Pregabalin

Is pregabalin safe?

Pregabalin is reasonably safe for most people who take it as prescribed, but it has a narrower safety margin than its reputation suggests. About 1 in 3 users feels dizzy and 1 in 4 drowsy in trials. It is controlled in both the US and the UK because people misuse it. And with opioids, alcohol or other sedatives it can slow breathing enough to kill. We score it 57, below gabapentin and above alprazolam.

In the US it is approved for diabetic nerve pain, nerve pain after shingles, nerve pain after spinal cord injury, fibromyalgia and as add-on treatment for partial seizures. In the UK it is also licensed for generalised anxiety disorder.

Breathing problems: who is at risk

The US label warns of serious, life-threatening or fatal breathing depression when pregabalin is taken with other sedatives, especially opioids, or by people whose breathing is already weak. It adds that there is more limited evidence of serious breathing depression without either. The FDA required this warning in December 2019 for both gabapentinoids.

The UK went further in February 2021. The MHRA said pregabalin had been linked to breathing depression in some people who were not taking opioids, and that studies link doses above 300 mg a day taken alongside opioids with a higher risk of opioid-related death. From 2014 to 2020 it received 122 UK reports of breathing problems; 80 also involved another sedative. Most cases were in older people. Its higher-risk list:

• lung or neurological disease, or reduced kidney function
• other brain-slowing medicines, including opioids, benzodiazepines and gabapentin
• age over 65

Misuse and rising deaths

Pregabalin does not act on opioid or benzodiazepine receptors, but the US label reports that recreational users rated a 450 mg dose much like 30 mg of diazepam for "high" and "liking". In clinical trials, 4% of patients reported euphoria against 1% on placebo.

That is the background to rising deaths. In England and Wales, pregabalin was mentioned on 38 drug poisoning death certificates registered in 2014 and 617 in 2024, according to the ONS. Only 16 of the 2024 deaths involved no other drug, and 134 involved alcohol. The UK made pregabalin and gabapentin Class C, Schedule 3 controlled drugsControlled substanceA medicine or drug that the law restricts because it can be misused or cause dependence. Countries group them into schedules or classes.More in the glossary on 1 April 2019, so prescriptions are valid for 28 days. In January 2026 the MHRA announced stronger warnings on addiction, dependence and withdrawal on UK leaflets and packs.

Stopping suddenly can cause insomnia, nausea, headache, diarrhoea, anxiety and, rarely, seizures. The label says to taper over at least one week; the MHRA notes that coming off a high dose can take weeks or months.

Doses on the label

Use (US label)	Start	Maximum
Diabetic nerve pain	50 mg three times a day	300 mg a day
Nerve pain after shingles	150 mg a day in 2 or 3 doses	600 mg a day
Fibromyalgia	75 mg twice a day	450 mg a day
Spinal cord injury pain	75 mg twice a day	600 mg a day
Partial seizures, adults	150 mg a day	600 mg a day

For diabetic nerve pain, 600 mg a day was studied but gave no clear extra benefit and was less well tolerated. Doses are lower for people with reduced kidney function, because pregabalin leaves the body through the kidneys.

Other side effects worth knowing

Dizziness (30% against 8% on placebo) and drowsiness (23% against 8%) usually start early and rise with dose; among those affected in short trials, dizziness lasted to the final dose in 30% and drowsiness in 42%. Swollen legs affected 6%, and weight gain is common. Angioedema, swelling of the face, mouth and throat, can threaten breathing and means stopping at once and getting emergency help.

In pregnancy, a Nordic study of more than 2,700 first-trimester exposures found major birth defects in 5.9% of babies against 4.1% in unexposed pregnancies, and modestly higher risk than with lamotrigine or duloxetine. The MHRA advises avoiding pregabalin in pregnancy unless clearly necessary, and using effective contraception.

Who should be careful

Talk to your doctor or pharmacist before taking pregabalin if you take an opioid such as oxycodone, a benzodiazepine or sleeping pills, drink alcohol, have lung, heart or kidney disease, are over 65, have ever misused drugs or alcohol, or could become pregnant. Do not drive until you know how it affects you, keep it out of reach of others, and do not stop it suddenly without a plan from your prescriber.

How we scored it

Track record (85) is the strongest factor after two decades of use. Serious side effects (62) and overdose marginOverdose marginHow far a normal dose is from a harmful one. A wide margin means an accidental extra dose is unlikely to cause serious harm.More in the glossary (55) are middling because harm at normal doses is uncommon, but overdose deaths are rising. Dependence (45), interactions (50) and regulatory warnings (50) are lower than for gabapentin because pregabalin is controlled in the US, has measurable euphoric effects, and has drawn more UK safety warnings.