Albizia bark

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15. Safety

Reviewed and decided by Medicine (the AIP comments in this section are Medicine’s). No red flag for acute harm has been found. The main open question is male fertility, which rests on rat data and has never been studied in people.

From human studies. Yadav and colleagues report "no adverse effects/reactions" in 52 patients over 28 days of the confection [11]. Kumar and colleagues do not report on adverse events at all [10]. Two small, short studies without placebo cannot establish safety. They show only that nobody noticed serious harm.

Case reports. No published case report of harm from the bark was found in the PubMed searches in section 13.1.

TGA Database of Adverse Event Notifications (DAEN – medicines). Searched in September 2026 (data to 15/09/2026) by trade name or active ingredient [33]. "Albizzia" and "Shirish" match no medicine. "lebbeck" matches four listed multi-ingredient products containing Albizia lebbeck: Allerg-Eze; Allergy Care AUST L 207638 (with ascorbic acid, Perilla frutescens, quercetin, Rosmarinus officinalis and Scutellaria baicalensis); Metagenics Alergeze AUST L 294587 (with bromelains, Phyllanthus emblica, Piper longum, Piper nigrum and quercetin, among others); and Nyal Allergy & Hayfever Relief (with Scutellaria baicalensis). Together they carry 10 reports, 9 with that product as the single suspected medicine and none with death as an outcome. The 19 reaction terms are: drug ineffective 3; dizziness 2; pruritus 2; one each of diarrhoea, lip swelling, nausea, vomiting, feeling abnormal, inflammation, hepatitis, decreased appetite, headache, loss of consciousness, seizure, somnolence, urinary incontinence, dyspnoea, pharyngeal swelling and rash. The hepatitis report (case 516873, entered 18/01/2021, a woman of 66) names Allergy Care, which also contains Baical skullcap. No single-ingredient Albizia product appears. DAEN entries are unverified reports and establish no cause.

Causality (AIP comment). On the WHO-UMC scale every one of these reports is unassessable for A. lebbeck: each product has four or more actives, and DAEN publishes no dechallenge, rechallenge or timing details. The lip, pharyngeal swelling and dyspnoea terms read as possible hypersensitivity, which any multi-herb product can cause. The hepatitis and seizure reports are single reports, but they are serious terms and belong in the pharmacovigilance record.

TGA safety alerts. A search of the TGA website in September 2026 found no safety alert, product recall or advisory naming Albizia. The Database of Recalls, Product Alerts and Product Corrections was not searched directly (section 20).

Toxicology.

• Acute oral toxicity: an ethanol extract of the stem bark caused no deaths at 5 g/kg in a limit test in four female BALB/c mice, so the LD50 is above 5 g/kg; the same extract had a CC50 above 1000 µg/mL against HeLa cells [19].
• Braun and Cohen cite a median lethal dose of 150 mg/kg for a "methanolic fraction" of an extract (Kasture et al. 2000) [14,31]. Braun and Cohen describe that fraction as coming from an ethanolic extract of the leaves, and their summary gives no route, so the figure does not transfer to oral bark.
• Male fertility. Braun and Cohen report three rat studies by Gupta and colleagues [14,31]. Saponins isolated from the stem bark (albiziasaponins A–C, 50 mg/kg) reduced testis, epididymis, seminal vesicle and ventral prostate weights and sperm concentration and abolished fertility after 60 days (2005). An oral methanolic extract of the bark (100 mg a day for 60 days) reduced reproductive organ weights and sperm motility and density, again with a 100 per cent loss of fertility (2006). A methanolic pod extract arrested spermatogenesis (2004) [31]. The two bark papers are reported here from Braun and Cohen’s account; their full texts have been requested and are not yet read. There are no human data.

Contraindications, cautions and special groups (each with its source and grade):

Herb–drug interactions. None has been observed clinically, and no pharmacokinetic interaction study exists.

MediHerb refers prescribers to its own herb–drug interaction chart for this herb [12]; that chart was not available to us.

Overdose. No reports.

Regulatory position. The Permissible Ingredients Determination attaches no specific requirement or label warning to ALBIZIA LEBBECK (item 436) [6]. The bark is not in the Poisons Standard [7].

Anyone considering Albizia bark, particularly a man planning a family, a woman who is pregnant or breastfeeding, a person with asthma, or anyone taking sedatives or antidepressants, should consult a degree-qualified herbalist with competencies and adequate training in pharmacognosy.