Bausch Health / Arazlo
TAZAROTENE LOTION 0.045%
The strongest topical retinoid result in this register — 25.5% and 29.6% success at twelve weeks — attached to the worst price and an absolute contraindication in pregnancy that requires a negative test before you start.
Worth buying for a specific person with a specific problem. Read who.
ASSESSED ON 75% OF THE MODEL. 2 CRITERIA LEFT UNSCORED — SEE SCORING FOR WHY.
We earn nothing on this link. Establish the covered price before the pharmacy fills it — the cash and covered prices for this drug differ by hundreds of dollars.
The verdict
On the numbers, this is the most effective topical retinoid we have assessed. Success on the evaluator's global severity score reached 25.5% and 29.6% across two trials, against 13% and 17.3% on vehicle. Non-inflammatory lesions fell 51.4% and 60%. Tazarotene is a more potent receptor-selective retinoid than tretinoin, and the trial data show it.
The formulation follows the same logic as its stablemate at R-36: put a potent retinoid in a polymeric emulsion lotion so people can keep using it. It works. Application-site pain was 5% and dryness 4%, and 2.4% of subjects discontinued because of local reactions. For a drug that at 0.1% cream was notorious for irritation, that is a real achievement.
The contraindication is what moves this from recommended to conditional. Arazlo is contraindicated in pregnancy — not cautioned, contraindicated. The label requires a negative pregnancy test within two weeks of starting and effective contraception throughout. Tazarotene produced malformations in rats and rabbits at topical doses during organogenesis. For a readership in its thirties and forties, a meaningful share of whom are pregnant, trying, or would not immediately know, that is not a footnote.
And then the price. Around $572 with a discount card, $680 at retail, for 45 g. That is roughly fifteen times a tube of generic tretinoin, for an incremental gain over tretinoin that has never been directly measured in these trials — the comparator was vehicle, not another retinoid. If insurance covers it, the calculus changes completely. Paying cash, it is very hard to justify.
- The largest retinoid effect size in this register: 25.5% and 29.6% success at 12 weeks.
- Confidence intervals published on every treatment difference.
- Non-inflammatory lesion reductions of 51.4% and 60%.
- Tolerability transformed relative to legacy tazarotene, with the discontinuation rate published.
- Contraindication stated in the highlights section, not hidden in a subsection.
- Animal reproductive toxicity data given in full, including the doses and species.
- Complete excipient list and stated fill weight.
- A tube, not a subscription.
- Contraindicated in pregnancy, with a negative test required within two weeks of starting.
- Around $572 to $680 for 45 g — roughly fifteen times generic tretinoin.
- No trial against another retinoid, so the premium over tretinoin is unmeasured.
- Application-site pain in 5% and severe local reactions in 1.3%.
- 2.4% of trial subjects discontinued because of local skin reactions.
- Indicated for acne only — any photoageing use is off-label.
- 42% of trial subjects were under eighteen.
- Coverage is erratic, so the price you pay is unpredictable until the pharmacy runs it.
Every active, assessed
- Tazarotene0.045%
Receptor-selective retinoid prodrug — converts to tazarotenic acid, binds RARβ and RARγ
- BENCHMARK
- 0.05% to 0.1% in the older cream and gel formulations
- ASSESSMENT
- A lower concentration than the legacy tazarotene products, in a vehicle designed to deliver more of it with less irritation — the same trade the whole polymeric-emulsion generation is making. More potent than tretinoin at the receptor level, and correspondingly less forgiving: this is the retinoid with an outright pregnancy contraindication rather than a class caution.
| ACTIVE | CONC. | BENCHMARK | ASSESSMENT |
|---|---|---|---|
| TazaroteneReceptor-selective retinoid prodrug — converts to tazarotenic acid, binds RARβ and RARγ | 0.045% | 0.05% to 0.1% in the older cream and gel formulations | A lower concentration than the legacy tazarotene products, in a vehicle designed to deliver more of it with less irritation — the same trade the whole polymeric-emulsion generation is making. More potent than tretinoin at the receptor level, and correspondingly less forgiving: this is the retinoid with an outright pregnancy contraindication rather than a class caution. |
Scoring
- EVIDENCE FOR THE ACTIVEWEIGHT 30%80/100
Two vehicle-controlled trials, 1,570 subjects, 12 weeks, with confidence intervals published on every treatment difference — the most statistically complete presentation in this register. The largest retinoid effect we have recorded. Marked down because the comparator was vehicle rather than tretinoin, so the question a prescriber actually faces was never tested.
- FORMULATION INTEGRITYWEIGHT 20%84/100
A polymeric emulsion lotion carrying a potent retinoid at below-legacy concentration with markedly better tolerability than the older tazarotene creams. Full excipient list, stated fill weight, pharmaceutical manufacture, and a discontinuation rate for local reactions published at 2.4%.
- DISCLOSUREWEIGHT 15%92/100
Concentration, fill weight, excipients, both trials with confidence intervals, adverse reactions against vehicle, the discontinuation rate, the severe-reaction rate at 1.3%, the animal reproductive toxicity data in detail, and a contraindication stated in the highlights rather than buried. Marked down only for the absence of any active comparator.
- TOLERANCE IN USEWEIGHT 15%NOT ASSESSED
Not assessed by us. The label gives 5% application-site pain, 4% dryness, 1.3% severe reactions and 2.4% discontinuation — good for tazarotene, worse than Altreno at R-36. A panel would establish where it actually sits against tretinoin in the same vehicle class.
- TEXTURE & WEARWEIGHT 10%NOT ASSESSED
Not assessed. A polymeric emulsion lotion is distinctive in use and deserves a panel rather than an assumption.
- COST PER APPLICATIONWEIGHT 10%34/100
Around $572 discounted and $680 retail for 45 g, against roughly $38 for generic tretinoin and $123 for the branded tretinoin lotion at R-36. The fill weight is published so the arithmetic is possible, and the arithmetic is bad: this is the most expensive gram of retinoid in the register with no head-to-head data justifying the premium.
What it is
Tazarotene 0.045% in a polymeric emulsion lotion, approved for acne vulgaris in patients nine and older, applied once daily. A 45 g tube, around $572 with a discount card. It is the most effective and most expensive topical retinoid in this register, and the only one contraindicated rather than cautioned in pregnancy.
The best retinoid numbers we have recorded
Success required clear or almost clear plus at least a two-grade improvement. Trial 1: N=402 against 411, treatment difference 12.5% (95% CI 7.1 to 17.9). Trial 2: N=397 against 404, difference 12.3% (95% CI 6.5 to 18.1). The two trials agree with each other, which is more than can be said for most pairs in this register.
Put those beside R-36: Altreno's tretinoin reached 16.5% and 19.8%. Arazlo's tazarotene reached 25.5% and 29.6%. It is tempting to read that as tazarotene beating tretinoin by ten points, and it is not a safe reading — different trials, different populations, different vehicles, different vehicle-arm responses. But it is consistent with what the receptor pharmacology predicts, and it is the direction the older comparative literature points.
Both Arazlo trials compared the drug to its own vehicle. Neither compared it to tretinoin. So the question every prescriber and every patient actually faces — is this worth four hundred dollars more than the retinoid I could have instead — has no answer in the registration data. Vehicle-controlled trials establish that a drug works. They do not establish that it is worth choosing, and a label that cost this much should be expected to answer the second question too.
The contraindication
ARAZLO is contraindicated in pregnancy… Patients of childbearing potential should have a negative pregnancy test within 2 weeks prior to initiating treatment and use effective contraception during treatment.
FDA-approved labelling, Contraindications and Warnings
Tazarotene elicits malformations and developmental effects associated with retinoids after both topical and oral administration to pregnant rats and rabbits during organogenesis. The label notes that limited case reports from the clinical programme have not shown a clear association with major birth defects in humans — but the contraindication stands, and the pre-treatment test requirement stands with it.
This matters more for this site's readership than the label's young trial population suggests. A drug requiring a documented negative pregnancy test and ongoing contraception is a different proposition at thirty-four than at fifteen. If a prescriber offers this without raising it, that is the question to ask before the prescription is written.
Tolerability, and what it cost to get there
For tazarotene, this is a good result. The legacy 0.1% cream had a reputation that kept it out of routine use; a lower concentration in a better vehicle has brought it into range. It is still meaningfully more irritating than the tretinoin lotion at R-36, which reported 3% pain and 4% dryness with no published discontinuation figure of this size.
If you are considering it
- Check coverage before the pharmacy fills it. Covered and cash prices here differ by hundreds of dollars.
- If you are paying cash and have not had a proper trial of tretinoin, have that first.
- Expect the pregnancy test requirement and plan contraception before you start.
- Twelve weeks before judging. Both trials read out then.
- Once nightly, on dry skin, and moisturise — the tolerability advantage assumes ordinary supportive care.
- Sunscreen daily.
- If irritation is your limiting factor rather than efficacy, R-36 is the better-tolerated tube at a fifth of the price.
Where we stand
At 77 this is a genuinely good drug carrying a genuinely bad price and a contraindication that this readership needs to take seriously. The evidence presentation is the most rigorous in the register — confidence intervals on every difference, discontinuation rates published, animal reproductive data given in full — and none of that rigour was spent on the comparison that would decide whether to buy it.
If your insurer covers it and you have failed tretinoin, take it. If you are paying cash, the honest advice is to try an adequately dosed tretinoin first, in a vehicle you can tolerate, and reserve this for when that has properly failed.
Who this is for
- Someone with stubborn comedonal acne who has already failed adequate tretinoin.
- Someone whose insurance covers it, which changes the value assessment entirely.
- Someone who is certain about contraception and can produce a negative pregnancy test before starting.
- Someone who wants the strongest topical retinoid evidence available and understands the comparator was vehicle.
- You are pregnant, trying to conceive, or might become pregnant without knowing promptly. This is a contraindication, not a caution.
- You are paying cash and have not yet tried adequately dosed tretinoin.
- You have had severe local reactions to retinoids before — 1.3% of subjects here had severe reactions and 2.4% stopped.
- You want this for lines rather than spots, in which case you are paying a large premium for an off-label use with no supporting data.
- Your coverage is unclear and you cannot check it before the pharmacy fills it.
We earn nothing on this link. Establish the covered price before the pharmacy fills it — the cash and covered prices for this drug differ by hundreds of dollars.
This is an editorial assessment of published information about a prescription product. It is not a diagnosis, not a prescription and not a substitute for your own prescriber. Hydroquinone and tretinoin are drugs. Decisions about them belong with a clinician who has seen your skin.
Sources
- S-01FDA-approved labelling — ARAZLO (tazarotene) lotion, 0.045%, Bausch Health US, LLC The 0.045% strength stated as 0.45 mg per gram; the pregnancy contraindication and the requirement for a negative pregnancy test within two weeks and effective contraception; the embryofetal toxicity data in rats and rabbits; the two 12-week trials (NCT03168321, NCT03168334) with EGSS success of 25.5% against 13% and 29.6% against 17.3% and confidence intervals on each difference; lesion reductions of 51.4% and 60%; and the adverse reaction table with 5% application-site pain, 1.3% severe reactions and 2.4% discontinuation. Read 2 August 2026.
- S-02GoodRx — Arazlo pricing Cash pricing around $538 to $584 with a discount card against average retail near $680 for the 45 g tube. Retrieved 2 August 2026.