Most medications are not tested for long-term side effects. And there is no clear definition of "long-term" in the literature.

So how long of a time period (median? average? range?) are medications tested for by the appropriate government institution? Where can the consumer go to look up this information for each drug? It would be really helpful to know how long one can be on a newer drug before experiencing a harmful long-term side effect.

  • The amount of time devoted to clinical studies before releasing a new drug depends on many factors, being the most important the regulatory requisites in your country. However, once it's released the drug is still monitored for years, even their whole commercial life and beyond. So "long term" is a hazy term when talking about drugs. Also, you can't expect he same kind of long-term effects from medicines for chronical conditions than from the ones you'd take sporadically.
    – Variax
    Commented Sep 9, 2016 at 8:15

1 Answer 1


You are correct that there are no hard and fast rules on how long a clinical trial has to take. There are recommendations or, if you'd like common practices, but the duration of the trial is decided separately for each drug, for each clinical trial phase and even for each individual study (when there is more than one study in a phase).

The FDA website for example, states that the duration of the study is decided by the research team, although it gives common duration span for each phase (emphasis mine):

Phase 1:

Patients: 20 to 100 healthy volunteers or people with the disease/condition.

Length of Study: Several months

Purpose: Safety and dosage

Phase 2:

Patients: Up to several hundred people with the disease/condition.

Length of Study: Several months to 2 years

Purpose: Efficacy and side effects

Phase 3:

Patients: 300 to 3,000 volunteers who have the disease or condition

Length of Study: 1 to 4 years

Purpose: Efficacy and monitoring of adverse reactions

The information on the conducted studies are included in the Summary of Product Characteristics (SPC or SmPC for short), you can find them on-line or from your regulatory agency. However, they do not always include the length of the study. For new medicines the companies sometimes give information about the clinical trials, although depending on the country you are in, this information might be available just to healthcare professionals for prescription medicines (because promotion of prescription medicines direct to consumer is prohibited in many countries).

The fourth, post-marketing phase is not time-limited, it lasts for as long as the medicine is on the market. The health professionals are obliged to report any side-effects that they become aware of that are either associated or even just concomitant to a medicine use. Patients can report any side effects they notice to their health care professional, but very often there is also an option to report directly to the company/manufacturer. Most companies have a section on their website (or at least an e-mail address) dedicated to this, or, depending on the country a patient is in, the adverse effects can be reported by phone. Aside from spontaneous reporting, post-marketing phase studies are also conducted.

This procedure is a part of the pharmacovigilance system. There are various national and international adverse reaction monitoring systems, and these should all contribute to greater knowledge and the better safety of a medicine.

For example, there are laws and good pharamcovigilance practice (GVP) guidelines in the EU, that can be found on the EMeA website. This legislature makes it obligatory for manufacturers to periodically update safety reports and include new findings.

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