Table 7.
Summary of adverse effects from the use of hydrogen peroxide.
| ID | Gender and age | Date and time | Route of administration | Adverse effect | Severity of adverse effect1 | Possible cause (causality) | Security problem2 | Countermeasure | Consequence of the event3 |
|---|---|---|---|---|---|---|---|---|---|
| 01 | Male, 38 | 05/12/20 20:00 (day 2) | Inhalatory (nebulization) | Momentary shortness of breath | Mild | Accidental use of undiluted solution: using 10 drops undiluted for 3 minutes | Related | Only observation. The discomfort was mild and resolved after 10 minutes | Recovered without after-effects |
| 05/14/20 19:01 (day 4) | Oral | Nausea | Mild | During the third meal of the day, he felt nauseous when ingesting the treatment quickly and continuously | Related | Only observation. The effect was momentary and disappeared after five minutes | Recovered without after-effects | ||
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| 02 | Male, 40 | 05/16/20 18:00 (day 6) | Inhalatory (nebulization) | Chest tightness | Mild | He had eaten in a hurry, just before doing the nebulization, so indigestion is suspected | Not related | Omeprazole 20 mg, a single dose. The effect disappeared after around 20 minutes | Recovered without after-effects |
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| 04 | Male, 35 | 05/22/20 16:00 (day 3) | Oral | Nausea and reflux | Mild | Gastroesophageal reflux disease (chronic) with poor adherence to treatment | Not related | Esomeprazole 40 mg single dose per day, irritant-free diet, and avoiding prolonged fasts. Abandoning oral treatment of his own accord (day 5) | Recovered without after-effects |
| 05/24/20 19:00 (day 5) | Inhalatory (nebulization) | Palpitations (heartbeat) | Mild | Possible mild intolerance due to gastroesophageal reflux | Not related | Only observation. The effect was momentary and disappeared five minutes later | Recovered without after-effects | ||
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| 05 | Male, 19 | 06/07/20 16:50 (day 1) | Inhalatory (nebulization) | Headache | Mild | He had headache, asthenia, adynamia, chills, and diaphoresis before starting treatment | Not related | Acetaminophen 500 mg, a single dose. Headache disappeared 1 hour later | Recovered without after-effects |
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| 06 | Female, 21 | 06/07/20 23:00 (day 1) | Inhalatory (nebulization) | Mild headache and eye irritation | Mild | When nebulizing, the steam escaped through the upper holes of the mask, causing the peroxide contact with the eyes | Related | Nebulization was stopped immediately, and mask openings were canceled | Recovered without after-effects |
| 06/07/20 23:00 (day 1) | Oral | Nausea | Mild | Drug gastritis (taking 6 drugs without gastric protection) | Not related | Delivery of medications was organized throughout the day, and omeprazole 40 mg was added in a single dose upon waking | Recovered without after-effects | ||
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| 09 | Male, 40 | 06/15/21 18:00 (day 1) | Oral | Odynophagia | Mild | Presence of prior ulcers in pharynx from upper respiratory infection | Not related | Sublingual ketorolac 30 mg, single dose 20 minutes before peroxide | Recovered without after-effects |
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| 24 | Male, 23 | 07/02/21 19:00 (day 2) | Oral | Sickness | Mild | Drug gastritis (taking 6 drugs without gastric protection) | Not related | The dosage of drugs is organized throughout the day and omeprazole 20 mg every 12 hours | Recovered without after-effects |
| 07/02/21 20:00 (day 2) | Inhalatory (nebulization) | Nasal irritation | Mild | Use of salbutamol and fluticasone (nebulized) 10 minutes before use of peroxide | Not related | Use of salbutamol and fluticasone 1 hour before nebulization with peroxide | Recovered without after-effects | ||
| 32 | Male, 30 | 07/09/21 20:00 (day 6) | Oral | Dizziness and bitter taste | Mild | Peroxide intolerance is suspected because adverse effect appears almost immediately | Related | Reduction of frequency of peroxide to two doses per day | Recovered without after-effects |
1In accordance with “NORMA Official Mexicana NOM-220-SSA1-2016” (about installation and operation of pharmacovigilance); 2in accordance with “Guía de Farmacovigilancia en Investigación Clínica” (COFEPRIS, 2020); 3in accordance with “Instructivo de llenado del formato Aviso de Sospechas de Reacciones Adversas de Medicamentos” (COFEPRIS, 2017).