Drug
Ibuprofen Capsule, Liquid-filled
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 | Drug Effective For Unapproved Indication | 252 | 46.6 | 49.7 | signal |
| 2 | Oral Discomfort | 71 | 27.4 | 27.9 | signal |
| 3 | Coeliac Disease | 47 | 25.7 | 26.0 | signal |
| 4 | Poor Quality Product Administered | 41 | 21.6 | 21.8 | signal |
| 5 | Product Complaint | 82 | 17.6 | 18.0 | signal |
| 6 | Drug Effect Less Than Expected | 37 | 14.1 | 14.2 | signal |
| 7 | Gallbladder Disorder | 44 | 13.2 | 13.3 | signal |
| 8 | Cholelithiasis | 79 | 12.9 | 13.2 | signal |
| 9 | Hypoaesthesia Oral | 36 | 12.8 | 12.9 | signal |
| 10 | Cholecystitis | 28 | 12.6 | 12.7 | signal |
| 11 | Product Taste Abnormal | 23 | 9.2 | 9.2 | signal |
| 12 | Product Physical Issue | 34 | 9.1 | 9.2 | signal |
| 13 | Product Use Complaint | 25 | 8.6 | 8.7 | signal |
| 14 | Product Use In Unapproved Indication | 305 | 6.7 | 7.2 | signal |
| 15 | Injection Site Haematoma | 16 | 5.8 | 5.9 | signal |
| 16 | Lip Swelling | 36 | 5.8 | 5.8 | signal |
| 17 | Throat Irritation | 46 | 5.5 | 5.6 | signal |
| 18 | Fear | 27 | 5.3 | 5.4 | signal |
| 19 | Retching | 21 | 5.3 | 5.3 | signal |
| 20 | Deep Vein Thrombosis | 64 | 5.2 | 5.3 | signal |
| 21 | Paraesthesia Oral | 14 | 5.2 | 5.2 | signal |
| 22 | Eye Swelling | 36 | 5.2 | 5.3 | signal |
| 23 | Cholecystectomy | 11 | 5.2 | 5.2 | signal |
| 24 | Glossodynia | 21 | 5.0 | 5.1 | signal |
| 25 | Atelectasis | 9 | 5.0 | 5.0 | signal |
| 26 | Inflammatory Bowel Disease | 9 | 4.9 | 4.9 | signal |
| 27 | Ulcer | 14 | 4.7 | 4.7 | signal |
| 28 | Faeces Discoloured | 19 | 4.7 | 4.7 | signal |
| 29 | Product Odour Abnormal | 9 | 4.6 | 4.7 | signal |
| 30 | Gastric Haemorrhage | 10 | 4.6 | 4.6 | signal |
| 31 | Renal Failure Acute | 36 | 4.5 | 4.5 | signal |
| 32 | Drug Administration Error | 26 | 4.5 | 4.5 | signal |
| 33 | Expired Product Administered | 26 | 4.2 | 4.2 | signal |
| 34 | Choking | 15 | 4.1 | 4.1 | signal |
| 35 | Hiatus Hernia | 10 | 4.1 | 4.1 | signal |
| 36 | Abdominal Pain Upper | 154 | 4.0 | 4.1 | signal |
| 37 | Pulmonary Embolism | 71 | 4.0 | 4.0 | signal |
| 38 | Injury | 52 | 3.9 | 4.0 | signal |
| 39 | Abnormal Dreams | 20 | 3.9 | 3.9 | signal |
| 40 | Drug Effect Decreased | 39 | 3.8 | 3.9 | signal |
| 41 | Pharyngeal Oedema | 11 | 3.8 | 3.8 | signal |
| 42 | Irritable Bowel Syndrome | 15 | 3.8 | 3.8 | signal |
| 43 | Multi-organ Failure | 12 | 3.7 | 3.7 | signal |
| 44 | Swelling Face | 44 | 3.6 | 3.7 | signal |
| 45 | Renal Injury | 20 | 3.6 | 3.6 | signal |
| 46 | Therapeutic Response Unexpected | 29 | 3.4 | 3.5 | signal |
| 47 | Gastrointestinal Pain | 7 | 3.4 | 3.4 | signal |
| 48 | Gastric Ulcer | 12 | 3.4 | 3.4 | signal |
| 49 | Haematemesis | 16 | 3.4 | 3.4 | signal |
| 50 | Feeling Jittery | 12 | 3.4 | 3.4 | signal |
| 51 | Drug Ineffective For Unapproved Indication | 35 | 3.4 | 3.4 | signal |
| 52 | Gastritis | 16 | 3.3 | 3.3 | signal |
| 53 | Dyspepsia | 58 | 3.2 | 3.2 | signal |
| 54 | Pollakiuria | 24 | 3.1 | 3.1 | signal |
| 55 | Swollen Tongue | 18 | 3.1 | 3.1 | signal |
| 56 | Feeling Hot | 35 | 3.1 | 3.1 | signal |
| 57 | Renal Pain | 6 | 3.0 | 3.0 | signal |
| 58 | Abdominal Discomfort | 94 | 3.0 | 3.1 | signal |
| 59 | Dysgeusia | 41 | 2.9 | 3.0 | signal |
| 60 | Pruritus Generalised | 12 | 2.9 | 2.9 | signal |
| 61 | Product Packaging Issue | 5 | 2.9 | 2.9 | signal |
| 62 | Flushing | 55 | 2.9 | 2.9 | signal |
| 63 | Toxic Epidermal Necrolysis | 8 | 2.8 | 2.8 | signal |
| 64 | Rash Macular | 18 | 2.8 | 2.8 | signal |
| 65 | Stress | 36 | 2.7 | 2.7 | signal |
| 66 | Burning Sensation | 35 | 2.7 | 2.7 | signal |
| 67 | Ovarian Cyst | 5 | 2.7 | 2.7 | no signal |
| 68 | Intentional Product Misuse | 43 | 2.7 | 2.7 | signal |
| 69 | Hypothermia | 5 | 2.6 | 2.6 | no signal |
| 70 | Sluggishness | 5 | 2.6 | 2.6 | no signal |
| 71 | Gastric Disorder | 17 | 2.6 | 2.6 | signal |
| 72 | Chromaturia | 11 | 2.6 | 2.6 | signal |
| 73 | Abasia | 12 | 2.6 | 2.6 | signal |
| 74 | Nervousness | 25 | 2.5 | 2.6 | signal |
| 75 | Hemiparesis | 8 | 2.5 | 2.5 | signal |
| 76 | Rotator Cuff Syndrome | 6 | 2.5 | 2.5 | no signal |
| 77 | Hip Arthroplasty | 7 | 2.5 | 2.5 | signal |
| 78 | Melaena | 10 | 2.4 | 2.4 | signal |
| 79 | Blood Triglycerides Increased | 8 | 2.4 | 2.4 | signal |
| 80 | Unevaluable Event | 34 | 2.4 | 2.4 | signal |
| 81 | Stevens-johnson Syndrome | 10 | 2.4 | 2.4 | signal |
| 82 | Eye Haemorrhage | 6 | 2.4 | 2.4 | no signal |
| 83 | Sneezing | 10 | 2.4 | 2.4 | signal |
| 84 | Nerve Compression | 4 | 2.3 | 2.3 | no signal |
| 85 | Urticaria | 72 | 2.3 | 2.3 | signal |
| 86 | Paraesthesia | 68 | 2.3 | 2.3 | signal |
| 87 | Rash Erythematous | 20 | 2.3 | 2.3 | signal |
| 88 | Laceration | 4 | 2.2 | 2.2 | no signal |
| 89 | Pharyngeal Swelling | 4 | 2.2 | 2.2 | no signal |
| 90 | Anhedonia | 11 | 2.2 | 2.2 | signal |
| 91 | Incorrect Dose Administered | 93 | 2.2 | 2.2 | signal |
| 92 | Oral Herpes | 8 | 2.2 | 2.2 | signal |
| 93 | Wrong Technique In Drug Usage Process | 15 | 2.2 | 2.2 | signal |
| 94 | Flatulence | 23 | 2.2 | 2.2 | signal |
| 95 | Paranoia | 7 | 2.2 | 2.2 | no signal |
| 96 | Tendon Rupture | 5 | 2.2 | 2.2 | no signal |
| 97 | Lacrimation Increased | 12 | 2.2 | 2.2 | signal |
| 98 | Influenza Like Illness | 32 | 2.1 | 2.1 | signal |
| 99 | Rash Generalised | 10 | 2.0 | 2.0 | signal |
| 100 | Convulsion | 22 | 2.0 | 2.0 | signal |
| 101 | Agranulocytosis | 7 | 2.0 | 2.0 | no signal |
| 102 | Overdose | 82 | 2.0 | 2.0 | signal |
| 103 | Middle Insomnia | 7 | 2.0 | 2.0 | no signal |
| 104 | Product Quality Issue | 50 | 2.0 | 2.0 | no signal |
| 105 | Body Height Decreased | 4 | 2.0 | 2.0 | no signal |
| 106 | Disturbance In Attention | 20 | 2.0 | 2.0 | no signal |
| 107 | Mental Disorder | 16 | 2.0 | 2.0 | no signal |
| 108 | Gingival Bleeding | 5 | 2.0 | 2.0 | no signal |
| 109 | Accidental Overdose | 13 | 1.9 | 1.9 | no signal |
| 110 | Menorrhagia | 7 | 1.9 | 1.9 | no signal |
| 111 | Intentional Drug Misuse | 7 | 1.8 | 1.8 | no signal |
| 112 | Pelvic Pain | 6 | 1.8 | 1.8 | no signal |
| 113 | Crying | 12 | 1.8 | 1.8 | no signal |
| 114 | Libido Decreased | 4 | 1.7 | 1.7 | no signal |
| 115 | Ocular Hyperaemia | 15 | 1.7 | 1.7 | no signal |
| 116 | Personality Change | 3 | 1.7 | 1.7 | no signal |
| 117 | Deformity | 3 | 1.7 | 1.7 | no signal |
| 118 | Hot Flush | 24 | 1.7 | 1.7 | no signal |
| 119 | Intraocular Pressure Increased | 4 | 1.7 | 1.7 | no signal |
| 120 | Dysmenorrhoea | 4 | 1.6 | 1.6 | no signal |
| 121 | Pharmaceutical Product Complaint | 8 | 1.6 | 1.6 | no signal |
| 122 | Toxic Skin Eruption | 3 | 1.6 | 1.6 | no signal |
| 123 | Emotional Distress | 36 | 1.6 | 1.6 | no signal |
| 124 | Drug Toxicity | 4 | 1.6 | 1.6 | no signal |
| 125 | Menstruation Delayed | 3 | 1.5 | 1.5 | no signal |
| 126 | Prostatic Specific Antigen Increased | 4 | 1.5 | 1.5 | no signal |
| 127 | Anosmia | 4 | 1.5 | 1.5 | no signal |
| 128 | Activities Of Daily Living Impaired | 5 | 1.3 | 1.3 | no signal |
| 129 | Drug Effect Incomplete | 9 | 1.3 | 1.3 | no signal |
| 130 | Circumstance Or Information Capable Of Leading To Medication Error | 8 | 1.3 | 1.3 | no signal |
| 131 | Wrong Technique In Product Usage Process | 48 | 1.3 | 1.3 | no signal |
| 132 | Injection Site Irritation | 3 | 1.3 | 1.3 | no signal |
| 133 | Extra Dose Administered | 9 | 1.2 | 1.2 | no signal |
| 134 | Skin Burning Sensation | 16 | 1.2 | 1.2 | no signal |
| 135 | Inappropriate Schedule Of Drug Administration | 16 | 1.2 | 1.2 | no signal |
| 136 | Injection Site Erythema | 27 | 1.2 | 1.2 | no signal |
| 137 | Multiple Sclerosis Relapse | 15 | 1.2 | 1.2 | no signal |
| 138 | Multiple Sclerosis | 9 | 1.0 | 1.0 | no signal |
| 139 | Amenorrhoea | 3 | 1.0 | 1.0 | no signal |
| 140 | Skin Irritation | 8 | 0.9 | 0.9 | no signal |
| 141 | Drug Exposure During Pregnancy | 6 | 0.9 | 0.9 | no signal |
| 142 | Injection Site Rash | 5 | 0.9 | 0.9 | no signal |
| 143 | Menstruation Irregular | 4 | 0.8 | 0.8 | no signal |
| 144 | Product Storage Error | 13 | 0.8 | 0.8 | no signal |
| 145 | Abortion Spontaneous | 6 | 0.8 | 0.8 | no signal |
| 146 | Tardive Dyskinesia | 4 | 0.8 | 0.8 | no signal |
| 147 | Intentional Overdose | 7 | 0.6 | 0.6 | no signal |
| 148 | Breast Cancer | 10 | 0.6 | 0.6 | no signal |
| 149 | Drug Withdrawal Syndrome | 9 | 0.5 | 0.5 | no signal |