unfortunately, i can't use Nizoral anymore.

I was diagnosed with Folliculitis a few weeks ago by my Derm. and told not to use Niz. anymore as its too harsh. I may even be one of the few with a KETOCONAZOLE allergy, as mentioned in the side effects listing for Niz. shampoo.

"One word of warning, anti-inflammatory products do seem to have the potential to promote folliculitis (let’s call it scalp acne) when they are used for a long time. It is ironic that an anti-inflammatory product should do this, but it does seem to occur in some people. If folliculitis develops just stop using the product and it should go away."

i tried the Niz. on the back of my head only the other day to compare the back to the top. bingo. i have massive itching on the back of my head only. the top is fine.

please remember nizoral 2% shampoo is a VERY powerful shampoo and has very good reason to be available only with a prescription in many countries. its supposed to be left to soak on your head for 5 mins for a MAXIMUM of twice per week...AND NO MORE ! the 2% is mean't to be used as a one-off treatment as its so powerful and the 1% is only supposed to be used twicve a week for 8 weeks then cut back.

i have seen several people over the years complain of how harsh it is when over used and even led to hairloss in some.

its such a great shampoo for AGA though that it must be tried....but i recommend you try the 1% version first (available without prescription), and remember, begin with once per week application and TWICE a week MAXIMUM.

I am only mentioning this so that you will know the symptoms of Folliculitis to look out for when trying Niz. for the first time. My symptoms were itching and the formation of something resembling boils/big soft bumps on the head. These burst eventually and become open sores. I had around 4 or 5 of them. This has been on and off for ages and i never considered it could be due to Niz. as its an anti-inflammatory shampoo and is normally the first shampoo recommended to treat.....Folliculitis !

i only used it once per week with the occasional twice per week as i knew how powerful it was.

I "cured" them within a week by pouring Lakewood Aloe Vera juice (from GNC) on my head every night (and left on overnight) for about 6/7 days.


Edited: 07/27/2006 at 06:17 PM by chrome

http://www.drugs.com/cons/Nizoral_Shampoo.html

Ketoconazole 1% shampoo is used to treat dandruff.
Ketoconazole 2% shampoo is used to treat ``sun fungus'' (tinea versicolor; pityriasis versicolor).
This medicine may also be used for other fungus infections of the skin as determined by your doctor.

Ketoconazole is available without a doctor's prescription, in the following dosage form:
Topical Shampoo (1%) (U.S.)

Ketoconazole is available only with your doctor's prescription, in the following dosage forms:
Topical Cream (U.S. and Canada)
Topical Shampoo (2%) (U.S. and Canada)


Allergies-Tell your doctor if you have ever had any unusual or allergic reaction to ketoconazole, miconazole or other imidazoles, or sulfites. The cream form of ketoconazole contains sulfites. Also tell your health care professional if you are allergic to any other substances, such as preservatives or dyes.

For patients using the 1% shampoo form of this medicine:

Wet your hair and scalp well with water.
Apply enough shampoo to work up a good lather and gently massage it over your entire scalp.
Rinse your hair and scalp with warm water.
Repeat application.
Rinse your hair and scalp well with warm water, and dry your hair.


For patients using the 2% shampoo form of this medicine:

Wet your hair and scalp well with water.
Apply the shampoo to the skin of the affected area and a wide margin surrounding this area.
Work up a good lather and leave it in place for 5 minutes.

DOSAGE:

For 1% shampoo dosage form: For dandruff:
Adults-Use every 3 or 4 days for up to 8 weeks. Then use only as needed to keep dandruff under control.
Children-Use and dose must be determined by your doctor.

For 2% shampoo dosage form: For pityriasis versicolor:
Adults-Use once.
Children-Use and dose must be determined by your doctor.

from elsewhere:

"Hi dr. Rassman.

Is My Hair Loss from Nizoral?

recently I was prescribed an antidandruff shampoo called nizoral 2% ketoconazole. I used it religiously and initially felt some relief. but i was only supposed to use it 2-3 times per week and instead i used it every day. now i have noticed tha ti have a bunch of white hairs or hairs that are both white and black on the same follicle or new brown hairs. I have also noticed that i have lost quite a bit of hair on one side in the front and increased itching/burning in that area. I am only 17 years old and am positively not suffering from male pattern baldness ( i have hair like growing down to my eyes). but I am wondering if you think that the hair i lost in front with nizoral will grow back or if i permanently damaged my scalp beyond repair. Also note that there is no pain anymore that i have discontinued use of it for a month. but the shedding associated with it only stopped a couple of weeks ago"

Dr Rassman,

"Possibly, you are allergic to the chemical in nizoral (2% ketoconazole). If your hair loss is due to an allergic reaction to medication or “chemical irritation,” then it will likely return back in 6 to 8 months after the offending chemical has been removed. Check back with me if there is no regrowth after 6-8 months."

another comment from elsewhere. this is the one that links Nizoral to causing Folliculitis .

" One word of warning, anti-inflammatory products do seem to have the potential to promote folliculitis (let’s call it scalp acne) when they are used for a long time. It is ironic that an anti-inflammatory product should do this, but it does seem to occur in some people. If folliculitis develops just stop using the product and it should go away."


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"Without exception, nizoral is the most successful shampoo on the market today at not only controlling the itch, but any underlying inflammation you may not be able to detect, while simulatneously helping stimulate minor hair growth. No other shampoo we know of can do this. Tgel is another good alternative, but no regimen should be without Nizoral. You can get Nizoral in the shampoo section of any grocery store, typically at the end, next to the Rogaine. We suggest all our users make use of it once every 3 days. Apply it immediately as you get in the shower, and let it soak for the duration of your shower. After a few weeks your itching should be gone, and we suggest continuing with it indefinitely. Its truly the only shampoo out there that can do what it does.

In the natural products isle at the local store you will also find aloe vera or tea tree lotions. These products can work well, but of course they only reduce the inflammation and do not treat the underlying cause of the inflammation. If you stop using them and the underlying promoter of the irritation is still present, then the inflammation will come back. One word of warning, anti-inflammatory products do seem to have the potential to promote folliculitis (let’s call it scalp acne) when they are used for a long time. It is ironic that an anti-inflammatory product should do this, but it does seem to occur in some people. If folliculitis develops just stop using the product and it should go away.

Inflammation and the Effectiveness of your Regimen

At this stage in our understanding of inflammatory cells and their influence on hair growth we don’t know which inflammatory signals are good and which are bad. However, it is reasonable to say that if your scalp is irritated/inflamed AND you see you are losing more hair, then the kind of skin irritation/inflammation you have is certainly not helping to grow hair and may even be exacerbating it. The best thing for you to do is make sure you are using Nizoral shampoo once every 3 days as part of your regimen. Its ability to reduce any noticeable (and unnoticeable) inflammation will only benefit your progress, and the effectiveness of your treatment regimen. Having antiandrogenic properties itself, it may also help stimulate hair growth, and it is literally the only shampoo on the store shelves today that can do this."

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Edited: 07/27/2006 at 06:27 PM by chrome

i am definately NOT trying to scare anyone from using Nizoral as its the perfect shampoo for MPB sufferers due to its confirmed anti=inflammatory and anti-DHT properties.

i am almost certainly in a minority here.

i am just posting my recent experience to emphasise that Nizoral 2% is a VERY powerful shampoo and deserves its prescription status.
it should be treated with respect and only used a MAXIMUM of twice per week , each time allowing to soak on the head for 5 mins.

i also wish to point out what to look for regarding Folliculitis. I had constant itching which then led to small soft bumps appearing over my scalp (similar to boils). After a while, they burst and formed open sores. As Nizoral is recommended to treat Folliculitis, i applied even more !
i only used it once a week anyway so going up to twice per week to treat these sores seemed OK. WRONG !!

Anyway, i hope this may have helped new users a little and maybe even a few experienced users may be having similar problems but haven't yet connected the two...like me ?

cheers anyway, chrome.

I have always said on various threads that Nizoral is very dangerous and harmful but unfortunately it is getting promoted quite aggressively in this and other hairloss orums. I have experienced something similar to you and I am pretty sure it is a result of Nizoral usage and keeping it "on" for few minutes. My scalp was very itchy and crappy, at the same time I noticed a big shed. I should have stopped right away but did not and lost a whole bunch on top and trust me they dont come back. Oiling your hair helps with itching...

Sometimes I wonder all this crap that we pour on our head or take orally is doing more harm than good...

damn, i should have ordered the 1% maybe, but already ordered the 2%. oh well, less often use i suppose and see how it goes.

I ve scaled down to 1 % from 2% which i used for 5 months.....

Use it twice a week in the morning and i put Emu/Coconut oil the night before so its not too harsh on my scalp while washing. Use zinc based shampoo like H and S if i have more irritation or scaling

I can't use Niz either...I had the same reaction after using it for a couple weeks...few boils or somehting on the scalp....scalp also became very oily and hair looked like crap for weeks...it also discolored my hair almost as if I used a dye. I think I found the same info posted here...I'm allergic to sulfa based drugs and didn't realize I should not use Niz because of it.

Edited: 07/27/2006 at 06:13 PM by beaner

Hairforless, I have experienced a similar negative reaction to the use of Nizoral, losing a significant amount of hair in the front that has not regrown. Although a number of posters claim all sorts of positive reactions and urge others to use this product, in fact it is potentially deleterious and may result in hairloss in those who are susceptible to its chemical components. My advice to other posters is to NOT TO listen to posters' anecdotal proclamations of positive outcomes with this product and to only use it if advised by a Dermatologist or other medical specialist.

Hairforless, I have experienced a similar negative reaction to the use of Nizoral, losing a significant amount of hair in the front that has not regrown. Although a number of posters claim all sorts of positive reactions and urge others to use this product, in fact it is potentially deleterious and may result in hairloss in those who are susceptible to its chemical components. My advice to other posters is to NOT TO listen to posters' anecdotal proclamations of positive outcomes with this product and to only use it if advised by a Dermatologist or other medical specialist.

http://www.ortho-mcneil.com/active/janus/en_US/assets/common/company/pi/nizoral_shampoo.pdf;jsessionid=VSQV2KDTKRV4WCQPCCFTC0YKB2IIQNSC

DESCRIPTION

NIZORAL ® (ketoconazole) 2% Shampoo is a red-orange liquid for topical application, containing the broadspectrum synthetic antifungal agent ketoconazole in a concentration of 2% in an aqueous suspension. It also contains: coconut fatty acid diethanolamide, disodium
monolauryl ether sulfosuccinate, F.D.&C. Red No. 40, hydrochloric acid, imidurea, laurdimonium hydrolyzed animal collagen, macrogol 120 methyl glucose dioleate, perfume bouquet, sodium chloride, sodium hydroxide, sodium lauryl ether sulfate, and purified water.

Ketoconazole is cis -1-acetyl-4-[4-[[2-(2,4-dichlorophenyl) -2-(1H -imidazol-1-ylmethyl)-1,3 - dioxolan-4-yl]methoxy] phenyl]piperazine

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CLINICAL PHARMACOLOGY

Tinea (pityriasis) versicolor is a non-contagious infection of the skin caused by Pityrosporum orbiculare (Malassezia furfur). This commensal organism is part of the normal skin flora. In susceptible individuals the condition is often recurrent and may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs.

Treatment of the infection may not immediately result in restoration of pigment to the affected sites. Normalization of pigment following
successful therapy is variable and may take months, depending on individual skin type and incidental skin exposure. The rate of recurrence of infection is variable.

When ketoconazole 2% shampoo was applied dermally to intact or abraded skin of rabbits for 28 days at doses up to 50 mg/kg and allowed to remain one hour before being washed away, there were no detectable plasma ketoconazole levels using an assay method having a
lower detection limit of 5 ng/mL. NIZORAL ® (ketoconazole) was not detected in plasma in 39 patients who shampooed 4-10 times per week for 6 months or in 33 patients who shampooed 2-3 times per week for 3-26 months (mean: 16 months).

An exaggerated use washing test on the sensitive antecubital skin of 10 subjects twice daily for five consecutive days showed that the irritancy potential of ketoconazole 2% shampoo was significantly less than that of 2.5% selenium sulfide shampoo.

A human sensitization test, a phototoxicity study, and a photoallergy study conducted in 38 male and 22 female volunteers showed no contact sensitization of the delayed hypersensitivity type, no phototoxicity and no photoallergenic potential due to NIZORAL ® (ketoconazole) 2% Shampoo.

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Mode of Action:

Interpretations of in vivo studies suggest that ketoconazole impairs the synthesis of ergosterol, which is a vital component of fungal cell
membranes. It is postulated, but not proven, that the therapeutic effect of ketoconazole in tinea (pityriasis) versicolor is due to the reduction of Pityrosporum orbiculare (Malassezia furfur) and that the therapeutic effect in dandruff is due to the reduction of Pityrosporum
ovale .

Support for the therapeutic effect in tinea versicolor comes from a three-arm, parallel, double-blind, placebocontrolled study in patients who had moderately severe tinea (pityriasis) versicolor. Successful response rates in the primary efficacy population for each of both three-day and single-day regimens of ketoconazole 2% shampoo were statistically significantly greater (73% and 69%, respectively) than a placebo regimen (5%).

There had been mycological confirmation of fungal disease in all cases at baseline. Mycological clearing rates were 84%
and 78%, respectively, for the three-day and one-day regimens of the 2% shampoo and 11% in the placebo regimen. While the differences in the rates of successful response between either of the two active treatments and placebo were statistically significant, the difference
between the two active regimens was not.

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Microbiology:

NIZORAL ® (ketoconazole) is a broadspectrum synthetic antifungal agent which inhibits the growth of the following common dermatophytes and yeasts by altering the permeability of the cell membrane:

dermatophytes: Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floccosum ; yeasts: Candida albicans, C. tropicalis, Pityrosporum ovale (Malassezia ovale) and Pityrosporum orbiculare (M. furfur).

Development of resistance by these microorganisms to ketoconazole has not been reported.

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INDICATIONS AND USAGE

NIZORAL ® (ketoconazole) 2% Shampoo is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare ).

Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization of pigment to the affected sites. Normalization
of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.

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CONTRAINDICATIONS

NIZORAL ® (ketoconazole) 2% Shampoo is contraindicated in persons who have shown hypersensitivity to the active ingredient or excipients of this formulation.

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PRECAUTIONS

General: If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued.

Information for Patients:
May be irritating to mucous membranes of the eyes and contact with this area should be avoided.There have been reports that use of the shampoo resulted in removal of the curl from permanently waved hair.

Carcinogenesis, Mutagenesis, Impairment of Fertility:
The dominant lethal mutation test in male and female mice revealed that single oral doses of ketoconazole as high as 80 mg/kg produced no mutation in any stage of germ cell development. The Ames Salmonella microsomal activator assay was also negative. A long-term feeding
study of ketoconazole in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity.

Pregnancy: Teratogenic effects: Pregnancy CategoryC:
Ketoconazole is not detected in plasma after chronic shampooing. Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given orally in the diet at 80 mg/kg/day (10 times the maximum recommended human oral dose). However,
these effects may be related to maternal to xicity, which was seen at this and higher dose levels.

There are no adequate and well-controlled studies in pregnant women. Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing mothers:
Ketoconazole is not detected in plasma after chronic shampooing. Nevertheless, caution should be exercised when NIZORAL ® (ketoconazole) 2% Shampoo is administered to a nursing woman.

Pediatric Use:
Safety and effectiveness in children have not been established.

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ADVERSE REACTIONS

In 11 double-blind trials in 264 patients using ketoconazole 2% shampoo for the treatment of dandruff or seborrheic dermatitis, an increase in normal hair loss and irritation occurred in less than 1% of patients. In three open-label safety trials in which 41 patients shampooed 4-10 times weekly for six months, the following adverse experiences each occurred once: abnormal hair texture, scalp pustules, mild dryness of the skin, and itching.

As with other shampoos, oiliness and dryness of hair and scalp have been reported. In a double-blind, placebo-controlled trial in which patients with tinea versicolor were treated with either a single application of NIZORAL ® (ketoconazole) 2% Shampoo (n=106), a daily application for three consecutive days (n=107), or placebo (n=105), drug-related adverse events occurred in 5 (5%), 7 (7%) and 4 (4%) of patients, respectively. The only events that occurred in more than one patient in any one of the three treatment
groups were pruritus, application site reaction, and dry skin; none of these events occurred in more than 3% of the patients in any one of the three groups.

In worldwide experience with NIZORAL ® Shampoo there have been rare reports of hair discoloration.

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OVERDOSAGE

NIZORAL ® (ketoconazole) 2% Shampoo is intended for external use only. In the event of accidental ingestion, supportive measures should be employed. Induced emesis and gastric lavage should usually be avoided.

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DOSAGE AND ADMINISTRATION

Apply the shampoo to the damp skin of the affected area and a wide margin surrounding this area. Lather, leave in place for 5 minutes, and then rinse off with water. One application of the shampoo should be sufficient.

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HOW SUPPLIED

NIZORAL ® (ketoconazole) 2% Shampoo is a red-orange liquid supplied in a 4-fluid ounce nonbreakable plastic bottle (NDC 50580-380-08).
Storage conditions: Store at a temperature not above 25°C (77 °F). Protect from light.

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Rx only.
Distributed by:
McNeil Consumer & Specialty Pharmaceuticals
DIVISION OF MCNEIL – PPC, INC.
FORT WASHINGTON, PA 19034 USA
© MCN-PPC, Inc. ’04
Revised August 1997, May 1999, October 2003
U.S. Patent No. 4,335,125
BLACK
INSERT NIZORAL SHAMPOO (Rx)
3003000 C-3
OCTOBER 30, 2003 RASHAD BARR
LIVE ART

A brief outline of side effects from that insert is below.

This seems to indicate that Niz. 2% is not absorbed systemivally and that it was tested and proved to be safe when used 4 - 10 times wekly for 6 months !

It does go on to say that "scalp pustules" (which is what i had) occurred ONCE in these studies. Like Fin. though, i suspect the figure is much higher than stated. Too many people report watery semen on Fin. to believe their statistics are accurate imho.


Anyway, here are the relevant side effects:

"NIZORAL ® (ketoconazole) 2% Shampoo is contraindicated in persons who have shown hypersensitivity to the active ingredient or excipients of this formulation."

"There have been reports that use of the shampoo resulted in removal of the curl from permanently waved hair."

"Ketoconazole is not detected in plasma after chronic shampooing"...so can't cause systemic sdide effects in theory such as dark circles under the eyes etc. Of course, this was a result of usage on rats and not humans so it can't be ruled out.

ADVERSE REACTIONS

In 11 double-blind trials in 264 patients using ketoconazole 2% shampoo for the treatment of dandruff or seborrheic dermatitis, an increase in normal hair loss and irritation occurred in less than 1% of patients. In three open-label safety trials in which 41 patients shampooed 4-10 times weekly for six months, the following adverse experiences each occurred once:

abnormal hair texture,
scalp pustules,
mild dryness of the skin, and itching.

As with other shampoos, oiliness and dryness of hair and scalp have been reported. In a double-blind, placebo-controlled trial in which patients with tinea versicolor were treated with either a single application of NIZORAL ® (ketoconazole) 2% Shampoo (n=106), a daily application for three consecutive days (n=107), or placebo (n=105), drug-related adverse events occurred in 5 (5%), 7 (7%) and 4 (4%) of patients, respectively.

The only events that occurred in more than one patient in any one of the three treatment groups were pruritus, application site reaction, and dry skin; none of these events occurred in more than 3% of the patients in any one of the three groups.

In worldwide experience with NIZORAL ® Shampoo there have been rare reports of hair discoloration.