What the FDA label warns about
These come from the Contrave prescribing information published on DailyMed.
Boxed warning: suicidal thoughts and behaviour
Contrave contains bupropion, the same active ingredient as several antidepressants. In short-term trials, antidepressants increased the risk of suicidal thoughts and behaviour in children, adolescents and young adults. The same trials showed no increase in that risk over the age of 24, and a reduction in people aged 65 and over.
The label says anyone starting Contrave should be watched closely for new or worsening depression and for suicidal thoughts or behaviour, particularly in the first months. Contrave is not approved for treating depression or any other psychiatric disorder, and is not approved for children.
Other warnings and precautions on the label:
- Seizures
- Neuropsychiatric events reported with bupropion used for stopping smoking
- Use alongside opioid painkillers — the naltrexone component blocks them
- Increases in blood pressure and heart rate
- Allergic reactions
- Liver damage
- Triggering mania
- Angle-closure glaucoma
- Low blood sugar in people with type 2 diabetes taking diabetes medicines
The label says Contrave must not be used if you:
- Have uncontrolled high blood pressure
- Have a seizure disorder or a history of seizures
- Take any other product containing bupropion
- Have bulimia or anorexia nervosa
- Use opioids long term, or are in acute opioid withdrawal
- Are stopping alcohol, benzodiazepines, barbiturates or antiepileptic drugs abruptly
- Are taking a monoamine oxidase inhibitor, or stopped one within the last 14 days
- Are allergic to bupropion, naltrexone or anything else in the tablet
The label numbers, against placebo
The FDA label reports these adverse reaction rates for Contrave at the full dose against placebo.
| Reaction | Contrave 32/360 mg | Placebo |
|---|---|---|
| Nausea | 32.5% | 6.7% |
| Constipation | 19.2% | 7.2% |
| Headache | 17.6% | 10.4% |
| Vomiting | 10.7% | 2.9% |
| Dizziness | 9.9% | 3.4% |
| Insomnia | 9.2% | 5.9% |
| Dry mouth | 8.1% | 2.3% |
| Diarrhoea | 7.1% | 5.2% |
How many people stopped because of side effects
of people taking Contrave stopped because of an adverse event, compared with 12% on placebo. The most common reasons were nausea (6.3%), headache (1.7%) and vomiting (1.1%).
Rare but serious — when to call your doctor
Call your doctor immediately if you have:
- New or worsening depression, agitation, or any thoughts of harming yourself
- A seizure — stop the medication and get medical help
- Severe headache with a very fast or pounding heartbeat, or a large rise in blood pressure
- Eye pain, blurred vision, or seeing halos around lights (possible angle-closure glaucoma)
- Yellowing of the skin or eyes, dark urine, or pain over your liver
- A rash, hives, swelling of the face or difficulty breathing
- Unusually high mood, racing thoughts or reduced need for sleep (possible mania)
- Symptoms of low blood sugar if you take diabetes medicines
What actually helps
Strategies that work best, based on trial and community experience.
Take it with food
Nausea was the single most common reason people stopped in the trials. Taking the tablets with food — especially the evening dose — is the tip most often shared by long-term users.
Check every other medicine
The naltrexone component blocks opioids, including codeine cough syrup and tramadol. Tell every prescriber and pharmacist that you take Contrave.
Get your blood pressure checked
The label warns about increases in blood pressure and heart rate, and uncontrolled high blood pressure is a contraindication. Regular checks are part of taking this drug.
Do not stop abruptly
Stopping suddenly can cause withdrawal from the bupropion component. Any stop should be tapered with your prescriber.
When to push through vs. talk to your doctor
You can push through if...
- Mild nausea in the first weeks that is settling
- Headache that responds to the usual measures
- Constipation that responds to fluids and fibre
- Mild dry mouth
Talk to your doctor if...
- New or worsening low mood, or thoughts of self-harm
- Any seizure, however brief
- A large rise in blood pressure or a racing heartbeat
- Eye pain or sudden vision changes
- Yellowing skin or eyes, or dark urine
- 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 Naltrexone / Bupropion ER side effect data
Side effect frequencies come from the COR-I trial. The boxed warning, warnings and precautions, contraindications, adverse reaction table and discontinuation figures come from the Contrave FDA prescribing information published on DailyMed.
- COR-I — Naltrexone / Bupropion: 1,742 adults with obesity or overweight with comorbidities, 56 weeks. The Lancet, 2010. View source ↗
- CONTRAVE (naltrexone HCl and bupropion HCl extended-release tablets) FDA prescribing information — DailyMed View source ↗
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