Pharmacovigilance Insights into Ibuprofen's Neuropsychiatric Safety: A Retrospective Analysis of EudraVigilance Reports.

Background/

Objectives

Mental health awareness is rising; thus, neurological and psychiatric side effects also benefit from increased attention from the medical and scientific community. Ibuprofen is a well-known non-steroidal anti-inflammatory drug (NSAID) that is often available over-the counter (OTC) for both adults and children, expressing good efficacy in reducing pain and fever through non-selective cyclooxygenase inhibition. As ibuprofen has already been associated with different neuropsychiatric disorders, the aim of this study was to perform an up-to-date analysis of such signals detected in the cases reported in EudraVigilance (EV).

Methods

The disproportionality analysis offered a contextual insight into the real-world situation depicted in the analyzed database.

Results

From the total cases reported for ibuprofen (n = 58,911), 13.9% contained nervous system disorders (n = 8214) and 10.7% entailed psychiatric disorders (n = 6295). The cases were distributed between all age groups, with a sensible higher incidence in teenagers and in women in general. Severe cases, including deaths, have been reported. By comparison with ketoprofen, acetylsalicylic acid, and diclofenac, ibuprofen presented a higher probability of reporting psychiatric and behavioral symptoms. Regarding cognitive and attention disorders and disturbances, no disproportionate signal was observed between ibuprofen and all other NSAIDs. Sleep disturbances (hypersomnia, narcolepsy and sleep paralysis) are reported as more probable for ibuprofen than for acetylsalicylic acid, naproxen, and diclofenac. A higher risk of reporting suicidal and self-injurious behaviors was noted for ibuprofen versus all other selected NSAIDs. A limitation of the study can be noted as due to suspected causality, not an established one, and EV reports cannot accurately determine adverse drug reaction frequencies.

Conclusions

Considering that ibuprofen is easily accessible as an OTC drug and the higher probability of reporting several neuropsychiatric adverse effects as shown by this study, patient counseling, when possible, and general education for the public are valuable tools in managing these adverse reactions.