If the mechanism of action of paracetamol is unknown, why is it considered a safe drug to use for humans?

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If the mechanism of action of paracetamol is unknown, why is it considered a safe drug to use for humans?

In: Biology

Because for a drug to be approved, it has to pass the clinical trial process. If the drug passes this process it can be approved. I would assume that during this process, the fever-reducing and pain-relieving properties showed improvements over placebo. I’d also assume that the rate of side effects was relatively low.

Ultimately it doesn’t matter *how* it works as long as it works and has no super unsafe side effects. The FDA has no requirement that you know how a drug works.

> Paracetamol has a central analgesic effect that is mediated through activation of descending serotonergic pathways. Debate exists about its primary site of action

https://pubmed.ncbi.nlm.nih.gov/18811827/

We do know how it works, there’s just debate over which receptor site in particular it uses. Paracetamol is an old drug that’s been used for decades, we know all the side effects, we know what groups can take it and what groups can’t. If it were invented today would it pass regulators with this discrepancy? Probably but it would be harder and probably more tightly controlled and not sold in most shops. We still don’t know fully how anaesthetics and hypnotic drugs work. We just know that they do.

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It works on the COX receptors, and the TRVP1 receptor: so in the same way as ibuprofen and cannabis. We do [know](https://en.wikipedia.org/wiki/Paracetamol) how and where it works.

For the same a surprising amount of medications are allowed to be sold, despite not knowing the exact mechanism of action; the have demonstrated efficacy, and aren’t harmful enough.

Drugs for depression have poorly understood mechanisms. We still don’t know how or why *ketamine* works, though we have some good ideas (NMDA, it’s thought, and the exact binding site was just recently resolved).