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Xenical & Alli

Xenical and Alli side effects

What the trials and the FDA label report

Last reviewed: September 2026

Orlistat blocks about 30% of the fat in your food from being absorbed, and that undigested fat has to go somewhere. Almost all of its side effects follow from that. Here is how common each one was:

Side effectHow common

Percentages from XENDOS (3,305 participants). Source: trial publication.

Based on XENDOS (3,305 participants). Frequencies are approximate and may vary.

What the FDA label warns about

These come from the Xenical prescribing information and the Alli over-the-counter Drug Facts label, both published on DailyMed.

Vitamin absorption: the warning that changes your routine

Because orlistat blocks fat absorption, it also reduces absorption of the vitamins that dissolve in fat. The Xenical label says people taking it should take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition, and that the supplement should be taken at least two hours before or after a dose — at bedtime, for example. The Alli label gives the same advice more simply: take a multivitamin once a day, at bedtime.

Timing matters for some other medicines too. The Xenical label says ciclosporin should be taken at least three hours before or after orlistat, and levothyroxine at least four hours apart.

Other warnings and precautions on the label:

  • Drug interactions and decreased vitamin absorption
  • Liver injury — there have been rare reports after marketing of severe liver injury, including liver failure
  • Oxalate kidney stones and oxalate nephropathy with kidney failure
  • Gallstones

The labels say orlistat must not be used if you:

  • Are pregnant
  • Have chronic malabsorption syndrome
  • Have cholestasis
  • Are allergic to orlistat or anything else in the capsule
  • Take ciclosporin, or have been diagnosed with problems absorbing food (from the Alli label)
  • Are not overweight (from the Alli label)

The label numbers, against placebo

The Xenical label reports these first-year gastrointestinal event rates against placebo.

Adverse reaction rates reported on the Orlistat FDA label, against placebo
ReactionXENICAL, year 1Placebo
Oily spotting26.6%1.3%
Flatus with discharge23.9%1.4%
Faecal urgency22.1%6.7%
Fatty or oily stool20.0%2.9%
Oily evacuation11.9%0.8%
Increased defecation10.8%4.1%
Faecal incontinence7.7%0.9%

Rare but serious — when to call your doctor

Call your doctor immediately if you have:

  • Yellowing of the skin or eyes, dark urine, itching, or pain over your liver (possible liver injury)
  • Severe pain in your side or back, or blood in your urine (possible kidney stone)
  • Pain in the upper right of your abdomen, particularly after eating (possible gallstones)
  • Passing much less urine than usual (possible kidney problems)
  • Severe or persistent abdominal pain
  • Rectal bleeding

What actually helps

Strategies that work best, based on trial and community experience.

Multivitamin at bedtime

Both labels recommend a daily multivitamin containing fat-soluble vitamins, taken at least two hours away from a dose — bedtime is the timing the labels themselves suggest.

Fat in the meal drives the effect

The gut effects scale with how much fat you eat. Both labels pair the drug with a reduced-calorie, lower-fat diet, and lower-fat meals make the effects far less noticeable.

Space out other medicines

The Xenical label says ciclosporin should be taken at least three hours apart from orlistat and levothyroxine at least four hours apart. Check anything else with your pharmacist.

Plan for the first weeks

Dark clothing and liners are the practical tips users share most often, especially early on while you work out how your meals affect you.

When to push through vs. talk to your doctor

You can push through if...

  • Oily stools or spotting after a higher-fat meal
  • Wind, urgency or more frequent bowel movements early on
  • Effects that get more predictable as you learn how your meals affect you
  • Mild abdominal discomfort

Talk to your doctor if...

  • Yellowing skin or eyes, dark urine, or itching
  • Severe pain in your side, back or abdomen
  • Rectal bleeding
  • Faecal incontinence that is affecting daily life
  • Any symptom you are unsure about

Common questions

Written and maintained by one person · Built with agentic AI tools · Every number checked against the cited trial · Not medical advice

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