Coldplex [Discontinued] by EuroMedica

POSSIBLY EFFECTIVE

• Common cold. Oral andrographis, taken alone or as part of a specific combination product (Kan Jang, Swedish Herbal Institute) also containing eleuthero, seems to improve symptoms of the common cold. It is unclear if oral andrographis is beneficial for preventing the common cold. Details: Most clinical research shows that taking andrographis alone or as part of a combination herbal supplement improves cold symptoms (2744,2773,2774,5784,10795,12380,12381,98222). Taking a specific combination product (Kan Jang, Swedish Herbal Institute) containing andrographis extract, standardized to andrographolides 4-5.6 mg, and eleuthero three times daily seems to improve symptoms of the common cold when started within 72 hours of symptom onset. Some symptoms can improve after 2 days of treatment, but it typically takes 4-5 days of treatment for maximal symptom relief (2744,2773,2774,5784,10795,12380). This combination also seems to relieve cold symptoms better than echinacea or placebo in children (12381). Other clinical research shows that taking a specific andrographis extract (KalmCold) 200 mg daily for 5 days reduces cold symptoms by approximately two-fold and increases the number of patients who respond to treatment when compared with placebo (31222). Preliminary clinical research shows that taking andrographis (Kan Jang, Swedish Herbal Institute) prophylactically might decrease the risk of developing a cold by about 50% after 2 months of continuous treatment (2772); however, more evidence is needed to confirm these results.
• Osteoarthritis. Oral andrographis extract has been evaluated for the treatment of osteoarthritis, with promising results. Details: In patients with mild to moderate osteoarthritis of the knee, clinical research shows that taking a specific brand of andrographis extract (ParActin, HP Ingredients) 300 mg and 600 mg daily for 12 weeks reduces pain and stiffness by approximately 40% and 46%, respectively, compared with changes of less than 10% with placebo (101116).
• Tonsillopharyngitis. Oral andrographis has been evaluated for the management of fever and sore throat associated with tonsillopharyngitis, with promising results. Details: Some clinical research shows that andrographis 6 grams daily is comparable to acetaminophen for reducing fever and sore throat associated with tonsillopharyngitis after 3 and 7 days of treatment (2748).
• Ulcerative colitis. Oral andrographis extract has been evaluated for the management of ulcerative colitis symptoms, with promising results. Details: Some clinical research shows that taking andrographis extract 1200-1800 mg daily for 8 weeks reduces symptoms of mild to moderate ulcerative colitis, but does not affect remission rates, when compared with placebo (31231). Additional clinical research also shows that taking andrographis extract 1200 mg daily for 8 weeks is as effective as mesalamine for reducing symptoms in patients with ulcerative colitis (31223).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acute bronchitis. Although there has been interest in using oral andrographis for acute bronchitis, there is insufficient reliable information about the clinical effects of andrographis for this purpose.
• Cognitive impairment. Oral andrographis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in a small number of patients with mild cognitive impairment shows that taking a combination product (Adaptra Forte, Europharma USA) containing andrographis extract 400 mg, standardized to andrographolides 40 mg, and ashwagandha extract 150 mg twice daily for 4 weeks modestly improves some measures of concentration and sleep quality when compared with placebo (104822).
• Coronavirus disease 2019 (COVID-19). It is unclear if oral andrographis is beneficial in mild to moderate COVID-19. Details: A moderate-sized clinical study in adults with mild to moderate COVID-19 receiving standard of care conducted in India shows that taking andrographis raw plant part extract 200 mg twice daily for 14 days improves the time to clinical improvement by 2-points on the World Health Organization (WHO) scale to about 4 days compared with about 6 days in the control group (112920). However, the interpretation of this finding is limited by unbalanced groups with sicker patients in the control group. Additionally, a large observational study conducted in Thailand in unvaccinated hospitalized adults with mild COVID-19 suggests that taking andrographis, dosed as andrographolide 60 mg, three times daily for 5 days is not associated with a decrease in the risk of developing pneumonia when compared with standard of care (112919).
• Diabetes. Oral andrographis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial in adults with type 2 diabetes who are taking metformin 1000 mg daily shows that taking a combination product containing andrographis and Syzygium polyanthum leaf extracts, 900 mg daily for 8 weeks, does not improve fasting blood glucose levels, glycated hemoglobin (HbA1c), blood pressure, or blood lipid levels when compared with placebo (101117).
• Familial Mediterranean fever. Oral andrographis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in children 3-15 years of age shows that taking a combination product (ImmunoGuard, Inspired Nutritionals) containing andrographis 16 mg, eleuthero, schisandra, and licorice daily for 1 month reduces the duration, frequency, and severity of attacks of familial Mediterranean fever (12382).
• Hypertriglyceridemia. It is unclear if oral andrographis is beneficial in patients with hypertriglyceridemia. Details: A small clinical study in adults with hypertriglyceridemia shows that taking andrographis, standardized to contain andrographolide 119.64-120.36 mg, by mouth daily for 8 weeks decreases triglycerides by 42 mg/dL, demonstrating comparable effects to gemfibrozil. However, compared to baseline, total cholesterol was increased by 15 mg/dL and low-density lipoprotein (LDL) cholesterol was increased by 21 mg/dL, suggesting that the benefits of lower triglycerides may be offset by elevations in other lipid levels. Taking a lower daily dose of andrographis, standardized to contain andrographolide 71.64-72.36 mg, does not seem to affect lipid levels (91839).
• Impaired glucose tolerance (prediabetes). It is unclear if oral andrographis is beneficial in patients with prediabetes. Details: A small crossover clinical study in adults with prediabetes conducted in Indonesia shows that taking andrographis 550 mg for 14 days increases glucagon-like peptide 1 (GLP-1) levels but does not statistically improve measures of insulin resistance (i.e., fasting insulin, fasting glucose, 2-hour postprandial glucose, 2-hour postprandial insulin, homeostatic model assessment for insulin resistance [HOMA-IR]) when compared with placebo (112918). However, it is unclear whether this improvement is clinically significant. In addition, the frequency of andrographis dosing is unclear.
• Influenza. Oral andrographis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that patients with influenza who take a specific product (Kan Jang, Swedish Herbal Institute) containing andrographis extract, standardized to andrographolides 4-5.6 mg, and eleuthero three times daily for 3-5 days have more rapid symptom relief when compared with patients taking amantadine. Taking this combination product also seems to reduce the risk of post-influenza complications such as rhinosinusitis or bronchitis when compared with amantadine (10441).
• Migraine headache. Oral andrographis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Research has evaluated a combination product (Vivinor, Brain Therapeutics; Partena, FB Health) containing andrographis 100 mg, magnesium 281 mg, riboflavin 5 mg, feverfew 150 mg, and coenzyme Q10 20 mg. A nonblinded, clinical study in patients with episodic migraines shows that taking 1-2 tablets of this product daily for 3 months decreases monthly average migraine days, migraine severity, and the number of days an acute migraine medication is used when compared with baseline. In the third month of treatment, 57% of patients had at least a 50% reduction in average migraine days (107473). The validity of this study is limited by the lack of randomization and placebo-control; additionally, it is unclear if any effects are due to andrographis, the other ingredients, or the combination.
• Multiple sclerosis (MS). It is unclear if oral andrographis is beneficial in patients with MS. Details: A small clinical study in patients with relapsing-remitting MS currently receiving interferon-beta shows that taking andrographis dried extract (Innobioscience Spa) 170 mg, standardized to contain andrographolides 85 mg, twice daily for 12 months decreases fatigue by 44%, but does not affect relapse rate or disability, when compared with placebo (91838). Another small clinical study of patients with primary or secondary, but not active, progressive MS shows that taking andrographolide, a constituent of andrographis, 140 mg twice daily for 24 months slows the progression of disability when compared with placebo (104821).
• Rheumatoid arthritis (RA). It is unclear if oral andrographis is beneficial in patients with RA. Details: Preliminary clinical research shows that taking andrographis extract 90 mg daily for 14 weeks reduces symptoms of RA when compared to baseline, but not when compared with placebo (31220).
• Rhinosinusitis. Although there has been interest in using oral andrographis for rhinosinusitis, there is insufficient reliable information about the clinical effects of andrographis for this purpose.
• Upper respiratory tract infection (URTI). Oral andrographis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small clinical study in adults with uncomplicated URTI shows that a specific combination product (Kan Jang, Swedish Herbal Institute) containing andrographis 195 mg and eleuthero root 11.4 mg per capsule, taken as two capsules three times daily for 5 days, reduces the median number of sick leave days to 2 days, compared with 3 days in the placebo group. It also increases the total number of recovered patients on day 3 to 75%, compared with 55% of those taking placebo (107471). More evidence is needed to rate andrographis for these uses.

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POSSIBLY EFFECTIVE

• Acute Bronchitis. Oral Pelargonium sidoides may be beneficial in adults and children with acute bronchitis when initiated within 48 hours of symptom onset. Details: Several clinical studies and a meta-analysis of 6 small-to-moderate sized clinical studies in adults and children with acute bronchitis show that taking Pelargonium sidoides extract daily, starting within 48 hours of symptom onset, significantly reduces symptoms such as cough intensity and rales after 7 days of treatment when compared with placebo. Additionally, patients report an earlier onset of effect and increased remission of cough when compared with placebo (14258,16647,16649,16651,81557,81565,94580,110015,112124). Another meta-analysis of 6 clinical trials in children aged 6-10 years with acute bronchitis or acute tonsillopharyngitis shows that taking a specific Pelargonium sidoides extract (EPs 7630, Dr. Willmar Schwabe Pharmaceuticals) 20 drops three times daily for 6 days reduces the amount of acetaminophen co-medication required to treat fever when compared with placebo (112126). However, most of the outcomes in these studies were patient-reported. Additionally, it is unclear whether any improvements are clinically significant. Various formulations of Pelargonium sidoides have been investigated. A specific liquid extract of Pelargonium sidoides containing the active ingredient EPs 7630 (Dr. Willmar Schwabe Pharmaceuticals) has been used in most studies (14258,16647,16649,16651,81557,81565,94580,110015,112124). In adults, this specific extract is administered as 30 drops of solution three times daily or in tablet form as 10-30 mg three times daily for 7 days (14258,16649,16651,81557,81565,94580). In children, this specific extract is administered as 10 drops three times daily in patients under 7 years of age or 20 drops three times daily for 7 days in those 7 years of age and older (16651,112124). In children aged 1-5 years of age, this specific extract is also available as a syrup dosed at 2.5 mL 3 times daily, which is equivalent to 10 drops of solution 3 times daily (112123). Some studies used extracts in tablet form; however, these tablet formulations have only been shown to be beneficial in adults, not in children (17417,94580).
• Chronic obstructive pulmonary disease (COPD). Oral Pelargonium sidoides extract (EPs 7630, Dr. Willmar Schwabe Pharmaceuticals) may decrease the frequency of exacerbations, improve symptoms, and reduce the need for antibiotics in patients with COPD; however, it does not seem to reduce the overall risk of exacerbations. Details: One clinical study in patients with moderate to severe COPD shows that taking Pelargonium sidoides (EPs 7630, Dr. Willmar Schwabe Pharmaceuticals) 1.5 mL three times daily in addition to standard treatment for 24 weeks lengthens the average time to COPD exacerbation by 14 days when compared with placebo (97319). The addition of Pelargonium sidoides to standard therapy is also associated with a reduction in total COPD symptoms, antibiotic use, and missed workdays (97319,97325). However, Pelargonium sidoides does not seem to decrease the overall number of COPD exacerbations (97325).
• Common cold. Oral Pelargonium sidoides extract (EPs 7630, Dr. Willmar Schwabe Pharmaceuticals) may reduce the severity and duration of cold symptoms and improve sleep quality in adults with the common cold. Details: Some clinical research in adults with the common cold shows that taking Pelargonium sidoides extract (EPs 7630, Dr. Willmar Schwabe Pharmaceuticals) 1.5 mL three times daily reduces symptoms of the common cold and increases the rate of complete resolution after 10 days of treatment, but not after 5 days of treatment, when compared with placebo (81569,94580). The same product taken at a higher dose of 3 mL three times daily reduces cold symptoms by an additional 10% and has a higher rate of complete resolution after 5 days of treatment. However, this dose is associated with a higher rate of mild to moderate adverse effects (97318). Additionally, a small uncontrolled study shows that this extract is equally effective for reducing common cold symptoms in patients testing positive for human coronavirus infection (not including COVID-19) when compared with other viruses (106648). Meta-analyses have evaluated the effects of this specific extract in adults with the common cold. One meta-analysis of 5 studies, some unpublished, using Pelargonium sidoides (EPs 7630, Dr. Willmar Schwabe Pharmaceuticals)extract 1.5-3 mL three times daily, or tablets 20-40 mg three times daily, for 10 days shows that the mean reduction in a subjective, 40-point, total cold intensity score is 2.3 points at 5 days and 1.2 points at 10 days. Although it is unclear if these decreases are clinically significant, the extract was associated with fewer lost work days, lower acetaminophen consumption, and improved sleep quality when compared with placebo (103604). A separate meta-analysis of five small-to-moderate size studies, some of which were included in the previous meta-analysis, shows that taking Pelargonium sidoides (EPs 7630, Dr. Willmar Schwabe Pharmaceuticals) in the same formulations and doses reduces cough intensity and increases remission of cough at day 5 when compared with placebo (110015). However, all outcomes in this meta-analysis were patient-reported. Lastly, a network meta-analysis comparing 18 herbal medicines often used for the common cold suggests that Pelargonium sidoides is the most beneficial of those studied for the relief of symptoms associated with the common cold (112122). However, it is unclear whether any improvements in cold symptoms are clinically significant.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Asthma. It is unclear if oral Pelargonium sidoides extract is beneficial in children with asthma who have an active viral upper respiratory tract infection. Details: One small clinical study in children with mild asthma and an active viral upper respiratory tract infection shows that taking 5-10 drops of a specific extract of Pelargonium sidoides (EPs 7630, Dr. Willmar Schwabe Pharmaceuticals) three times daily for 5 days reduces the number of children experiencing asthma attacks by 28% when compared with no treatment. It also reduces the number of children experiencing nasal symptoms by 34% and cough by 31% when compared with no treatment (94577).
• Genital herpes. Although there has been interest in using oral Pelargonium sidoides for genital herpes, there is insufficient reliable information about the clinical effects of Pelargonium sidoides for this purpose.
• Herpes labialis (cold sores). Although there has been interest in using oral Pelargonium sidoides for herpes labialis, there is insufficient reliable information about the clinical effects of Pelargonium sidoides for this purpose.
• Rhinosinusitis. Small clinical studies suggest that oral Pelargonium sidoides root extract may improve symptoms in adults with rhinosinusitis. Details: One small clinical study in adults with rhinosinusitis of unclear etiology shows that taking Pelargonium sidoides root extract (EPs 7630, Dr. Willmar Schwabe Pharmaceuticals) 60 drops three times daily for 21 days reduces symptoms of rhinosinusitis and increases the chance of complete resolution after treatment by 57% when compared with placebo (94580). Additionally, a small open-label study in adults with acute bacterial rhinosinusitus shows that taking this same product in tablet form as 60 mg daily for 10 days reduces the total symptom score, as well as subjective measures of nasal obstruction, facial pain and pressure, impaired sense of smell, mucosal edema, and mucopurulent secretions, when compared with taking amoxicillin 1500 mg daily for 10 days (103605). Additionally, a network meta-analysis comparing 18 herbal medicines often used for acute post-viral rhinosinusitis suggests that Pelargonium sidoides is the most beneficial after cineole for the relief of symptoms (112122).
• Tonsillopharyngitis. It is unclear if oral Pelargonium sidoides extract is beneficial in children with tonsillopharyngitis. Details: A small clinical study in children aged 6-10 years with acute tonsillopharyngitis shows that taking a specific Pelargonium sidoides extract (EPs 7630, Dr. Willmar Schwabe Pharmaceuticals) 20 drops three times daily for 7 days reduces symptoms such as sore throat and difficulty swallowing after 4 days of treatment when compared with placebo (14262). A meta-analysis of 6 clinical trials in children aged 6-10 years old with acute tonsillopharyngitis or acute bronchitis, including the study mentioned above, shows that taking a specific Pelargonium sidoides extract (EPs 7630, Dr. Willmar Schwabe Pharmaceuticals) 60-240 drops daily for 6 days reduces the amount of acetaminophen co-medication required to treat fever when compared with placebo (112126).
• Upper respiratory tract infection (URTI). A small clinical study suggests that oral Pelargonium sidoides root extract may improve symptoms in children with URTIs. Details: One clinical trial in children with uncomplicated URTIs shows that taking a specific Pelargonium sidoides root extract (Pelumm) three times daily for 7 days reduces total symptom scores when compared with placebo, with cough frequency and sneezing improving significantly within 3 days of treatment. The extract dose was based on patient age, with children 1-5 years of age taking 10 drops three times daily, children 5-12 years of age taking 20 drops three times daily, and children 13 years of age taking 30 drops three times daily (106646). More evidence is needed to rate Pelargonium sidoides for these uses.

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LIKELY SAFE ...when used orally and appropriately, short-term. Andrographis has been used with apparent safety in doses of up to 6 grams daily for up to 7 days. Andrographis extract has been used with apparent safety at doses of up to 340 mg daily for up to 12 months, 600 mg daily for up to 3 months, or 1200 mg daily for up to 8 weeks (2748,31220,31223,31231,91838,91839,101116). Andrographolide, a constituent of andrographis, has been used with apparent safety at a dose of 280 mg daily for 24 months (104821). A specific combination product containing andrographis extract 178-206 mg and eleuthero (Kan Jang, Swedish Herbal Institute) has been taken three times daily with apparent safety for up to 4-7 days (2744,2748,2773,2774,10441,10795,13016).

CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term. Andrographis, in combination with other herbs, has been used with apparent safety in clinical trials at doses up to 48 mg daily in children 3-15 years of age for up to one month (12381,12382).

PREGNANCY: POSSIBLY UNSAFE
when used orally. Andrographis is thought to have abortifacient effects (12); avoid using.

LACTATION:
Insufficient reliable information available; avoid using.

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LIKELY SAFE ...when used orally or appropriately, short-term. A specific extract of Pelargonium sidoides (EPs 7630, Dr. Willmar Schwabe Pharmaceuticals), in doses of 4.5-9 mL daily when administered as a solution or 90 mg daily when administered as a tablet, has been safely used for up to 24 weeks (14258,16641,16647,16649,16651,17417,81557,81565,94580,97318)(97319,106647). There is insufficient reliable information available about the safety of Pelargonium sidoides when used orally, long-term.

CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term. A specific extract of Pelargonium sidoides (EPs 7630, Dr. Willmar Schwabe Pharmaceuticals) in doses of 3 mL daily has been used with apparent safety in children aged 6-10 years for up to 7 days (14262,16641,16651,17417,94580).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

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ACECLOFENAC Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, andrographis extract might increase the maximum concentration and decrease the area under the curve of aceclofenac. The clinical significance of these changes is unclear.  Details Animal research suggests that andrographis extract taken orally increases the maximum concentration and decreases the area under the curve of aceclofenac (112916).

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, andrographis might increase the risk of bleeding when used with anticoagulant or antiplatelet drugs.  Details Animal and laboratory studies suggest that andrographis has antiplatelet effects (2758,2759).

ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, andrographis might increase the risk of hypotension when used with antihypertensive drugs.  Details Animal research suggests that andrographis has hypotensive effects (2755,2760).

CELECOXIB (Celebrex) Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, andrographis extract might increase the maximum concentration and time to peak concentration of celecoxib. The clinical significance of these changes is unclear.  Details Animal research suggests that andrographis extract taken orally increases the maximum concentration and time to peak concentration of celecoxib but does not appear to impact the area under the curve (112916).

ETORICOXIB (Arcoxia) Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, andrographis might decrease the absorption of etoricoxib, although the clinical significance is unclear.  Details Animal research shows that andrographis extract, or the constituent andrographolide, taken orally with etoricoxib decreases the bioavailability of etoricoxib. However, this reduced bioavailability is not correlated with a reduction in the anti-inflammatory effects of etoricoxib in arthritic mice models (91837). The clinical significance of this interaction is unclear.

GLIPIZIDE (Glucotrol) Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, andrographis extract might increase the maximum concentration and area under the curve of glipizide; however, opposite effects are seen with the constituent, andrographolide. The clinical significance of this interaction is unclear.  Details Animal research suggests that andrographis extract taken orally with glipizide in diabetes-induced rats increases the maximum concentration and area under the curve of glipizide. However, the opposite effect is seen with the constituent, andrographolide, in which the maximum concentration and area under the curve are decreased when taken with glipizide (112917).

IMMUNOSUPPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, andrographis might interfere with the effects of immunosuppressive drugs.  Details Laboratory research suggests that andrographolide has immunostimulant activity (2766).

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, Pelargonium sidoides might increase the risk of bleeding when taken with anticoagulant and antiplatelet drugs.  Details Pelargonium sidoides contains coumarin, which may reduce platelet aggregation (14259). However, in animal models, Pelargonium sidoides extract does not appear to inhibit coagulation or interact with warfarin (16648). This interaction has not been documented in humans.

IMMUNOSUPPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, Pelargonium sidoides might decrease the effectiveness of immunosuppressant therapy.  Details In vitro research suggests that Pelargonium sidoides has immunostimulant effects (14258,14259,16646,16650,16652).

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General ...Orally, andrographis is generally well tolerated. Adverse effects are more likely when doses reach or exceed 5-10 mg/kg of andrographolide content and when treatment duration exceeds 14 days.
Most Common Adverse Effects:
Orally: Abdominal discomfort, altered taste, diarrhea, dizziness, fatigue, headache, nausea and vomiting, pruritus, rash, and urticaria.
Serious Adverse Effects (Rare):
Orally: Severe allergic reactions, including anaphylaxis.

Cardiovascular ...Orally, andrographis has been reported to cause vasculitis, edema, and increased sweating (12380,13016,91841).

Dermatologic ...Orally, andrographis has been frequently reported to cause maculopapular, erythematous rash, pruritus, and urticaria (31223,31222,31233,12380,31231,31220,13016,91838,91841,104821)(107783,112921). Andrographis consumption has also been reported to cause angioedema, exfoliative dermatitis, skin exfoliation, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, bullous eruption, fixed eruption, stomatitis, allergic purpura, flushing, and swelling (91841).
Parenterally, there have been reports of maculopapular rash, urticaria, pruritus, and flushing with the use of andrographolide derivative injections; about one-third of patients experienced skin or subcutaneous reactions (112921).

Gastrointestinal ...Orally, andrographis has been reported to cause nausea, vomiting, diarrhea, dyspepsia, flatulence, altered or metallic taste, and abdominal discomfort (6767,31213,2748,13016,31220,31222,91841,104821,107783,112921). Andrographis intake has also been reported to cause epigastric pain, ulcerative stomatitis, melena, dry mouth, and dry lips (31213,10795,13016,91841).
Parenterally, there have been reports of diarrhea, nausea, vomiting, and abdominal discomfort with the use of andrographolide derivative injections; over 40% of patients experienced gastrointestinal events (112921).

Genitourinary ...Orally, there is one case report of increased urinary frequency associated with andrographis use (91841)

Hematologic ...Orally, there is one case report of epistaxis (nosebleed) associated with andrographis use (31222).

Hepatic ...Orally, there is one case report of hepatitis associated with andrographis use (91841).

Immunologic ...Orally, andrographis has been reported to cause anaphylactic shock in 2 cases with determined causality, and 7 cases with probable causality. Anaphylactic shock developed in 5 minutes to one day after oral intake, and included symptoms such as hypotension, chest pain, urticaria, angioedema, wheezing, and tachycardia (91841). Additionally, andrographis intake has been associated with cases of eosinophilia and fever (91841,107783). High doses of the andrographolide constituent (5-10 mg/kg daily) have been associated with two cases of lymphadenopathy and three cases of lymph node pain (6767).
Parenterally, there have been 97 cases reporting severe or life-threatening anaphylaxis after andrographolide derivative injections, 3 of which resulted in death (112921).

Musculoskeletal ...Orally, andrographis has been associated with case reports of pain, muscle weakness, cramps, and paralysis (31220,91841,107783).

Neurologic/CNS ...Orally, andrographis has been reported to cause headache, fatigue, anorexia, somnolence, insomnia, lethargy, malaise, and drowsiness (2748,5784,6767,10795,12380,13016,31220,31213,31222,91841,107783). Headache and fatigue occurred more often with high doses of the andrographolide constituent (5-10 mg/kg daily) in one clinical trial (6767).

Pulmonary/Respiratory ...Orally, andrographis has been reported to cause dyspnea, coughing, bronchospasm, increased sputum, and nasal congestion (10795,13016,31213,91841,107783).

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General ...Orally, Pelargonium sidoides is generally well tolerated.
Most Common Adverse Effects:
Orally: Allergic skin rash, diarrhea, gastrointestinal upset.

Cardiovascular ...Orally, Pelargonium sidoides has been reported to cause small increases in body temperature and pulse during clinical trials (16649,17417).

Dermatologic ...Orally, Pelargonium sidoides has been associated with allergic skin rash (14262,81557).

Gastrointestinal ...Orally, Pelargonium sidoides has been associated with gastrointestinal upset and diarrhea (14262,81557,97318,97319,106647,112123).

Hematologic ...Orally, Pelargonium sidoides has been associated with epistaxis in one clinical trial (97318).

Hepatic ...Orally, Pelargonium sidoides does not appear to cause hepatotoxicity. Evaluations of hepatotoxicity cases in patients taking Pelargonium sidoides show it was only possibly associated in 4 of the 28 reported cases. In the remaining 24 cases, Pelargonium sidoides was unlikely to be the cause of hepatotoxicity, or was excluded as the cause. Other causes of hepatotoxicity in these cases included infectious disease, pre-existing liver disease, acute pancreatitis, and hepatotoxicity due to conventional medication use (94578,94579).

Immunologic ...Orally, Pelargonium sidoides has been associated with over 34 reports of allergic reactions (81567). Urticaria is the most common reaction but there were also cases of conjunctivitis, rhinitis, and systemic allergic reactions including bronchospasm, dyspnea, tachycardia, and circulatory failure (16651,81567).

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