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Prasterone Side Effects

The most commonly reported side effects of prasterone include off label use, headache, and fatigue, based on 2,529 FDA adverse event reports from 2004 to 2025. 5.6% of reports found the drug to be ineffective.

Prasterone side effects

Percentages show how often each reaction appears relative to total reports for prasterone.

1
Off Label Use30.1%762
2
Headache6.2%156
3
Drug Ineffective5.6%142
4
Fatigue5.3%134
5
Product Dose Omission Issue4.5%113
6
Application Site Discharge4.4%112
7
Nausea4.3%108
8
Rash3.5%88
9
Vaginal Discharge3.3%84
10
Insomnia3.2%82
11
Pain3.2%81
12
Dizziness3.1%79
13
Vulvovaginal Burning Sensation3.0%77
14
Alopecia2.9%73
15
Pruritus2.6%66

These are voluntary reports and do not establish that prasterone caused these reactions.

Report severity

32.0%Serious810 reports
10.4%Hospitalizations263 reports
1.7%Fatal43 reports

Seriousness is determined by the reporter, not by OpenClaim.

Prasterone drug interactions

Other drugs that appear in adverse event reports alongside prasterone. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Sodium-oxybate3.7%94
2
Estradiol2.5%63
3
Dupilumab2.5%63
4
Progesterone1.9%47
5
Budesonide1.7%42
6
Somatropin1.5%39
7
Adalimumab1.5%37
8
Testosterone1.4%36
9
Loratadine1.1%28
10
Amlodipine0.9%23
11
Cenegermin-bkbj0.8%21
12
Treprostinil0.8%21
13
Rituximab0.8%19
14
Lenalidomide0.7%18
15
Zoledronic-acid0.6%15

Taken alongside

1
Ergocalciferol21.4%541
2
Levothyroxine-sodium13.5%341
3
Ascorbic-acid9.4%237
4
Acetaminophen9.2%232
5
Progesterone8.5%215
6
Cyanocobalamin8.4%213
7
Estradiol7.4%186
8
Magnesium-acetate-tetrahydrate7.3%185
9
Aspirin7.1%180
10
Fluticasone7.1%180
11
Calcium6.8%173
12
Fish6.8%172
13
Testosterone6.6%168
14
Omeprazole6.6%167
15
Albuterol6.5%165

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports prasterone side effects

81.2% of prasterone adverse event reports involve female patients and 9.6% involve male patients. The largest age group is adult at 64%. These figures reflect who reports side effects, not underlying risk.

Sex

Female81.2%
Male9.6%
Unknown9.2%

Age group

< 2<0.1%
2–110.0%
12–170.3%
18–6464.4%
65+35.3%

What is prasterone used for

Conditions and purposes for which patients were taking prasterone when the adverse event was reported.

Abdominal DistensionAbdominal PainActh DecreasedAdrenal DisorderAdrenal InsufficiencyAlopeciaAnal IncontinenceAndrogen DeficiencyAstheniaAtrophic VulvovaginitisAtrophyAdrenal InsufficiencyAdrenocortical CarcinomaAnal IncontinenceAndrogen Deficiency

Showing 15 of 208 indications

Prasterone brand names and reporting trend

Prasterone is sold under the brand name Intrarosa.

Brand names

Intrarosa1,075

Quarterly reports (20042025)

2005201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking prasterone with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.