ArticleDrug safety2023
Adverse Drug Reactions to Opioids: A Study in a National Pharmacovigilance Database.
Article in Drug safety, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
20 citing papers in PubMed, 3 syntheses or guidelines pooled it, 23 citations in OpenAlex.
- Impact of opioid-free anesthetic on postoperative complication following gynecological surgery: a meta-analysis.Revista da Escola de Enfermagem da U S P · 2025Pooled it
- Combatting opioid misuse, overuse and abuse: a systematic review of pharmacists' services and outcomes.Pain management · 2024Pooled it
- Effect of opioid-free anesthesia on postoperative nausea and vomiting after gynecological surgery: a systematic review and meta-analysis.Frontiers in pharmacology · 2023Pooled it
- Oxycodone combined with pulsed radiofrequency for refractory cancer pain from spinal metastases: a randomized controlled study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Trial
- Epidural injection of hydromorphone for postoperative pain after episiotomy: a randomized controlled trial.Scientific reports · 2024Trial
- Intraoperative Transcutaneous Electrical Acupoint Stimulation Attenuates Postoperative Mechanical Pain Sensitization and Visceral Pain After Elective Cesarean Delivery: A Randomized Controlled Trial.Advances in therapy · 2026Article
- Role of cytochrome phenotyping in patients with chronic noncancer pain with inadequate response to tramadol.Pain reports · 2026Article
- The Emerging Burden of Opioid Poisoning in Brazil, 2019-2025: A Nationwide Epidemiological and Toxicovigilance Analysis.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Machine Learning-Based Prediction of Early Patient-Controlled Analgesia Discontinuation After Total Knee Arthroplasty: A Retrospective Cohort Study.Journal of clinical medicine · 2026Article
- Real-world incidence of nausea and vomiting induced by antineoplastic agents: insights and future directions from the Japanese adverse drug event report database.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
- Nanocomposite hydrogel acupoint therapy for sustained pregabalin delivery and long-term neuropathic pain relief.Materials today. Bio · 2026Article
- Tramadol use is associated with reduced 28-day mortality in ICU patients after cardiac surgery: a retrospective study based on the MIMIC-IV database.Frontiers in pharmacology · 2026Article
- The Effect of Oliceridine Versus Sufentanil on the Quality of Postoperative Recovery in Patients Undergoing Laparoscopic Cholecystectomy.Journal of pain research · 2026Article
- Age disparities in adverse reactions of drugs used in pain therapies in Switzerland.Scientific reports · 2025Article
- Harmful Effects of Prescribed Opioids in Children and Adults: A Systematic Review.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Opioids in the Brazilian Healthcare Landscape: Crucial Analysis through Anvisa VigiMed Data and Pharmacogenetic Aspects.ACS omega · 2025Article
- Evaluating the Efficiency and Productivity of Opioid Substitution Treatment Units in Greece: A DEA-Malmquist Analysis.Healthcare (Basel, Switzerland) · 2025Article
- Transdermal fentanyl induced paralytic intestinal obstruction in advanced liver cancer: a case report.Frontiers in pharmacology · 2025Article
- Molecular Sex Differences and Clinical Gender Efficacy in Opioid Use Disorders: From Pain Management to Addiction.International journal of molecular sciences · 2024Review
- Misuse, Abuse and Medication Errors' Adverse Events Associated with Opioids-A Systematic Review.Pharmaceuticals (Basel, Switzerland) · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionOpioids are commonly used as analgesics; however, like any medicine, they can produce adverse drug reactions (ADRs), including nausea, constipation, dependence, and respiratory depression, that result in harmful and fatal events. Therefore, it is essential to monitor the safety of these drugs in clinical practice.
objectiveThis study aimed to characterize the safety profile of opioids by conducting a descriptive study based on a spontaneous reporting system (SRS) for ADRs in The Netherlands, focusing on abuse, misuse, medication errors, and differences between sexes.
methodsReports submitted to the Netherlands Pharmacovigilance Centre Lareb from January 2003 to December 2021 with an opioid drug as the suspected/interacting medicine were analyzed. Reporting odds ratios (RORs) for drug-ADR combinations were calculated, analyzed, and corrected for sex and drug utilization (expenditure) for the Dutch population.
resultsA total of 8769 reports were analyzed. Tramadol was the opioid with the most reports during the period (n = 2746), while oxycodone or tramadol had the highest number of reports per year in the study period. The most reported ADRs from opioid use were nausea, followed by dizziness and vomiting, independent of sex, and all of them were more often reported in women. Vomiting associated with tramadol (ROR females/males = 2.17) was significantly higher in women. Buprenorphine was responsible for most ADRs when corrected for expenditure, with high RORs observed with application site hypersensitivity, application site reaction, and application site rash. Fentanyl gave rise to most of the reports of ADRs concerning abuse, misuse, and medication errors.
conclusionPatients treated with opioids experienced ADRs, primarily nausea, dizziness, and vomiting. For those groups of drugs, no significant differences were found between the sexes, except for the vomiting associated with tramadol. In general, ADRs related to opioids presented higher RORs when uncorrected and corrected for sexes and expenditure than other drugs. There was more disproportionate reporting for ADRs concerning abuse, misuse, and medication errors for opioids than other drugs in the Dutch SRS.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.