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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-.

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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet].

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Last Update: January 16, 2020.



8-methoxsalen and 5-methoxsalen are furocoumarins referred to collectively as psoralens that have photosensitizing activity and are used orally and topically in conjunction with ultraviolet irradiation for the therapy of psoriasis and vitiligo. Psoralens have been linked to a low rate of transient serum enzyme elevations during therapy and to rare instances of clinically apparent acute liver injury.


Psoralen (sor’ a len) is a natural furocoumarin found in the seeds of Psoralea corylifolia and other botanicals and used for their photosensitizing activity in the therapy of psoriasis and vitiligo. Psoralen is actively taken up by epidermal cells and intercalates into DNA. Upon exposure to ultraviolet (UV) light, psoralen forms cross links between DNA causing cell injury and death. The most commonly used form of psoralen, known as 8-methoxsalen (meth ox’ a len) or 8-methoxypsoralen, has been available in the United States since the 1950s and was typically administered orally or topically as an ointment with ultraviolet light treatment. 8-methoxsalen with ultraviolet radiation (PUVA) was approved for use in refractory psoriasis in the United States in 1982. Its current indications are limited to severe, recalcitrant and disabling psoriasis. It also has been used to treat vitiligo and cutaneous T cell lymphoma. Psoralen is now not commonly used, largely because of concerns over the long term safety of ultraviolet light therapy and the availability of newer, more effective and better tolerated agents for psoriasis. 8-methoxsalen is available in 10 mg capsules for oral use and as lotions of 1% methoxsalen for topical administration generically and under the brand name Oxsoralen. The typical oral dose is adjusted by weight and ranges from 10 to 70 mg, 2 to 4 times weekly taken 1 to 2 hours before a controlled dose of ultraviolet irradiation. Common side effects include nausea, headache, dizziness, fatigue, depression and erythematous and pruritic skin reactions to UV light. Rare, but potentially severe adverse reactions include increased risk of basal cell carcinoma and melanoma.


In open label trials, serum ALT or AST elevations occurred in 2% to 12% of subjects treated with methoxsalen and UV light. The elevations were usually mild-to-moderate in severity, asymptomatic and self-limited in course. Clinically apparent acute liver injury has also been reported with oral methoxsalen therapy, but only in isolated case reports including one instance attributed to topical methoxsalen therapy. The time to onset has ranged from 1 to 5 months, the typical latency being 6 to 8 weeks. The onset is generally insidious, with appearance of nausea and abdominal pain followed by jaundice. Fever occurs in some cases, but rash and eosinophilia are not common. The typical pattern of injury is hepatocellular. Most published cases of psoralen hepatotoxicity have been mild-to-moderate in severity, but severe jaundice and death from hepatic failure has been described in patients with preexisting cirrhosis who developed further acute liver injury attributed to methoxsalen. Most cases resolve within 6 to 8 weeks.

Psoralen is also present in many herbal products used to treat various conditions including psoriasis and vitiligo. Case reports of acute liver injury have been reported with the use of seeds, powder and teas prepared from Psoralea corylifolia under various Chinese names such as Boh Gol Zhee, Xin Cu Hei Su and Qu Bai Ba Bu Gi Pian. Chemical analyses have shown the presence of psoralen in these products. The clinical features of these cases have resembled those attributed to methoxsalen with a latency of 1 to 2 months, a hepatocellular pattern of injury, absence of immunoallergic or autoimmune features, and self-limited course with recovery within 6 to 8 weeks.

Likelihood score: C (probable rare cause of clinically apparent liver injury)

Mechanism of Injury

The mechanism of possible liver injury due to psoralen is unknown. Psoralen is metabolized in the liver, and the liver injury may be due to a rare intermediate of its metabolism. In some cases, hypersensitivity may play a role.

Outcome and Management

While most cases of acute liver injury due to psoralen have been mild-to-moderate in severity and self-limited in course, fatal instances have been reported in patients with preexisting liver disease. Several instances of rapid recurrence of injury with rechallenge have been reported and rechallenge should be avoided.

Drug Class: Dermatologic Agents, Psoriasis Agents


Case 1. Acute hepatitis due to methoxypsoralen.(1)

A 55 year old woman with widespread psoriasis who had failed to respond to acitretin, ultraviolet (UV) light and triamcinolone cream developed nausea, abdominal pain and fatigue after 40 treatments with 5-methoxypsoralen. Methoxypsoralen was started in a dose of 20 mg and raised to 40 mg given orally three times weekly just before each UV light treatment. She had a history of a previous episode of jaundice 6 years previously that was attributed to flucloxacillin. She had no other major medical illnesses, had no risk factors for viral hepatitis and was taking no other medications or herbal preparations. Acitretin had been stopped 10 weeks before presentation and her liver tests had been normal before starting antipsoriasis therapy. Physical examination showed an improvement in her psoriatic lesions and mild jaundice. She had no fever, new onset rash or lymphadenopathy. Laboratory tests showed a total serum bilirubin of 3.2 mg/dL, ALT 2727 U/L, AST 1444 U/L and GGT 857 U/L. The white blood cell eosinophil count was normal. Tests for hepatitis A, B and C were negative as were routine autoantibodies (ANA, AMA). The methoxypsoralen and UV light treatment were discontinued. She worsened for a few days, serum bilirubin rising to 8.8 mg/dL. Thereafter, the abnormalities began to resolve and all tests were near normal 7 weeks after presentation (Table).

Key Points

Medication:5-methoxypsoralen (40 mg three times weekly; 40 courses)
Pattern:Hepatocellular-mixed (R=5.1)
Severity:3+(jaundice and hospitalization)
Latency:~3 months
Recovery:~2 months
Other medications:Triamcinolone cream

Laboratory Values

Time After StartingTime After
Alk P
Pre22650.4Diagnosis of psoriasis
Pre27540.2Acitretin started
3 months-2 days27278573.2Nausea, abdominal pain
9 days24387148.8
4 months18 days17506465.4
5 months52 days952020.7
Normal Values <40 <65 <1.2


This woman with refractory psoriasis had a good clinical response to photochemical therapy using 5-methoxypsoralen (also known as methoxsalen) and narrow beam UV light, but developed constitutional symptoms followed by jaundice after approximately 3 months of therapy. The pattern of serum enzyme elevations was mixed, with prominent increases in serum aminotransferase as well as GGT levels (alkaline phosphatase was not reported, so that the calculation of the R value had to use GGT instead which yielded a value in the low "hepatocellular" range). Recovery was slow, but there was no evidence of hepatic failure. Most cases of psoralen induced liver injury have had a similar latency of 1 to 4 months and a hepatocellular pattern of injury, with no immunoallergic or autoimmune features.

Case 2. Acute hepatitis due to herbal agent containing psoralen.(2)

A 44 year old Korean woman developed nausea and fatigue 4 weeks after starting an herbal agent called "Boh-Gol-Zhee", followed by jaundice 3 weeks later. She was taking the preparation for menopausal symptoms and ingested it with a cup of black tea "every 1 hour for 7 weeks". Physical examination showed jaundice, but no fever, rash or enlargement of the liver or spleen. Laboratory tests showed a total serum bilirubin of 7.3 mg/dL (direct 4.2 mg/dL), ALT 398 U/L, AST 774 U/L, alkaline phosphatase 367 U/L and GGT 192 U/L. Tests for hepatitis A, B and C were negative as were routine autoantibodies (ANA, SMA, anti-LKM). Ultrasonography showed an abnormal liver texture, but no evidence of obstruction. Liver biopsy showed severe hepatitis with confluent necrosis. The herbal preparation was stopped and she was admitted for observation for ten days. She improved without specific therapy and in follow up 4 months later, all liver tests were normal.

Key Points

Medication:Boh Gol Zhee (dried Psoralea corylifolia seeds)
Pattern:Mixed (R~3.6)
Severity:3+ (jaundice and hospitalization)
Latency:~1-2 months
Recovery:Within 2 months
Other medications:None mentioned

Laboratory Values

Time After
Time After
Alk P
4 weeks0Nausea and fatigue
7 weeks03983677.3Jaundice
6 days263Liver biopsy
8 weeks9 days1855.2Discharged
16 weeks2 months31Normal
Normal Values Not given <1.2


Boh-Gol-Zhee is the Korean name for the herbal product prepared from dried mature seeds of Psoralea corylifolia, which is used predominantly to treat menopausal symptoms. The seeds have more than 35 identified chemical constituents including psoralen, psoralidin, backuchiol, bavachin, genistein (a phytoestorgen), various resins and fatty oils. Powdered extracts of P. corylifolia have been linked to several instances of jaundice, and psoralen has been considered the most likely culprit in causing liver injury. The cases of liver injury from herbal sources of psoralen have resembled those attributed to methoxsalen treatment of psoriasis and vitiligo.

Case 3. Acute liver failure attributed to methoxsalen therapy.(3)

A 54 year old man with cirrhosis due to long term methotrexate therapy of psoriasis developed jaundice and evidence of hepatic failure a few weeks after starting 8-methoxsalen with UV irradiation. He had progressive weakness, nausea, abdominal pain, confusion, ascites and peripheral edema. He was transferred to a liver transplant center where laboratory test results showed a total serum bilirubin of 39.6 mg/dL (direct 16.8 mg/dL), ALT 83 U/L, AST 144 U/L, alkaline phosphatase 114 U/L and GGT 20 U/L. The prothrombin time was 23 seconds and serum albumin 2.7 g/dL. Tests for hepatitis B, CMV, EBV and HSV were negative. Emergency liver transplantation was done 3 days after transfer and the explant showed cirrhosis, sinusoidal fibrosis, acute hepatocellular necrosis and collapse, and marked cholestasis. He recovered and was discharged 6 weeks later and was active and working when the report was published 6 years later.

Key Points

Medication:8-methoxypsoralen (dose not given)
Pattern:Acute on chronic liver failure
Severity:5+ (liver failure, transplantation)
Latency:~4 weeks (not clearly stated)
Other medications:None mentioned, methotrexate previously for 15 years


A 54 year old man with well compensated cirrhosis attributed to long term methotrexate therapy of psoriasis developed acute hepatic decompensation after being started on therapy with methoxsalen and ultraviolet light. The latency to onset of symptoms and jaundice was not clearly defined in the report and pretreatment laboratory values were not provided. Drug induced liver injury superimposed upon chronic liver disease or cirrhosis often has a different pattern of clinical presentation, usually defined as "acute-on-chronic". Laboratory values may also be unusual, the only change from baseline abnormalities being a sudden appearance of jaundice followed rapidly by signs and symptoms of hepatitis failure. It remains unclear whether drug induced liver injury is more severe in patients with preexisting liver disease or if the injury is just less well tolerated. The two published instances of hepatic failure due to psoralen hepatotoxicity occurred in patients with known, preexisting cirrhosis.



8-Methoxsalen – Generic, Oxsoralen®


Dermatologic Agents, Psoriasis Agents


Product labeling at DailyMed, National Library of Medicine, NIH


8-Methoxsalen 298-81-7 C12-H8-O4 image 134974950 in the ncbi pubchem database


Stephens RB, Cooper A. Hepatitis from 5-methoxypsoralen occurring in a patient with previous flucloxacillin hepatitis. Australas J Dermatol 1999; 40: 217-9. 10570561. [PubMed: 10570561]
Nam SW, Baek JT, Lee DS, Kang SB, Ahn BM, Chung KW. A case of acute cholestatic hepatitis associated with the seeds of Psoralea corylifolia (Boh-Gol-Zhee). Clin Toxicol (Phila) 2005; 43: 589-91. 16255343. [PubMed: 16255343]
Markin RS, Donovan JP, Shaw BW Jr, Zetterman RK. Fulminant hepatic failure after methotrexate and PUVA therapy for psoriasis. J Clin Gastroenterol 1993; 17: 311-3. 8308218. [PubMed: 8308218]


References updated: 16 January 2020

Abbrevations used: UV, ultraviolet.

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  • Hernández N, Bessone F, Sánchez A, di Pace M, Brahm J, Zapata R, A Chirino R, et al. Profile of idiosyncratic drug induced liver injury in Latin America: an analysis of published reports. Ann Hepatol 2014; 13: 231-9. 24552865. [PubMed: 24552865]
    (Among 176 reports of drug induced liver injury from Latin America published between 1996 and 2012, none were attributed to psoralen).
  • Chalasani N, Bonkovsky HL, Fontana R, Lee W, Stolz A, Talwalkar J, Reddy KR, et al.; United States Drug Induced Liver Injury Network. Features and outcomes of 899 patients with drug-induced liver injury: The DILIN Prospective Study. Gastroenterology 2015; 148: 1340-52.e7. 25754159. [PMC free article: PMC4446235] [PubMed: 25754159]
    (Among 899 cases of drug induced liver injury enrolled in a US prospective study between 2004 and 2013, none were due to psoralen).
  • El-Mofty M, Rasheed H, El-Eishy N, Hegazy RA, Hafez V, Shaker O, El-Samanoudy SI. A clinical and immunological study of phototoxic regimen of ultraviolet A for treatment of alopecia areata: a randomized controlled clinical trial. J Dermatolog Treat 2019; 30: 582-7. 30411986. [PubMed: 30411986]
    (Among 40 patients with alopecia areata treated with topical psoralen and UV A phototherapy vs intralesional injections of corticosteroids, response rates [hair regrowth] were similar in both groups, whereas adverse events were more frequent with psoralen including itching and local erythemia; ALT elevations and hepatotoxicity were not mentioned).
  • Drugs for psoriasis. Med Lett Drugs Ther 2019; 61(1574): 89-96. 31381544. [PubMed: 31381544]
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