Aliskiren side effects: what 2,261 FDA adverse event reports show
Drug class
Not stated in label
Who reports
2,261 reports · 94% serious · 570 with death outcome · 52% female
Used for
Aliskiren tablets are a renin inhibitor (RI) indicated for the treatment of hypertension in adults and in pediatric patients weighing 50 kg or greater who are at least 6 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
What it is
Aliskiren tablets contain aliskiren hemifumarate, a direct renin inhibitor. Aliskiren hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]-octanamide hemifumarate and its structural formula is:
Boxed warning
FETAL TOXICITY When pregnancy is detected, discontinue aliskiren tablets as soon as possible. ( 5.1, 8.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1, 8.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 107 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Ocular discomfort | 196 | 170.5 148.9–195.1ROR 186.5 · χ² 32,266 / p <1e-300 | 164.7 EB05 146.2 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=196 · 92% clinician | no trial data cached |
| Generalised oedema | 196 | 150.0 131.1–171.7ROR 164.1 · χ² 28,412 / p <1e-300 | 145.5 EB05 129.2 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious PRR 100.2 · 95% clinician | no trial data cached |
| Affect lability | 152 | 148.1 126.9–172.9ROR 158.7 · χ² 21,722 / p <1e-300 | 143.2 EB05 125.1 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 124.4 · ♀ 100% (drug 52%) | no trial data cached |
| Motor dysfunction | 150 | 139.6 119.4–163.1ROR 149.4 · χ² 20,202 / p <1e-300 | 135.2 EB05 118.0 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious PRR 105.9 · ♀ 100% (drug 52%) | no trial data cached |
| Muscle spasticity | 150 | 113.5 97.2–132.7ROR 121.5 · χ² 16,425 / p <1e-300 | 110.6 EB05 96.5 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 98.1 · ♀ 100% (drug 52%) | no trial data cached |
| Head discomfort | 193 | 102.7 89.7–117.7ROR 112.2 · χ² 19,144 / p <1e-300 | 100.6 EB05 89.3 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 110.5 · 94% clinician | no trial data cached |
| Coordination abnormal | 152 | 101.4 86.9–118.4ROR 108.7 · χ² 14,862 / p <1e-300 | 99.1 EB05 86.6 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious PRR 85.2 · ♀ 99% (drug 52%) | no trial data cached |
| Hemiparesis | 156 | 85.7 73.6–99.7ROR 91.9 · χ² 12,857 / p <1e-300 | 84.0 EB05 73.5 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 56.2 · ♀ 97% (drug 52%) | no trial data cached |
| Altered state of consciousness | 192 | 83.4 72.8–95.5ROR 91.0 · χ² 15,418 / p <1e-300 | 82.0 EB05 72.7 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 51.0 · 94% clinician | no trial data cached |
| Photophobia (light sensitivity) | 158 | 79.1 68.0–92.1ROR 85.0 · χ² 12,020 / p <1e-300 | 77.8 EB05 68.1 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 77.8 · 93% clinician | no trial data cached |
| Presyncope (near-fainting) | 192 | 74.2 64.7–85.0ROR 81.0 · χ² 13,691 / p <1e-300 | 73.1 EB05 64.8 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 57.6 · 95% clinician | no trial data cached |
| Haematemesis (vomiting blood) | 201 | 73.9 64.7–84.4ROR 81.0 · χ² 14,285 / p <1e-300 | 72.8 EB05 64.8 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 45.9 · 94% clinician | no trial data cached |
| Diplopia (double vision) | 189 | 68.0 59.3–78.0ROR 74.1 · χ² 12,328 / p <1e-300 | 67.0 EB05 59.4 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 56.5 · 95% clinician | no trial data cached |
| Eating disorder | 149 | 65.1 55.7–76.1ROR 69.6 · χ² 9,283 / p <1e-300 | 64.1 EB05 55.9 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 54.8 · ♀ 100% (drug 52%) | no trial data cached |
| Ascites | 194 | 61.6 53.8–70.5ROR 67.2 · χ² 11,438 / p <1e-300 | 60.8 EB05 54.0 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 37.9 · 94% clinician | no trial data cached |
| Sinus congestion | 88 | 60.7 49.4–74.5ROR 63.1 · χ² 5,077 / p <1e-300 | 59.6 EB05 49.8 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=88 · ♀ 100% (drug 52%) · 99% clinician | no trial data cached |
| Skin haemorrhage | 90 | 58.2 47.5–71.3ROR 60.6 · χ² 4,974 / p <1e-300 | 57.2 EB05 47.9 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=90 · ♀ 99% (drug 52%) · 99% clinician | no trial data cached |
| Abortion induced | 58 | 57.4 44.5–74.1ROR 58.9 · χ² 3,140 / p <1e-300 | 56.1 EB05 45.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 36.4 · ♀ 100% (drug 52%) | no trial data cached |
| Haematuria (blood in urine) | 197 | 53.6 46.9–61.2ROR 58.6 · χ² 10,068 / p <1e-300 | 53.0 EB05 47.1 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 35.9 · 94% clinician | no trial data cached |
| Aphasia (loss of speech) | 155 | 47.7 41.0–55.6ROR 51.1 · χ² 7,015 / p <1e-300 | 47.2 EB05 41.3 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 34.5 · ♀ 99% (drug 52%) | no trial data cached |
| Respiratory tract congestion | 80 | 46.9 37.8–58.2ROR 48.6 · χ² 3,531 / p <1e-300 | 46.2 EB05 38.3 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 66.0 · ♀ 100% (drug 52%) · 99% clinician | no trial data cached |
| Diabetes mellitus inadequate control | 84 | 44.2 35.8–54.5ROR 45.9 · χ² 3,489 / p <1e-300 | 43.6 EB05 36.3 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 31.6 · ♀ 94% (drug 52%) · 92% clinician | no trial data cached |
| Blindness | 192 | 43.9 38.4–50.3ROR 47.9 · χ² 7,991 / p <1e-300 | 43.6 EB05 38.6 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 27.4 · 94% clinician | no trial data cached |
| Cardio-respiratory arrest | 197 | 43.6 38.1–49.9ROR 47.7 · χ² 8,137 / p <1e-300 | 43.2 EB05 38.4 · IC025 +5.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 26.6 · 94% clinician | no trial data cached |
| Sinus disorder | 88 | 41.3 33.7–50.8ROR 43.0 · χ² 3,411 / p <1e-300 | 40.8 EB05 34.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 54.3 · ♀ 100% (drug 52%) · 99% clinician | no trial data cached |
| Dysarthria (slurred speech) | 161 | 39.9 34.3–46.3ROR 42.8 · χ² 6,044 / p <1e-300 | 39.5 EB05 34.7 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 28.7 · ♀ 99% (drug 52%) | no trial data cached |
| Coma | 194 | 37.9 33.1–43.4ROR 41.4 · χ² 6,918 / p <1e-300 | 37.6 EB05 33.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 23.1 · 93% clinician | no trial data cached |
| Tinnitus (ringing in the ears) | 187 | 37.8 33.0–43.4ROR 41.2 · χ² 6,657 / p <1e-300 | 37.6 EB05 33.2 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 35.3 · 94% clinician | no trial data cached |
| Sneezing | 89 | 37.1 30.2–45.4ROR 38.5 · χ² 3,077 / p <1e-300 | 36.6 EB05 30.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 55.8 · ♀ 99% (drug 52%) · 99% clinician | no trial data cached |
| Angina pectoris | 111 | 35.8 29.9–43.0ROR 37.6 · χ² 3,713 / p <1e-300 | 35.5 EB05 30.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 22.6 · 96% clinician | no trial data cached |
| Eye pain | 197 | 33.2 29.0–37.9ROR 36.3 · χ² 6,114 / p <1e-300 | 33.0 EB05 29.3 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 46.3 · 93% clinician | no trial data cached |
| Cystitis | 84 | 24.4 19.8–30.1ROR 25.3 · χ² 1,862 / p <1e-300 | 24.3 EB05 20.2 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 20.3 · ♀ 100% (drug 52%) · 99% clinician | no trial data cached |
| Tachycardia (fast heart rate) | 213 | 22.3 19.6–25.3ROR 24.5 · χ² 4,317 / p <1e-300 | 22.2 EB05 19.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 · 92% clinician | no trial data cached |
| Syncope (fainting) | 233 | 21.6 19.2–24.4ROR 24.0 · χ² 4,576 / p <1e-300 | 21.6 EB05 19.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 14.1 · 93% clinician | no trial data cached |
| Hyperkalaemia (high potassium) | 76 | 20.2 16.2–25.2ROR 20.9 · χ² 1,370 / p 4e-300 | 20.1 EB05 16.6 · IC025 +3.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 12.6 · ♀ 31% (drug 52%) · 97% clinician | no trial data cached |
| Blood pressure increased | 305 | 18.5 16.7–20.5ROR 21.2 · χ² 5,057 / p <1e-300 | 18.4 EB05 16.8 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 16.4 · ♀ 84% (drug 52%) · 94% clinician | no trial data cached |
| Sepsis (blood infection) | 205 | 17.1 15.0–19.4ROR 18.7 · χ² 3,095 / p <1e-300 | 17.0 EB05 15.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 · 95% clinician | no trial data cached |
| Premature baby | 53 | 16.3 12.5–21.3ROR 16.7 · χ² 746 / p 2e-164 | 16.2 EB05 12.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 · ♀ 100% (drug 52%) · 90% clinician | no trial data cached |
| Chills | 202 | 16.0 14.0–18.2ROR 17.5 · χ² 2,833 / p <1e-300 | 15.9 EB05 14.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 · 95% clinician | no trial data cached |
| Hypertensive crisis | 19 | 15.8 10.1–24.7ROR 15.9 · χ² 249 / p 3e-56 | 15.2 EB05 9.9 · IC025 +2.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 9.7 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Asthenia (weakness) | 380 | 9.4 8.6–10.3ROR 11.1 · χ² 2,886 / p <1e-300 | 9.3 EB05 8.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · ♀ 83% (drug 52%) | no trial data cached |
| Fall | 375 | 10.5 9.5–11.5ROR 12.4 · χ² 3,251 / p <1e-300 | 10.4 EB05 9.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · ♀ 90% (drug 52%) · 90% clinician | no trial data cached |
| Dyspnoea (shortness of breath) | 325 | 5.3 4.8–5.9ROR 6.1 · χ² 1,170 / p 8e-257 | 5.3 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 93% clinician | no trial data cached |
| Headache | 320 | 4.7 4.3–5.2ROR 5.4 · χ² 970 / p 4e-213 | 4.7 EB05 4.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · ♀ 76% (drug 52%) · 92% clinician | no trial data cached |
| Malaise (feeling unwell) | 306 | 6.5 5.8–7.2ROR 7.3 · χ² 1,436 / p <1e-300 | 6.4 EB05 5.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · ♀ 78% (drug 52%) · 96% clinician | no trial data cached |
| Blood pressure increased | 305 | 18.5 16.7–20.5ROR 21.2 · χ² 5,057 / p <1e-300 | 18.4 EB05 16.8 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 16.4 · ♀ 84% (drug 52%) · 94% clinician | no trial data cached |
| Vomiting | 295 | 5.8 5.2–6.5ROR 6.6 · χ² 1,204 / p 4e-264 | 5.8 EB05 5.3 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 · ♀ 82% (drug 52%) · 94% clinician | no trial data cached |
| Cough | 294 | 9.8 8.8–10.9ROR 11.1 · χ² 2,330 / p <1e-300 | 9.7 EB05 8.8 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.5 · ♀ 73% (drug 52%) · 93% clinician | no trial data cached |
| Pyrexia (fever) | 279 | 7.5 6.7–8.3ROR 8.4 · χ² 1,584 / p <1e-300 | 7.4 EB05 6.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · ♀ 80% (drug 52%) · 96% clinician | no trial data cached |
| Dizziness | 262 | 4.9 4.4–5.5ROR 5.4 · χ² 824 / p 1e-181 | 4.8 EB05 4.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Syncope (fainting) | 233 | 21.6 19.2–24.4ROR 24.0 · χ² 4,576 / p <1e-300 | 21.6 EB05 19.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 14.1 · 93% clinician | no trial data cached |
| Decreased appetite (loss of appetite) | 220 | 8.8 7.8–10.0ROR 9.7 · χ² 1,532 / p <1e-300 | 8.7 EB05 7.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · 94% clinician | no trial data cached |
| Tachycardia (fast heart rate) | 213 | 22.3 19.6–25.3ROR 24.5 · χ² 4,317 / p <1e-300 | 22.2 EB05 19.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 15.1 · 92% clinician | no trial data cached |
| Arthralgia (joint pain) | 208 | 4.7 4.1–5.3ROR 5.0 · χ² 605 / p 6e-134 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 92% clinician | no trial data cached |
| Somnolence (drowsiness) | 205 | 9.5 8.3–10.8ROR 10.3 · χ² 1,557 / p <1e-300 | 9.4 EB05 8.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 · 92% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Ocular discomfort — n=196, PRR 170.5
- Generalised oedema — n=196, PRR 150.0
- Affect lability — n=152, PRR 148.1
- Motor dysfunction — n=150, PRR 139.6
- Muscle spasticity — n=150, PRR 113.5
- Head discomfort — n=193, PRR 102.7
- Coordination abnormal — n=152, PRR 101.4
- Hemiparesis — n=156, PRR 85.7
- Altered state of consciousness — n=192, PRR 83.4
- Photophobia — n=158, PRR 79.1
✓ A hand-written Bradford Hill causality assessment exists for this drug: Aliskiren ↔ Hyperkalaemia.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Aliskiren?
In FDA FAERS, the most frequently co-reported reaction terms for Aliskiren are asthenia, fall, dyspnoea, headache, malaise, blood pressure increased. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Aliskiren have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: FETAL TOXICITY When pregnancy is detected, discontinue aliskiren tablets as soon as possible. ( 5.1, 8.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1, 8.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning.
Do FAERS signals prove that Aliskiren causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID f3fd2503-25ef-4660-a29a-f62c491e28fb, effective 20221230; matched on
openfda.generic_name.exact:"ALISKIREN") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 147 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.