Drug
Milk Thistle
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Hepatitis C | 18 | 14.2 | 14.3 | signal |
| 2 | Hepatic Steatosis | 20 | 10.3 | 10.4 | signal |
| 3 | Hepatic Cirrhosis | 19 | 9.8 | 9.9 | signal |
| 4 | Immunodeficiency | 14 | 9.1 | 9.2 | signal |
| 5 | Red Blood Cell Count Decreased | 22 | 7.4 | 7.5 | signal |
| 6 | Hepatic Encephalopathy | 7 | 7.2 | 7.2 | signal |
| 7 | Muscle Atrophy | 9 | 6.9 | 6.9 | signal |
| 8 | Musculoskeletal Chest Pain | 11 | 6.8 | 6.9 | signal |
| 9 | Musculoskeletal Pain | 36 | 6.6 | 6.7 | signal |
| 10 | Foot Deformity | 7 | 6.1 | 6.1 | signal |
| 11 | Impaired Driving Ability | 7 | 5.9 | 5.9 | signal |
| 12 | Haemorrhoids | 12 | 5.9 | 5.9 | signal |
| 13 | Tooth Infection | 8 | 5.8 | 5.9 | signal |
| 14 | Influenza Like Illness | 50 | 5.8 | 5.9 | signal |
| 15 | Sluggishness | 6 | 5.7 | 5.7 | signal |
| 16 | Blood Bilirubin Increased | 16 | 5.7 | 5.7 | signal |
| 17 | Thyroid Disorder | 9 | 5.6 | 5.6 | signal |
| 18 | Tendonitis | 9 | 5.6 | 5.6 | signal |
| 19 | Incontinence | 6 | 5.5 | 5.5 | signal |
| 20 | Jaundice | 15 | 5.3 | 5.4 | signal |
| 21 | White Blood Cell Count Decreased | 60 | 5.3 | 5.4 | signal |
| 22 | Restless Legs Syndrome | 10 | 5.3 | 5.3 | signal |
| 23 | Product Substitution Issue | 30 | 5.0 | 5.1 | signal |
| 24 | Abasia | 13 | 5.0 | 5.0 | signal |
| 25 | Emotional Disorder | 16 | 5.0 | 5.0 | signal |
| 26 | Irritability | 31 | 5.0 | 5.0 | signal |
| 27 | Vitreous Floaters | 5 | 4.9 | 4.9 | signal |
| 28 | Splenomegaly | 6 | 4.9 | 4.9 | signal |
| 29 | Skin Disorder | 17 | 4.9 | 4.9 | signal |
| 30 | Insomnia | 136 | 4.9 | 5.2 | signal |
| 31 | Respiratory Tract Congestion | 8 | 4.8 | 4.9 | signal |
| 32 | Tinnitus | 23 | 4.8 | 4.9 | signal |
| 33 | Carpal Tunnel Syndrome | 7 | 4.8 | 4.8 | signal |
| 34 | Joint Stiffness | 13 | 4.8 | 4.8 | signal |
| 35 | Dry Throat | 5 | 4.7 | 4.7 | signal |
| 36 | Temperature Intolerance | 5 | 4.7 | 4.7 | signal |
| 37 | Feeling Jittery | 9 | 4.5 | 4.5 | signal |
| 38 | Musculoskeletal Disorder | 9 | 4.5 | 4.5 | signal |
| 39 | Retching | 10 | 4.5 | 4.5 | signal |
| 40 | Abnormal Dreams | 13 | 4.5 | 4.5 | signal |
| 41 | Hepatic Failure | 14 | 4.5 | 4.5 | signal |
| 42 | Bedridden | 6 | 4.4 | 4.4 | signal |
| 43 | Immune System Disorder | 6 | 4.4 | 4.4 | signal |
| 44 | Localised Infection | 11 | 4.4 | 4.4 | signal |
| 45 | Cold Sweat | 8 | 4.4 | 4.4 | signal |
| 46 | Full Blood Count Decreased | 9 | 4.3 | 4.3 | signal |
| 47 | Sinus Congestion | 6 | 4.3 | 4.3 | signal |
| 48 | Flatulence | 25 | 4.2 | 4.3 | signal |
| 49 | Anger | 15 | 4.2 | 4.3 | signal |
| 50 | Bone Disorder | 8 | 4.2 | 4.2 | signal |
| 51 | Sensory Disturbance | 7 | 4.2 | 4.2 | signal |
| 52 | Middle Insomnia | 8 | 4.1 | 4.1 | signal |
| 53 | Spinal Pain | 5 | 4.1 | 4.1 | signal |
| 54 | Faeces Discoloured | 9 | 4.0 | 4.0 | signal |
| 55 | Affect Lability | 4 | 4.0 | 4.0 | signal |
| 56 | Burning Sensation | 29 | 4.0 | 4.0 | signal |
| 57 | Flushing | 42 | 4.0 | 4.0 | signal |
| 58 | Frequent Bowel Movements | 11 | 3.9 | 3.9 | signal |
| 59 | Fluid Overload | 6 | 3.9 | 3.9 | signal |
| 60 | Tendon Rupture | 5 | 3.9 | 3.9 | signal |
| 61 | Tooth Disorder | 9 | 3.9 | 3.9 | signal |
| 62 | Dysgeusia | 30 | 3.9 | 3.9 | signal |
| 63 | Tooth Extraction | 5 | 3.9 | 3.9 | signal |
| 64 | Hypotonia | 4 | 3.8 | 3.8 | signal |
| 65 | Brain Injury | 4 | 3.8 | 3.8 | signal |
| 66 | Breast Pain | 4 | 3.6 | 3.6 | signal |
| 67 | Impaired Work Ability | 8 | 3.6 | 3.6 | signal |
| 68 | Malignant Melanoma | 5 | 3.6 | 3.6 | signal |
| 69 | Suicidal Ideation | 34 | 3.6 | 3.6 | signal |
| 70 | Hair Texture Abnormal | 5 | 3.6 | 3.6 | signal |
| 71 | Disturbance In Attention | 20 | 3.6 | 3.6 | signal |
| 72 | Gingival Bleeding | 5 | 3.5 | 3.5 | signal |
| 73 | Pruritus Generalised | 8 | 3.5 | 3.5 | signal |
| 74 | Ageusia | 9 | 3.5 | 3.5 | signal |
| 75 | Glossodynia | 8 | 3.4 | 3.5 | signal |
| 76 | Internal Haemorrhage | 4 | 3.4 | 3.4 | signal |
| 77 | Mood Swings | 11 | 3.3 | 3.3 | signal |
| 78 | Apathy | 5 | 3.3 | 3.3 | signal |
| 79 | Rash Generalised | 9 | 3.3 | 3.3 | signal |
| 80 | Knee Arthroplasty | 7 | 3.2 | 3.2 | signal |
| 81 | Blood Count Abnormal | 5 | 3.1 | 3.1 | signal |
| 82 | Increased Appetite | 6 | 3.1 | 3.1 | signal |
| 83 | Eructation | 6 | 3.0 | 3.0 | signal |
| 84 | Laceration | 3 | 3.0 | 3.0 | no signal |
| 85 | Knee Operation | 3 | 3.0 | 3.0 | no signal |
| 86 | Anorexia | 4 | 2.9 | 2.9 | no signal |
| 87 | Inability To Afford Medication | 3 | 2.9 | 2.9 | no signal |
| 88 | Mania | 5 | 2.9 | 2.9 | signal |
| 89 | Palmar-plantar Erythrodysaesthesia Syndrome | 7 | 2.9 | 2.9 | signal |
| 90 | Euphoric Mood | 3 | 2.8 | 2.8 | no signal |
| 91 | Product Odour Abnormal | 3 | 2.8 | 2.8 | no signal |
| 92 | Tooth Loss | 6 | 2.8 | 2.8 | signal |
| 93 | Gastric Disorder | 10 | 2.8 | 2.8 | signal |
| 94 | Local Swelling | 5 | 2.7 | 2.7 | no signal |
| 95 | Glycosylated Haemoglobin Increased | 7 | 2.7 | 2.7 | signal |
| 96 | Drug Effect Decreased | 15 | 2.6 | 2.7 | signal |
| 97 | Dry Skin | 35 | 2.6 | 2.6 | signal |
| 98 | Device Failure | 4 | 2.5 | 2.5 | no signal |
| 99 | Injection Site Bruising | 19 | 2.3 | 2.3 | signal |
| 100 | Injection Site Induration | 3 | 2.2 | 2.2 | no signal |
| 101 | Hand Deformity | 3 | 2.2 | 2.2 | no signal |
| 102 | Incorrect Product Storage | 3 | 2.2 | 2.2 | no signal |
| 103 | Product Taste Abnormal | 3 | 2.1 | 2.1 | no signal |
| 104 | Application Site Rash | 3 | 2.1 | 2.1 | no signal |
| 105 | Prostatic Specific Antigen Increased | 3 | 2.1 | 2.1 | no signal |
| 106 | Withdrawal Syndrome | 9 | 2.1 | 2.1 | no signal |
| 107 | Inappropriate Schedule Of Drug Administration | 14 | 1.9 | 1.9 | no signal |
| 108 | Drug Dose Omission | 32 | 1.8 | 1.8 | no signal |
| 109 | Product Quality Issue | 25 | 1.8 | 1.8 | no signal |
| 110 | Injection Site Pruritus | 11 | 1.6 | 1.6 | no signal |
| 111 | Vaginal Haemorrhage | 7 | 1.6 | 1.6 | no signal |
| 112 | Psoriasis | 21 | 1.5 | 1.6 | no signal |
| 113 | Drug Prescribing Error | 3 | 1.5 | 1.5 | no signal |
| 114 | Intentional Drug Misuse | 3 | 1.4 | 1.4 | no signal |
| 115 | Skin Burning Sensation | 10 | 1.4 | 1.4 | no signal |
| 116 | Injection Site Erythema | 17 | 1.3 | 1.3 | no signal |
| 117 | Wrong Technique In Drug Usage Process | 5 | 1.3 | 1.3 | no signal |
| 118 | Application Site Erythema | 3 | 1.1 | 1.1 | no signal |
| 119 | Device Malfunction | 7 | 1.0 | 1.0 | no signal |
| 120 | Drug Withdrawal Syndrome | 9 | 1.0 | 1.0 | no signal |
| 121 | Product Adhesion Issue | 3 | 0.8 | 0.8 | no signal |