What are the official prescribing‑information side‑effects for Neurocept‑PG (pregabalin+methylcobalamin)?
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Executive summary
Neurocept‑PG, a fixed‑dose combination of pregabalin and methylcobalamin sold in India, carries a side‑effect profile dominated by adverse events already well‑documented for pregabalin: common effects such as somnolence, dizziness, weight gain and peripheral edema, and less common but serious signals including angioedema, mood changes and withdrawal reactions [1] [2] [3]. Clinical reports of the pregabalin+methylcobalamin combination confirm tolerability in many patients but also record minor adverse events in roughly a quarter of treated subjects in small trials [4] [5].
1. Common, expected adverse effects: the day‑to‑day toll
Consumer and dispensing summaries for Neurocept‑PG and generic pregabalin+methylcobalamin list the same constellation of common adverse effects: sleepiness (somnolence), dizziness, headache, blurred vision, vertigo, balance disorder or ataxia, lethargy, increased appetite and weight gain, peripheral edema, constipation, vomiting and muscle cramps — symptoms that reflect pregabalin’s central nervous system and fluid‑retention effects [1] [2] [6].
2. Less frequent but clinically important problems: mood, cognition and sexual function
Sources flag cognitive and psychiatric signals including confusion, disorientation and new or worsening depression or suicidal thoughts as warnings that prescribers and patients should monitor, and they list erectile dysfunction among reported effects, showing the combination can affect mood, cognition and sexual function in some patients [1] [3] [7].
3. Serious but uncommon risks cited in product materials
Product listings and pharmacy advisories for the combination explicitly call out angioedema (swelling of face, mouth, throat) as a potential serious adverse event and urge caution in those with prior angioedema or cardiac/renal disease; withdrawal symptoms — anxiety, insomnia, nausea, pain and sweating — are reported if pregabalin is stopped abruptly [8] [3] [9].
4. What trials and real‑world reports say about tolerability
A randomized or observational clinical report of pregabalin+methylcobalamin in post‑thoracotomy pain reported minor adverse events in 28% of patients receiving the combination versus 4% with diclofenac, but these events were not treatment‑terminating [4]. A real‑world Indian study of a sustained‑release pregabalin+methylcobalamin fixed‑dose combination examined safety as an objective and supports that the FDC was generally tolerated in routine practice, although the study excluded patients with contraindications per the product’s prescribing information [5].
5. How the B12 component (methylcobalamin) factors in — limited separate signals
Methylcobalamin is presented across sources as a neurotrophic vitamin B12 form intended to support myelin and nerve repair; the safety signals listed for Neurocept‑PG come principally from pregabalin, with methylcobalamin not singled out in these sources as producing unique adverse reactions when combined [2] [6]. The combined labeling therefore reflects the additive clinical picture rather than new, methylcobalamin‑specific toxicities as described in the available materials [2].
6. Practical framing and limitations of the public record
Prescribing‑information summaries and pharmacy sites give a granular list of expected adverse effects and warn about abrupt discontinuation, angioedema, and psychiatric symptoms, and small trials corroborate that a substantial minority will experience minor adverse events [1] [3] [4]. The available reporting is largely product descriptions, pharmacy monographs and small clinical reports; full manufacturer‑issued, regulatory prescribing information for Neurocept‑PG itself is not included among the supplied sources, so precise incidence rates, boxed warnings (if any), and rare laboratory‑based signals cannot be confirmed from these materials alone [2] [5].