Does Colace Actually Work?

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<p>At the start of my third trimester of pregnancy, blood tests showed that my ferritin — a measure of the body’s stored iron — was startlingly low: 7 ng/mL, well below the <a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC10727057/#:~:text=ng/L%E2%80%8A*-,%3C30%E2%80%8A%E2%80%86ng/L%E2%80%8A**,-Hemoglobin">30 ng/mL</a> or higher that many experts recommend. Iron deficiency <a href="https://medshadow.org/integrative-health/non-drug-supplements/low-ferritin-iron-deficiency-women/">is common in pregnancy</a> because blood volume expands while the developing baby draws on the body's iron supply.</p>
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<p>I was prescribed iron supplements, but unfortunately, within a few days, the 325 mg ferrous sulfate tablets I’d started taking caused severe constipation (iron supplements are <a href="https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD009532.pub3/full">infamous for this particular side effect)</a>. Since I was already staying active and hydrated, and eating lots of fiber — lifestyle habits that <a href="https://www.niddk.nih.gov/health-information/digestive-diseases/constipation/treatment">promote regular bowel movements</a> — my midwife recommended I pick up some Colace (docusate sodium), an over-the-counter stool softener. </p>
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<p>Desperate and uncomfortable, that’s exactly what I did.</p>
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<p>At work, I spend my days digging into drug safety and questioning medical assumptions. But in that moment, I was scared, uncomfortable, and looking for quick relief. I didn’t research the recommendation or think to question it. I did, however, ask the on-staff pharmacist whether it was okay to take the medication for several months, since the bottle warned against using it for more than seven days. She said yes: “You’ll need them as long as you’re taking the iron.”</p>
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<p>The first day I took Colace, I skipped my iron supplement, and that combination seemed to do the trick.</p>
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<p>For the next two months, I took both the iron and Colace dutifully every day. But as I neared my delivery date, I learned that stool softeners are also commonly recommended to ease the first bowel movement right after the baby arrives. That made me wonder: Had I already been taking Colace for too long? Could I have developed a tolerance? Would I need a different medication after delivery?</p>
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<p>Luckily, the answer to those questions was no. But looking into it led me to something surprising: there is little evidence that Colace works any better than a placebo. </p>
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<p>It was possible I’d been taking the medication every day for nearly two months for no real benefit at all.</p>
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<p>Frustrated, I reached out to <a href="https://pharmacy.ufl.edu/profile/hatton-randy/">Randy Hatton</a>, PharmD, a clinical professor of pharmaceutical outcomes and policy at the University of Florida, who has advocated for renewed research into over-the-counter drugs that have been on the market so long that manufacturers <a href="https://medshadow.org/drug-updates-recalls/drug-safety/whats-really-inside-your-otc-drugs-we-dont-actually-know-and-heres-why/">were never required to submit efficacy data to the FDA</a>. Phenylephrine, <a href="https://medshadow.org/drug-updates-recalls/can-i-take-this-with-that/can-i-take-sudafed-and-dayquil-together/">a decongestant found in some cold medicines</a>, is one well-known example. (Hatton has pushed the FDA to remove it from the market after studies found it ineffective.)</p>
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<p>Hatton responded immediately via email, suggesting that docusate sodium is likely safe, but totally ineffective, adding “Polyethylene glycol (PEG) 3350, available OTC as generics and Miralax, is probably a better option.”</p>
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<h2 class="wp-block-heading">How Colace Got on Pharmacy Shelves</h2>
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<p>In <a href="https://www.govinfo.gov/content/pkg/STATUTE-76/pdf/STATUTE-76-Pg780.pdf">October 1962</a>, Congress passed the <a href="https://www.congress.gov/crs-product/R46985">Kefauver-Harris Drug Amendments</a>, which required companies to conduct clinical trials and submit evidence to the FDA demonstrating that a drug is not only safe but also effective before it could be sold.</p>
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<p>But many drugs were already on the market before 1962 — too many for the FDA to require fresh clinical trials for each one. Instead, <a href="https://medshadow.org/drug-updates-recalls/drug-safety/whats-really-inside-your-otc-drugs-we-dont-actually-know-and-heres-why/">the agency reviewed categories of older drugs</a> and their active ingredients to determine whether they were generally safe within certain dose ranges. If an ingredient passed that review, companies could continue selling products made with it. </p>
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<p>One such ingredient was docusate sodium. It had been on the market<a href="https://www.thepharmajournal.com/archives/2026/vol15issue7/PartA/15-4-32-619.pdf"> since the 1950s</a>, and when regulators reviewed its ingredient history in the 70s, they did not identify any major safety concerns. They also noted its long history of use and clinicians' trust of the drug.</p>
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<p>“Docusate is a good example of a medication that survived on tradition more than outcomes. It is generally low-risk, which is why it remains popular in pregnancy and hospice care, but low risk does not automatically mean high benefit,” says <a href="https://www.pharmalinkacademy.co.uk/about-us">Pankti Shah</a>, PharmD, a medical writer for PharmaLink Academy, a training program for regulatory medical writers in the United Kingdom.</p>
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<h2 class="wp-block-heading">Rethinking a Constipation Staple</h2>
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<p>Colace is often marketed as being “gentle,” making it a common recommendation for people who are <a href="https://colacecapsules.com/why-colace/">pregnant, postpartum, or who recently had surgery</a>. It’s also<a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC11715462/"> frequently recommended</a> for people who are taking opioids for cancer-related pain.</p>
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<p>But as evidence questioning the drug's effectiveness has grown, some healthcare systems have begun moving away from it. In January 2020, nearly 10% of inpatients at a Mayo Clinic hospital in Florida were given docusate sodium. Researchers then introduced an intervention to reduce what they viewed as unnecessary use of a medication with limited evidence behind it, and by the end of <a href="https://pubmed.ncbi.nlm.nih.gov/36807543/">the study</a>, fewer than 3% of patients at the hospital received the drug.</p>
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<p>“Many providers have moved away from using docusate alone, and now rely on stimulant laxatives, such as senna, and osmotic agents, such as polyethylene glycol,” explains <a href="https://mariettaspringstreatment.com/contributors/dr-brian/">Brian Honeyman, M.D</a>., a palliative care physician and clinical advisor at Marietta Springs Behavioral Healthcare.</p>
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<p>Kathi Evans, 71, has struggled with constipation for most of her life, but says her symptoms worsened after she started taking a GLP-1 medication, a class of drugs <a href="https://link.springer.com/article/10.1007/s12020-025-04494-3">known to cause constipation in some people</a>. Years ago, after a colonoscopy, her gastroenterologist recommended docusate sodium. When her constipation worsened, she returned to that advice and, on her own, increased her dose to six capsules a day — well above the typical recommended dose of one to three capsules daily.</p>
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<p>Even then, the medication hasn't provided the relief she hoped for. If she has two bowel movements per week without straining, Kathi says, “I consider it a good week.”</p>
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<p>Like me, Ali Smith, a digital PR manager, experienced severe constipation during pregnancy. At around 14 weeks, her midwife recommended the usual lifestyle changes: drinking more water and increasing her fiber intake. Smith did what she could, but nausea made it hard to eat much. With her midwife’s blessing, she started taking two Colace pills a day — one in the morning and one at night.</p>
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<p>“I think at one point I went almost seven days” without a bowel movement, she says. Still, she assumed the medication must be helping somewhat and worried her constipation would get worse if she stopped.</p>
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<p>After taking Colace for around two weeks, however, Smith had to have her appendix removed. Her doctors suspected that a piece of fecal matter may have blocked the organ. It’s impossible to know for sure what role, if any, her constipation treatment played. But today, she still wonders whether a different approach might have helped her avoid an appendectomy during pregnancy.  </p>
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<h2 class="wp-block-heading">Why the Evidence Doesn't Support Routine Use</h2>
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<p>“I teach a class every year and ask the pharmacists what OTC drugs they think are ineffective. Docusate often comes up,” says Dr. Hatton.</p>
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<p>In 1976, experts were <a href="https://www.sciencedirect.com/science/article/abs/pii/0021968176900680?">sounding the alarm</a> that docusate sodium may be ineffective. A 2021<a href="https://journals.lww.com/ajg/fulltext/10.14309/01.ajg.0000773232.60122.be~s190docusate-is-not-different-from-placebo-for-stool"> analysis of seven trials</a> showed that people who used the drug had no more bowel movements than those given a placebo. Their bowels also didn’t contain substantially more water (docusate sodium is thought to soften stools by increasing their water content).</p>
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<p>Despite the fact that several medical associations, including the<a href="https://gastro.org/clinical-guidance/pharmacological-management-of-chronic-idiopathic-constipation-cic/"> American Gastroenterological Association</a>, the<a href="https://www.ovid.com/jnls/dcrjournal/fulltext/10.1097/dcr.0000000000003430~the-american-society-of-colon-and-rectal-surgeons-clinical"> American Society of Colon and Rectal Surgeons</a>, the<a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC2794454/"> Canadian Association of Gastroenterology</a>, and the<a href="https://jnccn.org/view/journals/jnccn/17/8/article-p977.xml"> National Comprehensive Cancer Network</a>, have either stopped including docusate sodium among recommended constipation treatments or noted limited evidence for its use, the drug remains available over-the-counter. And, as in my case, it is still recommended to patients as a first choice.</p>
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<p>“Docusate is still frequently recommended, and it is not surprising due to the fact that it is over the counter, inexpensive, and perceived as gentle,” says Dr. Shah, “However, from an evidence-based pharmacy perspective, docusate should be avoided and clinicians should be asking themselves, ‘Have we recommended this because it actually is effective, or because it is a long time recommendation?’”</p>
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<p>Once I started looking into the research on Colace, I stopped taking docusate sodium. Instead, during the last few weeks of my pregnancy, I skipped my iron supplement a couple of days each week. By then, my ferritin levels were already approaching a healthy range, <a href="https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00463-7/fulltext">and some research suggests</a> that taking iron every other day can provide similar benefits with fewer gastrointestinal side effects.</p>
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<p>(That said, this approach isn't right for everyone. The study I relied on compared three months of daily iron supplementation with six months of alternate-day dosing, meaning participants ultimately received the same total amount of iron. If your iron stores are very low and you need to raise them quickly, talk to your healthcare provider before changing your regimen.)</p>
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<p>I also picked up some MiraLAX, which several medical associations, such as the American Gastroenterological Association, now recommend as the first-line treatment for constipation, to keep in my cabinet, just in case. And yes, I’ll be sure to discuss all these changes with my doctor at my next prenatal visit.</p>
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