--- title: Is a combination of naproxen, paracetamol, and pamabrom safe and effective for PMS? description: Yes, this combination was safe and effective. Only 3% of women experienced adverse events, and 70.7% achieved at least 50% reduction in pain. url: https://niyora.com/research/papers/safety-and-effectiveness-of-naproxen-220-mg-paracetamol-300-mg-pamabrom-25-mg-2024/ --- - [Niyora](https://niyora.com/) - [Research](https://niyora.com/research/) - [Library](https://niyora.com/research/library/) - Is a combination of naproxen, paracetamol, and pamabrom safe and effective for PMS? Non-randomised trial, 2024 # Is a combination of naproxen, paracetamol, and pamabrom safe and effective for PMS? Yes, this combination was safe and effective. Only 3% of women experienced adverse events, and 70.7% achieved at least 50% reduction in pain. Early or limited evidence 270 women older than 18 with PMS, mean age 28.9 years ## What they did Prospective observational study in routine clinical practice from December 2017 to December 2019. 270 women older than 18 years with PMS received a fixed-dose tablet containing naproxen 220 mg, paracetamol 300 mg, and pamabrom 25 mg. Researchers tracked adverse events, pain intensity, and PMS symptoms across multiple centers. ## What they found Eight out of 270 women (3%) experienced adverse events: headache (5 cases), gastritis (2), dyspepsia (1), diarrhea (1), and nausea (1). Pain intensity decreased significantly with a median reduction of 4.5 points. 70.7% of women achieved at least 50% pain reduction. ## What it means for you This three-drug combination is a safe and effective option for PMS pain and symptoms, with low adverse event rates. However, this was an observational study without a control group or blinding, so we cannot be certain the medication alone caused the improvement. 270 women in study 3% experienced adverse events 70.7% achieved 50% or greater pain reduction ## About the study Original title Safety and Effectiveness of Naproxen 220 mg + Paracetamol 300 mg + Pamabrom 25 mg Fixed Dose Combination in Women with Premenstrual Syndrome: A Post-Marketing, Open-Label, Uncontrolled, Prospective, Multicenter, Observational Study Authors Álvaro Eduardo Peña-Jiménez, Omar Benítez-Aguilar, Jesús E. Villegas et al. Journal Women Year 2024 Study design Non-randomised trial Participants 270 What was tested Fixed-dose combination tablet: naproxen 220 mg, paracetamol 300 mg, and pamabrom 25 mg Open access Yes Read the paper [doi.org/10.3390/women4010002](https://doi.org/10.3390/women4010002) 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? Randomised trial, 2002 What treatments work best for cyclical breast pain? Ask AI about this page Copy prompt ChatGPT ↗ Claude ↗ Perplexity ↗ Google AI Mode ↗ Grok ↗