Pelargonium sidoides
EPs 7630 / Umckaloabo
Evidence Rating
C Moderate
Confidence Level
High
Traditions
Western
Last Updated
2/9/2026
Summary
Pelargonium sidoides root extract EPs 7630 (Umckaloabo) is one of the best-evidenced herbal medicines in European phytotherapy, with 10+ RCTs involving over 2,000 patients demonstrating efficacy for acute bronchitis. It received full marketing authorization in Germany in 2005 -- not merely traditional use registration -- and has an EMA/HMPC monograph. The extract works through a unique triple mechanism: immunomodulation (cytokine and NK cell activation), antibacterial activity (anti-adhesion, not bactericidal), and cytoprotective/antiviral effects. It is one of the top-selling OTC medicines in German pharmacies. The evidence base is substantially stronger than for most herbal medicines, with robust meta-analyses showing reduced sick days and faster recovery from acute bronchitis.
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Drug Interactions
This herb has significant drug interactions. Do not use if you are taking medications without consulting a healthcare provider first. See detailed interaction information below.
Regulatory Status
| Regulatory Body | Status |
|---|---|
| Commission E (Germany) | âś“ Approved |
| ESCOP (European) | âś“ Approved |
| EMA/HMPC (EU) | âś“ Approved |
Metadata
| Field | Details |
|---|---|
| Common Names (EN) | South African geranium, Umckaloabo, Pelargonium |
| Common Names (DE) | Kapland-Pelargonie, Umckaloabo |
| Botanical Name | Pelargonium sidoides DC. (also Pelargonium reniforme Curt.) |
| Plant Family | Geraniaceae |
| Part Used | Root (radix) |
| Evidence Quality Rating | Good-High — multiple high-quality RCTs with consistent results |
Approved Indications
Commission E (Germany)
- No original Commission E monograph (herb was not assessed during the 1978-1994 period; it entered European use later)
- Full marketing authorization granted by German BfArM (Federal Institute for Drugs and Medical Devices) in 2005 for the proprietary extract EPs 7630, for symptomatic treatment of acute bronchitis
ESCOP
- No ESCOP monograph identified [NEEDS-RESEARCH]
EMA/HMPC
- EU herbal monograph adopted for Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix (Revision 2)
- Indication: Traditional herbal medicinal product for the relief of symptoms of the common cold
- Category: Traditional use registration
- Preparations covered: Liquid extracts obtained with ethanol as solvent
German BfArM (National)
- Full marketing authorization (2005): Symptomatic treatment of acute viral respiratory tract infections (acute bronchitis)
- This is a higher regulatory status than traditional use registration, requiring demonstration of efficacy through clinical trials
Agreement/Disagreement
- Unique position: Pelargonium sidoides holds BOTH a national full marketing authorization in Germany (for acute bronchitis) and an EU-level traditional use monograph (for common cold). The German authorization is more specific and more rigorous.
- The HMPC traditional use indication (common cold) is narrower than the German national authorization (acute bronchitis), reflecting the different evidence standards applied.
Conditions Treated
- Acute bronchitis (primary German-approved indication; strongest evidence)
- Common cold (HMPC traditional use; also supported by RCT evidence)
- Acute rhinosinusitis (emerging evidence from clinical trials)
- Acute tonsillopharyngitis (clinical trial evidence, particularly in children)
- Upper respiratory tract infections (general category)
Mechanism of Action
Active Compounds
| Compound Class | Key Compounds | Activity |
|---|---|---|
| Polyphenols | Catechin, gallocatechin, proanthocyanidins | Antibacterial (anti-adhesion), immunomodulatory |
| Coumarins (7-hydroxycoumarin derivatives) | Umckalin, 6,8-dihydroxy-5,7-dimethoxycoumarin | Immunomodulatory, antibacterial |
| Simple phenols | Gallic acid | Antioxidant |
| Minerals and proteins | Various | Supportive |
Triple Mechanism of Action (Unique Feature)
Pelargonium sidoides EPs 7630 exhibits a multifactorial mechanism that is distinct from most herbal respiratory medicines [Source: Frontiers in Pharmacology, 2024, DOI: 10.3389/fphar.2024.1455870]:
1. Immunomodulation
- Enhancement of interferon-beta (IFN-beta) synthesis
- Activation of natural killer (NK) cell activity
- Stimulation of TNF-alpha and nitric oxide release from macrophages
- Induction of cytokine gene expression (IL-1, IL-6, IL-10, TNF-alpha) in macrophages
- Modulation of secretory IgA production in saliva
- Enhancement of IL-15 in serum and nasal mucosa
- Enhancement of IL-6 in serum
- [Source: Pubmed 11268110, PMC5849386]
2. Antibacterial Activity (Anti-Adhesion)
- Does NOT kill bacteria directly (not bactericidal)
- Prevents bacterial adhesion to epithelial cell surfaces, blocking colonization
- This anti-adhesion mechanism reduces risk of bacterial superinfection following viral URTI
- Particularly relevant for preventing secondary bacterial bronchitis after viral infection
- Active against Group A streptococci and other respiratory pathogens in vitro
3. Cytoprotective and Antiviral Effects
- Stimulation of ciliary beat frequency (enhances mucociliary clearance)
- Induction of interferon release (innate antiviral defense)
- In vitro activity demonstrated against influenza A (H1N1, H3N2), respiratory syncytial virus, parainfluenza virus, and coxsackie virus
- Inhibition of viral hemagglutinin and neuraminidase activity
- [Source: ScienceDirect, Michaelis 2011]
Clinical Evidence Summary
Meta-Analyses
Timmer et al. (2013, updated) — Cochrane-quality systematic review
- Multiple RCTs included; overall positive findings for acute bronchitis
Meta-analysis of BSS (Bronchitis Severity Score) outcomes
- 4 RCTs, n=1,011 patients
- EPs 7630 vs. placebo: Proportion unable to work reduced to 14-19% (EPs 7630) vs 41-55% (placebo)
- Weighted mean difference: 1.73 fewer sick days (EPs 7630)
- [Source: Multidisciplinary Respiratory Medicine, 2014]
Key Individual Trials
| Trial | Population | n | Design | Key Finding |
|---|---|---|---|---|
| Matthys 2003 | Adults, acute bronchitis | 468 | RCT, DB, PC | BSS decrease 5.9 pts (EPs 7630) vs 3.2 pts (placebo); work inability 16% vs 43% |
| Chuchalin 2005 | Adults, acute bronchitis | 124 | RCT, DB, PC | Significant improvement in BSS and general well-being |
| Matthys 2007 | Adults, acute bronchitis | 406 | RCT, DB, PC, dose-finding | 30 mg 3x/day optimal dose; significant BSS improvement |
| Kamin 2010 | Children 1-18 yrs, acute bronchitis | 200 | RCT, DB, PC | Significant improvement in symptoms; well tolerated |
| Riley 2019 | Adults, common cold | 207 | RCT, DB, PC | Significant reduction in cold symptoms; median 2 days faster resolution |
| Dome (pediatric) | Children 6-18 yrs, acute pharyngitis | 143 | RCT, DB, PC | Significant symptom improvement |
Pediatric Evidence
- 8 RCTs involving 1,253 children and adolescents (aged 1-18 years)
- Demonstrated both efficacy and safety in pediatric populations
- [Source: PMC5849386]
Totals
- >10 RCTs with >2,000 patients across adults and children
- Consistent positive findings across independent research groups
- Evidence quality: Among the highest for any herbal medicine
European vs. US/Anglophone Consensus
| Dimension | European (especially German) Consensus | US/Anglophone Consensus |
|---|---|---|
| Regulatory status | Full marketing authorization in Germany (2005); HMPC traditional use monograph | Dietary supplement only; no therapeutic claims |
| Market position | One of the most widely purchased OTC medicines in German pharmacies; mainstream medicine | Niche product; limited consumer awareness |
| Clinical acceptance | Prescribed and recommended by German physicians; included in treatment guidelines for acute bronchitis | Virtually unknown to most US physicians; used primarily by naturopathic practitioners |
| Evidence perception | Considered well-proven; evidence base comparable to conventional OTC medicines | Limited awareness of the evidence base |
| Brand recognition | Umckaloabo is a household name in Germany | Minimal brand recognition |
| Key divergence | This represents perhaps the LARGEST EU-US gap of any herb in this module. A mainstream German OTC medicine is essentially invisible in the US market. |
Safety Profile
Contraindications
- Allergy to Pelargonium species or other Geraniaceae
- Increased bleeding tendency: Due to coumarin content; contraindicated in patients with bleeding disorders or on anticoagulation therapy
- Severe hepatic or renal impairment: Precautionary; limited data
- Children under 6 years: Not recommended without medical supervision (EMA restriction). German national authorization allows use from age 1 year with medical oversight.
Drug Interactions
- Anticoagulants (warfarin, heparin, DOACs): Theoretical potentiation due to coumarin content. Clinically significant interaction not established but precaution warranted.
- Immunosuppressants: Theoretical antagonism (as with all immunomodulators)
- Overall: Drug interaction risk is LOW-MODERATE (primarily coumarin-related)
Side Effects
- Frequency: 1-15% of treated patients
- Gastrointestinal: Nausea, vomiting, diarrhea, heartburn (most common)
- Skin: Rash, itching, urticaria (hypersensitivity)
- All adverse events in clinical trials assessed as non-serious
- In the pivotal Matthys 2003 trial: AEs in 20/233 patients on EPs 7630 vs 16/235 on placebo (comparable rates)
- [Source: PMC9971625 for pediatric safety data]
Pregnancy/Lactation
- Pregnancy: Insufficient data. Not recommended. No teratogenicity studies identified.
- Lactation: Insufficient data. Not recommended.
Clinical Dosage
EPs 7630 (Umckaloabo)
- Adults: 30 drops (approximately 1.5 mL) three times daily, OR 20 mg film-coated tablets three times daily (60 mg/day total)
- Children 6-12 years: 20 drops three times daily
- Children 1-5 years: 10 drops three times daily (under medical supervision)
- Duration: 7-14 days, or until symptom resolution
- Timing: Take between meals (30 minutes before or 2 hours after)
Key Commercial Products
- Umckaloabo (ISO-Arzneimittel/Dr. Willmar Schwabe): Original German product; liquid and tablet forms. The MOST studied product — essentially all clinical evidence pertains to this specific extract.
- Umcka ColdCare (Nature’s Way): US market version
- Kaloba (Dr. Willmar Schwabe): International market brand name for EPs 7630
- Pelargonium sidoides 1X (Zeel/Heel): Homeopathic preparation (different from EPs 7630; not supported by the same evidence base)
Important Note on Extract Specificity
Virtually ALL clinical evidence pertains specifically to the EPs 7630 extract (1:8-10 ethanol extraction ratio). Other Pelargonium sidoides preparations should not be assumed to have equivalent efficacy. This is a case where the specific extract IS the medicine, not the plant in general.
Sources
- Matthys H et al. “Efficacy and safety of an extract of Pelargonium sidoides (EPs 7630) in adults with acute bronchitis.” Phytomedicine. 2003;10(Suppl IV):7-17. (Pubmed 12807337)
- Matthys H et al. “Treatment of acute bronchitis in adults with a pelargonium sidoides preparation (EPs 7630): a randomized, double-blind, placebo-controlled trial.” Phytomedicine. 2007;14(Suppl 6):69-73. (Pubmed 16781588)
- Agbabiaka TB et al. “Pelargonium sidoides for acute bronchitis: a systematic review and meta-analysis.” Phytomedicine. 2008;15(5):378-385. (Pubmed 18222667)
- EMA/HMPC: Community herbal monograph on Pelargonium sidoides DC/Pelargonium reniforme Curt., radix (Revision 2)
- Riley DS et al. “Treatment with EPs 7630 is effective and safe in patients with the common cold.” Mol Cell Pediatr. 2019;6(1):4. (PMC6601435)
- Kolodziej H. “Immunomodulatory principles of Pelargonium sidoides.” Phytother Res. 2000;14:S45-S47. (Pubmed 11268110)
- Conrad A et al. “Extract of Pelargonium sidoides (EPs 7630) improves phagocytosis, oxidative burst, and intracellular killing of human peripheral blood phagocytes.” Phytomedicine. 2007;14(Suppl 6):46-51.
- Kayser O et al. “Pelargonium sidoides extract EPs 7630: a review of its clinical efficacy and safety for treating acute respiratory tract infections in children.” Int J Gen Med. 2018;11:91-98. (PMC5849386)
- German BfArM marketing authorization (2005): Reference in Wiener Medizinische Wochenschrift 2007. (Pubmed 17704982)
Connections
- Andrographis: Both are non-European traditional herbs with strong clinical evidence; P. sidoides succeeded in getting EU recognition while Andrographis did not
- Echinacea: Complementary indications (Echinacea for common cold; Pelargonium for acute bronchitis progressing to lower respiratory tract)
- Elderberry: Complementary timing — elderberry for onset; Pelargonium for established bronchitis