement when at least half of its outcomes in this area improved. Reviews of combination products do not count as meta-analyses; results that only describe side effects or shares of users do not count as an effect. The same study is counted only once.
3. What the Studies Show in Detail
Lugol's Solution, Hyperthyroidism and Graves' Disease: Human Studies
In Graves' disease before thyroid surgery, preoperative administration of Lugol's solution lowered thyroid hormones in a randomized study 9; a controlled study found the same for potassium iodide 25. A randomized and a controlled study also found lower thyroid blood flow 1123. In a randomized study, thyroid hormones before surgery were too low in just over a third of those treated with Lugol's solution 13. A controlled study with saturated potassium iodide solution (SSKI) found no difference in thyroid status and in the frequency of hyper- and hypofunction six weeks after radioiodine 15. The strength of evidence is moderate: nine controlled studies, predominantly with small participant numbers and without information on manufacturer funding, in which Lugol's solution was mostly investigated preoperatively and partly in combination with antithyroid drugs. It remains open whether preoperative administration actually improves the surgical course or the longer-term disease course.
| Study | Design · participants | Preparation · dose · duration · comparison | Result |
|---|---|---|---|
| 9 Schiavone et al. 2024 | randomised controlled | preoperative Lugol solution; 7 days; vs. no Lugol treatment (LS-) | free tri-iodothyronine (FT3): improved (significantly reduced); free thyroxine (FT4): improved (significantly reduced) |
| 11 Erbil et al. 2007 | randomised controlled | preoperative Lugol solution; vs. no preoperative Lugol treatment | Mean thyroid artery blood flow: improved; Microvessel density (MVD): improved; CD-34 expression: improved |
| 13 Kaur et al. 1988 | randomised controlled | Lugol's iodine; 10 days preoperatively; vs. antithyroid drugs and thyroxine alone or continued | subnormal thyroid hormone levels at operation: worsened (Over a third of patients in Group I) |
| 15 Bazzi et al. 1993 | controlled · 112 participants | Saturated solution of potassium iodide (SSKI), 10 drops daily; 10 drops once a day; 6-month follow-up, starting 5 days after radioiodine; vs. Propylthiouracil 100 mg three times daily or no adjunctive drug | Thyroid status 6 weeks after radioiodine: no difference; Incidence of hyperthyroidism at 6 months: no difference; Incidence of hypothyroidism at 6 months: no difference |
| 21 Jeong et al. 2014 | controlled | potassium iodide plus antithyroid drugs; 8 weeks; vs. antithyroid drugs alone | triiodothyronine levels: improved (P<0.05); free thyroxine levels: improved (P<0.05); thyroid function tests at 8 weeks: no difference |
| 22 Cardoso et al. 2002 | controlled | Saturated solution of potassium iodide (SSKI) vs. iopanoic acid; SSKI 10-15 days; iopanoic acid 7 days; vs. Iopanoic acid (IOP) vs. SSKI, both with thionamides | Serum total T3 after 7 days: improved (significantly decreased); Serum rT3 after 7 days (IOP): improved (significantly increased); Serum total and free T4 after 7 days SSKI: improved (decreased) |
| 23 Rangaswamy et al. 1989 | controlled | Lugol's iodine added to carbimazole; up to six weeks; vs. carbimazole alone or normal thyroid | Thyroid Vascularity Index (TVI): improved (p less than 0.01); sustained fall in TVI with chronic iodine therapy: improved (p less than 0.001) |
| 24 Roti et al. 1988 | controlled | Methimazole plus saturated solution of potassium iodide (SSKI); SSKI 6 drops twice daily, methimazole 40 mg/day; 10 days; vs. Methimazole alone and methimazole plus sodium ipodate | Serum T4 decrease: no difference; Serum T3 decrease: no difference; Heart rate decrease: no difference |
Further studies in this area: 25 27 30 33 36 39 40 41 43 44 45 48 49 51 53 55 56 57 58 59 61 64 65 66 67 71 72 73 75 76 78 79 80 81 82 83 84 87 93 94 95 98 100 101 106 107 111 113 114 116 118 122 123 129 130 136 137 138 140 143
Lugol's Solution and Preparation for Thyroid Surgery: Human Studies
In thyroid surgery, preoperative administration of Lugol's solution showed lower intraoperative blood loss in two randomized studies 711. Three randomized studies found no difference in blood loss compared with preparation without Lugol's solution 6913. The strength of evidence is moderate: the seven controlled studies with a total of 121 participants are opposed by 34 further works, which are predominantly designed as case series or observational studies. Mostly the classical Lugol's solution was investigated; for saturated potassium iodide solution (SSKI) only one observational study is available 35. It remains open which patient groups and which dosage regimen actually benefit, since the comparison groups and concomitant medications vary greatly between the studies.
| Study | Design · participants | Preparation · dose · duration · comparison | Result |
|---|---|---|---|
| 6 Coyle et al. 1982 | randomised controlled · 44 participants | Lugol's iodine versus placebo; vs. placebo | bleeding: no difference; operative facility: no difference |
| 7 Yilmaz et al. 2016 | randomised controlled · 40 participants | preoperative Lugol's solution; vs. Group 1 with Lugol vs. Group 2 without Lugol | Intraoperative blood loss: improved (7.40-fold decrease); Mean thyroid artery blood flow: improved; Lugol treatment as independent determinant of blood loss: improved (OR, 7.40; 95% CI, 1.02-58.46; p = 0.001) |
| 8 Chang et al. 1987 | randomised controlled · 12 participants | Lugol's iodine versus placebo; 0.3 ml three times daily; 9 days; vs. placebo, double-blind, randomized | superior thyroid artery diameter: improved; time-averaged velocity (TAV): improved (p less than 0.01); volume flow (VF): improved (p less than 0.005) |
| 9 Schiavone et al. 2024 | randomised controlled | preoperative Lugol solution; 7 days; vs. no Lugol treatment (LS-) | intraoperative/postoperative blood loss: no difference (median 80.5 versus 94 ml); duration of surgery: no difference (75 min in both groups); postoperative morbidity: no difference |
| 11 Erbil et al. 2007 | randomised controlled | preoperative Lugol solution; vs. no preoperative Lugol treatment | Intraoperative blood loss: improved (9.33-fold decreased rate of intraoperative blood loss) |
| 13 Kaur et al. 1988 | randomised controlled | Lugol's iodine; 10 days preoperatively; vs. antithyroid drugs and thyroxine alone or continued | vascularity of the gland: no difference; operative blood loss: no difference; thyroid follicular size: no difference |
| 18 Ansaldo et al. 2000 | controlled · 25 participants | Lugol's solution 2% (iodine-iodide solution); increasing doses until total 75 mg iodine; 7 days; vs. healthy controls; before vs. after treatment | intrathyroid Doppler resistance index: improved (+16.46 +/- 10.22%, p< 0.0005); basal resistance index vs. controls: worsened (0.4718 +/- 0.0625 versus 0.55 +/- 0.05, p = 0.008) |
| 28 Ganchev et al. 1994 | case series · 848 participants | Classical Lugol's solution for preoperative preparation; vs. 1-2 tablets Metizole preoperatively | Preoperative preparation with Lugol's solution: worsened; Postoperative hyperthyroid complications: improved |
Further studies in this area: 29 30 31 32 34 35 38 42 43 49 58 62 68 69 70 83 86 89 90 99 102 103 106 109 113 114 115 123 124 125 134 142 150
Lugol's Solution, Breast Tissue and Breast Pain: Human Studies
In breast pain and fibrocystic changes, a randomized controlled trial with molecular iodine showed improvement in pain, tenderness and nodularity compared with placebo 3. The strength of evidence is moderate; molecular iodine (I2) was investigated, not Lugol's solution or potassium iodide. The exact dose, the duration and the transferability to other iodine preparations remain open.
| Study | Design · participants | Preparation · dose · duration · comparison | Result |
|---|---|---|---|
| 3 Kessler et al. 2004 | randomised controlled · 111 participants | Molecular iodine; 1.5, 3.0 or 6.0 mg/day; 6 months; vs. Placebo | Lewin overall pain scale: improved (p < 0.01); Physician assessments of pain, tenderness and nodularity: improved (3.0 mg/day (7/28; 25%) and 6.0 mg/day (15/27; 18.5%)); Pain reduction by month 3: improved (more than 50% of the 6.0 mg/day treatment group recorded a clinically significant reduction in overall pain) |
| 10 Moreno-Vega et al. 2019 | randomised controlled | Oral molecular iodine (I2), alone or with FEC/TE; 5 mg/day I2; 7-35 days before surgery; then 170 days FEC/TE + I2; vs. Placebo (colored water) | response rate: improved (0, 33%, 73%, and 100%, respectively); pathologic complete response: improved (18%, and 36%); five-year disease-free survival rate: improved (82% versus 46%) |
| 26 Ghent et al. 1993 | study · 1,365 participants | Sodium iodide, protein-bound iodide, molecular iodine; Molecular iodine 0.07-0.09 mg/kg; 2 to 5 years (study 1); vs. Placebo (brown vegetable dye and quinine) | Clinical improvement with sodium iodide: improved (70%); Clinical improvement with protein-bound iodide: improved (40%); Clinical improvement in crossover series: improved (74%) |
| 145 Aceves et al. 2013 | review | Molecular iodine (I2), partly via seaweed intake; vs. no uniform control, review | development and size of benign and cancerous neoplasias: improved |
Lugol's Solution and Thyroid Protection from Radiation: Human Studies
A systematic review of potassium iodide tablets after nuclear accidents found evidence of a reduced risk of thyroid cancer in children, with low quality of evidence 1. A controlled study (not randomized) in healthy volunteers found a reduction in thyroid dose for high-dose potassium iodide 17. In the efficacy comparison, high-dose potassium iodide did not perform better than sodium perchlorate 17. Potassium iodide tablets and high-dose potassium iodide were studied; efficacy and risk in children, in iodine deficiency and with longer administration remain open.
| Study | Design · participants | Preparation · dose · duration · comparison | Result |
|---|---|---|---|
| 1 Pfinder et al. 2016 | systematic review | Potassium iodide (KI); not well described; vs. KI administration versus no KI after nuclear accident | Thyroid cancer in children: improved; Hypothyroidism: unclear; Benign thyroid nodules: unclear |
| 17 Hänscheid et al. 2011 | controlled · 27 participants | Potassium iodide (KI) or sodium perchlorate (SP); 100 mg KI; 100 mg SP; 1 g SP; Single dose, assessment 48 h later; vs. KI at -24, 2, 8, 24 h vs. SP at 2, 8 h | Mean thyroid dose reduction: improved (88.7, 59.7, 25.4, and 2.8%); Efficacy of 1 g SP vs. 100 mg KI: no difference (equally effective); Residual uptake after 100 mg SP: worsened (residual uptake was observed) |
| 52 Takamura et al. 2004 | study · 8 participants | oral potassium iodide; 50 mg or 100 mg potassium iodide (38 or 76 mg iodide); single dose, measurement at 24 h; vs. 50 mg versus 100 mg potassium iodide | thyroid uptake of 123I at 24 h: improved (p = 0.03); protective effect at 24 h (50 mg): improved (73.3%); protective effect at 24 h (100 mg): improved (79.5%) |
| 131 Simonović et al. 1984 | study | Potassium iodide 130 mg plus calcium alginate 10 g and ferrihexacyanoferrate(II) 3 g; 130 mg potassium iodide, 10 g calcium alginate, 3 g ferrihexacyanoferrate(II); 30 minutes before 131I administration; vs. No comparison; blockade of 131I uptake | 131I thyroid uptake: improved (almost complete block) |
| 132 Broga et al. 1983 | case series | Potassium iodide as blocking agent; Follow-up over several months; vs. no control group | Thyroid uptake of 125I: unclear (significant thyroid uptakes); Value of administering a blocking agent in 125I release: improved |
| 139 da et al. 2024 | review | Potassium iodide (tablets or granules) | Risk of thyroid cancer: improved; Benefits outweigh risks of adverse effects |
| 144 Fisher et al. 2014 | review | Potassium iodide (KI); vs. Adults or limited study evidence | Effectiveness of KI in children: unclear; HPT axis response to KI: worsened |
| 146 Reiners et al. 2013 | review | High-dose potassium iodide (KI); up to 1 week with repeated release; vs. no treatment or potassium perchlorate as alternative | Blockade of radioiodine thyroid uptake: improved; Thyroid cancer risk in adults: no difference (negligible); Thyroid cancer risk in iodine deficiency: worsened |
Further studies in this area: 149
Lugol's Solution and Infections: Human Studies
For infections, a comparison with placebo or other agents is lacking: A randomized study in patients with cutaneous sporotrichosis compared only one and three daily doses of saturated potassium iodide solution (SSKI) and found no difference in healing and relapse 12. A systematic review of oral high-dose potassium iodide in cutaneous sporotrichosis comes to no clear efficacy result 2. The strength of evidence is therefore unclear; both works studied saturated potassium iodide solution as an oral preparation. It remains open whether and at what dosage potassium iodide works at all in these infections.
| Study | Design · participants | Preparation · dose · duration · comparison | Result |
|---|---|---|---|
| 2 Xue et al. 2009 | systematic review | Oral potassium iodide; vs. Placebo or another treatment | Efficacy in sporotrichosis: unclear |
| 12 Cabezas et al. 1996 | randomised controlled | Saturated solution of potassium iodide (SSKI); full daily dose once daily vs. three times daily; 45 days of follow-up; vs. once daily vs. three times daily SSKI | cure rate: no difference (26 (89.6%) and 25 (89.2%)); relapse: no difference (No relapse was detected after 45 days of follow-up) |
| 37 Mahajan et al. 2005 | case series · 103 participants | Saturated solution of potassium iodide (SSKI) as first-line treatment; Healing in 4-32 weeks (average 8.7 weeks); vs. Itraconazole in 12 patients; fluconazole in one patient | Healing of lesions: improved (93%); Side-effects (without significant side-effects) |
| 54 Das et al. 2019 | case series · 6 participants | Oral saturated solution of potassium iodide along with other drugs | Complete resolution: improved (five patients) |
| 60 Ramírez-Soto et al. 2013 | case series · 2 participants | Oral saturated solution of potassium iodide (SSKI); 3 drops tid, up to maximum 40 drops tid; 2 months | Mycological and clinical cure: improved (after 2 months of treatment) |
| 74 Sandhu et al. 2022 | case report · 1 participants | Supersaturated potassium iodide solution (SSKI) plus itraconazole; SSKI 5 drops thrice daily, increased to 20 drops thrice daily; itraconazole 100 mg twice daily; 6 months follow-up | lesion resolution: improved (complete resolution at 6 months follow-up) |
| 77 Lyra et al. 2021 | case report · 1 participants | Saturated potassium iodide solution (SSKI); vs. Prior treatment: 18 months itraconazole and terbinafine plus cryosurgery, treatment failure | Cure of sporotrichosis: improved (The patient was cured) |
| 85 Mahajan et al. 2015 | case report · 1 participants | Topical amphotericin B 0.1% w/w; SSKI/itraconazole/terbinafine not tolerated; 0.1% w/w topical; 8 weeks; vs. no comparison (case report) | healing of the skin lesion: improved (healed after 8weeks) |
Further studies in this area: 88 91 96 97 104 105 108 110 112 117 120 121 126 127 128 147 148
Lugol's Solution: Further Outcomes in Studies
In this area, the studies show a mixed picture with low strength of evidence. A randomized study with preoperative Lugol's solution in Graves' disease found no difference in sonographically measured blood flow and vessel density in the tissue 9. In cutaneous sporotrichosis, the side effects did not differ between once and three times daily administration of saturated potassium iodide solution 12. A controlled study with saturated potassium iodide solution in people with previous iodine-induced hyperthyroidism found no difference in T4 and T3, but in some the TSH rose significantly 20. A controlled study found that iodine from potassium iodide was better absorbed and excreted than from a kombu preparation 19. In nodular goiter, a controlled study under Lugol's solution found no change in thyroid blood flow 23. Lugol's solution, saturated potassium iodide solution and high-dose potassium iodide were studied; statements on duration, comparison groups and transferability remain open, since the strength of evidence is low and several studies were not randomized.
| Study | Design · participants | Preparation · dose · duration · comparison | Result |
|---|---|---|---|
| 4 Wang et al. 2026 | randomised controlled · 97 participants | Lugol's solution added to radioiodine therapy; Follow-up 6 to 9 months; vs. Radioiodine therapy alone (control group) | Rate of negative DxWBS: no difference (93.3% vs. 91.2%, p = 0.748); Successful ablation rate (sTg <1 ng/mL): no difference (82.8% vs. 66.7%, p=0.131); Successful ablation rate (sTg <0.2 ng/mL): improved (65.7% vs. 40.0%, p = 0.041) |
| 5 Bacher et al. 2002 | randomised controlled · 68 participants | Potassium iodide (KI) 100 mg/day; 100 mg per day; 2 days before to 2 weeks after 131I-lipiodol; vs. no KI (non-KI group) | Thyroid uptake of 131I: improved (0.23%+/-0.06% vs 0.42%+/-0.20%); Absorbed radiation dose to the thyroid: improved (5.5+/-1.6 Gy vs 11.9+/-5.9 Gy) |
| 9 Schiavone et al. 2024 | randomised controlled | preoperative Lugol solution; 7 days; vs. no Lugol treatment (LS-) | ultrasonographic vascularization: no difference; microvessel density at final pathology: no difference |
| 12 Cabezas et al. 1996 | randomised controlled | Saturated solution of potassium iodide (SSKI); full daily dose once daily vs. three times daily; 45 days of follow-up; vs. once daily vs. three times daily SSKI | side effects (P = 0.17) |
| 14 Phillips et al. 1988 | controlled · 5,999 participants | Oral potassium iodide, oral iodized oil, intramuscular iodized oil, placebo; Potassium iodide 0.5 g, 1.0 g or 2.0 g single dose; iodized oil 2 ml; 8 months follow-up; vs. Placebo and intramuscular iodized oil | Bloodspot thyroxine (T4) concentration in women of reproductive age: no difference; Goitre prevalence: unclear (61%); Urinary iodine excretion: unclear (10.9 (SD 6.8) micrograms/g creatinine) |
| 16 Roti et al. 1990 | controlled · 30 participants | Saturated solution of potassium iodide (SSKI); 10 drops daily, 300 mg iodide; 120 days, follow-up 2-4 months after; vs. prior subacute thyroiditis vs. prior thyroid surgery | Clinical hypothyroidism: worsened (Two SAT subjects developed clinical evidence of hypothyroidism); At least 1 abnormal thyroid function test: worsened |
| 19 Liu et al. 2025 | controlled · 18 participants | Potassium iodide (KI) vs. kombu supplement; KI 547 and 1263 µg iodine; kombu 993 and 1735 µg iodine; 48 h urine sampling, 18 time points; vs. kombu supplement vs. potassium iodide | 0–24 h urinary iodine concentration: improved (95 µg/L vs. 113 µg/L, p > 0.05; 109 µg/L vs. 223 µg/L, p < 0.001); iodine bioavailability: improved (29.5% vs. 83.5%, p < 0.001; 23.7% vs. 63.7%, p < 0.001); urinary iodine excretion velocity (peaks): improved (22 and 25 µg/h vs. 57 and 109 µg/h) |
| 20 Roti et al. 1992 | controlled · 10 participants | Saturated solution of potassium iodide (SSKI); 10 drops SSKI daily; vs. SSKI-treated euthyroid controls without amiodarone or thyroid disease | Basal and TRH-stimulated TSH: worsened (6 patients developed marked iodine-induced basal and/or TRH-stimulated serum TSH elevations); Basal and TRH-stimulated TSH: improved (2 had suppressed basal and TRH-stimulated TSH values); Serum T4 and T3: no difference (remained normal and unchanged) |
Further studies in this area: 22 23 30 44 45 46 47 49 50 51 63 64 67 68 73 76 80 82 84 86 89 92 97 98 101 106 108 111 119 122 129 133 135 141 145
4. How Is Lugol's Solution Dosed? Preparation, Dose and Duration in Studies
The classical Lugol's solution, saturated potassium iodide solution (SSKI), high-dose potassium iodide and molecular iodine (I2) were investigated. Lugol's solution was mainly tested preoperatively in Graves' disease and thyroid surgery, sometimes in addition to radioiodine therapy. SSKI and high-dose potassium iodide were used in thyroid hyperfunction, after radioiodine, in radiation exposure, in cutaneous sporotrichosis and in studies on iodine excretion; the doses are shown in the table.
| Preparation or form | Dose | Duration | Study |
|---|---|---|---|
| Molecular iodine | 1.5, 3.0 or 6.0 mg/day | 6 months | 3 |
| Lugol's solution added to radioiodine therapy | — | Follow-up 6 to 9 months | 4 |
| Potassium iodide (KI) 100 mg/day | 100 mg per day | 2 days before to 2 weeks after 131I-lipiodol | 5 |
| Lugol's iodine versus placebo | 0.3 ml three times daily | 9 days | 8 |
| preoperative Lugol solution | — | 7 days | 9 |
| Oral molecular iodine (I2), alone or with FEC/TE | 5 mg/day I2 | 7-35 days before surgery; then 170 days FEC/TE + I2 | 10 |
| Saturated solution of potassium iodide (SSKI) | full daily dose once daily vs. three times daily | 45 days of follow-up | 12 |
| Lugol's iodine | — | 10 days preoperatively | 13 |
| Oral potassium iodide, oral iodized oil, intramuscular iodized oil, placebo | Potassium iodide 0.5 g, 1.0 g or 2.0 g single dose; iodized oil 2 ml | 8 months follow-up | 14 |
| Saturated solution of potassium iodide (SSKI), 10 drops daily | 10 drops once a day | 6-month follow-up, starting 5 days after radioiodine | 15 |
| Saturated solution of potassium iodide (SSKI) | 10 drops daily, 300 mg iodide | 120 days, follow-up 2-4 months after | 16 |
| Potassium iodide (KI) or sodium perchlorate (SP) | 100 mg KI; 100 mg SP; 1 g SP | Single dose, assessment 48 h later | 17 |
| Lugol's solution 2% (iodine-iodide solution) | increasing doses until total 75 mg iodine | 7 days | 18 |
| Potassium iodide (KI) vs. kombu supplement | KI 547 and 1263 µg iodine; kombu 993 and 1735 µg iodine | 48 h urine sampling, 18 time points | 19 |
| Saturated solution of potassium iodide (SSKI) | 10 drops SSKI daily | — | 20 |
5. Is Lugol's Solution Safe? Side Effects in Studies
The studies predominantly report good tolerability of the iodine doses, with frequently mild and transient adverse events 3512. With saturated potassium iodide solution, adverse effects occurred frequently but mildly in a controlled study, with no difference between once and three times daily administration 12. In several controlled studies, hypothyroidism or excessively low thyroid hormones occurred under high-dose iodine, sometimes detectable only by an elevated TSH value 131620. After thyroid surgery, patients with Lugol's solution needed short-term calcium more frequently in a large cohort study 29. In a further cohort study, vocal cord nerve paralysis and parathyroid hypofunction occurred more frequently, while neck bruising occurred less frequently 31. Details are shown in the table.
| Study | Reported side effects |
|---|---|
| 2 Xue et al. 2009 | Adverse effects were to be collected from trials; no data |
| 3 Kessler et al. 2004 | No dose-related increase in adverse events; acceptable safety profile |
| 4 Wang et al. 2026 | Short-term comparable; long-term 2 cases in control, none in test group |
| 5 Bacher et al. 2002 | very good tolerance of KI treatment |
| 9 Schiavone et al. 2024 | no difference in postoperative morbidity |
| 10 Moreno-Vega et al. 2019 | I2 supplementation showed significant attenuation of side effects |
| 12 Cabezas et al. 1996 | common but mild: 61% qd, 42% tid, P = 0.17 |
| 13 Kaur et al. 1988 | In Group I subnormal thyroid hormone levels, complications of partial thyroidectomy |
| 16 Roti et al. 1990 | Two SAT patients developed clinical hypothyroidism with markedly elevated TSH |
| 20 Roti et al. 1992 | 6 patients developed marked iodine-induced TSH elevations (subclinical hypothyroidism) |
| 26 Ghent et al. 1993 | Sodium iodide: high rate of side effects |
| 27 Suzuki et al. 2026 | Adverse events in 294 patients (289 high-dose, 5 low-dose) |
6. What Remains Open: Limits of the Evidence
- The controlled studies on thyroid hyperfunction and thyroid surgery mostly have small participant numbers and no information on manufacturer funding.
- The comparison groups and concomitant medications differ greatly between the studies, so it remains unclear which patient groups and dosage regimens benefit.
- For saturated potassium iodide solution (SSKI) in thyroid surgery, only one observational study is available.
- For breast tissue and breast pain, molecular iodine (I2) was investigated, not Lugol's solution or potassium iodide; dose and duration remain open.
- For thyroid protection after radiation exposure and in infections, the strength of evidence is unclear, and data on children, iodine deficiency and longer-term administration are lacking.
7. Bottom Line: What Is Established About Lugol's Solution
Lugol's solution and related high-dose iodine preparations are best studied for preoperative preparation in Graves' disease and thyroid surgery. There, in several controlled studies, they lowered thyroid hormones and thyroid blood flow and sometimes reduced blood loss, while other controlled studies found no difference in blood loss and operating time. The strength of evidence is moderate, the studies are predominantly small and without information on manufacturer funding.
For breast pain and fibrocystic changes, a randomized controlled trial with molecular iodine showed improvement compared with placebo, although Lugol's solution was not investigated. For thyroid protection after radiation exposure and in infections such as cutaneous sporotrichosis, the strength of evidence is unclear because comparisons with placebo are lacking or the evidence is weak. Overall, effect and risk depend strongly on dose, preparation and concomitant treatment.
Frequently Asked Questions
How well has Lugol's solution been studied in humans?
We evaluated 154 human studies on Lugol's solution, including 11 randomised controlled trials and 2 meta-analyses or systematic reviews; the controlled studies include 6,593 participants in total. As of 3 October 2026.
Does Lugol's solution help with hyperthyroidism and Graves' disease? What the studies show
Does Lugol's solution help with preparation for thyroid surgery? What the studies show
Does Lugol's solution help with breast tissue and breast pain? What the studies show
Does Lugol's solution help with thyroid protection from radiation? What the studies show
Does Lugol's solution help with infections? What the studies show
What is Lugol's solution investigated for in human studies?
Most frequently, it was tested preoperatively in Graves' disease and before thyroid surgery. One randomized controlled trial investigated it in addition to radioiodine therapy in differentiated thyroid carcinoma 4.
Do Lugol's solution, SSKI and potassium iodide tablets differ in the studies?
Yes, the studies investigate different preparations. Lugol's solution was mainly used preoperatively, saturated potassium iodide solution (SSKI) among others in thyroid hyperfunction, after radioiodine and in cutaneous sporotrichosis 121522. Potassium iodide tablets were investigated for thyroid protection in radiation exposure 1.
What do the studies show for preparation for thyroid surgery?
What adverse effects do the studies report?
Mild and transient adverse events were frequently reported, for example with SSKI with no difference between once and three times daily administration 12.
Is there evidence of a benefit in breast complaints or infections?
In breast pain and fibrocystic changes, a randomized controlled trial with molecular iodine showed improvement in pain, tenderness and nodularity compared with placebo 3; however, Lugol's solution was not investigated. In cutaneous sporotrichosis, a randomized controlled trial with SSKI found no difference between one and three daily doses 12, and a systematic review reaches no clear efficacy result 2.
Sources
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Every statement on this page carries its evidence tier — proven, plausible or hypothesis — and leads to the original work. The decision in the individual case rests with the practitioner; we provide the connections.