What the FDA label warns about
These come from the Qsymia prescribing information published on DailyMed.
Pregnancy: the most serious warning on the label
The label states that Qsymia can cause fetal harm. Pregnancy registries and epidemiological studies show that a fetus exposed to topiramate in the first trimester has an increased risk of major congenital malformations — including cleft lip and cleft palate — and of being small for gestational age.
Because of that risk, the label recommends a negative pregnancy test before starting Qsymia and monthly during treatment for anyone who can become pregnant. Qsymia is also only available through a restricted REMS programme, which means only certified pharmacies can dispense it.
Other warnings and precautions on the label:
- Suicidal behaviour and ideation
- Eye problems, including acute myopia and raised pressure in the eye
- Mood and sleep disorders
- Cognitive impairment
- Slowing of linear growth in adolescents
- Metabolic acidosis
- Decreased kidney function
- Risk of seizures if the drug is stopped abruptly
- Kidney stones
- Reduced sweating and overheating
- Low potassium
- Serious skin and multi-organ hypersensitivity reactions, including DRESS
- Anaphylaxis and angioedema
The label says Qsymia must not be used if you:
- Are pregnant
- Have glaucoma
- Have an overactive thyroid
- Are taking a monoamine oxidase inhibitor, or stopped one within the last 14 days
- Have had an allergic reaction or idiosyncratic reaction to phentermine, topiramate, sympathomimetic amines, or anything else in the capsule
The label numbers, against placebo
The FDA label reports these adult adverse reaction rates for the full 15/92 mg dose against placebo.
| Reaction | Qsymia 15/92 mg | Placebo |
|---|---|---|
| Tingling in hands and feet | 20% | 2% |
| Dry mouth | 19% | 3% |
| Constipation | 16% | 6% |
| Dizziness | 9% | 3% |
| Change in taste | 9% | 1% |
| Insomnia | 9% | 5% |
How many people stopped because of side effects
of adults on Qsymia stopped because of tingling in the hands and feet, and 0.6% because of a change in taste. The label reports discontinuation reason by reason rather than giving a single overall figure for adults.
Rare but serious — when to call your doctor
Call your doctor immediately if you have:
- You think you may be pregnant, or you have a positive pregnancy test
- New or worsening depression, or any thoughts of harming yourself
- Sudden blurred vision, eye pain, or a rapid change in how well you see
- Confusion, difficulty concentrating, or trouble finding words
- Fast or pounding heartbeat
- Severe pain in your side or back, or blood in your urine (possible kidney stone)
- A rash, especially with fever, swollen glands, or blistering skin
- Reduced sweating with a high body temperature, particularly in hot weather
What actually helps
Strategies that work best, based on trial and community experience.
Drink water consistently
Topiramate raises the risk of kidney stones, and the label lists kidney stones among its warnings. Staying well hydrated is one of the main ways to reduce that risk.
Pregnancy testing on schedule
The label recommends a negative pregnancy test before starting and monthly during treatment for anyone who can become pregnant, along with effective contraception.
Never stop it abruptly
The label warns about seizures on abrupt withdrawal and says the 15/92 mg dose should be stepped down under supervision, not stopped in one go.
Take heat seriously
Reduced sweating and overheating are listed warnings. Be careful in hot weather and during hard exercise, and get help if your temperature rises.
When to push through vs. talk to your doctor
You can push through if...
- Mild tingling in your fingers or toes that is not getting worse
- Dry mouth that improves with sipping water through the day
- Constipation that responds to fluids and fibre
- Mild sleep disruption early on
Talk to your doctor if...
- Any chance that you are pregnant
- New or worsening low mood, or thoughts of self-harm
- Blurred vision, eye pain, or a sudden change in your sight
- Trouble finding words, confusion or memory problems
- Severe pain in your side or back
- Any symptom you are unsure about
Common questions
Written and maintained by one person · Built with agentic AI tools · Every number checked against the cited trial · Not medical advice
Sources for Phentermine / Topiramate ER side effect data
Side effect frequencies come from the CONQUER trial. The pregnancy warning, REMS requirement, warnings and precautions, contraindications, adverse reaction table and discontinuation figures come from the Qsymia FDA prescribing information published on DailyMed.
- CONQUER — Phentermine / Topiramate: 2,487 adults with obesity and at least 2 weight-related health conditions, 56 weeks. The Lancet, 2011. View source ↗
- QSYMIA (phentermine and topiramate extended-release capsules) FDA prescribing information — DailyMed View source ↗
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