> ## Documentation Index
> Fetch the complete documentation index at: https://docs.hi-doctor.ai/llms.txt
> Use this file to discover all available pages before exploring further.

# Qsymia — why it is not prescribed in most of the EU

> Qsymia (phentermine/topiramate): why the EMA refused EU-wide approval, where it is sold under the name Qsiva, and EU-authorised alternatives.

Qsymia is the United States brand name for a capsule that combines phentermine and topiramate, approved there in July 2012. Hi-Doctor does not prescribe it: it has no EU-wide marketing authorisation, so in most member states — including Spain — a doctor cannot prescribe it for weight loss.

## What is Qsymia?

Qsymia is a once-daily capsule combining phentermine, which dampens appetite, with a slow-release form of topiramate — an epilepsy and migraine medicine that also reduces how much people want to eat.

<Note>
  In Europe the same product is called Qsiva.
</Note>

## Why it is not marketed across the EU

There is no EU-wide approval. The European Medicines Agency refused the Europe-wide application in 2013 because of concerns about long-term effects on the heart, on mood, and on memory and attention. The manufacturer later obtained national approvals through a separate route led by Sweden, and the product is on the market in a small number of northern European countries — Sweden, Denmark, Finland and Poland, plus Norway and Iceland.

<Warning>
  Qsymia has no EU marketing authorisation for weight loss in most member states, including Spain. No doctor there — including ours — can prescribe it for this use. It may be an approved medicine for something else, or approved in another country, but that does not make it prescribable here.
</Warning>

## What the studies reported

<Note>
  Every NCT identifier links to its ClinicalTrials.gov record. A readout is not the same as peer-reviewed publication.
</Note>

The CONQUER trial ran for 56 weeks across 93 centres in the United States only. When the EMA reviewed this programme, it judged that a cardiovascular outcomes trial would be needed before it could accept the long-term safety of the combination — and that trial has not been published.

## What has been reported

| Effect                          | Higher dose | Lower dose | Placebo |
| ------------------------------- | ----------- | ---------- | ------- |
| Dry mouth                       | 21%         | 13%        | 2%      |
| Pins and needles (paraesthesia) | 21%         | 14%        | 2%      |

Figures are from the CONQUER trial. The EU product information also lists constipation, dizziness, insomnia, depression and anxiety as reported effects, along with effects on the heart and circulation, and a risk in pregnancy — none of these are quantified in the harvested source for this page.

<AccordionGroup>
  <Accordion title="Sources">
    * EMA — Qsiva: refusal of marketing authorisation (EMEA/H/C/002350)
    * EMA — Questions and answers on the refusal of the marketing authorisation for Qsiva
    * Swedish Medical Products Agency — Qsiva Public Assessment Report, procedure SE/H/1963/01-04/DC, finalised 22 December 2020
    * VIVUS — commercialisation of QSIVA in Sweden, Denmark, Finland, Iceland, Norway and Poland (October 2024)
    * *Lancet* — CONQUER trial
    * FDA — Qsymia prescribing information
    * ClinicalTrials.gov · NCT00553787
  </Accordion>
</AccordionGroup>

## Why buying Qsymia online is not a shortcut

A medicine bought online without an EU marketing authorisation and without a doctor's review carries risks the CONQUER trial and the EMA's own assessment flag directly — including the unresolved cardiovascular question that led to the EU refusal. Check for the EU common logo on any online pharmacy before buying medication anywhere.

## What can I take instead?

Semaglutide is approved in the EU, has published peer-reviewed trial results, and can be prescribed today if a doctor decides it suits you. A licensed doctor decides case by case — Hi-Doctor never prescribes without evaluation.

<CardGroup cols={2}>
  <Card title="Semaglutide (Wegovy / Ozempic)" icon="syringe">
    Weekly GLP-1 receptor agonist. A doctor may prescribe it if your BMI and history match the indications. Requires follow-up.
  </Card>

  <Card title="Tirzepatide (Mounjaro)" icon="syringe">
    Dual GLP-1/GIP agonist. Assessed by the doctor based on comorbidities and BMI.
  </Card>

  <Card title="Liraglutide (Saxenda)" icon="syringe">
    Daily GLP-1 agonist. Indicated in selected patients with elevated BMI after medical evaluation.
  </Card>

  <Card title="Orlistat 120mg" icon="pills">
    Fat-absorption inhibitor. A non-GLP-1 alternative a doctor may consider based on your history.
  </Card>
</CardGroup>

Rybelsus (oral semaglutide) is a once-daily tablet authorised for type 2 diabetes; any use in weight management is an individual medical decision and may be off-label.

<Note>
  You pay for any medication separately at the pharmacy you choose. Hi-Doctor does not sell medications.
</Note>

## Common questions

<AccordionGroup>
  <Accordion title="What is Qsymia and what is it used for?">
    Qsymia is a once-daily capsule combining phentermine, which dampens appetite, with a slow-release form of topiramate — an epilepsy and migraine medicine that also reduces how much people want to eat. In Europe the same product is called Qsiva.
  </Accordion>

  <Accordion title="Why is Qsymia not available across the EU?">
    The European Medicines Agency refused the Europe-wide application in 2013 because of concerns about long-term effects on the heart, on mood, and on memory and attention. The manufacturer later obtained national approvals through a separate route led by Sweden.
  </Accordion>

  <Accordion title="Which countries can prescribe it?">
    The product is on the market in a small number of northern European countries — Sweden, Denmark, Finland and Poland, plus Norway and Iceland. In most EU countries, including Spain, it is not authorised for weight loss.
  </Accordion>

  <Accordion title="What did the CONQUER trial show?">
    CONQUER ran for 56 weeks across 93 centres in the United States only. When the EMA reviewed this programme, it judged that a cardiovascular outcomes trial would be needed before it could accept the long-term safety — and that trial has not been published.
  </Accordion>

  <Accordion title="What can I take instead of Qsymia?">
    [Semaglutide](/library/medicines/semaglutide) is approved in the EU, has published peer-reviewed trial results, and can be prescribed today if a doctor decides it suits you. Other options include [tirzepatide](/library/medicines/mounjaro), [liraglutide](/library/medicines/saxenda) and [orlistat](/library/medicines/orlistat). A licensed doctor decides case by case.
  </Accordion>

  <Accordion title="What side effects were reported in the trial?">
    Dry mouth was reported by 21% on the higher dose and 13% on the lower dose in CONQUER, versus 2% on placebo. Pins and needles (paraesthesia) was reported by 21% on the higher dose and 14% on the lower dose, versus 2% on placebo. Constipation, dizziness, insomnia, depression and anxiety were also reported.
  </Accordion>
</AccordionGroup>

## How Hi-Doctor handles it

Weight-loss treatment runs as an ongoing plan, with a first consultation and doctor-reviewed renewals. See the full set of available options on the [treatment areas page](/library/treatments/weight-management-program), and [pricing](/essentials/pricing) for how the plan is billed.

## Start a consultation

<Card title="Weight-loss consultation" icon="stethoscope" href="https://hi-doctor.ai/consultation/weight-loss/1">
  Answer the weight-loss questionnaire and a registered doctor reviews it.
  They decide whether treatment is appropriate, which one, and at what dose —
  and declining is a normal outcome. See [what it costs](/essentials/pricing)
  and [how the review works](/essentials/how-it-works).
</Card>

<Warning>
  This page is reference information, not medical advice and not a prescription.
  Whether a medicine is appropriate for you is decided by a registered doctor
  after reviewing your consultation.
</Warning>