--- title: Is the combination of naproxen, paracetamol, and pamabrom safe and effective for PMS pain? description: Yes. The combination significantly reduced pain, and only 3% of women experienced side effects like headache or stomach problems. url: https://niyora.com/research/papers/safety-and-effectiveness-of-naproxen-220mg-paracetamol-300mg-pamabrom-25mg-fixed-2023/ --- - [Niyora](https://niyora.com/) - [Research](https://niyora.com/research/) - [Library](https://niyora.com/research/library/) - Is the combination of naproxen, paracetamol, and pamabrom safe and effective for PMS pain? Non-randomised trial, 2023 # Is the combination of naproxen, paracetamol, and pamabrom safe and effective for PMS pain? Yes. The combination significantly reduced pain, and only 3% of women experienced side effects like headache or stomach problems. Early or limited evidence 270 women over 18 years old with premenstrual syndrome, mean age 28.9 years ## What they did Observational study from 2017 to 2019 of 270 women over 18 with premenstrual syndrome. Women took a fixed-dose combination pill containing naproxen 220 mg, paracetamol 300 mg, and pamabrom 25 mg. Researchers tracked adverse events, pain intensity, and PMS symptoms. ## What they found Only 8 women (3%) experienced side effects including headache, gastritis, dyspepsia, diarrhea, and nausea. Pain intensity decreased by a median of 4.5 points. 70.7% of women achieved at least 50% reduction in pain. ## What it means for you The combination drug appears safe and effective for reducing PMS pain. A main limitation is this was an observational study without a control group, so we cannot be certain the drug caused the improvement rather than natural improvement over time. 3% experienced side effects 70.7% had at least 50% pain reduction 4.5 points median decrease in pain intensity ## About the study Original title Safety and Effectiveness of Naproxen 220mg + Paracetamol 300mg + Pamabrom 25mg Fixed Dose Combination in Women With Premenstrual Syndrome: A Post-marketing, Open-Label, Prospective, Multicenter, Observational Study Authors Peña-Jiménez AE, Benítez-Aguilar O, Villegas JE et al. Journal Preprints.org Year 2023 Study design Non-randomised trial Participants 270 What was tested Naproxen 220 mg plus paracetamol 300 mg plus pamabrom 25 mg fixed-dose combination Read the paper [doi.org/10.20944/preprints202308.0034.v1](https://doi.org/10.20944/preprints202308.0034.v1) Original abstract Premenstrual syndrome is characterized by pain and symptoms affecting the women´s quality of life. We aimed to evaluate the safety and effectiveness of an oral fixed dose combination containing naproxen 220 mg + paracetamol 300 mg + pamabrom 25 mg tablet (Analgen Fem®) during the routine clinical practice. A prospective, open-label, multicenter, observational post-marketing study was conducted from December 2017 to December 2019 including 270 women older than 18 years. Primary endpoint was the proportion of adverse events, meanwhile the pain intensity, premenstrual syndrome symptoms, and patient proportion with a pain score reduction by at least 50% were secondary endpoints. The mean age of population was 28.9 ± 8.8 years. Among the 270 women, 8 (3%) experienced 10 adverse events. These were headache (5/8), gastritis (2/8) dyspepsia (1/8), diarrhea (1/8) and nausea (1/8). The investigator discontinued the study medication in 3/8 patients because of adverse events. The median of differences between the pain intensity at baseline and at last observation (-4.5, 95%CI; -5, -4) demonstrated that naproxen 220 mg + paracetamol 300 mg + pamabrom 25 mg fixed dose combination reduced pain intensity (p<0.001). In addition, the proportion of patients with pain reduction by at least 50% at the end of the treatment was 70.7%. The study demonstrated that this drug represents a safe and tolerated treatment, reducing pain intensity and premenstrual symptoms. Reproduced under CC-BY. ## Topics [Premenstrual syndrome (PMS)](https://niyora.com/research/topics/condition-pms/)[Pain and headache](https://niyora.com/research/topics/symptom-pain/)[Diuretics and other drugs](https://niyora.com/research/topics/treatment-diuretics-other-drugs/) Research tells you what helps on average. Niyora helps on the day it hits. Calm down, see it another way, and decide what to say, with a PMS and PMDD app built by a doctor. ## Related studies Randomised trial, 2014 Does the combination of sumatriptan and naproxen sodium reduce menstrual symptoms and migraine? Randomised trial, 2024 Do hormonal changes in obese women cause worse PMS, and can medications help? Randomised trial, 2011 Does sumatriptan-naproxen help women with period migraines and period pain function better? Randomised trial, 2010 Which works better for premenstrual breast pain, cabergoline or bromocriptine? Review, 2003 What treatments work best for PMS and PMDD? 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