Paracetamol for headaches, ibuprofen for joint pain, pseudoephedrine to clear a stuffy nose: these over-the-counter medications are purchased without a prescription and consumed without consultation. Their accessibility in pharmacies or online creates a perception of absolute safety. Assessing the real risks of self-medication requires examining recent pharmacovigilance data, particularly from the ANSM and EMA, which reveal concerning signals regarding several common molecules.
Cumulative paracetamol from multiple products: an underestimated hepatic risk
Paracetamol is included in the composition of dozens of different products: pure analgesics, cold medications, flu preparations. A patient taking a tablet for fever and a packet for flu symptoms may absorb a cumulative dose much higher than they realize, without ever exceeding the dosage indicated on each box taken in isolation.
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The ANSM highlights in its pharmacovigilance reports from 2022-2024 an increase in hospitalizations for acute hepatic damage due to unintentional accumulation, particularly among young adults combining multiple products containing paracetamol and alcohol. The liver metabolizes paracetamol into a toxic derivative normally neutralized by glutathione. When the total dose exceeds the detoxification capacity, liver damage can become irreversible.
As detailed in the article from Utile au Quotidien, this phenomenon also affects profiles without apparent risk factors. The difficulty lies in the fact that each box complies with regulations: it is the combination of several boxes that creates the danger.
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Pseudoephedrine and psychiatric effects: recent signals from the ANSM and EMA
Nasally administered decongestants containing pseudoephedrine are among the best-selling over-the-counter medications during the winter season. Since 2023, the ANSM and the EMA pharmacovigilance committee have documented serious psychiatric effects related to pseudoephedrine, even at recommended doses: agitation, hallucinations, suicidal thoughts.
These reports involve patients without psychiatric histories. The mechanism relies on the sympathomimetic action of the molecule, which stimulates the central nervous system beyond mere nasal vasoconstriction.
What makes this risk particularly deceptive
Pseudoephedrine is perceived as a simple cold medication. The labels mention cardiovascular risks (hypertension, tachycardia), but neuropsychiatric effects remain little known to the general public. Prolonged or repeated use, common among those experiencing consecutive winter infections, increases the likelihood of these reactions.
The ANSM published a specific information point on vasoconstrictors in October 2023, reminding that the treatment duration should not exceed a few days and that any neurological or psychiatric symptoms require immediate cessation.
Interactions between over-the-counter anti-inflammatories and chronic treatments
Ibuprofen and naproxen are easily found without a prescription. Regulatory authorities have been alerting since 2022-2023 about their interactions with common chronic treatments. Two scenarios are drawing the attention of pharmacovigilance experts:
| Over-the-counter medication | Concerned chronic treatment | Documented risk |
|---|---|---|
| Ibuprofen, naproxen (NSAIDs) | Antihypertensives | Reduced treatment efficacy, increased blood pressure |
| Ibuprofen, naproxen (NSAIDs) | Renal insufficiency treatment | Worsening of renal function, risk of acute renal failure |
| Antacids (OTC PPIs) | Some anticoagulants, antifungals | Altered absorption, reduced treatment efficacy |
These interactions do not occur in everyone, but they affect large populations: hypertensive patients represent a significant portion of NSAID buyers in self-medication. The problem is that pharmacists do not always have access to the patient’s complete medication history, especially during a quick counter purchase.
Antacids and disrupted drug absorption
Proton pump inhibitors (PPIs) available without a prescription alter gastric pH. This change affects the absorption of many molecules. A patient on antifungal or anticoagulant treatment who takes an over-the-counter antacid may unknowingly reduce the effectiveness of their primary treatment.
Self-medication and misuse: when the correct dose is not enough
The Public Health Code defines misuse as an intentional and inappropriate use of a medication, not compliant with its marketing authorization. This definition covers a broader spectrum than simple overdose:
- Taking a medication for an indication different from that intended (an anti-inflammatory to aid sleep, for example)
- Extending treatment beyond the recommended duration without medical advice, which frequently concerns decongestants and laxatives
- Combining multiple products containing the same active ingredient without checking the complete composition on the label
The ANSM and companies marketing these medications report and monitor these misuse cases. A portion of the serious adverse effects reported each year is classified as avoidable, meaning it could have been prevented by appropriate information or a verification at the time of purchase.
Concrete checks before any intake
- Read the complete composition (section “active ingredients”) of each box to identify duplicates of molecules
- Inform the pharmacist of all ongoing treatments, including dietary supplements
- Adhere to the maximum duration indicated on the label and consult a doctor if symptoms persist beyond that
- Never combine alcohol and paracetamol, even at standard doses
Over-the-counter does not mean absence of health risk. Recent pharmacovigilance data show that the most common molecules can produce serious effects in contexts of accumulation or interaction. The difference between safe use and a medication accident often comes down to careful reading of the composition and a few minutes of discussion with a pharmacist.