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.
| Reaction | XENICAL, year 1 | Placebo |
|---|---|---|
| Oily spotting | 26.6% | 1.3% |
| Flatus with discharge | 23.9% | 1.4% |
| Faecal urgency | 22.1% | 6.7% |
| Fatty or oily stool | 20.0% | 2.9% |
| Oily evacuation | 11.9% | 0.8% |
| Increased defecation | 10.8% | 4.1% |
| Faecal incontinence | 7.7% | 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
Sources for Orlistat side effect data
Side effect frequencies come from the XENDOS trial. The warnings and precautions, contraindications, adverse reaction table, vitamin advice and interaction timings come from the Xenical FDA prescribing information and the Alli over-the-counter Drug Facts label, both published on DailyMed.
- XENDOS — Orlistat: 3,305 adults with obesity, including those with prediabetes, 4 years (208 weeks). Diabetes Care, 2004. View source ↗
- Sjostrom 1-year RCT — Orlistat: 743 adults with obesity, 1 year (52 weeks). International Journal of Obesity, 2000. View source ↗
- XENICAL (orlistat) 120 mg FDA prescribing information — DailyMed View source ↗
- alli (orlistat) 60 mg over-the-counter Drug Facts label — DailyMed View source ↗
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Next step most people take
Built with agentic AI tools and not a substitute for medical advice
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