Drug
Cevimeline Hydrochloride
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 | Seasonal Allergy | 16 | 8.8 | 8.9 | signal |
| 2 | Infusion Site Pain | 14 | 8.5 | 8.6 | signal |
| 3 | Dry Mouth | 87 | 8.4 | 8.6 | signal |
| 4 | Impaired Gastric Emptying | 13 | 7.9 | 8.0 | signal |
| 5 | Coeliac Disease | 10 | 7.9 | 8.0 | signal |
| 6 | Ocular Discomfort | 11 | 7.9 | 7.9 | signal |
| 7 | Eye Pain | 55 | 7.8 | 7.9 | signal |
| 8 | Candida Infection | 16 | 7.5 | 7.5 | signal |
| 9 | Hereditary Angioedema | 10 | 7.4 | 7.4 | signal |
| 10 | Autoimmune Disorder | 9 | 7.3 | 7.3 | signal |
| 11 | Dry Eye | 44 | 7.1 | 7.2 | signal |
| 12 | Dental Caries | 10 | 7.1 | 7.1 | signal |
| 13 | Foot Fracture | 17 | 7.0 | 7.0 | signal |
| 14 | Sleep Apnoea Syndrome | 17 | 6.9 | 7.0 | signal |
| 15 | Eye Discharge | 9 | 6.9 | 6.9 | signal |
| 16 | Rotator Cuff Syndrome | 11 | 6.6 | 6.7 | signal |
| 17 | Squamous Cell Carcinoma | 8 | 6.6 | 6.6 | signal |
| 18 | Systemic Lupus Erythematosus | 30 | 6.6 | 6.7 | signal |
| 19 | Sciatica | 13 | 6.4 | 6.4 | signal |
| 20 | Foot Deformity | 9 | 6.3 | 6.3 | signal |
| 21 | Respiratory Tract Congestion | 12 | 5.9 | 5.9 | signal |
| 22 | Osteoarthritis | 32 | 5.9 | 5.9 | signal |
| 23 | Hyperlipidaemia | 9 | 5.8 | 5.9 | signal |
| 24 | Localised Infection | 18 | 5.8 | 5.8 | signal |
| 25 | Fibromyalgia | 18 | 5.8 | 5.8 | signal |
| 26 | Tooth Fracture | 8 | 5.7 | 5.7 | signal |
| 27 | Cardiomegaly | 9 | 5.7 | 5.7 | signal |
| 28 | Osteopenia | 11 | 5.6 | 5.6 | signal |
| 29 | Knee Operation | 7 | 5.6 | 5.6 | signal |
| 30 | Eye Infection | 8 | 5.6 | 5.6 | signal |
| 31 | Bone Disorder | 13 | 5.5 | 5.5 | signal |
| 32 | Salivary Hypersecretion | 7 | 5.5 | 5.5 | signal |
| 33 | Bacterial Infection | 13 | 5.5 | 5.5 | signal |
| 34 | Eye Irritation | 39 | 5.5 | 5.5 | signal |
| 35 | Oral Candidiasis | 9 | 5.4 | 5.4 | signal |
| 36 | Dry Throat | 7 | 5.4 | 5.4 | signal |
| 37 | Pulmonary Arterial Hypertension | 10 | 5.3 | 5.4 | signal |
| 38 | Tooth Abscess | 7 | 5.3 | 5.3 | signal |
| 39 | Intervertebral Disc Protrusion | 15 | 5.3 | 5.4 | signal |
| 40 | Bursitis | 8 | 5.2 | 5.2 | signal |
| 41 | Neuralgia | 16 | 5.1 | 5.2 | signal |
| 42 | Nerve Compression | 6 | 5.1 | 5.1 | signal |
| 43 | Product Use Complaint | 10 | 5.0 | 5.0 | signal |
| 44 | Intervertebral Disc Degeneration | 6 | 5.0 | 5.0 | signal |
| 45 | Photophobia | 12 | 5.0 | 5.0 | signal |
| 46 | Deformity | 6 | 5.0 | 5.0 | signal |
| 47 | Sputum Discoloured | 6 | 4.9 | 5.0 | signal |
| 48 | Nerve Injury | 7 | 4.9 | 4.9 | signal |
| 49 | Cystitis | 20 | 4.9 | 4.9 | signal |
| 50 | Sinusitis | 64 | 4.9 | 4.9 | signal |
| 51 | Gastroenteritis | 9 | 4.8 | 4.8 | signal |
| 52 | Hiatus Hernia | 8 | 4.8 | 4.8 | signal |
| 53 | Cholecystectomy | 7 | 4.8 | 4.8 | signal |
| 54 | Ankylosing Spondylitis | 8 | 4.8 | 4.8 | signal |
| 55 | Hospice Care | 6 | 4.7 | 4.8 | signal |
| 56 | Tooth Infection | 8 | 4.7 | 4.7 | signal |
| 57 | Insurance Issue | 9 | 4.7 | 4.7 | signal |
| 58 | Clostridium Difficile Infection | 13 | 4.7 | 4.7 | signal |
| 59 | Oral Discomfort | 8 | 4.5 | 4.5 | signal |
| 60 | Pulmonary Hypertension | 12 | 4.5 | 4.5 | signal |
| 61 | Mouth Ulceration | 12 | 4.4 | 4.5 | signal |
| 62 | Small Intestinal Obstruction | 7 | 4.4 | 4.5 | signal |
| 63 | Lacrimation Increased | 17 | 4.4 | 4.5 | signal |
| 64 | No Therapeutic Response | 7 | 4.4 | 4.4 | signal |
| 65 | Skin Laceration | 6 | 4.3 | 4.3 | signal |
| 66 | Osteomyelitis | 10 | 4.3 | 4.3 | signal |
| 67 | Psoriatic Arthropathy | 22 | 4.3 | 4.3 | signal |
| 68 | Herpes Zoster | 31 | 4.2 | 4.2 | signal |
| 69 | Tooth Disorder | 12 | 4.2 | 4.2 | signal |
| 70 | Hypoaesthesia Oral | 8 | 4.1 | 4.1 | signal |
| 71 | Ear Infection | 14 | 4.1 | 4.1 | signal |
| 72 | Scar | 9 | 4.1 | 4.1 | signal |
| 73 | Musculoskeletal Discomfort | 9 | 4.1 | 4.1 | signal |
| 74 | Bronchitis | 38 | 4.0 | 4.0 | signal |
| 75 | Ligament Sprain | 5 | 3.9 | 4.0 | signal |
| 76 | Ulcer | 8 | 3.9 | 3.9 | signal |
| 77 | Aphonia | 7 | 3.9 | 3.9 | signal |
| 78 | Taste Disorder | 10 | 3.9 | 3.9 | signal |
| 79 | Carpal Tunnel Syndrome | 7 | 3.9 | 3.9 | signal |
| 80 | Emphysema | 5 | 3.8 | 3.9 | signal |
| 81 | Paralysis | 7 | 3.8 | 3.8 | signal |
| 82 | Tendon Rupture | 6 | 3.8 | 3.8 | signal |
| 83 | Product Dose Omission In Error | 13 | 3.8 | 3.8 | signal |
| 84 | Middle Insomnia | 9 | 3.8 | 3.8 | signal |
| 85 | Weight Fluctuation | 5 | 3.7 | 3.7 | signal |
| 86 | Knee Arthroplasty | 10 | 3.7 | 3.7 | signal |
| 87 | Transfusion | 5 | 3.7 | 3.7 | signal |
| 88 | Musculoskeletal Disorder | 9 | 3.7 | 3.7 | signal |
| 89 | Glaucoma | 9 | 3.6 | 3.6 | signal |
| 90 | Oral Herpes | 9 | 3.6 | 3.6 | signal |
| 91 | Body Height Decreased | 5 | 3.6 | 3.6 | signal |
| 92 | Pharyngitis Streptococcal | 5 | 3.6 | 3.6 | signal |
| 93 | Hip Arthroplasty | 7 | 3.6 | 3.6 | signal |
| 94 | Kidney Infection | 9 | 3.6 | 3.6 | signal |
| 95 | Pain In Jaw | 13 | 3.6 | 3.6 | signal |
| 96 | Injection Site Nodule | 5 | 3.5 | 3.5 | signal |
| 97 | Lymphoma | 7 | 3.5 | 3.5 | signal |
| 98 | Upper Limb Fracture | 9 | 3.5 | 3.5 | signal |
| 99 | Basal Cell Carcinoma | 7 | 3.5 | 3.5 | signal |
| 100 | Sinus Congestion | 6 | 3.5 | 3.5 | signal |
| 101 | Scab | 5 | 3.4 | 3.4 | signal |
| 102 | Conjunctivitis | 8 | 3.4 | 3.4 | signal |
| 103 | Mass | 6 | 3.3 | 3.3 | signal |
| 104 | Dysphonia | 25 | 3.3 | 3.4 | signal |
| 105 | Nephropathy | 4 | 3.3 | 3.3 | signal |
| 106 | Eye Inflammation | 4 | 3.3 | 3.3 | signal |
| 107 | Joint Swelling | 51 | 3.3 | 3.3 | signal |
| 108 | Unevaluable Event | 32 | 3.3 | 3.3 | signal |
| 109 | Therapeutic Response Unexpected | 19 | 3.3 | 3.3 | signal |
| 110 | Irritable Bowel Syndrome | 9 | 3.3 | 3.3 | signal |
| 111 | Covid-19 Pneumonia | 5 | 3.3 | 3.3 | signal |
| 112 | Pharyngeal Swelling | 4 | 3.3 | 3.3 | signal |
| 113 | Wrist Fracture | 5 | 3.2 | 3.3 | signal |
| 114 | Spinal Operation | 5 | 3.2 | 3.2 | signal |
| 115 | Melaena | 9 | 3.2 | 3.2 | signal |
| 116 | Fluid Overload | 6 | 3.2 | 3.2 | signal |
| 117 | Hip Fracture | 13 | 3.2 | 3.2 | signal |
| 118 | Product Availability Issue | 9 | 3.1 | 3.1 | signal |
| 119 | Activities Of Daily Living Impaired | 8 | 3.1 | 3.1 | signal |
| 120 | Ovarian Cyst | 4 | 3.1 | 3.1 | no signal |
| 121 | Surgery | 23 | 3.1 | 3.1 | signal |
| 122 | Fluid Retention | 20 | 3.1 | 3.1 | signal |
| 123 | Rheumatoid Arthritis | 44 | 3.0 | 3.1 | signal |
| 124 | Poor Venous Access | 4 | 3.0 | 3.0 | no signal |
| 125 | Toothache | 7 | 3.0 | 3.0 | signal |
| 126 | Tendonitis | 6 | 3.0 | 3.0 | signal |
| 127 | Ocular Hyperaemia | 18 | 3.0 | 3.0 | signal |
| 128 | Fracture | 7 | 2.9 | 2.9 | signal |
| 129 | Injection Site Rash | 11 | 2.8 | 2.8 | signal |
| 130 | Impaired Driving Ability | 4 | 2.7 | 2.7 | no signal |
| 131 | Tardive Dyskinesia | 10 | 2.7 | 2.7 | signal |
| 132 | Subdural Haematoma | 5 | 2.7 | 2.7 | no signal |
| 133 | Arthropathy | 19 | 2.7 | 2.7 | signal |
| 134 | Local Swelling | 6 | 2.6 | 2.6 | signal |
| 135 | Injection Site Urticaria | 8 | 2.6 | 2.6 | signal |
| 136 | Device Failure | 5 | 2.6 | 2.6 | no signal |
| 137 | Increased Tendency To Bruise | 3 | 2.5 | 2.5 | no signal |
| 138 | Personality Change | 3 | 2.5 | 2.5 | no signal |
| 139 | Injection Site Irritation | 4 | 2.5 | 2.5 | no signal |
| 140 | Eructation | 6 | 2.5 | 2.5 | no signal |
| 141 | Laceration | 3 | 2.4 | 2.5 | no signal |
| 142 | Glossodynia | 7 | 2.4 | 2.4 | signal |
| 143 | Hand Deformity | 4 | 2.4 | 2.4 | no signal |
| 144 | Injection Site Bruising | 23 | 2.3 | 2.3 | signal |
| 145 | Gastric Disorder | 10 | 2.2 | 2.2 | signal |
| 146 | Needle Issue | 8 | 2.2 | 2.2 | no signal |
| 147 | Drug Effect Decreased | 15 | 2.1 | 2.1 | signal |
| 148 | Bipolar Disorder | 3 | 2.1 | 2.1 | no signal |
| 149 | Blood Glucose Fluctuation | 3 | 2.1 | 2.1 | no signal |
| 150 | Expired Product Administered | 9 | 2.1 | 2.1 | signal |
| 151 | Injection Site Pruritus | 18 | 2.1 | 2.1 | signal |
| 152 | Pain Of Skin | 7 | 2.0 | 2.0 | no signal |
| 153 | Sexual Dysfunction | 3 | 2.0 | 2.0 | no signal |
| 154 | Injection Site Warmth | 5 | 1.9 | 1.9 | no signal |
| 155 | Multiple Fractures | 4 | 1.9 | 1.9 | no signal |
| 156 | Osteonecrosis Of Jaw | 6 | 1.9 | 1.9 | no signal |
| 157 | Injection Site Extravasation | 3 | 1.9 | 1.9 | no signal |
| 158 | Hair Colour Changes | 3 | 1.9 | 1.9 | no signal |
| 159 | Synovitis | 4 | 1.7 | 1.7 | no signal |
| 160 | Injection Site Erythema | 26 | 1.6 | 1.6 | no signal |
| 161 | Product Preparation Error | 4 | 1.5 | 1.5 | no signal |
| 162 | Psoriasis | 25 | 1.5 | 1.5 | no signal |
| 163 | Product Substitution Issue | 11 | 1.5 | 1.5 | no signal |
| 164 | Wrong Technique In Drug Usage Process | 7 | 1.5 | 1.5 | no signal |
| 165 | Injection Site Reaction | 13 | 1.5 | 1.5 | no signal |
| 166 | Device Defective | 3 | 1.4 | 1.4 | no signal |
| 167 | Injection Site Pain | 55 | 1.4 | 1.4 | no signal |
| 168 | Circumstance Or Information Capable Of Leading To Medication Error | 6 | 1.4 | 1.4 | no signal |
| 169 | Application Site Pruritus | 4 | 1.4 | 1.4 | no signal |
| 170 | Drug Dose Omission | 29 | 1.3 | 1.4 | no signal |
| 171 | Product Adhesion Issue | 6 | 1.3 | 1.3 | no signal |
| 172 | Withdrawal Syndrome | 7 | 1.3 | 1.3 | no signal |
| 173 | Product Administered At Inappropriate Site | 3 | 1.3 | 1.3 | no signal |
| 174 | Injection Site Swelling | 12 | 1.2 | 1.2 | no signal |
| 175 | Application Site Erythema | 4 | 1.2 | 1.2 | no signal |
| 176 | Injection Site Haemorrhage | 11 | 1.1 | 1.1 | no signal |
| 177 | Device Issue | 12 | 1.1 | 1.1 | no signal |
| 178 | Device Malfunction | 9 | 1.0 | 1.0 | no signal |
| 179 | Oesophageal Carcinoma | 4 | 1.0 | 1.0 | no signal |
| 180 | Exposure Via Skin Contact | 3 | 1.0 | 1.0 | no signal |
| 181 | Device Breakage | 5 | 1.0 | 1.0 | no signal |
| 182 | Dermatitis Atopic | 6 | 0.9 | 0.9 | no signal |
| 183 | Incorrect Dose Administered By Device | 3 | 0.9 | 0.9 | no signal |
| 184 | Breast Cancer | 11 | 0.9 | 0.9 | no signal |
| 185 | Device Delivery System Issue | 3 | 0.9 | 0.9 | no signal |
| 186 | Pharmaceutical Product Complaint | 3 | 0.9 | 0.9 | no signal |
| 187 | Menstruation Irregular | 3 | 0.9 | 0.9 | no signal |
| 188 | Injection Site Mass | 4 | 0.8 | 0.8 | no signal |
| 189 | Product Storage Error | 9 | 0.8 | 0.8 | no signal |
| 190 | Pancreatic Carcinoma | 3 | 0.8 | 0.8 | no signal |
| 191 | Device Use Error | 3 | 0.7 | 0.7 | no signal |
| 192 | Incorrect Route Of Drug Administration | 3 | 0.6 | 0.6 | no signal |
| 193 | Device Difficult To Use | 5 | 0.6 | 0.6 | no signal |