Download QA401_2_Valerian

Medicines Q&As
Q&A 401.2
What side effects does valerian have?
Prepared by UK Medicines Information (UKMi) pharmacists for NHS healthcare professionals
Before using this Q&A, read the disclaimer at www.ukmi.nhs.uk/activities/medicinesQAs/default.asp
Date prepared: 4th August 2014
Background
Valerian (Valeriana officinalis) is most commonly taken to help mild anxiety and to aid sleep (1, 2, 3).
This Medicines Q&A discusses the adverse effects that have been observed.
Answer
Limited data on the safety of valerian are available from controlled clinical trials (2) and the safety of
long-term use is unknown (1).
Side effects of valerian that have been reported are generally mild and include gastrointestinal
disturbance (e.g. nausea, abdominal cramps) (1, 3, 4). Headache, insomnia, excitability, increased
muscle relaxation, cardiac disturbance, mental dullness, dizziness, unsteadiness and uneasiness, dry
mouth, decreased sensibility, hypothermia, hallucinations and vivid dreams have also been reported
(1, 4, 5).
Residual daytime drowsiness (a so-called “hangover” effect) may occur and has been associated with
valerian doses of 900mg in clinical trials (4). Since valerian may have sedative effects, patients
affected should not drive or operate heavy machinery whilst taking valerian (1, 3, 4).
Withdrawal symptoms similar to those caused by benzodiazepines have been reported on valerian
discontinuation (6). A 58 year old man with a history of coronary artery disease, hypertension and
congestive heart failure was admitted to hospital for biopsy of a lung nodule. The patient later
developed sinus tachycardia, oliguria and increasing oxygen requirement. Following administration of
naloxone he developed extreme tremulousness and worsening ventilation. Tachycardia and mental
status worsened and the patient was transferred to the intensive care unit. The patient’s family
revealed that he had self-medicated daily for "many years" with a preparation of valerian root extract
(530 mg to 2 g per dose) five times daily to help him "relax and sleep." The patient denied use of
alcohol or other drugs. After it was considered that the cardiac failure might be secondary to a
withdrawal reaction following long-term use of valerian root, midazolam was trialled. This resulted in
an improvement of signs and symptoms (6). However, as the patient had also used other medications
and had undergone surgery, a causal link with valerian was difficult to establish (2, 4, 6). However,
after extended use, it is recommended that patients taper valerian doses slowly (1).
Some multiple-ingredient preparations containing valerian have been associated with hepatotoxicity.
These preparations may have contained additional substances that may have been the cause of the
liver toxicity (1, 7). Hepatotoxicity has also been reported with single ingredient preparations, although
it is possible that these reactions were idiosyncratic (1, 2). In one case report, the patient, who had
been taking valerian for 3 months, had hepatic inflammation on examination, laboratory tests and
imaging, which returned to normal on discontinuation of treatment (8). The long-term effect of valerian
on liver function is not known (1). It is recommended that valerian is avoided in patients with liver
disease or with risk factors for liver disease (8).
Hyponatraemia has been reported in a patient who consumed excess quantities of valerian-containing
drinks. However the authors felt that the hyponatraemia was more likely related to excess water
consumed in the drinks rather than an adverse pharmacological consequence of the valerian (9).
1
Available through NICE Evidence Search at www.evidence.nhs.uk
Medicines Q&As
Summary
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Valerian can cause generally mild side effects such as headache, dizziness and
gastrointestinal disturbance.
Residual daytime drowsiness (a so-called “hangover” effect) may occur. Since valerian may
have sedative effects, patients affected should not drive or operate heavy machinery whilst
taking valerian (1, 3, 4).
Withdrawal reactions after taking high doses of valerian for a long time have been reported.
After extended use, it is recommended that patients taper valerian doses slowly (1).
Some preparations containing valerian have been associated with hepatotoxicity. The longterm effect of valerian on liver function is not known (1). It is recommended that valerian is
avoided in patients with liver disease or with risk factors for liver disease (8).
Limitations
 The knowledge of the safety and efficacy of valerian is limited by the lack of good quality trial
data. The safety of long-term use is unknown (1).
 Evidence for the efficacy of valerian has not been considered in this Medicines Q&A.
 This Medicines Q&A has only considered fully published articles. Conference abstracts have
been excluded.
References
(1) Natural Medicines Comprehensive Database. Valerian. Accessed via
http://naturaldatabase.therapeuticresearch.com on 4th August 2014.
(2) Veitch NC, Smith M, Barnes J, Anderson LA, Phillipson JD. Herbal Medicines. Valerian
monograph. Electronic edition. London: Pharmaceutical Press. Accessed via
www.medicinescomplete.com on 4th August 2014.
(3) European Medicines Agency. Committee on herbal medicinal products (HMPC). Draft
Community Herbal Monograph on Valeriana officinalis L., Radix and Humulus Lupulus L.,
Flos London, 14 May 2009. Doc. Ref. EMEA/HMPC/585558/2007. Accessed via
http://www.ema.europa.eu/docs/en_GB/document_library/Herbal__Community_herbal_monograph/2009/12/WC500017821.pdf on 5th August 2014.
(4) Cramer K, Charrois TL, Vohra S. Valerian: Practical management of adverse effects and
drug interactions. Canadian Pharmacists Journal 2006; 139(3): 39-41.
(5) Klepser TB, Klepser ME. Unsafe and potentially safe herbal therapies. Am J Health Syst
Pharm 1999, 56(2): 125-138.
(6) Garges HP, Varia I, Doraiswamy PM. Cardiac complications and delirium associated with
valerian root withdrawal. JAMA 1998; 280: 1566–1567
(7) MacGregor FB, Abernethy VE, Dahabra S, et al. Hepatotoxicity of herbal remedies. BMJ
1989;299:1156-7.
(8) Cohen DL, Del Toro Y. A case of valerian-associated hepatotoxicity. J Clin Gastroenterol
2008; 42(8):961-2.
(9) Takeshita S, Takeshita J. A case of hyponatremia due to self-treatment of anxiety with a
beverage containing valerian root. Prim Care Companion CNS Disord 2013;
15(1).doi:10.4088/PCC.12101482
Quality Assurance
Prepared by
Alex Weston (based on earlier work by Katie Taylor), Senior Medicines Information Pharmacist,
Wessex Drug and Medicines Information Centre, University Hospital Southampton NHS Foundation
Trust.
Date Prepared
4th August 2014
2
Available through NICE Evidence Search at www.evidence.nhs.uk
Medicines Q&As
Checked by
Kate Pickett, Lead Pharmacist - Formulary and Medicines Q&As, Wessex Drug and Medicines
Information Centre, University Hospital Southampton NHS Foundation Trust.
Date of check
16th September 2014
Search strategy
 Medline search via NICE Evidence Search: exp VALERIAN/
 Embase search via NICE Evidence Search:
1. EMBASE; VALERIAN/ae [ae=Adverse Drug Reaction].
2. EMBASE; exp VALERIAN/
3. EMBASE; exp SIDE EFFECT/
4. EMBASE; 2 AND 3
5. EMBASE; 1 OR 4
 Google : Valerian side effects
 Natural Medicines Database. Accessed via http://naturaldatabase.therapeuticresearch.com
Valerian monograph
 Herbal Medicines. Accessed via www.medicinescomplete.com Valerian monograph
 Previous NHS Direct Q&A N98.2. What are the side effects of valerian?
3
Available through NICE Evidence Search at www.evidence.nhs.uk